Ciclopirox Topical Solution

Ciclopirox Topical Solution, 8%

Nail Lacquer
For use on fingernails and toenails and immediately adjacent skin only. Not for use in eyes.

Rx Only

Ciclopirox Topical Solution Description

Ciclopirox Topical Solution, 8% contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.

Each gram of Ciclopirox Topical Solution, 8% contains 80 mg ciclopirox in a solution base consisting of butyl ester of poly [vinylmethylether/maleic acid copolymer] in isopropyl alcohol, ethyl acetate, and isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application.

Ciclopirox Topical Solution, 8% is a clear, colorless to slightly yellowish solution.

The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:

Ciclopirox Topical Solution - Clinical Pharmacology

Microbiology

Mechanism of Action -

The mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. One in vitro study suggested that ciclopirox acts by chelation of polyvalent cations (Fe+3 or Al+3) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. The clinical significance of this observation is not known.

Activity in vitro and ex vivo -

In vitro methodologies employing various broth or solid media with and without additional nutrients have been utilized to determine ciclopirox minimum inhibitory concentration (MIC) values for the dermatophytic molds.(1-2) As a consequence, a broad range of MIC values, 1-20 ug/mL, were obtained for Trichophyton rubrum and Trichophyton mentagrophytes species. Correlation between in vitro MIC results and clinical outcome has yet to be established for ciclopirox.

One ex vivo study was conducted evaluating 8% ciclopirox against new and established Trichophyton rubrum and Trichophyton mentagrophytes infections in ovine hoof material.(3) After 10 days of treatment the growth of T. rubrum and T. mentagrophytes in the established infection model was very minimally affected. Elimination of the molds from hoof material was not achieved in either the new or established infection models.

Susceptibility testing for Trichophyton rubrum species -

In vitro susceptibility testing methods for determining ciclopirox MIC values against the dermatophytic molds, including Trichophyton rubrum species, have not been standardized or validated. Ciclopirox MIC values will vary depending on the susceptibility testing method employed, composition and pH of media and the utilization of nutritional supplements. Breakpoints to determine whether clinical isolates of Trichophyton rubrum are susceptible or resistant to ciclopirox have not been established.

Resistance -

Studies have not been conducted to evaluate drug resistance development in T. rubrum species exposed to 8% Ciclopirox Topical Solution. Studies assessing cross-resistance to ciclopirox and other known antifungal agents have not been performed.

Antifungal Drug Interactions -

No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% Ciclopirox Topical Solution and systemic antifungal agents for onychomycosis is not recommended.

Pharmacokinetics -

As demonstrated in pharmacokinetic studies in animals and man, ciclopirox olamine is rapidly absorbed after oral administration and completely eliminated in all species via feces and urine. Most of the compound is excreted either unchanged or as glucuronide. After oral administration of 10 mg of radiolabeled drug (14C-ciclopirox) to healthy volunteers, approximately 96% of the radioactivity was excreted renally within 12 hours of administration. Ninety-four percent of the renally excreted radioactivity was in the form of glucuronides. Thus, glucuronidation is the main metabolic pathway of this compound.

Systemic absorption of ciclopirox was determined in five patients with dermatophytic onychomycoses, after application of Ciclopirox Topical Solution, 8%, to all 20 digits and adjacent 5 mm of skin once daily for six months. Random serum concentrations and 24 hour urinary excretion of ciclopirox were determined at two weeks and at 1, 2, 4 and 6 months after initiation of treatment and four weeks post-treatment. In this study, ciclopirox serum levels ranged from 12-80 ng/mL. Based on urinary data, mean absorption of ciclopirox from the dosage form was <5% of the applied dose. One month after cessation of treatment, serum and urine levels of ciclopirox were below the limit of detection.

In two vehicle-controlled trials, patients applied Ciclopirox Topical Solution, 8%, to all toenails and affected fingernails. Out of a total of 66 randomly selected patients on active treatment, 24 had detectable serum ciclopirox concentrations at some point during the dosing interval (range 10.0-24.6 ng/mL). It should be noted that 11 of these 24 patients took concomitant medication containing ciclopirox as ciclopirox olamine.

The penetration of the Ciclopirox Topical Solution, 8% was evaluated in an in vitro investigation. Radiolabeled ciclopirox applied once to onychomycotic toenails that were avulsed demonstrated penetration up to a depth of approximately 0.4 mm. As expected, nail plate concentrations decreased as a function of nail depth. The clinical significance of these findings in nail plates is unknown. Nail bed concentrations were not determined.

Indications and Usage for Ciclopirox Topical Solution

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.

• No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% Ciclopirox Topical Solution and systemic antifungal agents for onychomycosis, is not recommended.


• Ciclopirox Topical Solution, 8% should be used only under medical supervision as described above.


• The effectiveness and safety of Ciclopirox Topical Solution, 8% in the following populations has not been studied. The clinical trials with use of Ciclopirox Topical Solution, 8% excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded.


• The safety and efficacy of using Ciclopirox Topical Solution, 8% daily for greater than 48 weeks have not been established.

Clinical Trials Data -

The results of use of Ciclopirox Topical Solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the United States. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with Ciclopirox Topical Solution, 8% in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox Topical Solution, 8%, was applied for 48 weeks. At baseline, patients had 20–65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint "complete cure" (clear nail and negative mycology), and in two studies for the endpoint "almost clear" (≤10% nail involvement and negative mycology) at the end of study. These results are presented below.

At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population
	Study 312		Study 313
	Active	Vehicle	Active	Vehicle
Complete Cure*	6/110 (5.5%)	1/109 (0.9%)	10/118 (8.5%)	0/117 (0%)
Almost Clear**	7/107 (6.5%)	1/108 (0.9%)	14/116 (12%)	1/115 (0.9%)
Negative Mycology Alone***	30/105 (29%)	12/106 (11%)	41/115 (36%)	10/114 (9%)
* Clear nail and negative mycology ** ≤10% nail involvement and negative mycology *** Negative KOH and negative culture

The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below. Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure.

Contraindications

Ciclopirox Topical Solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

Ciclopirox Topical Solution, 8% is not for ophthalmic, oral, or intravaginal use. It is for use on nails and immediately adjacent skin only.

Precautions

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Topical Solution, 8% treatment should be discontinued and appropriate therapy instituted. So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.

Information for Patients

Patients should have detailed instructions regarding the use of Ciclopirox Topical Solution, 8% as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product.

The patient should be told to:

1. Use Ciclopirox Topical Solution, 8% as directed by a health care professional. Avoid contact with the eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% is for external use only.


2. Ciclopirox Topical Solution, 8% should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, Ciclopirox Topical Solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). Contact with the surrounding skin may produce mild, transient irritation (redness).


3. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with use of this medication. Inform a health care professional if they have diabetes or problems with numbness in the toes or fingers for consideration of the appropriate nail management program.


4. Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing).


5. Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% and professional removal of the unattached, infected nail, as frequently as monthly, are considered the full treatment needed to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement).


6. Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.


7. A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail.


8. Do not use the medication for any disorder other than that for which it is prescribed.


9. Do not use nail polish or other nail cosmetic products on the treated nails.


10. Avoid use near heat or open flame, because product is flammable.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

No carcinogenicity study was conducted with Ciclopirox Topical Solution, 8% formulation. A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) in female mice dosed topically twice per week for 50 weeks followed by a six-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application sites. In human systemic tolerability studies following daily application (~340 mg of Ciclopirox Topical Solution, 8%) in subjects with distal subungual onychomycosis, the average maximal serum level of ciclopirox was 31±28 ng/mL after two months of once daily applications. This level was 159 times lower than the lowest toxic dose and 115 times lower than the highest nontoxic dose in rats and dogs fed 7.7 and 23.1 mg ciclopirox (as ciclopirox olamine)/kg/day.

The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with and without metabolic activation (positive); gene mutation assay in the HGPRT-test with V79 Chinese hamster lung fibroblasts (negative); unscheduled DNA synthesis in human A549 cells (negative); and BALB/c3T3 cell transformation assay (negative). In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg.

The following in vitro genotoxicity tests were conducted with Ciclopirox Topical Solution, 8%: Ames Salmonella test (negative); unscheduled DNA synthesis in the rat hepatocytes (negative); cell transformation assay in BALB/c3T3 cell assay (positive). The positive response of the lacquer formulation in the BALB/c3T3 test was attributed to its butyl monoester of poly[methylvinyl ether/maleic acid] resin component (Gantrez® ES-435), which also tested positive in this test. The cell transformation assay may have been confounded because of the film-forming nature of the resin.

Gantrez® ES-435 tested nonmutagenic in both the in vitro mouse lymphoma forward mutation assay with or without activation and unscheduled DNA synthesis assay in rat hepatocytes.

Oral reproduction studies in rats at doses up to 3.85 mg ciclopirox (as ciclopirox olamine)/kg/day [equivalent to approximately 1.4 times the potential exposure at the maximum recommended human topical dose (MRHTD)] did not reveal any specific effects on fertility or other reproductive parameters. MRHTD (mg/m2) is based on the assumption of 100% systemic absorption of 27.12 mg ciclopirox (~340 mg Ciclopirox Topical Solution, 8%) that will cover all the fingernails and toenails including 5 mm proximal and lateral fold area plus onycholysis to a maximal extent of 50%.

Pregnancy:

Teratogenic effects:

Pregnancy Category B -

Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations.

There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Ciclopirox Topical Solution, 8% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers -

It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Ciclopirox Topical Solution, 8% is administered to a nursing woman.

Pediatric Use -

Based on the safety profile in adults, Ciclopirox Topical Solution, 8% is considered safe for use in children 12 years and older. No clinical trials have been conducted in the pediatric population.

Geriatric Use -

Clinical studies of Ciclopirox Topical Solution, 8% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

Adverse Reactions

In the vehicle-controlled clinical trials conducted in the United States, 9% (30/327) of patients treated with Ciclopirox Topical Solution, 8%, and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material.

The incidence of these adverse events, within each body system, was similar between the treatment groups except for skin and appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively. The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with Ciclopirox Topical Solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration.

The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the Ciclopirox Topical Solution, 8%, group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with Ciclopirox Topical Solution, 8%, (3/327) and vehicle (4/328).

A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the Ciclopirox Topical Solution, 8%, 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema. There was no evidence of allergic contact sensitization for either the Ciclopirox Topical Solution, 8% or the vehicle base. In a separate study of the photosensitization potential of Ciclopirox Topical Solution, 8% in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted. In four subjects localized allergic contact reactions were observed. In the vehicle-controlled studies, one patient treated with Ciclopirox Topical Solution, 8% discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).

Use of Ciclopirox Topical Solution, 8% for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle-controlled studies. Three percent (9/281) of subjects treated with Ciclopirox Topical Solution, 8% experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. Four patients discontinued therapy because of TEAEs. Two of the four had events considered to be related to test material: one patient's great toenail "broke away" and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).

Ciclopirox Topical Solution Dosage and Administration

Ciclopirox Topical Solution, 8% should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS).

Nail Care By Health Care Professionals -

Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders.

Nail Care By Patient -

Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after Ciclopirox Topical Solution, 8% is removed with alcohol.

Ciclopirox Topical Solution, 8% should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. Ciclopirox Topical Solution, 8% should be applied evenly over the entire nail plate.

If possible, Ciclopirox Topical Solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

Ciclopirox Topical Solution, 8% should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.

How is Ciclopirox Topical Solution Supplied

Ciclopirox Topical Solution, 8% is available as follows:

6.6 mL glass bottle with a screw cap fitted with a brush (NDC 45802-141-67)

Protect from light (store bottle in the carton after every use).

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

CAUTION: Flammable. Keep away from heat and flame.

MANUFACTURED BY PERRIGO, BRONX, NY 10457

DISTRIBUTED BY PERRIGO, ALLEGAN, MI 49010

References

1. Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic compound with a broad antimicrobial spectrum. Arzneim-Forsch./ Drug Res. 23:670-674.


2. Niewerth et. al., 1998. Antimicrobial susceptibility testing of dermatophytes: Comparison of the agar macrodilution and broth microdilution tests. Chemotherapy. 44:31-35.


3. Yang et. al. 1997. A new simulation model for studying in vitro topical penetration of antifungal drugs into hard keratin. J. Mycol. Med. 7:195-98.

Gantrez® is a registered trademark of GAF Corporation.

Rev. 02/10

Ciclopirox Topical Solution, 8%

Nail Lacquer

Patient Information and Instructions

Patients should have detailed instructions regarding the use of Ciclopirox Topical Solution, 8% as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product. Discuss your treatment plan with your health care professional for regular removal of the unattached, infected nail.

Before using this medication, tell your doctor if you:

● Are pregnant or nursing

● Are an insulin dependent diabetic or have diabetic neuropathy

● Have a history of immunosuppression

● Are immunocompromised (e.g., received an organ transplant, etc.)

● Require medication to control epilepsy

● Use or require topical corticosteroids on a repeated monthly basis

● Use steroid inhalers on a regular basis

Patient Information:

● Use Ciclopirox Topical Solution, 8% as directed by your health care professional.

● Ciclopirox Topical Solution, 8% is for external use only.

● Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided.

● Avoid contact with the eyes and mucous membranes.

● Removal of the unattached, infected nail, as frequently as monthly, by your health care professional is needed with use of this medication to obtain maximal benefit with use of this product. If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material.

● Inform your health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing).

● Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% and professional removal, as frequently as monthly, of the unattached, infected nail are considered the full treatment time to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement). Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.

● A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a clear or almost clear toenail.

● Do not use nail polish or other nail cosmetic products on the treated nails.

● Avoid use near heat or open flame, because product is flammable.

Patient Instructions

 

Patient Instruction #1 Image

1- Before starting treatment, remove any loose nail or nail material using scissors, nail clippers or a nail file. If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material.

Patient Instruction #2 Image

2- Apply Ciclopirox Topical Solution, 8% once daily (preferably at bed time) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, nail lacquer should also be applied to the underside of the nail and to the skin beneath it. Allow lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying the medication, wait eight hours before taking a bath or shower.

3- Apply Ciclopirox Topical Solution, 8% daily over the previous coat.

Patient Instruction #3 Image

4- Once a week, remove the Ciclopirox Topical Solution, 8% with alcohol. Remove as much of the damaged nail as possible using scissors, nail clippers, or a nail file.

5- Repeat process (steps 2 through 4).

Please Note: 1- To prevent screw cap from sticking to the bottle, do not allow solution to get into the bottle threads. 2- To prevent the solution from drying out, bottle should be closed tightly after every use. 3- To protect from light, replace bottle in carton after each use.

Bottle Storage Image

 MANUFACTURED BY PERRIGO

BRONX, NY 10457

DISTRIBUTED BY PERRIGO®

ALLEGAN, MI 49010

Rev. 02/10

3C000 RC J4

Principal Display Panel - Carton

Ciclopirox Topical Solution, 8%

Nail Lacquer

For Dermatologic Use Only

Not for Use in Eyes

Rx Only

Ciclopirox Topical Solution, 8% Carton Image 1

Ciclopirox Topical Solution, 8% Carton Image 2

Principal Display Panel - Label

Ciclopirox Topical Solution, 8%

Nail Lacquer

Rx Only

Ciclopirox Topical Solution, 8% Label

CICLOPIROX  ciclopirox  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-141 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CICLOPIROX (CICLOPIROX) CICLOPIROX 2.9 g  in 6.6 mL

Inactive Ingredients Ingredient Name Strength ETHYL ACETATE   ISOPROPYL ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45802-141-67 1 BOTTLE In 1 CARTON contains a BOTTLE, WITH APPLICATOR 1 6.6 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (45802-141-67)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077623	09/19/2007

Labeler - Perrigo New York Inc (078846912)

Revised: 09/2011Perrigo New York Inc

More Ciclopirox Topical Solution resources

• Ciclopirox Topical Solution Side Effects (in more detail)
• Ciclopirox Topical Solution Use in Pregnancy & Breastfeeding
• Ciclopirox Topical Solution Support Group
• 9 Reviews for Ciclopirox Topical - Add your own review/rating

Compare Ciclopirox Topical Solution with other medications

• Cutaneous Candidiasis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Seborrheic Dermatitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Cardiotek-RX

Pronunciation: MUL-ti-VYE-ta-mins/FOE-lik AS-id/a-MEE-noe AS-ids
Generic Name: Multivitamins with Folic Acid/Amino Acids
Brand Name: Cardiotek-RX

Cardiotek-RX is used for:

Treating or preventing low levels of vitamins, folic acid, and amino acids in the body. It may also be used for other conditions as determined by your doctor.

Cardiotek-RX is a vitamin, folic acid, and amino acid supplement. It works by providing extra vitamins, folic acid, and amino acids to the body when you need more than what you get in your diet.

Do NOT use Cardiotek-RX if:

• you are allergic to any ingredient in Cardiotek-RX


• you have high blood levels of arginine (argininemia)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cardiotek-RX:

Some medical conditions may interact with Cardiotek-RX. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have certain blood disorders (eg, pernicious anemia), kidney or liver problems, or urea cycle disorder


• if you have a history of herpes simplex virus infection

Some MEDICINES MAY INTERACT with Cardiotek-RX. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluorouracil because the risk of its side effects may be increased by Cardiotek-RX


• Hydantoins (eg, phenytoin) or levodopa because their effectiveness may be decreased by Cardiotek-RX

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cardiotek-RX may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cardiotek-RX:

• Use Cardiotek-RX as directed by your doctor. Check the label on the medicine for exact dosing instructions.


• Take Cardiotek-RX by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Cardiotek-RX with a full glass of water (8 oz/240 mL).


• If you miss a dose of Cardiotek-RX, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cardiotek-RX.

Important safety information:

• Do not take large doses of vitamins while you use Cardiotek-RX unless your doctor tells you to.


• Cardiotek-RX has folic acid in it. Before you start any medicine check the label to see if it has folic acid in it too. If it does not or if you are not sure, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: Cardiotek-RX is not indicated for use during pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cardiotek-RX while you are pregnant. It is not known if Cardiotek-RX is found in breast milk. Do not breast-feed while taking Cardiotek-RX.

Possible side effects of Cardiotek-RX:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Cardiotek-RX. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cardiotek-RX side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; nausea; stomach cramps; vomiting.

Proper storage of Cardiotek-RX:

Store Cardiotek-RX at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cardiotek-RX out of the reach of children and away from pets.

General information:

• If you have any questions about Cardiotek-RX, please talk with your doctor, pharmacist, or other health care provider.


• Cardiotek-RX is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cardiotek-RX. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cardiotek-RX resources

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Carimune

Generic Name: immune globulin (Intramuscular route, Intravenous route, Subcutaneous route)

i-MUNE GLOB-ue-lin

Intravenous route(Powder for Solution;Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose . Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Gammagard (R), Gamunex(R)-C, and Previgen(R) do not contain sucrose . Glycine is used as a stabilizer in Gamunex(R)-C .

Subcutaneous route(Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose. Gammagard(R) does not contain sucrose .

Commonly used brand name(s)

In the U.S.

• Baygam


• Carimune


• Gamimune N


• Gammagard


• Gammar-P


• Hizentra


• Iveegam EN


• Octagam


• Panglobulin NF


• Polygam S/D


• Sandoglobulin


• Vivaglobin

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Immune Serum

Uses For Carimune

Immune globulin injection belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

This medicine is to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, immune globulin is used in certain patients with the following medical conditions:

• Chronic parvovirus B19 infection (treatment).


• Dermatomyositis (treatment).


• Guillain-Barré syndrome (treatment).


• Hyperimmunoglobulinemia E syndrome (treatment).


• Infections in low-birth-weight preterm high-risk neonates (prophylaxis and treatment adjunct).


• Lambert-Eaton myasthenic syndrome (treatment).


• Multifocal motor neuropathy (treatment).


• Relapsing-remitting multiple sclerosis (treatment).

Before Using Carimune

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. However, safety and efficacy have not been established in children with CIDP, safety and efficacy have not been established for Flebogamma® and subcutaneous injection of Gamunex®-C in children with PI, and safety and efficacy have not been established for Gammagard Liquid and Vivaglobin® in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia, history of or


• Bleeding problems, history of or


• Hyponatremia (low sodium in the blood) or


• Kidney problems—Use with caution. May make these conditions worse.

• Atherosclerosis (hardening of the arteries), history of or


• Blood clotting problems, history of or


• Diabetes or


• Heart attack or stroke, recent or


• Heart or blood vessel disease or


• Hyperproteinemia (high protein in the blood) or


• Hyperviscosity (thick blood), known or suspected or


• Hypovolemia (low blood volume or major loss of body fluids) or


• IgA (immunoglobulin A) deficiency with antibodies against IgA or


• Paraproteinemia (paraproteins in the blood) or


• Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.

Proper Use of immune globulin

This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Carimune. Please read with care.

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gamunex®-C, Hizentra®, and Vivaglobin® products may sometimes be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. If you or your child are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. Be sure you understand how to use the medicine.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself an injection.

If you or your child are using Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin® at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems.

Allow the Gammagard Liquid, Gamunex®-C, or Vivaglobin® brand to reach room temperature before using it.

To use Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin®:

• First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.


• Wash your hands with soap and water before and after using this medicine.


• If you have been told to wear gloves when preparing your infusion, put the gloves on.


• Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.


• If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.


• Follow your doctor's instructions on how to prepare the correct amount of medicine.


• Choose an injection site on your body (e.g., abdomen or stomach area, thigh, upper arm, upper leg, or hip). Clean the injection site with a fresh alcohol wipe, and let it dry.


• With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.


• Put sterile gauze and tape over the injection site to keep the needle from coming out.


• Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.


• Follow your doctor's instructions on how to use the infusion pump.


• Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.


• It usually takes about 60 minutes for each infusion.


• When all of the medicine has been infused, turn off the pump.


• Take the gauze off and remove the needle and tube from your skin.


• Clean and store the infusion pump.


• Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Hizentra® product at room temperature, away from heat and moisture. Keep from freezing.

Protect the Hizentra® product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C and Vivaglobin® products in the refrigerator, but do not freeze the medicine. Store it in the original container.

You may store the Gammagard Liquid product in the refrigerator for 36 months, or at room temperature for up to 12 months (if within the first 24 months of the date of manufacture). Check the box for the date of manufacture. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

Precautions While Using Carimune

It is very important that your doctor check the progress of you or your child at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).

This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.

Check with your doctor right away if you or your child start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you or your child have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you or your child start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; fever; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. .

Check with your doctor right away if you or your child start having red or dark brown urine; lower back or side pain; a sudden weight gain; a swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Carimune Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Chills


• cough


• difficulty with breathing


• fast, pounding, or irregular heartbeat or pulse


• fever


• noisy breathing


• shortness of breath


• tightness in the chest


• troubled breathing


• unusual tiredness or weakness

Less common

• Bluish coloring of the lips or nailbeds


• burning sensation in the head


• faintness or lightheadedness

Rare

• Difficulty with swallowing


• hives or welts


• itching, especially of the feet or hands


• reddening of the skin, especially around the ears


• swelling of the eyes, face, or inside of the nose

Incidence not known

• Back, leg, or stomach pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloody, black, or tarry stools


• blurred vision


• change in consciousness


• chest pain or discomfort


• cold, clammy, or pale skin


• confusion


• convulsions


• coughing that sometimes produces a pink frothy sputum


• dark urine


• decrease in urine amount


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fever with or without chills


• headache that is severe and occurs suddenly


• increased sweating


• light-colored stools


• loss of appetite


• loss of bladder control


• loss of consciousness


• low blood pressure or pulse


• muscle spasm or jerking of all extremities


• nausea or vomiting


• nosebleeds


• painful or difficult urination


• pains in the chest, groin, or legs, especially calves of the legs


• red skin lesions, often with a purple center


• red, irritated eyes


• shakiness in the legs, arms, hands, or feet


• shivering


• skin blisters


• slurred speech that occurs suddenly


• slow breathing


• sores, ulcers, or white spots in the mouth or on the lips


• sudden loss of consciousness


• sudden loss of coordination


• sudden vision changes


• sudden, severe weakness or numbness in the arm or leg


• sweating


• swelling in the legs and ankles


• tightness in the chest


• trembling or shaking of the hands or feet


• unusual bleeding or bruising


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• dizziness


• headache


• joint pain


• muscle pain


• redness, swelling, itching, or pain at the injection site


• skin rash

Less common

• Hip pain


• leg cramps

Incidence not known

• Feeling of warmth


• redness of the face, neck, arms, and occasionally, upper chest


• stomach pain


• swollen glands


• tiredness


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Carimune side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Neomycin, Polymyxin B, Dexamethasone

Dosage Form: ophthalmic suspension
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension

Sterile

DESCRIPTION

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is:

MW = 392.45

Established name: dexamethasone

Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17, 21-trihydroxy-16-methyl-, (11β, 16α)-.

The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is:

The structural formula for polymyxin B sulfate is:

Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative).

CLINICAL PHARMACOLOGY

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

INDICATIONS AND USAGE

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.

This product does not provide adequate coverage against: Serratia marcesens and streptococci, including Streptococcus pneumoniae.

CONTRAINDICATIONS

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Products containing neomycin sulfate may cause cutaneous sensitization.

PRECAUTIONS

General

The initial prescription and renewal of the medication order beyond 20 mL of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.

Information for Patients

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 μg/mL) tested. However, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.

In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.

There are no adequate or well-controlled studies in pregnant women. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids.

DOSAGE AND ADMINISTRATION

One to two drops in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

FOR TOPICAL OPHTHALMIC USE ONLY.

HOW SUPPLIED

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is supplied as a sterile ophthalmic suspension in a white, low density polyethylene DROP-TAINER* dispenser with a pink, polypropylene cap.

5 mL in 8 mL bottle (NDC 61314-630-06)

STORAGE

Store upright at 8° - 27°C (46° - 80° F).

Rx Only

*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.

Revised: April 2008

Printed in USA

Dist. By:

FALCON Pharmaceuticals, Ltd.

Fort Worth, Texas 76134 USA

Mfd. By:

ALCON LABORATORIES, INC

Fort Worth, Texas 76134 USA

9003573-0408

PRINCIPAL DISPLAY PANEL

NDC 61314-630-06      Rx Only

FALCON

PHARMACEUTICALS®

    

Neomycin and

Polymyxin B

Sulfates and

Dexamethasone

Ophthalmic

Suspension

    

5 mL STERILE

   

AFFILIATE OF

ALCON LABORATORIES, INC.

   

QUALITY RX

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE  neomycin sulfate, polymyxin b sulfate and dexamethasone  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61314-630 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg  in 1 mL POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP'U]  in 1 mL DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   HYPROMELLOSE 2910 (4000 MPA.S)   SODIUM CHLORIDE   POLYSORBATE 20   HYDROCHLORIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61314-630-06 5 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA062341	02/21/1996

Labeler - Falcon Pharmaceuticals, Ltd. (874345820)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 08/2011Falcon Pharmaceuticals, Ltd.

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• Blepharitis
• Conjunctivitis, Bacterial
• Keratitis
• Keratoconjunctivitis
• Uveitis

Myfortic

Generic Name: mycophenolate sodium (Oral route)

mye-koe-FEN-oh-late SOE-dee-um

Oral route(Tablet, Enteric Coated)

Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe mycophenolate sodium, and they should have complete information requisite for the follow-up of the patient. Female contraception must be used due to increased risk of congenital malformations and pregnancy loss .

Commonly used brand name(s)

In the U.S.

• Myfortic

Available Dosage Forms:

• Tablet, Enteric Coated

Therapeutic Class: Immune Suppressant

Uses For Myfortic

Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines to lower the body's natural immunity in patients who receive kidney transplants.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate prevents the white blood cells from rejecting the transplanted organ.

This medicine is available only with your doctor's prescription.

Before Using Myfortic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate in children. However, safety and efficacy have not been established in children younger than 5 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mycophenolate in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving mycophenolate.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Activated Charcoal


• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Azathioprine


• Bacillus of Calmette and Guerin Vaccine, Live


• Cholestyramine


• Colesevelam


• Colestipol


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Influenza Virus Vaccine, Live


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Iron


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Valacyclovir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (e.g., neutropenia) or


• Stomach ulcers or bleeding—Use with caution. May make these conditions worse.

• Infection—May decrease your ability to fight an infection.

• Kelley-Seegmiller syndrome (rare genetic disease) or


• Lesch-Nyhan syndrome (rare genetic disease)—Should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Myfortic

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may lead to rejection of your transplanted organ.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine on an empty stomach, either one hour before or 2 hours after meals, unless your doctor tells you otherwise.

Swallow the delayed-release tablet whole. Do not break, crush, or chew them.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

If you are also using antacids that contain aluminum or magnesium (such as Maalox® or Mylanta®), do not use them at the same time as mycophenolate. Use them 1 hour before or 2 hours after your dose of mycophenolate. If you have questions, talk with your doctor about the best times to use your medicines.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release tablets):
  
  • For kidney transplants:
    
    • Adults—720 milligrams (mg) two times a day.
    
    
    • Older adults—720 milligrams (mg) two times a day.
    
    
    • Teenagers and children 5 years of age and older—Dose is based on body size as determined by the doctor. The dose is 400 milligrams (mg) per square meter [m(2)] two times a day, up to a maximum dose of 720 mg two times a day.
    
    
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Myfortic

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that mycophenolate is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Your birth control pills may not work as well while you are using this medicine. You must use two forms of birth control together for 1 month before starting this medicine, for the entire time that you are being treated, and for 6 weeks after you receive your last dose of this medicine. Use birth control pills together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

Mycophenolate can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

This medicine may increase your risk of developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.

While you are using this medicine, and after you stop, do not have any immunizations (vaccinations) without your doctor's approval. Mycophenolate will lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Do not stop taking this medicine without checking first with your doctor. Doing so may cause rejection of your transplanted organ. Your doctor will decide how long you should take this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Myfortic Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal pain or cramps


• black, tarry stools


• bladder pain


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• bloody or cloudy urine


• blurred vision


• body aches or pain


• bone pain


• burning or stinging of the skin


• burning while urinating


• chest pain


• confusion


• constipation


• convulsions


• cough


• decrease in the amount of urine


• decrease in frequency of urination


• decreased frequency or amount of urine


• decreased urine


• depression


• difficult, burning, or painful urination


• difficulty with breathing


• difficulty in passing urine (dribbling)


• dizziness


• drowsiness


• dry mouth


• ear congestion


• fainting


• fast, pounding, or irregular heartbeat or pulse


• fever or chills


• flushed, dry skin


• frequent urge to urinate


• fruit-like breath odor


• headache


• incoherent speech


• increase in heart rate


• increased blood pressure


• increased hunger


• increased thirst


• increased urination


• joint pain, stiffness, or swelling


• lightheadedness


• loss of appetite


• loss of consciousness


• loss of voice


• lower back, side, or stomach pain


• metallic taste


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle spasms (tetany) or twitching


• muscle weakness


• nasal congestion


• nausea or vomiting


• nervousness


• noisy, rattling breathing


• numbness and tingling around the mouth, fingertips, hands, or feet


• painful blisters on the trunk of the body


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• pale skin


• pinpoint red spots on the skin


• rapid breathing


• rapid weight gain


• red, tender, or oozing skin at incision


• runny nose


• shortness of breath


• sneezing


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sudden decrease in the amount of urine


• sunken eyes


• sweating


• swelling


• swelling of the face, fingers, hands, or lower legs


• swollen glands


• thirst


• tightness in the chest


• tremor


• troubled breathing


• troubled breathing at rest


• troubled breathing with exertion


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• weakness or heaviness of the legs


• weight gain


• weight loss


• wheezing


• wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• anxiety


• back pain


• belching


• bleeding gums


• blemishes on the skin


• bloated


• bruise


• diarrhea


• difficulty with moving


• excess air or gas in the stomach or intestines


• facial hair growth in females


• fractures


• full feeling


• full or round face, neck, or trunk


• heartburn


• increased hair growth, especially on the face


• increased thirst or urination


• indigestion


• irritability


• irritation in the mouth


• itching skin


• loose stools


• loss of sexual desire or ability


• menstrual irregularities


• muscle pains or stiffness


• muscle wasting


• pain


• pain or tenderness around the eyes and cheekbones


• passing gas


• pimples


• redness and swelling of the gums


• shakiness in the legs, arms, hands, or feet


• shortness of breath or troubled breathing


• sleeplessness


• sore mouth or tongue


• stomach discomfort, upset, or pain


• stuffy or runny nose


• trouble sleeping


• unable to sleep


• upper abdominal or stomach pain


• white patches in the mouth or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Myfortic side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Myfortic resources

• Myfortic Side Effects (in more detail)
• Myfortic Use in Pregnancy & Breastfeeding
• Drug Images
• Myfortic Drug Interactions
• Myfortic Support Group
• 3 Reviews for Myfortic - Add your own review/rating

• Myfortic Prescribing Information (FDA)


• Myfortic Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Myfortic Consumer Overview

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• Dermatomyositis
• Rejection Prophylaxis

hydralazine Oral, Injection, Intravenous

hye-DRAL-a-zeen

Commonly used brand name(s)

In the U.S.

• Apresoline

Available Dosage Forms:

• Powder for Solution


• Tablet


• Solution

Therapeutic Class: Peripheral Vasodilator

Uses For hydralazine

Hydralazine belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension). It is also used to control high blood pressure in the mother during pregnancy (pre-eclampsia or eclampsia) or in emergency situations when blood pressure is extremely high (hypertensive crisis).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Hydralazine works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload.

Hydralazine may also be used for other conditions as determined by your doctor.

Hydralazine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not specifically included in product labeling, hydralazine is used in certain patients with the following medical condition:

• Congestive heart failure

Before Using hydralazine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For hydralazine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hydralazine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of hydralazine in children with use in other age groups, hydralazine is not expected to cause different side effects or problems in children than it does in adults. However, the oral solution contains aspartame, which is converted to phenylalanine in the body. Children with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydralazine in the elderly with use in other age groups, hydralazine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking hydralazine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydralazine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Metoprolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydralazine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use hydralazine, or give you special instructions about the use of food, alcohol, or tobacco.

• Enteral Nutrition


• food

Other Medical Problems

The presence of other medical problems may affect the use of hydralazine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease or


• Stroke—Lowering blood pressure may make problems resulting from these conditions worse

• Kidney disease—Effects may be increased because of slower removal of hydralazine from the body


• Phenylketonuria—The oral solution of hydralazine contains aspartame, which is converted to phenylalanine in the body. Patients with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage

Proper Use of hydralazine

For patients taking hydralazine for high blood pressure:

• In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.


• Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.


• Remember that hydralazine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

For patients taking the oral solution form of hydralazine :

• The oral solution may be mixed with fruit juice or applesauce. If mixed with fruit juice or applesauce, take immediately after mixing. Be sure to take all of the mixture to get the full dose of the medicine.

hydralazine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same times each day.

Dosing

The dose of hydralazine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of hydralazine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (oral solution and tablets):
  
  • For high blood pressure:
    
    • Adults—40 to 200 milligrams (mg) per day divided into two or four doses
    
    
    • Children—Dose is based on body weight. The usual dose is 0.75 to 7.5 mg per kilogram (kg) (0.34 to 3.4 mg per pound) of body weight a day. This is divided into two or four doses.
    
    
  
  


• For injection dosage form:
  
  • For high blood pressure:
    
    • Adults—5 to 40 mg injected into a muscle or a vein. Your doctor may repeat the dose as needed.
    
    
    • Children—Dose is based on body weight. The usual dose is 1.7 to 3.5 mg per kg (0.77 to 1.6 mg per pound) of body weight a day. This is divided into four to six doses and injected into a muscle or a vein.
    
    
  
  
  • For high blood pressure during pregnancy:
    
    • Adults—5 mg injected into a vein every fifteen to twenty minutes.
    
    
  
  

Missed Dose

If you miss a dose of hydralazine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the bottle closed when you are not using it. Keep it in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using hydralazine

It is important that your doctor check your progress at regular visits to make sure that hydralazine is working properly.

Hydralazine may cause some people to have headaches or to feel dizzy. Make sure you know how you react to hydralazine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

The oral solution contains 1.4 milligrams (mg) of phenylalanine per teaspoonful (5 mL). Patients with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage.

For patients taking hydralazine for high blood pressure :

• Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

hydralazine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Blisters on skin


• chest pain


• general feeling of discomfort or illness or weakness


• joint pain


• muscle pain


• numbness, tingling, pain, or weakness in hands or feet


• skin rash or itching


• sore throat and fever


• swelling of feet or lower legs


• swelling of lymph glands

Rare

• Fever


• general feeling of discomfort or illness


• sore throat


• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• fast heartbeat


• headache


• loss of appetite


• nausea or vomiting


• pounding heartbeat

Less common

• Constipation


• dizziness or lightheadedness


• redness or flushing of face


• shortness of breath


• stuffy nose


• watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: hydralazine Oral, Injection, Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More hydralazine Oral, Injection, Intravenous resources

• Hydralazine Oral, Injection, Intravenous Side Effects (in more detail)
• Hydralazine Oral, Injection, Intravenous Use in Pregnancy & Breastfeeding
• Drug Images
• Hydralazine Oral, Injection, Intravenous Drug Interactions
• Hydralazine Oral, Injection, Intravenous Support Group
• 1 Review for Hydralazine Oral, Injection, Intravenous - Add your own review/rating

Compare hydralazine Oral, Injection, Intravenous with other medications

• Heart Failure
• High Blood Pressure
• Hypertensive Emergency