AddressSIGA Technologies, Inc., 420 Lexington Avenue Suite 408, New York, NY 10170 Contact DetailsPhone: (212) 672-9100Website: http://www.siga.com Careers: http://www.siga.com/index.php?ID=7 |
Thursday, 13 September 2012
SIGA Technologies, Inc.
Wednesday, 12 September 2012
Maxitrol Ointment
1. Name Of The Medicinal Product
MAXITROL ointment
2. Qualitative And Quantitative Composition
1 gram ointment contains 1 mg dexamethasone, 6000 IU polymyxin B sulphate, and 3500 IU neomycin sulphate (as base).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Eye ointment
White to very pale yellow homogeneous translucent ointment
4. Clinical Particulars
4.1 Therapeutic Indications
MAXITROL eye ointment is indicated for the short-term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.
4.2 Posology And Method Of Administration
Children and Adults (including the Elderly)
Apply a small amount into the conjunctival sac(s) up to three to four times daily or, may be used adjunctively with drops at bedtime.
4.3 Contraindications
• Hypersensitivity to the active substances or to any component of the preparation.
• Epithelial herpes simplex keratitis.
• Vaccinia, varicella, or other viral infection of cornea and conjunctiva (except herpes zoster keratitis).
• Fungal diseases of ocular structures.
• Mycobacterial ocular infections.
4.4 Special Warnings And Precautions For Use
• For topical ophthalmic use only. Not for injection or ingestion.
• As with all antibacterial preparation prolonged use may lead to overgrowth of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.
• Sensitivity to topically applied aminoglycosides may occur in some patients. Cross-sensitivity to other aminoglycosides may also occur. If signs of serious reactions or hypersensitivity occur, discontinue use of MAXITROL eye ointment.
• Patients using ophthalmic preparations containing neomycin sulphate should be advised to consult a physician if ocular pain, redness, swelling, or irritation worsens or persists.
• Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic neomycin or when applied topically to open wounds or damaged skin. Nephrotoxic and neurotoxic reactions have also occurred with systemic polymyxin B. Although these effects have not been reported following topical ocular use of this product, caution is advised when used concomitantly with systemic aminoglycoside or polymyxin B therapy.
• Prolonged use of ophthalmic use may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently.
• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
• Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral, or fungal infections and mask the clinical signs of infection, preventing recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to substances in the product. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs and corticosteroid therapy should be discontinued if fungal infection occurs.
• To avoid the risk of enhancement of herpetic corneal disease, frequent slip lamp examination is essential.
• Contact lens wear is not recommended during treatment of an ocular infection. Therefore patients should be advised not to wear contact lenses during treatment with MAXITROL eye ointment.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interaction studies have been performed.
Concomitant and/or sequential use of an aminoglycoside (neomycin) and other systemic, oral, or topical drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, whenever possible.
If more than one ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
4.6 Pregnancy And Lactation
Pregnancy
There are no or limited amount of data from the use of MAXITROL eye ointment in pregnant women. Studies in animals with some active components of MAXITROL eye ointment have shown reproductive toxicity (see section 5.3).
MAXITROL eye ointment is not recommended during pregnancy.
Lactation
It is unknown whether topical ophthalmic dexamethasone, neomycin or polymyxin B are excreted in human milk. Because systemic corticosteroids and aminoglycosides may be distributed into milk, a risk to the suckling child cannot be excluded.
A decision on whether to discontinue breast-feeding or to discontinue therapy with MAXITROL eye ointment taking into account the benefit of breast-feeding for the child and the benefit of the product to the woman.
4.7 Effects On Ability To Drive And Use Machines
MAXITROL eye ointment has no or negligible influence on the ability to drive and use machines. As with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.
4.8 Undesirable Effects
Tabulated summary of adverse reactions
The following adverse effects are classified according to the following convention: very common (
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Description of selected adverse event
Due to the steroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (See Section Special warnings and precautions for use).
Topical ophthalmic steroid use may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects. Also it may lead to posterior subcapsular cataract formation (See Section Special warnings and precautions for use).
Sensitivity to topically administered aminoglycosides may occur in some patients (See Section Special warnings and precautions for use). Systemic side effects may occur with extensive use.
4.9 Overdose
No case of overdose has been reported.
Signs and symptoms of an overdosage of MAXITROL eye ointment may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, increased lacrimation, oedema and lid itching).
A topical ophthalmic overdose of MAXITROL eye ointment may be flushed from the eye(s) with lukewarm water.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: ophthalmologicals; anti-infectives
ATC code: S01CA01
Mechanism of Action
MAXITROL eye ointment has a dual effect: suppression of inflammation symptoms by the corticosteroidal component dexamethasone, and an anti-infective effect due to the presence of two antibiotics, polymyxin B and neomycin.
Dexamethasone is a synthetic glucorticoid with potent anti-inflammatory activity. Polymyxin B is a cyclic lipopeptide that penetrates the cell wall of gram-negative bacilli to destabilize the cytoplasmic membrane. It is generally less active against gram-positive bacteria. Neomycin is an aminoglycoside antibiotic that primarily exerts its effect on bacterial cells by inhibiting polypeptide assembly and synthesis on the ribosome.
Mechanism of Resistance
Resistance of bacteria to polymyxin B is of chromosomal origin and is uncommon. A modification of the phospholipids of the cytoplasmic membrane appears to play a role.
Resistance to neomycin occurs by several different mechanisms including (1) alterations of the ribosomal subunit within the bacterial cell; (2) interference with the transport of neomycin into the cell, and (3) inactivation by an array of adenylating, phosphorylating, and acetylating enzymes. Genetic information for production of inactivating enzymes may be carried on the bacterial chromosome or on plasmids.
Breakpoints
Each gram of MAXITROL eye ointment contains 6000 IU polymyxin B sulphate and 3500 IU neomycin sulphate. The breakpoints and the in vitro spectrum as mentioned below are based on the dual activity of either polymyxin B or neomycin. The breakpoints listed here are based upon acquired resistance for specific species found in ocular infections and the ratio in International Units of polymyxin B to neomycin in MAXITROL eye ointment:
Resistance breakpoints: >5:2.5 to >40:20 depending upon the bacterial species
Susceptibility
The information listed below provides guidance on the approximate probabilities on the susceptibility of microorganisms to polymyxin B or neomycin in MAXITROL eye ointment. The presentation below lists bacterial species recovered from external ocular infections of the eye.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the combination of polymyxin B or neomycin as in MAXITROL eye ointment in at least some types of infections is questionable.
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Dexamethasone is a moderately powerful corticosteroid having good penetration in ocular tissue. Cortico-steroids have an anti-inflammatory as well as a vasoconstrictive effect. They suppress the inflammatory response and symptoms in various disorders without basically curing these disorders.
5.2 Pharmacokinetic Properties
Dexamethasone, like other corticosteroids, is absorbed rapidly after oral administration and has a biological half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. Intraocular penetration of dexamethasone occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.
Polymyxin B sulphate is not absorbed from the gastrointestinal tract or through intact skin, although the intact corneal epithelium prevents penetration into the corneal stroma, therapeutic concentrations do enter the stroma after epithelial damage. Good stromal penetration occurs after epithelial abrasion following topical instillation, subconjunctival injection, or corneal bath. No significant polymyxin B penetration into the vitreous is demonstrable after parenteral or local administration of the drug.
Neomycin is poorly absorbed from the gastrointestinal tract and after topical administration an insufficient amount is absorbed to produce systemic effects. Absorption has been reported to occur from wounds and inflamed skin. After absorption neomycin is rapidly excreted by the kidneys in active form.
5.3 Preclinical Safety Data
Mutagenicity and Carcinogenicity
Genotoxicity studies performed with neomycin and polymyxin B, with and without metabolic activation, were negative in bacterial (Ames test) or mammalian cells (chromosomal aberration assay in CHO cells). Dexamethasone was clastogenic in vivo in the mouse micronucleus assay at doses in excess of those obtained following topical application. Conventional long term carcinogenicity studies with MAXITROL or its active constituents have not been performed.
Teratogenicity
Pregnant rats treated daily with high doses of neomycin produced offspring that exhibited significant ototoxicity. The teratogenic dose is far greater (> 10,000-fold) than the clinical daily exposure from MAXITROL. Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.
Local Tolerance and Systemic Effects
Systemic exposure to dexamethasone is associated with its pharmacological effects as a potent glucocorticoid. Prolonged exposure to the steroid can result in glucocorticoid imbalance. Topical ocular safety studies with dexamethasone in rabbits have shown systemic effects after 1 month of treatment. In rabbits, MAXITROL was shown to have minimal irritation potential after administration to either control or irritated eyes.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Methylparaben
Propylparaben
Liquid lanolin
Petrolatum
6.2 Incompatibilities
None known.
6.3 Shelf Life
30 months
Discard 28 days after first opening.
6.4 Special Precautions For Storage
Do not store above 25°C.
Keep away from direct sunlight.
Do not refrigerate.
Keep the container tightly closed.
6.5 Nature And Contents Of Container
3.5 g metal tube with nozzle and screw cap.
6.6 Special Precautions For Disposal And Other Handling
Do not touch the top of the tube to any surface as this may contaminate the contents.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
HP2 7UD
UK
8. Marketing Authorisation Number(S)
0649/5916R
9. Date Of First Authorisation/Renewal Of The Authorisation
18 January 1991 / April 2001
10. Date Of Revision Of The Text
10/03/2011
Clonazepam
Pronunciation: kloe-NAZ-e-pam
Generic Name: Clonazepam
Brand Name: Klonopin
Clonazepam is used for:
Controlling certain types of seizures in the treatment of epilepsy and for the treatment of panic disorders. It may also be used for other conditions as determined by your doctor.
Clonazepam is a benzodiazepine. It works by increasing the activity of a naturally occurring chemical in the brain.
Do NOT use Clonazepam if:
- you are allergic to any ingredient in Clonazepam or to another benzodiazepine (eg, diazepam)
- you have a severe mental disorder, acute angle glaucoma, or severe liver disease
- you are taking sodium oxybate (GHB)
Contact your doctor or health care provider right away if any of these apply to you.
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Before using Clonazepam:
Some medical conditions may interact with Clonazepam. 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 a history of alcohol or substance abuse or dependence, or if you consume more than 3 alcohol-containing drinks per day
- if you have a history of mental or mood problems (eg, depression, suicidal thoughts or attempts)
- if you have myasthenia gravis (a condition in which the muscles become progressively weakened)
- if you have angle-closure glaucoma, kidney or liver problems, or the blood disorder porphyria
- if you have chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, or other breathing problems
Some MEDICINES MAY INTERACT with Clonazepam. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Methadone or sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe may occur
- Paroxetine or tricyclic antidepressants (eg, amitriptyline) because side effects, including confusion, excessive sweating, fever, restlessness, seizures, and twitching, which can rarely be life-threatening, may occur
- Antifungals (eg, fluconazole), cimetidine, disulfiram, hormonal contraceptives (eg, birth control pills), nefazodone, omeprazole, or valproic acid because they may increase the risk of Clonazepam's side effects
- Rifampin or St. John's wort because they may decrease Clonazepam's effectiveness
- Valproic acid because the effectiveness of both drugs may be decreased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Clonazepam 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 Clonazepam:
Use Clonazepam as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Clonazepam by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Swallow Clonazepam whole with a full glass of water (8 oz/240 mL).
- If you are taking Clonazepam for the prevention of seizures, taking Clonazepam at the same times each day will help you remember to take it.
- Continue to take Clonazepam even if you feel well. Do not miss any doses. Clonazepam works best when there is a constant level of Clonazepam in your body.
- If you miss a dose of Clonazepam and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Clonazepam.
Important safety information:
- Clonazepam may cause drowsiness, dizziness, lightheadedness, blurred vision, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use Clonazepam with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Clonazepam may cause you to lose consciousness if you have a history of seizures. Use Clonazepam with caution. Do not perform tasks that could be unsafe for you or others if you should lose consciousness (eg, driving, swimming, running heavy machinery).
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Clonazepam; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Patients who take Clonazepam may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Clonazepam closely. Contact the doctor at once if new, worsened, or sudden symptoms such as anxious, restless, or irritable behavior; depressed mood; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Notify your doctor if seizure control worsens.
- Carry an ID card at all times that says you take Clonazepam if it is used for seizures.
- Lab tests, including liver function, complete blood cell counts, and electrocardiograms, may be performed while you use Clonazepam. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Clonazepam with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion and drowsiness.
- Clonazepam should not be used in CHILDREN younger than 18 years old with panic disorder; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Clonazepam may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clonazepam while you are pregnant. Clonazepam is found in breast milk. Do not breast-feed while taking Clonazepam.
When used for long periods of time or at high doses, Clonazepam may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Clonazepam stops working well. Do not take more than prescribed.
When used for longer than a few weeks or at high doses, some people develop a need to continue taking Clonazepam. This is known as DEPENDENCE or addiction. If you stop taking Clonazepam suddenly, you may have WITHDRAWAL symptoms. These may include abnormal thoughts or behavioral disorder, anxiety, depression, hallucinations, personality changes, or loss of contact with reality; convulsions (seizures); insomnia; stomach and muscle cramps; tremor. Do not suddenly stop taking Clonazepam. If you need to stop Clonazepam, your doctor will lower your dose over time.
Possible side effects of Clonazepam:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; cough; dizziness; drowsiness; dry mouth; headache; increased saliva production; lightheadedness; loss of coordination; nausea; runny nose; tiredness.
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); behavior changes; blurred vision or other vision changes; change in appetite; change in the amount of urine produced or painful urination; changes in sexual function; confusion; dark urine; excessive hair growth or loss; fever, chills, or sore throat; hallucinations; irregular heartbeat; memory loss or problems; muscle aches or weakness; new or worsening mental or mood changes (eg, agitation, aggression, anxiety, behavior changes, depression, hostility, irritability, nervousness); new or worsening seizures; painful menstrual periods; pale stools; severe drowsiness; severe or persistent tiredness or weakness; shortness of breath; slow or shallow breathing; slurred speech or other speech problems; suicidal thoughts or actions; tremor; unusual bruising or bleeding; yellowing of the skin or eyes.
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: Clonazepam 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 clumsiness; confusion; difficult or slow breathing; dizziness; drowsiness leading to unresponsiveness or coma; lightheadedness, especially upon standing; loss of consciousness.
Proper storage of Clonazepam:
Store Clonazepam at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clonazepam out of the reach of children and away from pets.
General information:
- If you have any questions about Clonazepam, please talk with your doctor, pharmacist, or other health care provider.
- Clonazepam 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 Clonazepam. 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 Clonazepam resources
- Clonazepam Side Effects (in more detail)
- Clonazepam Dosage
- Clonazepam Use in Pregnancy & Breastfeeding
- Drug Images
- Clonazepam Drug Interactions
- Clonazepam Support Group
- 350 Reviews for Clonazepam - Add your own review/rating
- Clonazepam Prescribing Information (FDA)
- Clonazepam Professional Patient Advice (Wolters Kluwer)
- Clonazepam Monograph (AHFS DI)
- Klonopin Consumer Overview
- Klonopin Prescribing Information (FDA)
- clonazepam Advanced Consumer (Micromedex) - Includes Dosage Information
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- Insomnia
- Migraine Prevention
- Night Terrors
- Panic Disorder
- Periodic Limb Movement Disorder
- Restless Legs Syndrome
- Seizure Prevention
Tuesday, 11 September 2012
NovoSeven RT
Pronunciation: koe-AG-yoo-lay-shun FAK-tor
Generic Name: Coagulation Factor VIIa (Recombinant) (RT)
Brand Name: NovoSeven RT
NovoSeven RT is used for:
Treating or preventing bleeding episodes in certain patients with bleeding problems such as hemophilia A or B, acquired hemophilia, or congenital FVII deficiency.
NovoSeven RT is a clotting factor. It works by activating the body's clotting system.
Do NOT use NovoSeven RT if:
- you are allergic to any ingredient in NovoSeven RT, unless your doctor tells you otherwise
Contact your doctor or health care provider right away if any of these apply to you.
Before using NovoSeven RT:
Some medical conditions may interact with NovoSeven RT. 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
- you are allergic to mouse, hamster, or cow proteins
- if you have kidney problems, hardening of the arteries, disseminated intravascular coagulation (DIC), an infection of the blood or tissues, or blood conditions other than hemophilia
- if you have a blood clot or history of blood clots
- if you have a crush injury
- if you are also using another type of coagulation factor VIIa
Some MEDICINES MAY INTERACT with NovoSeven RT. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Activated or nonactivated prothrombin complex concentrates because the risk of blood clots may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if NovoSeven RT 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 NovoSeven RT:
Use NovoSeven RT as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- NovoSeven RT is usually given as an injection at your doctor's office, hospital, or clinic.
- If you miss a dose of NovoSeven RT, contact your doctor right away.
Ask your health care provider any questions you may have about how to use NovoSeven RT.
Important safety information:
- Lab tests, including bleeding time, may be performed while you use NovoSeven RT. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using NovoSeven RT while you are pregnant. It is not known if NovoSeven RT is found in breast milk. Do not breast-feed while taking NovoSeven RT.
Possible side effects of NovoSeven RT:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Headache; joint aches; mild fever; mild pain, swelling, or redness at the injection site; nausea; vomiting.
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); bleeding at the injection site; bloody stools; calf or stomach pain, tenderness, or swelling; chest pain; confusion; dizziness; fainting; numbness of an arm or leg; one-sided weakness; shortness of breath; sudden severe headache or vomiting; swelling; uncontrolled bleeding; vision or speech changes; vomiting blood or material that looks like coffee grounds; wheezing.
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: NovoSeven RT 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.
Proper storage of NovoSeven RT:
NovoSeven RT is usually handled and stored by a health care provider. If you are using NovoSeven RT at home, store NovoSeven RT as directed by your pharmacist or health care provider. Keep NovoSeven RT out of the reach of children and away from pets.
General information:
- If you have any questions about NovoSeven RT, please talk with your doctor, pharmacist, or other health care provider.
- NovoSeven RT 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 NovoSeven RT. 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 NovoSeven RT resources
- NovoSeven RT Side Effects (in more detail)
- NovoSeven RT Use in Pregnancy & Breastfeeding
- NovoSeven RT Drug Interactions
- NovoSeven RT Support Group
- 0 Reviews for NovoSeven RT - Add your own review/rating
- NovoSeven RT Prescribing Information (FDA)
- NovoSeven RT injection Concise Consumer Information (Cerner Multum)
- NovoSeven RT Monograph (AHFS DI)
- NovoSeven RT Advanced Consumer (Micromedex) - Includes Dosage Information
Compare NovoSeven RT with other medications
- Factor VII Deficiency
- Hemophilia A
- Hemophilia B
Saturday, 8 September 2012
Trimox
Pronunciation: a-MOX-i-SIL-in
Generic Name: Amoxicillin
Brand Name: Examples include Amoxil and Trimox
Trimox is used for:
Treating infections caused by certain bacteria. It is also used with other medicines to treat Helicobacter pylori infection and ulcers of the small intestines.
Trimox is a penicillin antibiotic. It works by killing sensitive bacteria.
Do NOT use Trimox if:
- you are allergic to any ingredient in Trimox or another penicillin antibiotic (eg, ampicillin)
- you have recently received or will be receiving live oral typhoid vaccine
- you have infectious mononucleosis (mono)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Trimox:
Some medical conditions may interact with Trimox. 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 a history of allergies, asthma, hay fever, or hives
- if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to a cephalosporin (eg, cephalexin) or another beta-lactam antibiotic (eg, imipenem)
- if you have kidney problems or gonorrhea
Some MEDICINES MAY INTERACT with Trimox. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
- Probenecid because it may increase the amount of Trimox in your blood
- Chloramphenicol, macrolide antibiotics (eg, erythromycin), sulfonamides (eg, sulfamethoxazole), or tetracycline antibiotics (eg, doxycycline) because they may decrease Trimox's effectiveness
- Methotrexate because the risk of its side effects may be increased by Trimox
- Live oral typhoid vaccine or hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Trimox
This may not be a complete list of all interactions that may occur. Ask your health care provider if Trimox 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 Trimox:
Use Trimox as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Trimox by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- To clear up your infection completely, take Trimox for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Trimox, 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 Trimox.
Important safety information:
- Trimox may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Trimox with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Trimox only works against bacteria; it does not treat viral infections (eg, the common cold).
- Be sure to use Trimox for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Long-term or repeated use of Trimox may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Trimox. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Brown, yellow, or gray tooth discoloration has occurred rarely in some patients taking Trimox. It occurred most often in children. The discoloration was reduced or removed by brushing or dental cleaning in most cases. Contact your doctor if you experience this effect.
- Diabetes patients - Trimox may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
- Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed if you use Trimox for a long period of time. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Trimox with caution in the ELDERLY; they may be more sensitive to its effects, especially patients with kidney problems.
- Use Trimox with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.
- Caution is advised when using Trimox in CHILDREN younger than 3 months old; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trimox while you are pregnant. Trimox is found in breast milk. If you are or will be breast-feeding while you use Trimox, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Trimox:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; nausea; vomiting.
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); bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; stomach pain or cramps; unusual bruising or bleeding; vaginal discharge or irritation; yellowing of the skin or eyes.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
See also: Trimox 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 decreased urination.
Proper storage of Trimox:
Store Trimox at or below 68 degrees F (20 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trimox out of the reach of children and away from pets.
General information:
- If you have any questions about Trimox, please talk with your doctor, pharmacist, or other health care provider.
- Trimox 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 Trimox. 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 Trimox resources
- Trimox Side Effects (in more detail)
- Trimox Use in Pregnancy & Breastfeeding
- Drug Images
- Trimox Drug Interactions
- Trimox Support Group
- 0 Reviews for Trimox - Add your own review/rating
- Trimox Advanced Consumer (Micromedex) - Includes Dosage Information
- Trimox Consumer Overview
- Amoxicillin Prescribing Information (FDA)
- Amoxicillin Professional Patient Advice (Wolters Kluwer)
- Amoxicillin Monograph (AHFS DI)
- Amoxicillin and Clavulanate Potassium Monograph (AHFS DI)
- Amoxil Consumer Overview
- Amoxil Prescribing Information (FDA)
- Amoxil Advanced Consumer (Micromedex) - Includes Dosage Information
- Biomox Prescribing Information (FDA)
- DisperMox Prescribing Information (FDA)
- Moxatag Prescribing Information (FDA)
- Moxatag Consumer Overview
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- Lyme Disease, Arthritis
- Lyme Disease, Carditis
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Wednesday, 5 September 2012
Nafarelin
Pronunciation: NAF-a-REL-in
Generic Name: Nafarelin
Brand Name: Synarel
Nafarelin is used for:
Treating endometriosis, including relieving pain and reducing lesions. It is also used to treat early puberty (central precocious puberty [CPP]) in children of both sexes. It may also be used for other conditions as determined by your doctor.
Nafarelin is a gonadotropin-releasing hormone (GnRH) agonist analog. It works by decreasing production of certain steroids in the body, which decreases the symptoms of endometriosis or early puberty.
Do NOT use Nafarelin if:
- you are allergic to any ingredient in Nafarelin or to GnRH
- you are pregnant, may become pregnant, or are breast-feeding
- you have undiagnosed abnormal vaginal bleeding
Contact your doctor or health care provider right away if any of these apply to you.
Before using Nafarelin:
Some medical conditions may interact with Nafarelin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- you are planning to become pregnant
- 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 a runny or stuffy nose, osteoporosis (weak bones), or a family history of osteoporosis
- if you regularly use alcohol or tobacco
- if the patient is a child with endometriosis
Some MEDICINES MAY INTERACT with Nafarelin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone) because the risk of decreased bone density (weak bones) may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nafarelin 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 Nafarelin:
Use Nafarelin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Nafarelin. Talk to your pharmacist if you have questions about this information.
- To use a nose spray, gently blow your nose. Sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for at least 30 seconds between sprays.
- After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
- If you are also using a decongestant nasal spray, do not use it within 2 hours after using Nafarelin. Check with your doctor if you have questions about using Nafarelin along with your other medicines.
- It may take 4 to 8 weeks for Nafarelin to work. Continue to use Nafarelin even if you feel well. Do not miss any doses.
- If you miss a dose of Nafarelin, use 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.
- If you miss more than 1 dose of Nafarelin, contact your doctor.
Ask your health care provider any questions you may have about how to use Nafarelin.
Important safety information:
- Avoid sneezing during or immediately after using Nafarelin, if possible, because Nafarelin's effectiveness may be decreased.
- Do not exceed the recommended dose or use Nafarelin for longer than prescribed without checking with your doctor.
- If you are using Nafarelin for CPP, you may experience some signs of puberty (eg, vaginal bleeding, breast enlargement, increased pubic hair) or temporary body odor during the first month of treatment. This is normal. If these side effects persist or are severe, contact your doctor.
- If you are using Nafarelin for endometriosis, you may experience irregular or unusual vaginal bleeding during the first 2 months you use Nafarelin. This is normal. If you experience severe or persistent vaginal bleeding or if you have unusual vaginal bleeding that lasts longer than 2 months after you start Nafarelin, contact your doctor.
- If you are using Nafarelin for endometriosis, your menstrual period should stop while you use Nafarelin. Contact your doctor if your regular menstrual period continues while you are using Nafarelin.
- Women who may become pregnant must have a negative pregnancy test before beginning treatment with Nafarelin.
- Women of childbearing age should avoid becoming pregnant while using Nafarelin. To prevent pregnancy, use a nonhormonal form of birth control (eg, condoms) while using Nafarelin.
- Women who miss more than one dose of Nafarelin in a row may experience breakthrough vaginal bleeding and ovulation, with the possibility of pregnancy. Contact your doctor if you miss more than one dose of Nafarelin.
- Nafarelin may interfere with certain lab tests, including diagnostic tests of pituitary gonadotropic and gonadal function. Be sure your doctor and lab personnel know you are using Nafarelin.
- Lab tests, including gonadal sex steroid levels and growth rate, may be performed while you use Nafarelin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Nafarelin should be used with extreme caution in CHILDREN younger than 18 years old who have endometriosis; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Nafarelin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Nafarelin is found in breast milk. Do not breast-feed while taking Nafarelin.
Possible side effects of Nafarelin:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Acne; dandruff; decreased sexual desire; headache; hot flashes; mood swings; muscle pain; nasal irritation; runny nose; temporary increase or decrease in breast size; trouble sleeping; vaginal dryness; weight change.
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); abdominal pain; chest pain; continued menstrual periods; depression; irregular heartbeat; mental or mood changes; severe, persistent, or unusual vaginal bleeding; shortness of breath; sudden headache or vomiting; swelling of the hands or feet; vision changes; whitish or brownish vaginal discharge.
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: Nafarelin 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.
Proper storage of Nafarelin:
Store Nafarelin upright at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Nafarelin out of the reach of children and away from pets.
General information:
- If you have any questions about Nafarelin, please talk with your doctor, pharmacist, or other health care provider.
- Nafarelin 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 Nafarelin. 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 Nafarelin resources
- Nafarelin Side Effects (in more detail)
- Nafarelin Use in Pregnancy & Breastfeeding
- Nafarelin Support Group
- 2 Reviews for Nafarelin - Add your own review/rating
- nafarelin Nasal Advanced Consumer (Micromedex) - Includes Dosage Information
- Nafarelin Acetate Monograph (AHFS DI)
- Synarel Prescribing Information (FDA)
- Synarel Concise Consumer Information (Cerner Multum)
Compare Nafarelin with other medications
- Endometriosis
- Precocious Puberty
Sunday, 2 September 2012
Vigamox
Generic Name: moxifloxacin hydrochloride
Dosage Form: ophthalmic solution
FULL PRESCRIBING INFORMATION
INDICATIONS AND USAGE
Vigamox® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Acinetobacter lwoffii*
Haemophilus influenzae
Haemophilus parainfluenzae*
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
DOSAGE AND ADMINISTRATION
Instill one drop in the affected eye 3 times a day for 7 days.
DOSAGE FORMS AND STRENGTHS
4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin hydrochloride, 0.5% as base.
Contraindications
Vigamox® solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
Warnings and Precautions
Topical Ophthalmic Use Only
NOT FOR INJECTION. Vigamox® solution is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.
Hypersensitivity Reaction
In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
Growth of Resistant Organisms with Prolonged Use
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.
Avoidance of Contact Lens Wear
Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients.
Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
Drug Interactions
Drug-drug interaction studies have not been conducted with Vigamox® solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C.
Teratogenic Effects: Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day.
Since there are no adequate and well-controlled studies in pregnant women, Vigamox® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Vigamox® solution is administered to a nursing mother.
Pediatric Use
The safety and effectiveness of Vigamox® solution in infants below 1 year of age have not been established.
There is no evidence that the ophthalmic administration of Vigamox® solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.
Geriatric Use
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Vigamox Description
Vigamox® (moxifloxacin hydrochloride ophthalmic solution) 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position.
Chemical Name:
1 - Cyclopropyl - 6 - fluoro - 1,4 - dihydro - 8 - methoxy - 7 - [(4aS,7aS) - octahydro - 6H - pyrrolol[3,4 - b]pyridin - 6 - yl] - 4 - oxo - 3 - quinoline carboxylic acid, monohydrochloride. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of Vigamox® solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base.
Contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8.
Vigamox® solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg.
Vigamox - Clinical Pharmacology
Mechanism of Action
Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs (See 12.4 Microbiology).
Pharmacokinetics
Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of Vigamox® solution 3 times a day. The mean steady-state Cmax (2.7 ng/mL) and estimated daily exposure AUC (45 ng•hr/mL) values were 1,600 and 1,000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.
Microbiology
The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.
In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10-9 to < 1 x 10-11 for Gram-positive bacteria.
Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:
Aerobic Gram-positive microorganisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Aerobic Gram-negative microorganisms:
Acinetobacter lwoffii*
Haemophilus influenzae
Haemophilus parainfluenzae*
Other microorganisms:
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of Vigamox® solution in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials.
The following organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 μg/ml or less (systemic susceptible breakpoint) against most (≥ 90%) strains of the following ocular pathogens.
Aerobic Gram-positive microorganisms:
Listeria monocytogenes
Staphylococcus saprophyticus
Streptococcus agalactiae
Streptococcus mitis
Streptococcus pyogenes
Streptococcus Group C, G and F
Aerobic Gram-negative microorganisms:
Acinetobacter baumannii
Acinetobacter calcoaceticus
Citrobacter freundii
Citrobacter koseri
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Moraxella catarrhalis
Morganella morganii
Neisseria gonorrhoeae
Proteus mirabilis
Proteus vulgaris
Pseudomonas stutzeri
Anaerobic microorganisms:
Clostridium perfringens
Fusobacterium species
Prevotella species
Propionibacterium acnes
Other microorganisms:
Chlamydia pneumoniae
Legionella pneumophila
Mycobacterium avium
Mycobacterium marinum
Mycoplasma pneumoniae
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis).
Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice.
Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose. At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.
Clinical Studies
In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, Vigamox® solution produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of baseline pathogens ranged from 84% to 94%. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.
How Supplied/Storage and Handling
Vigamox® solution is supplied as a sterile ophthalmic solution in Alcon’s DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
3 mL in a 4 mL bottle - NDC 0065-4013-03
Storage: Store at 2°C- 25°C (36°F - 77°F).
Patient Counseling Information
Patients should be advised not to touch the dropper tip to any surface to avoid contaminating the contents.
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Patients should be told to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.
Rx Only
Licensed to Alcon by Bayer Pharma AG.
U.S. PAT. NO. 5,607,942; 6,716,830; 7,671,070
© 2003-2011 Novartis
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
9007343-1011
PRINCIPAL DISPLAY PANEL
NDC 0065 - 4013 - 03 STERILE
Vigamox®
(moxifloxacin hydrochloride
ophthalmic solution)
0.5% as base
3 mL
ALCON®
| Vigamox moxifloxacin hydrochloride solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021598 | 05/07/2003 | |
| Labeler - Alcon Laboratories, Inc. (008018525) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Alcon Laboratories, Inc. | 008018525 | MANUFACTURE | |
More Vigamox resources
- Vigamox Side Effects (in more detail)
- Vigamox Dosage
- Vigamox Use in Pregnancy & Breastfeeding
- Vigamox Support Group
- 4 Reviews for Vigamox - Add your own review/rating
- Vigamox eent Monograph (AHFS DI)
- Vigamox Advanced Consumer (Micromedex) - Includes Dosage Information
- Vigamox Drops MedFacts Consumer Leaflet (Wolters Kluwer)
- Vigamox Consumer Overview
- Moxeza Consumer Overview
Compare Vigamox with other medications
- Conjunctivitis, Bacterial
- Ophthalmic Surgery
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