Monday, 23 July 2012

FML



fluorometholone

Dosage Form: ophthalmic suspension
FML®

(fluorometholone ophthalmic suspension, USP) 0.1%

Sterile



DESCRIPTION


FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.


Chemical Name:


Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.


Structural Formula:



Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust the pH. FML® suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.



CLINICAL PHARMACOLOGY


Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.


There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.


Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of documented steroid-responders, fluorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. The ultimate magnitude of the rise was equivalent for both drugs.



INDICATIONS AND USAGE


FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.



CONTRAINDICATIONS


FML® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. FML® 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.


Corticosteroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.



PRECAUTIONS



General:


The initial prescription and renewal of the medication order beyond 20 milliliters of FML® 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 local 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).



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 the reach of children.


The preservative in FML® suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling FML® suspension to insert soft contact lenses.



Carcinogenesis, mutagenesis, impairment of fertility:


No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.



Pregnancy:



Teratogenic effects. Pregnancy Category C: Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.



Nursing Mothers:


It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use:


Safety and effectiveness in infants 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 include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.


Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.


Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.


The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS).


Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of FML® suspension. Other adverse events reported with the use of FML® suspension include: allergic reactions, visual disturbance (blurry vision), and taste perversion.



DOSAGE AND ADMINISTRATION


Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.


If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).


The dosing of FML® suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.



HOW SUPPLIED


FML® (fluorometholone ophthalmic suspension, USP) 0.1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:


     5mL in 10mL bottle NDC 11980-211-05

   10mL in 15mL bottle NDC 11980-211-10

   15mL in 15mL bottle NDC 11980-211-15


Note: Store between 2° and 25°C (36° - 77°F); protect from freezing. Shake well before using.

Rx Only


Revised June 2003



©2003 Allergan, Inc.

Irvine, CA 92612, U.S.A. 4708X

® Marks owned by Allergan, Inc. 71598US10M



ALLERGAN


NDC 11980-211-15


Rx Only


FML®


(fluorometholone


ophthalmic suspension,


USP) 0.1%


15 mL sterile




ALLERGAN


NDC 11980-211-15 Rx Only


FML®


(fluorometholone


ophthalmic suspension,


USP) 0.1%


15 mL sterile










FML 
fluorometholone  suspension/ drops










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)11980-211
Route of AdministrationOPHTHALMICDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fluorometholone (fluorometholone)fluorometholone1 mg  in 1 mL






















Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
edetate disodium 
polysorbate 80 
polyvinyl alcohol 
water 
sodium chloride 
sodium phosphate, dibasic 
sodium phosphate, monobasic 
sodium hydroxide 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
111980-211-051 BOTTLE In 1 CARTONcontains a BOTTLE, DROPPER
15 mL In 1 BOTTLE, DROPPERThis package is contained within the CARTON (11980-211-05)
211980-211-101 BOTTLE In 1 CARTONcontains a BOTTLE, DROPPER
210 mL In 1 BOTTLE, DROPPERThis package is contained within the CARTON (11980-211-10)
311980-211-151 BOTTLE In 1 CARTONcontains a BOTTLE, DROPPER
315 mL In 1 BOTTLE, DROPPERThis package is contained within the CARTON (11980-211-15)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01685102/01/1972


Labeler - Allergan, Inc. (144796497)









Establishment
NameAddressID/FEIOperations
Allergan, Inc.362898611MANUFACTURE
Revised: 10/2010Allergan, Inc.

More FML resources


  • FML Side Effects (in more detail)
  • FML Dosage
  • FML Use in Pregnancy & Breastfeeding
  • FML Drug Interactions
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Saturday, 14 July 2012

Varibar Thin oral and rectal


Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)

Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen


What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.


Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.


Barium sulfate may also be used for purposes not listed in this medication guide.


What is the most important information I should know about barium sulfate?


You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.


Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.


Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?


You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:



  • asthma, eczema, or allergies;




  • a blockage in your stomach or intestines;




  • cystic fibrosis;




  • a colostomy;




  • rectal cancer;




  • heart disease or high blood pressure;




  • Hirschsprung's disease (a disorder of the intestines);




  • a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);




  • a recent history of surgery on your esophagus, stomach, or intestines;




  • a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;




  • if you have recently had a rectal biopsy;




  • if you have ever choked on food by accidentally inhaling it into your lungs;




  • if you are allergic to simethicone (Gas-X, Phazyme, and others); or




  • if you are allergic to latex rubber.




It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.

How should I use barium sulfate?


Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.


Barium sulfate comes in tablets, paste, cream, or liquid forms.


In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.


You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.


If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.


Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.


If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.


Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?


If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.


What should I avoid before or after using barium sulfate?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Barium sulfate side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain;




  • severe cramping, diarrhea, or constipation;




  • sweating;




  • ringing in your ears;




  • confusion, fast heart rate; or




  • pale skin, weakness.



Less serious side effects may include:



  • mild stomach cramps;




  • nausea, vomiting;




  • loose stools or mild constipation.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect barium sulfate?


There may be other drugs that can interact with barium sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Varibar Thin resources


  • Varibar Thin Side Effects (in more detail)
  • Varibar Thin Use in Pregnancy & Breastfeeding
  • Varibar Thin Support Group
  • 0 Reviews for Varibar Thin - Add your own review/rating


Compare Varibar Thin with other medications


  • Computed Tomography


Where can I get more information?


  • Your doctor or pharmacist can provide more information about barium sulfate.

See also: Varibar Thin side effects (in more detail)


Thursday, 12 July 2012

cabazitaxel


Generic Name: cabazitaxel (ka BAZ i TAX el)

Brand Names: Jevtana


What is cabazitaxel?

Cabazitaxel is a cancer medication that interferes with the growth and spread of cancer cells in the body.


Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body (metastatic).


Cabazitaxel is usually given after other cancer medicines have been tried without successful treatment.


Cabazitaxel may also be used for purposes not listed in this medication guide.


What is the most important information I should know about cabazitaxel?


Do not use cabazitaxel if you are pregnant. It could harm the unborn baby. You should not use this medication if you are allergic to cabazitaxel, or if you have liver disease, low white blood cell counts, or an allergy to any medicine that contains polysorbate 80. You should not breast-feed while you are receiving cabazitaxel.

Before you receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.


Cabazitaxel is used together with prednisone, and you may also be given other medications to help prevent certain side effects. Use all medications as directed by your doctor.


To make sure cabazitaxel is helping your condition and not causing harmful effects, your blood will need to be tested often.

What should I discuss with my health care provider before receiving cabazitaxel?


You should not use this medication if you are allergic to cabazitaxel, or if you have:

  • liver disease;




  • low white blood cell counts; or




  • an allergy to any medicine that contains polysorbate 80.



To make sure you can safely receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.


FDA pregnancy category D. Do not use cabazitaxel if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether cabazitaxel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving cabazitaxel. Serious side effects may be more likely in older adults receiving cabazitaxel.

How is cabazitaxel given?


Cabazitaxel is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Cabazitaxel must be given slowly, and the IV infusion can take about 1 hour to complete.


Cabazitaxel is usually given once every 3 weeks. You will most likely take prednisone by mouth every day throughout your cabazitaxel treatment. Follow your doctor's dosing instructions very carefully.


Do not stop taking prednisone without your doctor's advice, or you could have unpleasant side effects caused by cabazitaxel. Tell your doctor if you have missed any doses or have stopped taking prednisone for any reason.

About 30 minutes before you receive cabazitaxel, you may be given other medications to help prevent certain side effects.


Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.


To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Your doctor may tell you to check your temperature at home throughout your treatment with cabazitaxel.


Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while receiving cabazitaxel, which can lead to a serious electrolyte imbalance.


What happens if I miss a dose?


Call your doctor for instructions if you miss an appointment for your cabazitaxel injection.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.


What should I avoid while receiving cabazitaxel?


Avoid taking an herbal supplement containing St. John's wort while you are being treated with cabazitaxel.

Cabazitaxel side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives, red skin rash; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • fever, cough, chills, muscle aches, flu symptoms, sores in your mouth and throat, rapid and shallow breathing, fainting;




  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;




  • severe or ongoing diarrhea;




  • trouble breathing;




  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;




  • swelling or rapid weight gain; or




  • blood in your urine, pain or burning when you urinate.



Less serious side effects may include:



  • nausea, vomiting, stomach pain;




  • constipation, mild diarrhea;




  • weakness, tired feeling;




  • joint pain, back pain;




  • numbness, burning pain, or tingly feeling en your hands or feet;




  • changes in your sense of taste; or




  • hair loss.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Cabazitaxel Dosing Information


Usual Adult Dose for Prostate Cancer:

Initial dose: 25 mg/m2 IV every 3 weeks in combination with prednisone 10 mg orally once daily.


What other drugs will affect cabazitaxel?


Many drugs can interact with cabazitaxel. Below is just a partial list. Tell your doctor if you are using:



  • conivaptan (Vaprisol);




  • imatinib (Gleevec);




  • isoniazid (for treating tuberculosis);




  • aprepitant (Emend);




  • cimetidine (Tagamet);




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • haloperidol (Haldol);




  • lidocaine (Xylocaine);




  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl), norfloxacin (Noroxin), telithromycin (Ketek), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);




  • antifungal medication such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);




  • an antidepressant such as nefazodone, desipramine (Norpramin), or sertraline (Zoloft);




  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or




  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).




This list is not complete and there are many other drugs that can interact with cabazitaxel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More cabazitaxel resources


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


  • cabazitaxel Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cabazitaxel Professional Patient Advice (Wolters Kluwer)

  • Cabazitaxel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cabazitaxel Monograph (AHFS DI)

  • Jevtana Prescribing Information (FDA)

  • Jevtana Consumer Overview



Compare cabazitaxel with other medications


  • Prostate Cancer


Where can I get more information?


  • Your doctor or pharmacist can provide more information about cabazitaxel.

See also: cabazitaxel side effects (in more detail)


Migraine Medications


Definition of Migraine:

Migraine headaches are a type of headache that some people get repeatedly over time. Migraines are different from other headaches because they occur with symptoms such as nausea, vomiting, or sensitivity to light.


Some people who get migraines have warning symptoms, called an aura, before the actual headache begins. Most people, however, do not have such warning symptoms.

Drugs associated with Migraine

The following drugs and medications are in some way related to, or used in the treatment of Migraine. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Migraine

  • Migraine Prevention (39 drugs)

  • Trochleitis (0 drugs)

Learn more about Migraine





Drug List:

Wednesday, 11 July 2012

Zanaflex Capsule



Generic Name: tizanidine (Oral route)

tye-ZAN-i-deen

Commonly used brand name(s)

In the U.S.


  • Comfort Pac w/Tizanidine

  • Zanaflex

  • Zanaflex Capsule

Available Dosage Forms:


  • Capsule

  • Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting


Uses For Zanaflex Capsule


Tizanidine is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or certain injuries to the spine. Tizanidine does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.


Tizanidine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine's side effects.


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


Before Using Zanaflex Capsule


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


Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tizanidine in children with use in other age groups.


Geriatric


Studies in older adults show that tizanidine stays in the body a little longer than it does in younger adults. Your doctor will consider this when deciding on your dose.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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


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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Ciprofloxacin

  • Fluvoxamine

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.


  • Acyclovir

  • Amiodarone

  • Cimetidine

  • Desogestrel

  • Dienogest

  • Drospirenone

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethynodiol Diacetate

  • Etonogestrel

  • Famotidine

  • Levonorgestrel

  • Medroxyprogesterone Acetate

  • Mestranol

  • Mexiletine

  • Norelgestromin

  • Norethindrone

  • Norfloxacin

  • Norgestimate

  • Norgestrel

  • Ofloxacin

  • Propafenone

  • Rofecoxib

  • Ticlopidine

  • Vemurafenib

  • Verapamil

  • Zileuton

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.


  • Fosphenytoin

  • Lisinopril

  • Phenytoin

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.


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:


  • Kidney disease or

  • Liver disease—The chance of side effects may be increased; higher blood levels of tizanidine may result and a smaller dose may be needed

Proper Use of tizanidine

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


When you take the different dosage forms (tablets, capsules, capsule contents sprinkled over applesauce) of tizanidine with food, it effects the amount of the medicine absorbed into your blood differently. Follow your doctor's instructions for when to take this medicine and whether or not you should take it with food.


Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.


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 (capsules and tablets):
    • For muscle relaxation:
      • Adults—The dose is 8 milligrams (mg) every six to eight hours as needed. No more than 36 mg should be taken within a twenty-four-hour period.

      • Children—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.


Precautions While Using Zanaflex Capsule


Your doctor should check your progress at regular visits, especially during the first few weeks of treatment with this medicine. During this time the amount of medicine you are taking may have to be changed often to meet your individual needs.


Do not suddenly stop taking this medicine. Unwanted effects may occur if the medicine is stopped suddenly. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.


This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using tizanidine.


This medicine may cause dizziness, drowsiness, lightheadedness, clumsiness or unsteadiness, or vision problems in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.


Tizanidine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.


Zanaflex Capsule 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:


More common
  • Chest pain or discomfort

  • fever

  • loss of appetite

  • lower back or side pain

  • nausea and/or vomiting

  • nervousness

  • pain or burning while urinating

  • painful or difficult urination

  • sores on the skin

  • tingling, burning, or prickling sensations

  • unusual tiredness

  • yellow eyes or skin

Less common
  • Black, tarry stools

  • bloody vomit

  • blurred vision

  • chills or sore throat

  • coldness

  • convulsions (seizures)

  • cough or hoarseness

  • dark urine

  • dry, puffy skin

  • eye pain

  • fainting

  • influenza (flu)-like symptoms

  • irregular heartbeat

  • kidney stones

  • persistent anorexia

  • pruritus

  • right upper quadrant tenderness

  • seeing things that are not there

  • shortness of breath

  • slow or irregular heartbeat

  • unusual tiredness or weakness

  • weight gain

Incidence not known
  • Continuing vomiting

  • general feeling of tiredness or weakness

  • headache

  • light-colored stools

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Blurred vision

  • change in consciousness

  • chest pain or discomfort

  • confusion

  • decreased awareness or responsiveness

  • difficult or troubled breathing

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

  • irregular, fast or slow, or shallow breathing

  • lightheadedness, dizziness or fainting

  • loss of consciousness

  • pale or blue lips, fingernails, or skin

  • severe sleepiness

  • shortness of breath

  • sleepiness or unusual drowsiness

  • slow or irregular heartbeat

  • sweating

  • unusual tiredness or 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
  • Anxiety

  • back pain

  • constipation

  • depression

  • diarrhea

  • difficulty in speaking

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

  • drowsiness

  • dry mouth

  • heartburn

  • increased sweating

  • increased muscle spasms or tone

  • muscle weakness

  • pain or burning in throat

  • runny nose

  • skin rash

  • sleepiness

  • stomach pain

  • uncontrolled movements of the body

Less common
  • Difficulty swallowing

  • dry skin

  • general feeling of discomfort or illness

  • increased need to urinate

  • joint or muscle pain or stiffness

  • loss of hair

  • migraine headache

  • mood changes

  • neck pain

  • passing urine more often

  • shivering

  • swelling of feet or lower legs

  • swollen area that feels warm and tender

  • trembling or shaking

  • trouble sleeping

  • unusual feeling of well-being

  • unusual tiredness or weakness

  • weight loss

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: Zanaflex Capsule 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 Zanaflex Capsule resources


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


Compare Zanaflex Capsule with other medications


  • Cluster Headaches
  • Muscle Spasm

Tuesday, 10 July 2012

Zofran Tablets



Pronunciation: on-DAN-se-tron
Generic Name: Ondansetron
Brand Name: Zofran


Zofran is used for:

Preventing nausea and vomiting associated with cancer chemotherapy, radiation treatment, or surgery. It may also be used for other conditions as determined by your doctor.


Zofran is a serotonin 5-HT3 receptor blocker. It works by blocking a chemical thought to be a cause of nausea and vomiting in certain situations (eg, chemotherapy).


Do NOT use Zofran if:


  • you are allergic to any ingredient in Zofran

  • you are taking apomorphine

  • you have a certain type of irregular heartbeat (congenital long QT syndrome)

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



Before using Zofran:


Some medical conditions may interact with Zofran. 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 had an allergic reaction to another serotonin 5-HT3 receptor blocker (eg, dolasetron, granisetron)

  • if you have liver problems, heart problems (eg, congestive heart failure, slow or irregular heartbeat, QT prolongation), or electrolyte problems (eg, low potassium or magnesium levels)

  • if you take medicines that may affect your heartbeat. Check with your doctor if you are unsure if any of your medicines may affect your heartbeat

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


  • Apomorphine because the risk of its side effects may be increased by Zofran

  • Antineoplastic agents (eg, cyclophosphamide) or tramadol because their effectiveness may be decreased by Zofran.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zofran 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 Zofran:


Use Zofran as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Zofran by mouth with or without food.

  • To prevent or reduce the possibility of nausea or vomiting, continue taking Zofran for the entire time recommended by your doctor even if you do not notice any nausea.

  • If you miss a dose of Zofran, 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 Zofran.



Important safety information:


  • Zofran may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Zofran with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Zofran should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zofran while you are pregnant. It is not known if Zofran is found in breast milk. If you are or will be breast-feeding while you use Zofran, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Zofran:


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; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.



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, throat, or tongue; wheezing; unusual hoarseness); chest or jaw pain, numbness of an arm or leg, or sudden severe headache or vomiting; fainting; fast, slow, or irregular heartbeat; fever; seizures; severe or persistent dizziness; skin tingling or numbness; stomach pain; trouble urinating; uncontrolled muscle movements; vision changes or loss.



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: Zofran 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 fainting; severe dizziness; slowed/irregular heartbeat; sudden, temporary blindness.


Proper storage of Zofran:

Store Zofran between 36 and 86 degrees F (2 and 30 degrees C) in a tightly closed container. Protect from heat, moisture, and light. Do not store in the bathroom. Keep Zofran out of the reach of children and away from pets.


General information:


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

  • Zofran 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 Zofran. 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 Zofran resources


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


Compare Zofran with other medications


  • Alcohol Dependence
  • Gastroenteritis
  • Nausea/Vomiting
  • Nausea/Vomiting, Chemotherapy Induced
  • Nausea/Vomiting, Postoperative
  • Nausea/Vomiting, Radiation Induced
  • Obsessive Compulsive Disorder
  • Postanesthetic Shivering
  • Pruritus

Thursday, 5 July 2012

Maxidone


Generic Name: hydrocodone and acetaminophen (Oral route)


a-seet-a-MIN-oh-fen, hye-droe-KOE-done bye-TAR-trate


Oral route(Solution;Tablet)

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product .



Commonly used brand name(s)

In the U.S.


  • Anexsia

  • Ceta Plus

  • Co-Gesic

  • Dolorex Forte

  • Hycet

  • Lorcet

  • Lortab

  • Maxidone

  • Norco

  • Stagesic

  • Vicodin

  • Zydone

Available Dosage Forms:


  • Tablet

  • Solution

  • Syrup

  • Elixir

  • Capsule

  • Liquid

Therapeutic Class: Opioid/Acetaminophen Combination


Chemical Class: Hydrocodone


Uses For Maxidone


Hydrocodone and acetaminophen combination is used to relieve moderate to moderately severe pain.


Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.


Hydrocodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.


When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.


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


Before Using Maxidone


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 have not been performed on the relationship of age to the effects of hydrocodone and acetaminophen tablets in the pediatric population. Safety and efficacy have not been established.


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen oral solution in children. However, safety and efficacy have not been established 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 hydrocodone and acetaminophen combination in the elderly. However, elderly patients are more likely to have confusion and drowsiness, and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydrocodone and acetaminophen combination.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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


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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Naltrexone

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.


  • Adinazolam

  • Alfentanil

  • Alprazolam

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Bromazepam

  • Brotizolam

  • Buprenorphine

  • Butabarbital

  • Butalbital

  • Butorphanol

  • Carisoprodol

  • Chloral Hydrate

  • Chlordiazepoxide

  • Chlorzoxazone

  • Clobazam

  • Clonazepam

  • Clorazepate

  • Codeine

  • Dantrolene

  • Dezocine

  • Diazepam

  • Estazolam

  • Ethchlorvynol

  • Fentanyl

  • Flunitrazepam

  • Flurazepam

  • Fospropofol

  • Halazepam

  • Hydrocodone

  • Hydromorphone

  • Ketazolam

  • Levorphanol

  • Lorazepam

  • Lormetazepam

  • Medazepam

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Metaxalone

  • Methocarbamol

  • Methohexital

  • Midazolam

  • Morphine

  • Morphine Sulfate Liposome

  • Nalbuphine

  • Nitrazepam

  • Nordazepam

  • Opium

  • Oxazepam

  • Oxycodone

  • Oxymorphone

  • Pentazocine

  • Pentobarbital

  • Phenobarbital

  • Prazepam

  • Propoxyphene

  • Quazepam

  • Remifentanil

  • Secobarbital

  • Sodium Oxybate

  • Sufentanil

  • Tapentadol

  • Temazepam

  • Thiopental

  • Triazolam

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.


  • Acenocoumarol

  • Carbamazepine

  • Escitalopram

  • Isoniazid

  • Phenytoin

  • Warfarin

  • Zidovudine

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 this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Using this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Cabbage

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:


  • Addison's disease (adrenal gland problem) or

  • Alcohol abuse, history of or

  • Breathing or lung problems (e.g., asthma, chronic obstructive pulmonary disease [COPD], cor pulmonale, emphysema, hypoxia) or

  • CNS depression or

  • Drug dependence, especially narcotic abuse or dependence, or history of or

  • Enlarged prostate (BPH, prostatic hypertrophy) or

  • Hypothyroidism (an underactive thyroid) or

  • Problems with passing urine—Use with caution. May increase risk for more serious side effects.

  • Brain tumor or

  • Head injuries or

  • Increased pressure in the head—Some of the side effects of hydrocodone can cause serious problems in people who have these medical problems.

  • Kidney disease or

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

  • Lung disease or

  • Respiratory depression (hypoventilation or slow breathing)—Use with caution. May make these conditions worse.

  • Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.

Proper Use of hydrocodone and acetaminophen

This section provides information on the proper use of a number of products that contain hydrocodone and acetaminophen. It may not be specific to Maxidone. Please read with care.


Take this medicine only 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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.


This medicine should come with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.


Measure the oral liquid with a marked measuring spoon, oral syringe, dropper, or medicine cup. The average household teaspoon may not hold the right amount of liquid.


This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).


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 moderate to moderately severe pain:
    • For oral dosage form (solution):
      • Adults and teenagers 14 years of age and older—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.

      • Children 10 to 13 years of age and weighing 32 to 45 kg—10 mL (2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.

      • Children 7 to 9 years of age and weighing 23 to 31 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.

      • Children 4 to 6 years of age and weighing 16 to 22 kg—5 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mL (6 teaspoonfuls) per day.

      • Children 2 to 3 years of age and weighing 12 to 15 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.

      • Children younger than 2 years of age—Use and dose must be determined by your doctor.


    • For oral dosage form (tablets):
      • Adults—One or two tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 5 to 12 tablets per day.

      • Children—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 Maxidone


It is very important that your doctor check the progress of you or your child while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.


This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.


This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.


This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.


Before you or your child have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of certain tests may be affected by this medicine.


Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.


Using this medicine while you are pregnant may cause the neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has the following symptoms: an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or failure to gain weight.


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.


Maxidone 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:


Incidence not known
  • Back, leg, or stomach pains

  • black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • blood in vomit

  • bluish lips or skin

  • chills

  • choking

  • cough or hoarseness

  • dark urine

  • decrease in the frequency of urination

  • decrease in urine volume

  • difficult or troubled breathing

  • difficulty in passing urine (dribbling)

  • difficulty with breathing

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • fever

  • fever with or without chills

  • general body swelling

  • general feeling of tiredness or weakness

  • headache

  • hives

  • irregular, fast or slow, or shallow breathing

  • itching

  • light-colored stools

  • loss of appetite

  • lower back or side pain

  • nausea or vomiting

  • nosebleeds

  • not breathing

  • painful or difficult urination

  • pale or blue lips, fingernails, or skin

  • pale skin

  • pinpoint red spots on the skin

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • severe or continuing stomach pain

  • shortness of breath or troubled breathing

  • skin rash

  • sore throat

  • sore tongue

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

  • tightness in the chest

  • unable to speak

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • upper right abdominal or stomach pain

  • wheezing

  • yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Bloody or cloudy urine

  • change in consciousness

  • chest pain or discomfort

  • cold and clammy skin

  • decreased awareness or responsiveness

  • extreme drowsiness

  • general feeling of discomfort or illness

  • increased sweating

  • irregular heartbeat

  • lightheadedness, dizziness, or fainting

  • loss of consciousness

  • no blood pressure or pulse

  • no muscle tone or movement

  • not breathing

  • severe sleepiness

  • slow or irregular heartbeat

  • stopping of heart

  • sudden decrease in the amount of urine

  • unconsciousness

  • unpleasant breath odor

  • vomiting of blood

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
  • Drowsiness

  • relaxed and calm

  • sleepiness

Incidence not known
  • Belching

  • changes in mood

  • difficulty having a bowel movement (stool)

  • fear or nervousness

  • feeling of indigestion

  • hearing loss

  • impaired hearing

  • pain in the chest below the breastbone

  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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: Maxidone side effects (in more detail)



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