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Diprolene AF

betamethasone dipropionate

Dosage Form: cream
DIPROLENE® AF

brand of augmented betamethasone dipropionate1

Cream 0.05%

(potency expressed as betamethasone)

1

Vehicle augments the penetration of the steroid.

For Dermatologic Use Only – Not for Ophthalmic Use

PRODUCT INFORMATION

Diprolene AF Description

DIPROLENE® AF Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of Diprolene AF Cream 0.05% contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in an emollient cream base of purified water; chlorocresol; propylene glycol; white petrolatum; white wax; cyclomethicone; sorbitol solution; glyceryl oleate/propylene glycol; ceteareth-30; carbomer 940; and sodium hydroxide.

Diprolene AF - Clinical Pharmacology

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.

Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION).

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

DIPROLENE® AF Cream 0.05% was applied once daily at 7 grams per day for 1 week to diseased skin, in adult patients with psoriasis or atopic dermatitis, to study its effects on the hypothalamic-pituitary-adrenal (HPA) axis. The results suggested that the drug caused a slight lowering of adrenal corticosteroid secretion, although in no case did plasma cortisol levels go below the lower limit of the normal range.

Sixty-seven pediatric patients ages 1 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Diprolene AF Cream 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable patients, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Studies performed with Diprolene AF Cream 0.05% indicate that it is in the high range of potency as compared with other topical corticosteroids.

Indications and Usage for Diprolene AF

DIPROLENE® AF Cream 0.05% is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.

Contraindications

DIPROLENE® AF Cream 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure (see DOSAGE AND ADMINISTRATION).

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 60 evaluable patients, of the 19 who showed evidence of suppression, 4 patients were tested 2 weeks after discontinuation of DIPROLENE® AF Cream 0.05%, and 3 of the 4 (75%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use section).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

1. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.


2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive (see DOSAGE AND ADMINISTRATION).


4. Patients should report any signs of local adverse reactions.


5. Other corticosteroid-containing products should not be used with Diprolene AF Cream 0.05% without first talking to your physician.

Laboratory Tests

The following tests may be helpful in evaluating HPA axis suppression:

 

Urinary-free cortisol test

 

ACTH stimulation test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.

Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the human dose based on a mg/m2 comparison, respectively.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 0.2-fold the maximum human dose based on a mg/m2 comparison. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates.

Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, 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

Use of Diprolene AF Cream 0.05% in pediatric patients 12 years of age and younger is not recommended (see CLINICAL PHARMACOLOGY and ADVERSE REACTIONS). In an open-label study, 19 of 60 (32%) evaluable pediatric patients (aged 3 months–12 years old) using Diprolene AF Cream 0.05% for treatment of atopic dermatitis demonstrated HPA axis suppression. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group (see CLINICAL PHARMACOLOGY, Pharmacokinetics section).

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. The study described above supports this premise, as adrenal suppression in 9–12 year olds, 6–8 year olds, 2–5 year olds, and 3 months–1 year old was 17%, 32%, 38%, and 50%, respectively.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatric Use

Clinical studies of Diprolene AF Cream 0.05% included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

The only local adverse reaction reported to be possibly or probably related to treatment with DIPROLENE® AF Cream 0.05% during adult-controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.

Adverse reactions reported to be possibly or probably related to treatment with Diprolene AF Cream 0.05% during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months–12 years of age.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Diprolene AF Dosage and Administration

Apply a thin film of DIPROLENE® AF Cream 0.05% to the affected skin areas once or twice daily. Treatment with Diprolene AF Cream 0.05% should be limited to 50 g per week.

Diprolene AF Cream 0.05% is not to be used with occlusive dressings.

How is Diprolene AF Supplied

DIPROLENE® AF Cream 0.05% is supplied in 15-g (NDC 0085-0517-01) and 50-g (NDC 0085-0517-04) tubes; boxes of one.

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Manufactured by: Schering-Plough Canada, Inc., Pointe Claire, Quebec, Canada

Distributed by: Schering Corporation, a subsidiary of

MERCK & CO., INC.

Whitehouse Station, NJ 08889, USA

Copyright © 1987, 2001 Schering Corporation, a subsidiary of Merck & Co., Inc.

All rights reserved.

Rev. 08/10

34489300T

PRINCIPAL DISPLAY PANEL - 50 g Tube Box

NDC 0085-0517-04

50 g

Diprolene®AF

brand of augmented

betamethasone

dipropionate*

Cream, 0.05%

(Potency expressed

as betamethasone)

*Vehicle augments the

penetration of the steroid.

For dermatologic

use only.

Not for

ophthalmic use.

Rx only

Diprolene AF  betamethasone dipropionate  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-0517 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength betamethasone dipropionate (betamethasone) betamethasone 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength water   chlorocresol   propylene glycol   petrolatum   white wax   cyclomethicone   sorbitol   ceteareth-30   carbomer homopolymer type c

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0085-0517-01 1 TUBE In 1 BOX contains a TUBE 1 15 g In 1 TUBE This package is contained within the BOX (0085-0517-01) 2 0085-0517-04 1 TUBE In 1 BOX contains a TUBE 2 50 g In 1 TUBE This package is contained within the BOX (0085-0517-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019555	06/23/2011

Labeler - Schering Corporation (001317601)

Establishment
Name	Address	ID/FEI	Operations
SCHERING CANADA INC		207093332	MANUFACTURE

Revised: 06/2011Schering Corporation

More Diprolene AF resources

• Diprolene AF Side Effects (in more detail)
• Diprolene AF Use in Pregnancy & Breastfeeding
• Diprolene AF Drug Interactions
• Diprolene AF Support Group
• 1 Review for Diprolene AF - Add your own review/rating

• Diprolene AF Concise Consumer Information (Cerner Multum)


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Ofloxacin

Pronunciation: oh-FLOX-a-sin
Generic Name: Ofloxacin
Brand Name: Floxin

Ofloxacin is associated with an increased risk of tendon problems. These include pain, swelling, inflammation, and possible breakage of tendons. The risk of tendon problems is greater in patients who are older than 60 years, patients who take corticosteroids (eg, prednisone), and in those who have received kidney, heart, or lung transplants. The Achilles tendon in the back of the foot/ankle is most often affected. However, problems may also occur in other tendons (eg, in the shoulder, arm, hand). Problems may occur while you take Ofloxacin or up to several months after you stop taking it.

Signs of tendon problems may include pain, soreness, redness, or swelling of a tendon or joint; bruising right after an injury in a tendon area; hearing or feeling a snap or pop in a joint or tendon area; or inability to move or bear weight on a joint or tendon area. Tell your doctor right away if you experience any of these symptoms while you take Ofloxacin or within several months after you stop taking it.

Ofloxacin may worsen muscle weakness and breathing problems in patients with myasthenia gravis. Do not take Ofloxacin if you have a history of myasthenia gravis.

Ofloxacin is used for:

Treating mild to moderate infections caused by certain bacteria.

Ofloxacin is a fluoroquinolone antibiotic. It kills sensitive bacteria by stopping the production of essential proteins needed by the bacteria to survive.

Do NOT use Ofloxacin if:

• you are allergic to any ingredient in Ofloxacin or any other fluoroquinolone antibiotic (eg, ciprofloxacin)


• you have a history of myasthenia gravis


• you have abnormal blood electrolyte levels (eg, low potassium or magnesium) or a history of a certain type of irregular heartbeat (eg, QTc interval prolongation)


• you are taking certain antiarrhythmic medicines (eg, quinidine, procainamide, amiodarone, sotalol)


• you are taking a nonsteroidal anti-inflammatory drug (NSAIDs) (eg, ibuprofen) or typhoid oral vaccine

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

Before using Ofloxacin:

Some medical conditions may interact with Ofloxacin. 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 diabetes, liver problems, or a recent heart attack


• if you or a family member have heart problems (eg, angina), irregular heartbeat (eg, QT prolongation), fast or slow heartbeat, or low potassium levels


• if you have Alzheimer disease, hardening in the arteries in the brain, seizures, increased pressure on the brain, or another central nervous system disorder


• if you have a history of joint or tendon problems; rheumatoid arthritis; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant


• if your skin is sensitive to sunlight

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

• Antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, quinidine, sotalol), cisapride, diuretics (eg, furosemide, hydrochlorothiazide), macrolide or ketolide antibiotics (eg, erythromycin, telithromycin), medicines for mental or mood disorders, medicines that may affect your heartbeat, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because the risk of serious side effects, including irregular heartbeat and other heart problems, may be increased. Check with your doctor or pharmacist if you are unsure if any of your medicines may affect your heartbeat


• Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased


• Foscarnet, NSAIDs (eg, ibuprofen), or tramadol because the risk of seizures may be increased


• Insulin or other medicines for diabetes (eg, glipizide) because the risk of low blood sugar may be increased


• Anticoagulants (eg, warfarin), procainamide, or theophylline because the risk of their side effects may be increased by Ofloxacin


• Live typhoid vaccine because its effectiveness may be decreased by Ofloxacin


• Aluminum salts (eg, aluminum hydroxide), iron salts (oral) (eg, ferrous sulfate), or magnesium salts (eg, magnesium hydroxide) because they may decrease Ofloxacin's effectiveness. Take ofloxacin 2 hours before or 2 hours after these medicines to offset this effect

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

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

• Take Ofloxacin by mouth with or without food.


• Take Ofloxacin with a full glass of water (8 oz/240 mL). Drink several glasses of water daily, unless otherwise instructed by your doctor.


• Do not drink milk or eat dairy products, or take antacids, didanosine, sucralfate, or vitamins within 2 hours before or after taking Ofloxacin.


• Ofloxacin works best if it is taken at the same time each day.


• To clear up your infection completely, take Ofloxacin for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose, 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 Ofloxacin.

Important safety information:

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


• Ofloxacin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ofloxacin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Diabetes patients - Ofloxacin may affect your blood sugar when taken along with insulin or other medicines for diabetes. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Tell your doctor or dentist that you take Ofloxacin before you receive any medical or dental care, emergency care, or surgery.


• Ofloxacin only works against bacteria; it does not treat viral infections (eg, the common cold).


• Long-term or repeated use of Ofloxacin 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.


• If you experience pain or inflammation, or rupture a tendon during or shortly after taking ofloxacin, contact your health care provider immediately.


• 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.


• Be sure to use Ofloxacin 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.


• Lab tests, including kidney function, may be performed while you use Ofloxacin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Ofloxacin with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat).


• Ofloxacin should not be used in CHILDREN younger than 18 years; 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 taking Ofloxacin while you are pregnant. Ofloxacin is found in breast milk. Do not breast-feed while taking Ofloxacin.

Possible side effects of Ofloxacin:

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; dizziness; headache; loss of appetite; nausea; sensitivity to sunlight; trouble sleeping; 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; unusual hoarseness); agitation; anxiety; bizarre behavior; bloody stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; change in sense of touch or temperature; confusion; convulsions; dark urine; decreased urination; depression; diarrhea (severe or continuing); difficulty swallowing; excessive urination, thirst, or hunger; fainting; fast or irregular heartbeat; fatigue; fever, chills, or unusual cough; hallucinations; joint pain or swelling; light-headedness; loss of consciousness; mental or mood changes; muscle pain or weakness; nervousness; nightmares; pale stools; red, swollen, blistered, or peeling skin; restlessness; seizures; shortness of breath; shock (pale skin); sleeplessness; severe or persistent stomach pain or cramps; shortness of breath or trouble breathing; suicidal thoughts; tendon pain, inflammation, or swelling; tightness of the throat; tremors; unusual bruising or bleeding; unusual tiredness or weakness; urination problems; vaginal irritation or discharge; 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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately. Symptoms may include facial swelling and numbness; hot and cold flushes; mild to moderate disorientation; slurring of speech.

Proper storage of Ofloxacin:

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

General information:

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


• Ofloxacin 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 summary only. It does not contain all information about Ofloxacin. 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.

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• Ofloxacin Support Group
• 3 Reviews for Ofloxacin - Add your own review/rating

• Ofloxacin Prescribing Information (FDA)


• Ofloxacin Professional Patient Advice (Wolters Kluwer)


• Ofloxacin Monograph (AHFS DI)


• ofloxacin Advanced Consumer (Micromedex) - Includes Dosage Information


• Floxin Prescribing Information (FDA)


• Floxin Consumer Overview


• Floxin I.V.

Compare Ofloxacin with other medications

• Anthrax
• Anthrax Prophylaxis
• Bladder Infection
• Bone infection
• Bronchitis
• Campylobacter Gastroenteritis
• Cervicitis
• Chancroid
• Chlamydia Infection
• Epididymitis, Non-Specific
• Epididymitis, Sexually Transmitted
• Gonococcal Infection, Disseminated
• Gonococcal Infection, Uncomplicated
• Joint Infection
• Kidney Infections
• Methicillin-Resistant Staphylococcus Aureus Infection
• Mycobacterium avium-intracellulare, Treatment
• Nongonococcal Urethritis
• Pelvic Inflammatory Disease
• Plague
• Pneumonia
• Prostatitis
• Salmonella Enteric Fever
• Salmonella Gastroenteritis
• Shigellosis
• Skin Infection
• Traveler's Diarrhea
• Tuberculosis, Active
• Urinary Tract Infection

Noxtor

Noxtor may be available in the countries listed below.

Ingredient matches for Noxtor

Ketotifen

Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Noxtor in the following countries:

• Greece

International Drug Name Search

Toltérodine

Toltérodine may be available in the countries listed below.

Ingredient matches for Toltérodine

Tolterodine

Toltérodine (DCF) is known as Tolterodine in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Terbinafina Pensa

Terbinafina Pensa may be available in the countries listed below.

Ingredient matches for Terbinafina Pensa

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafina Pensa in the following countries:

• Spain

International Drug Name Search