Frazole Forte Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Omeprazole

Indications/Uses

Reflux esophagitis, acid-PUD, Zollinger-Ellison syndrome. Adjunctive in duodenal ulcers associated w/ H. pylori combined w/ appropriate antibiotics. Prophylaxis of acid aspiration before surgery. Prevention & treatment of NSAID associated ulcers.

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Dosage/Direction for Use

PUD 20-40 mg/day as single dose after breakfast for 4-8 wk. Zollinger-Ellison syndrome 180 mg/day in divided doses. GERD or severe esophagitis 20 mg/day for 4-8 wk. Acid aspiration prophylaxis 40 mg in the evening before surgery.

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Administration

Should be taken on an empty stomach: Swallow whole, do not chew/crush.

Contraindications

Hypersensitivity. Gastric malignancy.

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Special Precautions

Asians who show 4-fold increase in AUC compared w/ Caucasians given 20 mg single dose. Severe liver disease. Avoid in pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Reversible confusional states, agitation, depression, hallucination; nausea, diarrhea, abdominal colic; agranulocytosis, pancytopenia, thrombocytopenia; erythematous skin rashes, erythema multiforme, exfoliative dermatitis; interstitial nephritis, hematuria, glycosuria; hypoglycemia, alopecia, blurred vision, arthralgia.

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Drug Interactions

Enhanced effect of oral anticoagulants, antiepileptics, diazepam, MTX, digoxin. Reduced absorption of ketoconazole, itraconazole, Fe salts, ampicillin esters.

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Storage

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Description

View Frazole Forte description for details of the chemical structure and excipients (inactive components).

Action

View Frazole Forte mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Antacids, Antireflux Agents & Antiulcerants

ATC Classification

A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

Regulatory Classification

Presentation/Packing

Form

Frazole Forte cap 40 mg

Packing/Price

40's

Frazole Forte

omeprazole

Manufacturer:

Biopharma

Distributor:

Starpharm

Marketer:

JF Draf