Omicap

Omicap

omeprazole

Manufacturer:

Micro Labs

Distributor:

Atlanta Medicare
Full Prescribing Info
Contents
Omeprazole.
Description
Each capsule contains Omeprazole 20 mg. (As enteric coated granules). Omeprazole has a chemical name of 5-methoxy-2-[{(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl}sulfinyl]-1H-benzimidazole.
Action
Pharmacotherapeutic Group: Proton Pump Inhibitors.
Pharmacology: Pharmacodynamics: Omeprazole markedly inhibits basal and stimulated gastric acid secretion. It has a unique mode of irreversibly blocking the so called proton pump of the parietal cells which is supposedly the terminal step in the acid secretory pathway.
Pharmacokinetics: Omeprazole is rapidly absorbed after release from enteric-coated formulations. Peak plasma concentration of Omeprazole occurs within 0.5 to 3.5 hours following oral administration. Plasma protein binding of it is about 95-96%. Omeprazole is eliminated rapidly and almost completely by metabolism. Three metabolites observed in plasma are sulfide and sulfone derivatives of Omeprazole and hydroxyomeprazole. These metabolites have very little or no antisecretory activity.
Indications/Uses
Duodenal and gastric ulcers, Zollinger Ellison syndrome, Reflux oesophagitis.
Dosage/Direction for Use
This drug should be taken immediately before breakfast once a day. Active gastric duodenal ulcers: 20 mg/day for 2 to 4 weeks.
Severe duodenal ulcers: 40 mg/day for 4 to 8 weeks.
Reflux oesophagitis: 20 mg/day for 4 to 8 weeks.
Severe erosive oesophagitis: 40 mg/day for 4 to 8 weeks.
Zollinger-Ellison syndrome: 60 mg/day duration adjusted to response.
Dosage adjustment is not necessary in elderly patients or in patients with renal impairment.
Overdosage
Dosage u to 360 mg/day is well tolerated. No specific antidote is known. Omeprazole is extensively protein bound and is therefore not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
Contraindications
Omeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
Special Precautions
Omeprazole produces a dose-related increase in gastric carcinogenic tumours. Biopsy specimens from human stomach have not detected risk from short-term exposure to Omeprazole.
Use in Children: Omeprazole is not recommended for use in children.
Use In Pregnancy & Lactation
Omeprazole should be use during pregnancy only if the potential benefit justifies the potential risk to the foetus. Breast feeding should be discontinued by women being treated with Omeprazole.
Adverse Reactions
The most frequent side effects reported with Omeprazole are headache, diarrhoea, abdominal colic, nausea, dizziness, vomiting, rash, flatulence, constipation, cough & asthenia.
Drug Interactions
Omeprazole has the potential to interfere with the Cytochrome P450 enzyme system and then to induce or inhibit the metabolism of drugs like diazepam, warfarin and phenytoin. Because of its profound and long lasting inhibition of gastric acid secretion, Omeprazole may interfere with absorption of drugs where gastric pH is an important determination of their bioavailability (eg. Ketoconazole, Ampicillin, Esters and Iron salts).
Storage
Store in a cool and dry place.
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).
Presentation/Packing
Cap 20 mg x 10 x 10's.
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