Omicap

Omicap

omeprazole

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Omeprazole.
Description
Omeprazole is 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole. Its empirical formula is C17H19N3O3S.
Action
Proton-pump inhibitor.
Pharmacology: Omeprazole markedly inhibits basal and stimulated gastric acid secretion. It has a unique mode of action, irreversibly blocking the 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 after 3-4 or 5-6 hrs following oral administration. The mean half-life is 0.5-1.5 hrs. 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 and reflux oesophagitis.
Dosage/Direction for Use
Active Gastric Duodenal Ulcer: 20 mg/day for 2-4 weeks.
Severe Duodenal Ulcer: 40 mg/day for 4-8 weeks.
Reflux Oesophagitis: 20 mg/day for 4-8 weeks.
Severe Erosive Oesophagitis: 20-40 mg/day for 4-8 weeks.
Zollinger-Ellison Syndrome: 60 mg/day, duration adjusted to response.
Dosage adjustment is not necessary in the elderly or in patients with renal or hepatic impairment.
Overdosage
There is no experience to date with deliberate overdosage. Dosages up to 360 mg/day are 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
Patients with known hypersensitivity to any component of Omicap.
Special Precautions
In long-term studies in rats, omeprazole produced a dose-related increase in gastric carcinoid tumours. Biopsy specimen from human stomach has not detected risk from short-term exposure to omeprazole. Further human data on the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumors in humans receiving long-term therapy with Omicap (omeprazole).
Use in pregnancy & lactation: The safety of Omicap in human pregnancy has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether omeprazole is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from omeprazole and because of the potential for tumorigenicity shown for omeprazole in rat carcinogenic studies, a decision should be made whether to discontinue nursing or to discontinue omeprazole, taking into account the importance of the drug to the mother.
Use in children: Safety and effectiveness in children have not been established.
Use In Pregnancy & Lactation
The safety of Omicap in human pregnancy has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether omeprazole is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from omeprazole and because of the potential for tumorigenicity shown for omeprazole in rat carcinogenic studies, a decision should be made whether to discontinue nursing or to discontinue omeprazole, taking into account the importance of the drug to the mother.
Side Effects
The most frequent side effects reported with omeprazole are headache, diarrhoea, abdominal colic, nausea, dizziness, vomiting, rash, flatulence, constipation, cough and asthenia. These are mainly transient and do not require a reduction in dose.
Drug Interactions
Omeprazole has the potential to interfere with the cytochrome P-450 enzyme system and then to induce or inhibit the metabolism of drugs eg, 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 important in the determination of their bioavailability (eg, ketoconazole, ampicillin, esters and iron salts).
Storage
Store in a cool, dark and dry place.
Shelf-Life: 24 months.
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 (enteric-coated granules) x 10 x 10's.
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