1, African Church close, off Coker Road, Ilupeju, Lagos, Nigeria
Tel: 01-773-1473, 01-8179648, 08033160649
MICRO LABS LIMITED 92, SIPCOT, HOSUR-635 126. INDIA.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Capsule (NRN: 04-5648): Each capsule contains: Omeprazole BP 20 mg (As enteric coated granules)
Pack size: 3 x 10's.
CHEMISTRY: 5-methoxy-2 - [[(4-methoxy-3, 5-dimethylpyridin-2-yl) methyl] sulphinyl]-1 H-benzimidazole
PHARMACOLOGICAL CATEGORY: Antiulcerant (Proton Pump Inhibitor)
Omeprazole markedly inhibits basal and stimulated gastric acid secretion. It has a unique mode of irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphatase, the so called proton pump of the parietal cells which is supposedly the terminal step in the acid secretory pathway.
Omeprazole is rapidly absorbed after release from enteric coated formulations. Peak plasma concentration of Omeprazole occurs within 05 to 3.5 hours following oral administration. Enteric coating increases bioavailability to over 65%. Plasma protein binding is about 95-96%. Omeprazole is eliminated rapidly and almost completely by metabolism.
Duodenal and gastric ulcers, Zollinger Ellison syndrome, Reflux oesophagitis.
Omeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation
Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy.
Use in children: Omeprazole is not recommended for use in children
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 phenyl oin. 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 determinant of their bioavailability (e.g. Ketoconazole, ampicillin esters and iron salts).
USE IN PREGNANCY AND LACTATION:
Omeprazole should be used 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
The most frequent side effects reported with Omeprazole are headache, diarrhoea, abdominal pain, nausea, dizziness, vomiting, rash, flatulence, constipation, cough & asthenia. They are mainly transient and do not require a reduction in dose
Dosage & Administration
Active duodenal ulcer: 20 mg/day for 4 weeks extended up to 8 weeks if required.
Gastric ulcer: 20 mg/day for 8 weeks
Reflux oesophagitis: 20 mg/day for 4 to 8 weeks.
Severe Erosive oesophagitis: 20 mg/day for 4 to 8 weeks.
Zollinger-Ellison syndrome: 60 mg/day duration adjusted to response.
Omeprazole should be preferably taken In the morning before food.
Dosage adjustment is not necessary in elderly patients or in patients with renal or hepatic Impairment.
OVERDOSAGE, SYMPTOMS AND TREATMENT:
Dosage 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
Store below 25°C, in a dark and dry place. Keep away from the reach of children