Aspra

Generic Name: Omeprazole

Therapeutic Class: Antiulcerant

View Prescribing Detail

Composition
Aspra-20 Capsule: Each capsule contains Omeprazole USP 20 mg as enteric coated 22.5% Omeprazole in pellets.
Aspra-40 Capsule: Each capsule contains Omeprazole USP 40 mg as enteric coated 22.5% Omeprazole in pellets.
Pharmacology
Aspra (Omeprazole) is a substituted benzimidazole that suppresses gastric acid secretion by specific inhibition of the
gastric acid proton pump (H+/K+ ATPase enzyme system) at the secretory surface of the gastric parietal cell. It blocks
the final step of acid production. After oral administration, the onset of the antisecretory effect of Omeprazole occurs
within one hour, with the maximum effect occurring within two hours and the duration of inhibition lasts up to 72 hours.
The antisecretory effect lasts far longer than would be expected from the very short (less than one hour) plasma
half-life, apparently due to prolonged binding to the parietal H+/K+ ATPase enzyme. Following absorption,
Omeprazole is almost completely metabolized and rapidly eliminated mostly through urine.
Indication
Aspra is indicated in the treatment of heartburn, any symptoms of GERD, erosive esophagitis (both curative and
maintenance therapy), duodenal ulcer, gastric ulcers, reduction of risk of upper GI bleeding in critically ill patients.
Dosage & Administration
Aspra should be taken before meal. No dose adjustment is necessary for patients with renal impairment, hepatic
dysfunction or for the elderly.
Duodenal Ulcer: The recommended adult oral dose is 20 mg once daily. Most patients heal within four weeks. Some
patients may require an additional four weeks of therapy.
Gastric Ulcer: The recommended adult oral dose is 40 mg once a day for 4-8 weeks.
Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose is 20 mg daily for up to 4 weeks.
Erosive esophagitis: The recommended adult oral dose is 20 mg daily for 4 to 8 weeks.
Zollinger-Ellison syndrome: The recommended adult oral starting dose is 60 mg once a day. Doses should be
adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg t.i.d.
have been administered. Daily dosages of greater than 80 mg should be administered in divided doses.
Contraindication
Omeprazole is contraindicated in patients with known hypersensitivity to any components of the formulation.
Precaution
Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy.
Side Effect
Omeprazole is well tolerated and adverse reactions have generally been mild and reversible. Side-effects may include
headache, diarrhoea, constipation, abdominal pain, nausea/vomiting and flatulence, dizziness, paraesthesia,
somnolence, insomnia and vertigo, increased liver enzymes, rash, dermatitis and/or pruritus, urticaria, Malaise.
Others include hypersensitivity reactions e.g. angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic
shock.
Use in Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies on the use of Omeprazole in pregnant women.
Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Omeprazole should be used
during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.
Lactation: Omeprazole is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the mother.
Overdosage
Symptoms were transient, and no serious clinical outcome has been reported with Omeprazole overdose. No specific
antidote for Omeprazole overdose is known. Omeprazole is extensively bound with protein and is, therefore, not
readily dialyzable. In the event of overdose, treatment should be symptomatic and supportive.