Omeprazole

DESCRIPTION 

Omeprazole- capsule contains enteric-coated pellets of omeprazole. It is a specific inhibitor of the gastric proton pump (H+/K+-ATPase) in the parietal cell. There it produces dose - dependent inhibition of acid secretion by binding to the enzyme and effectively reduces gastric acid secretion. This effect leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. After oral administration, the onset of the antisecretory effect of Losectil occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.

INDICATIONS 

Treatment of oesophageal reflux disease.
Treatment of duodenal and benign gastric ulcers including those complicating NSAID therapy.
Relief of reflux-like symptoms (e.g. heartburn) and/ or ulcer like symptoms (e.g. epigastric pain) associated with acid-related dyspepsia.
Treatment and prophylaxis of NSAID- associated benign gastric ulcers, duodenal ulcers, and gastroduodenal erosion in-patients with a previous history of gastroduodenal lesions who require continued NSAID treatment. Relief of associated dyspeptic symptoms.
Helicobacter pylori eradication : Omeprazole should be used in combination with antibiotics for eradication of Helicobacter pylori (Hp) in peptic ulcer disease.
Relief of associated dyspeptic symptoms.
Prophylaxis of acid aspiration.
Zollinger-Ellison syndrome.

DOSAGE AND ADMINISTRATION

Losectil capsule should be taken before meal. Dose adjustment is not required in elderly.
Benign gastric ulcers: 20 mg once daily for 8 weeks; in severe or recurrent cases increase to 40 mg daily.
Duodenal ulcers: 20 mg once daily for 4 weeks in duodenal ulceration; in severe or recurrent cases increase to 40 mg daily.
Maintenance for recurrent duodenal ulcer 20 mg once daily.
Prevention of relapse in duodenal ulcer: 10 mg daily increasing to 20 mg once daily if symptoms return.
NSAID-associated peptic ulcer and gastroduodenal erosions 20 mg once daily for 4 weeks, followed by a further 4 weeks if not fully healed.
Prophylaxis in patients with a history of NSAID-associated gastroduodenal lesions who require continued NSAID treatment 20 mg once daily.
Zollinger - Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (above 80 mg in 2 divided doses).
Gastric acid reduction during general anaesthesia (prophylaxis of acid aspiration): 40 mg on the preceding evening then 40 mg 2-6 hours before surgery.
Gastro- oesophageal reflux disease: 20 mg once daily for 4 weeks, followed by a further 4-8 weeks if not fully healed.
Gastro- oesophageal reflux disease refractory to other treatment: 40 mg once daily has been given for 8 weeks may be continued at 20 mg once daily.
Acid reflux disease (long-term management): 10 mg daily increasing to 20 mg once daily if symptoms return.
Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks according to response.
Eradication of Helicobacter pylori: 20 mg twice daily plus amoxicillin 500 mg four times daily plus metronidazole 400 mg thrice daily for 2 weeks.

Child over 2 years : Severe ulcerating reflux oesophagitis : 0.7 -1.4 mg/kg daily for 4-12 weeks; maximum 40 mg daily (to be initiated by hospital paediatricians).
Impaired renal function: Dose adjustment is not required in patients with impaired renal function.
Impaired hepatic function: As bioavailability and half life can increase in patients with impaired hepatic function, the dose requires adjustment with a maximum daily dose of 20 mg.

CONTRAINDICATIONS

Omeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
 

USE IN PREGNANCY AND LACTATION

Pregnancy : Omeprazole should be used in pregnancy if the potential benefit justifies the possible risk of the fetus.
Nursing mothers : It is not known whether omeprazole is secreted in human milk.


SIDE EFFECTS

Omeprazole is generally well tolerated. Nausea, headache, diarrhoea, constipation and flatulence have been reported but are rare. Skin rashes have occurred in a few patients. These events have usually been mild and transient and there has been no consistent relationship with treatment.
 

DRUG INTERACTIONS

Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. Monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary, when omeprazole is added to treatment.

PRECAUTIONS

Before treatment the presence of gastric malignancy should be excluded

PHARMACEUTICAL PRECAUTION

Store in a cool dry place, away from light. Keep out of reach of children.

PACKAGING

Omeprazole-10 Capsule: Box containing 8 strips of 6 capsules each. Each capsule contains omeprazole BP 10 mg as enteric coated pellets.
Omeprazole-20 Capsule: Box containing 5 strips of 6 capsules each. Each capsule contains omeprazole BP 20mg as enteric coated pellets.
Omeprazole-40 Capsule: Box containing 5 strips of 4 capsules each. Each capsule contains omeprazole BP 40mg as enteric coated pellets.


 

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