Losectil powder for suspension is a preparation 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. Losectil¨ powder for oral suspension is formulated as an immediate release one for oral administration.
 

Losectil is indicated for short-term treatment of active duodenal ulcer, gastric ulcer, heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy, maintenance of healing of erosive esophagitis and reduction of risk of upper gastrointestinal bleeding in critically ill patients.

Short-Term Treatment of Active Duodenal Ulcer: The recommended adult oral dose of omeprazole, 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 for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

Maintenance of Healing of Erosive Esophagitis: The recommended adult oral dose is 20 mg daily. Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients The recommended adult oral dose of Losectil is 40 mg initially, followed by 40 mg after 6 to 8 hours as a loading dose on the first day, then 40 mg once daily for up to 14 days. The use of Losectil in critically ill patients beyond 14 days has not been evaluated.

Losectil should be taken on an empty stomach at least 1 hour prior to meal.
Directions for use: Empty packet contents into a small cup containing 1-2 tablespoon of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately.

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

Pregnancy: Omeprazole should be used in pregnancy if the potential benefit justifies the possible risk of the fetus.
Nursing mothers: Omeprazole concentrations have been measured in breast milk of a woman following oral administration of 20 mg. The peak concentration of omeprazole in breast milk was less than 7% of the peak serum concentration. As omeprazole is excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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.

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.

Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.

Store at or below 25°C (preferably in refrigerator) and dry place, away from light. Keep out of reach of children. Excursions permitted to 15-300 C.

Losectil powder for oral suspension: Losectil 20 :Each box contains 20 sachets. Each sachet contains omeprazole USP 20 mg as immediate release formulation.
Losectil 40: Each box contains 20 sachets. Each sachet contains omeprazole USP 40 mg as immediate release formulation. 



Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK