FORMULA:
Each Lansoprol Micropellet Capsule contains 15 mg of lansoprazole in the form of gastric acid resistant, enteric-coated micropellets.

PHARMACOLOGICAL PROPERTIES:
Lansoprazole suppresses gastric acid secretion by specific inhibition of the (H+,K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. Lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.
The absorption of lansoprazole is rapid, with mean Cmax occurring approximately 1.7 hours after oral dosing, and relatively complete with absolute bioavailability over 80%. Lansoprazole is 97% bound to plasma proteins.

INDICATIONS:

• Short-term treatment of healing and maintenance of healed duodenal ulcers,
• Maintenance of healed gastric ulcers,
• Treatment of moderate or advanced reflux (erosive) esophagitis.

CONTRAINDICATIONS:
Lansoprol 15 mg Micropellet Capsule is contraindicated in patients with known hypersensitivity to any component of the formulation.

DRUG INTERACTIONS and OTHER INTERACTIONS:
Studies have shown that lansoprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P 450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisone, diazepam, clarithromycin, or terfenadine in healthy subjects.

SIDE EFFECTS / ADVERSE EVENTS:
Lansoprol 15 mg Micropellet Capsule treatment has been well-tolerated in both short-term and long-term trials.
The following adverse events were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of lansoprazole-treated patients: abdominal pain, diarrhea and nausea.

WARNINGS / PRECAUTIONS:
Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.

DOSAGE and ADMINISTRATION:
Duodenal Ulcers:
Short-term therapy : The recommended adult dose is 15 mg once daily for up to 4 weeks.
Maintenance of healed duodenal ulcer: The recommended adult dose is 15 mg once daily. Controlled studies did not extend beyond 12 months.
Maintenance of healed gastric ulcers: The recommended adult oral dose is 15 mg once daily. Controlled studies did not extend beyond 8 weeks.
Treatment of moderate or advanced reflux (erosive) esophagitis: The recommended adult oral dose is 15 mg once daily for 8 weeks. For patients who do not heal with lansoprazole for 8 weeks, it may be helpful to give an additional 8 weeks of treatment. Controlled studies did not extend beyond 12 months.
No dosage adjustment is necessary in patients with renal insufficiency or elderly patients. For patients with severe liver disease, dosage adjustment should be considered.
Lansoprol 15mg Micropellet Capsule SHOULD BE TAKEN BEFORE EATING. MICROPELLETS IN CAPSULES SHOULD NOT BE CHEWED OR CRUSHED.

OVERDOSE:
Lansoprazole has no known antidote. It is not removed from the body by dialysis. In any event of overdosage, symptomatic and supportive treatment should be instituted.

HOW SUPPLIED:
Lansoprol 15 mg Micropellet Capsule; in blister packages of 28 capsules.

OTHER PHARMACEUTICAL DOSAGE FORMS:
Lansoprol 30 mg Micropellet Capsule; In blister packages of 28 capsules.