Class: Gastrointestinal System
Dosage Form: Tablets
Description: Proton pump inhibitor for the treatment of peptic ulcer
Lansoprazole……………………15 or 30 mg
Lansoprazole belongs to a class of anti-secretory compound, the substituted benzimidazole, that do not exhibit antichlorinergic or histamine H2 receptor antagonist properties, but that suppress gastric acid secretion by specific inhibition of the (H+/ K+) ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as teh acid (proton) pump within the 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 ihibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.
The absorption of Lansoprazole is rapid and there is no significant food effect if the drug is given before meals. Lansoprazole is 97% bound to plasma proteins. It is extensively metabolized in the liver and the acid inhibitory effect lasts for more than 24 hours.
Zollipak is indicated in:
- Active duodenal ulcer
- Gastric ulcer
- Erosive esophagus
- Pathological hypersecretory conditions including Zollinger-Ellison Syndrome
Zollipak is contraindicated in patients with known hypersensitivity to any component of the formulation.
During concomitant administration of lansoprazole with theophylline, a minor increase (10%) in the clearance of theophylline was seen.
Lansoprazole causes a profound and long lasting inhibition of gastric secretion, therefore, it is theoretically possible that lansoprazole may interfere with the absorption of drug when gastric pH is an important determinant of bioavailability (ex: Ketoconazole, ampicillin esters, iron salts, and digoxin).
Zollipak is generally well tolerated. In exceptional cases nausea, dizziness, flatulence, constipation, headache or diarrhea may occur. Effects are generally mild and transient, and don’t require a reduction in dosage.
Dosage and Administration:
- 1 capsule daily for 4 weeks
2. Benign gastric ulcer:
- 1 capsule daily for 4-6 weeks
3. Erosive esophagitis:
- 1 capsule daily for up to 8 weeks
4. Pathological hypersecretory conditions including Zollinger-Ellison Syndrome:
- The recommended adult oral starting dose is 2 capsules (60 mg) once daily
- Dosage up to 90 mg (3 capsules) twice daily
- Daily doses of greater than 120 mg should be administered in divided doses
No dosage adjustment is necessary in patients with renal insufficiency or the elderly.
For patients with severe hepatic insufficiency, dosage adjustment should be considered.
Pregnancy and Lactation:
There is no adequate well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Because of the potential for serious adverse reactions in nursing infants from lansoprazole, 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.
Box of 10 capsules.
Store at room temperature, below 25°C.