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Lanzotec

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

Lanzotec

Manufacturer

Jordan Sweden Medical and Sterilization Co., Na'ur, Jordan

Therapeutic Class

Antiulcerants, Proton pump inhibitors (PPI)

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN:04-2847): Lansoprazole 30 mg.

How to identify the Product: Enteric-coated pellets.

Pack size: 15's.

Pharmacology

Lansoprazole, the active ingredient in Lanzotec, is a substituted benzimidazole proton pump inhibitor.

Lanzotec suppresses gastric acid secretion by the specific inhibition of the (H+, K+) ATPase enzyme system (acid pump) at the surface of gasric parietal cells, resulting in the blocking of the final step of acid production and so the inhibition of both basal and stimulated acid secretion regardless of the stimulus.

Lanzotec is available in the form of enteric coated pellets that are rapidly absorbed only after they leave the stomach, with an absolute bioavailability over 80%, a plasma half life of 1.5 hrs, and a duration of action >24 hrs. It is extensively metabolised in the liver into inactive metabolites that undergo significant biliary excretion.

Indications

  • Short-term treatment of active duodenal ulcer (DU).
  • Maintenance of healed duodenal ulcer;
  • Eradication of H.pylori infection to prevent DU recurrence;
  • Short-term treatment of active benign gastric ulcer;
  • Short-term treatment of erosive esophagitis;
  • Maintenance of healing of erosive esophagitis;
  • Long-term treatment of pathological hypersecretory conditions including ZE syndrome.

Contra-indications

Hypersensitivity to Lansoprazole or any component of the product.

Precautions/Warnings

As with other antiulcerants, symptomatic response to treatment with Lansoprazole does not preclude gastric malignancy.

Pregnancy: Category B: Use during pregnancy only if clearly needed.

Lactation: It is not known if Lansoprazole is excreted in human breast milk, the physician should decide to discontinue nursing or to discontinue the drug according to the importance of the drug to the mother.

Children: Safety and efficacy are not established in children

Liver impairment: Consider dosage reduction in severe cases of hepatic impairment.

Elderly: Doses >30 mg daily should be administered only if additional acid suppression is needed.

Dysphagia: For patients with difficulty in swallowing, capsule can be opened and pellets can be swallowed immediately, without crushing or chewing the pellets.

Interactions

Lansoprazole does not have clinically significant interactions with drugs metabolized by CYP-450 system. Lansoprazole may theoretically interfere with drug absorption that is determined by gastric pH since it profoundly inhibits acid secretion (e.g. Ketoconazole, Ampicillin, Iron salts and Digoxin).

Adverse Effects

Generally, Lansoprazole therapy is well tolerated in both short and long-term treatments. Some adverse reactions like diarrhea, nausea, abdominal pain, headache and skin rashes may occur.

Dosage & Administration

For best results take Lanzotec capsule 30 minutes before meals. No dosage adjustment is necessary in elderly or renal impairment patients. Adjust dosage in case of severe liver impairment.

Duodenal Ulcer: Short-term treatment: 15-30 mg once daily for 4 weeks. Maintenance of healed duodenal ulcer: 15 mg once daily.

Eradication of H.pylori to prevent DU recurrence: Suggested regimens: Triple therapy: (Lanzotec/Amoxicillin/Clarithromycin): 30 mg Lanzotec, 1 g Amoxicillin and 500 mg Clarithromycin all given BID (every 12 hours) for 2 weeks.

Four-day triple therapy (Lanzotec/Azithromycin/Tinidazole): Lanzotec 30 mg BID on days 1-4, Azithromycin 500 mg once daily on days 2-4, and Tinidazole 2000 mg once on day 4.

Dual therapy (Lanzotec/Amoxicillin): Lanzotec 30 mg and Amoxicillin 1 g TID for 2 weeks.

Active benign gastric ulcer: Short-term treatment: 30 mg once daily for up to 8 weeks.

Erosive esophagitis: Short-term treatment: 30 mg once daily for 8 weeks, additional 8 weeks may be needed for patients who do not heal. In case of recurrence consider another 8 weeks.

Healing maintenance: 15 mg once daily.

Pathological hypersecretory conditions including ZE syndrome: The dosage should be individualized according to the desired patient response and for as long as needed. The usual starting dose is 60 mg once daily. Daily doses >120 mg should be administered in divided doses.

Directions: Take before meals; Replace cap firmly after each use; Use the drug within one month from opening date; If you have difficulty in swallowing the capsule, open it and swallow the content immediately without chewing or crushing the content.

Overdosage:

Lansoprazole is not removed from circulation by hemodialysis. Treatment should be symptomatic and supportive.

Storage/Handling Recommendations

Keep in a cool dry place and away from children.

Review Date

2017-09-24 10:41:23