products-page-bottom-left-box

Milan

Elbe Pharma Nig. Ltd
1, African Church close, off Coker Road, Ilupeju, Lagos, Nigeria
Email: elbepharma@gmail.com
Tel: 01-773-1473, 01-8179648, 08033160649
Fax: 01-452-8219

Brand Name

Milan

Manufacturer

MICRO LABS LIMITED, 92, SIPCOT, HOSUR-635 126. INDIA

Therapeutic Class

Antiulcerants, Proton pump inhibitors (PPI)

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN: 04-3006): Each capsule contains: Lansoprazole 30 mg (as enteric coated granules)

Pack size: 1 x 2 x 30's.

 Milan

Pharmacology

Chemistry: 2-{(3-Methyl-4-(2,2,2-trihydrofluoroethoxy)-2 pyridryl) methyl} sulphinyl benzimidazole.

Pharmacological Category: Antiulcerant (Proton Pump Inhibitor)

Lansoprazole inhibits the H+/K+-ATPase (the proton pump) of the parietal cells in the gastric mucosa. Lansoprazole has a prolonged pharmacological action and provides effective acid suppression over 24 hours. Lansoprazole is effective in the treatment of acid-related disorders of the upper gastrointestinal tract, with the advantage of rapid symptom relief.

Absorption is rapid, with mean peak plasma levels of Lansoprazole occurring at approximately 1.7 hours. Peak plasma concentrations of Lansoprazole (Cmax) and the area under the plasma concentration curve (AUC) are approximately proportional to dose throughout the range that has been studied (up to 60 mg).

Binding to plasma proteins is approximately 97%. Lansoprazole is eliminated primarily by hepatic metabolism, the metabolites being excreted both via the bile and in urine. About 64% of a dose is recovered in the feces, the greater part in the form of metabolites; less than 2% is excreted unchanged in the urine

Indications

Lansoprazole is indicated in the healing and maintenance of duodenal ulcer, and gastro-oesophageal reflux disease, healing of benign gastric ulcer, and reflux oesophagitis.

Contra-indications

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

Precautions/Warnings

In Hepatically impaired patients with moderate impairment, doses higher than 30 mg per day should not be administered unless there are compelling clinical indications.

Interactions

Caution should be exercised when oral contraceptives and preparations such as phenytoin, theophylline, or warfarin, are taken concomitantly with the administration of Lansoprazole. Antacids and sucralfate may reduce the bioavailability of lansoprazole and should therefore not be taken within an hour of Lansoprazole administration.

Use in Pregnancy and Lactation: There are no adequate or wellcontrolled studies in pregnant women. Therefore, Lansoprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
It is not known whether Lansoprazole is excreted in human milk. Because drugs are excreted in human milk, Lansoprazole should not be given to nursing mothers unless its use is considered essential.

Use in Children: Safety and effectiveness in children have not been established.
When gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with Lansoprazole is instituted, as treatment with this drug may alleviate symptoms and delay diagnosis

Adverse Effects

Most common adverse reactions are diarrhoea, nausea, headache, dermatological reactions.

Dosage & Administration

Duodenal Ulcer: 30 mg daily for 4-8 weeks then 15 mg/day for maintenance dose.

Benign gastric ulcer: 30 mg daily for 8 weeks.

Reflux oesophagitis: 30 mg daily for 4-8 weeks, then 15 mg for maintenance dose,

Zollinger-Ellison syndrome: 60 mg daily to be continued till clinically indicated.

Overdosage, Symptoms and Antidote: There is no information on the effect of overdosage. As in all cases where overdosing is suspected, treatment should be supportive and symptomatic

Storage/Handling Recommendations

Keep in a cool, dry place and away from the reach of children.

Review Date

2015-09-24 07:08:43