Composition

Each strip contains One Lansoprazole 30 mg capsule, One Clarithromycin 500 mg tablet and Two Amoxicillin 500 mg capsules.

Indications

This is indicated for the eradication of H. pylori in active chronic gastric, duodenal and gastric ulcers.

Therapeutic Class

Anti H. pylori drugs

Pharmacology

Lansoprazole is a proton-pump inhibitor which inhibits the stomach’s production of gastric acids.

Amoxicillin is a penicillin antibiotic. It acts by inhibiting the synthesis of bacterial cell walls.lt inhibits cross-linkage between the linear peptidoglycan polymer chains that make up a major component of the cell walls of both Gram-positive and Gram-negative bacteria.

Clarithromycin is a macrolide antibiotic.It prevents bacteria from growing by interfering with their protein synthesis. It binds to the subunit 50S of the bacterial ribosome and thus inhibits the translation of peptides

Dosage & Administration

One strip twice daily for 7-14 days or as per the physician’s advice.

Interaction

Lansoprazole is metabolized through the cytochrome P450 system,specially through the CYP3A and CYP2C19 isozymes.Studies in healthy subjects have shown that Lansoprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisolone, diazepam, clarithromycin or terfenadine.

Clarithromycin use in patients who are receiving theophylline may be associated with increase of serum theophylline concentrations.

There have been reports of interactions of erythromycin and/or clarithromycin with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfetanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide & astemizole.

Contraindications

This is contraindicated in patients with known hypersensitivity to any of its component.

Side Effects

Adverse reactions which were reported as possibly or probably related to treatment (>3%) in clinical trials when all three components of this therapy were given concomitantly are listed below and devided by body systems.

Digestive system: Nausea, vomitng, diarrhoea, dark stools, dry mouth, glossitis, oral moniliasis, stomatitis, tongue discoloration

Musculoskeletal System: myalgia

Nervous System: confusion,headache,dizziness;

Skin: skin reactions

Urogenital System: vaginitis,vaginal moniliasis.

Pregnancy & Lactation

There were no adequate and well-controlled studies in pregnant women. This should be used during pregnancy only if the potential benefit justifies the potential risk of the mother. Amoxicillin is excreted in human milk in very small amounts. Because of the potential for serious adverse reactions in nursing infants. A decision should be made whether to discontinue nursing or to discontinue the drug therapy, taking into account the importance of the therapy to the mother.

Precautions & Warnings

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on Amoxicillin therapy. These reactions are more appropriate to occur in individuals with a history of penicillin hypersensitivity. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.

Use in Special Populations

Pediatric Use: Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (≤ 3 months)

Geriatric use: Elderly patients may suffer from asymptomatic renal and hepatic dysfunction. Care should be taken when administering to these patients.

Storage Conditions

Store in a cool and dry place, protected from light.