Drug Catalog - Product Detail
LANSOPRAZOLE DR CAP/AMOXICILLIN CAP/CLARITHROMYCIN TAB CP/CP/TB 30/500/500MG 14X8
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-4054-42 | SANDOZ | 112 | NA | MISCELLANEOUS |
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Description
DESCRIPTION triple therapy Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg consists of a daily administration card containing two lansoprazole 30 mg delayed-release capsules USP, four amoxicillin 500 mg capsules USP, and two clarithromycin 500 mg tablets USP, for oral administration. Lansoprazole Delayed-Release Capsules USP The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a proton pump inhibitor. Its molecular formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.37. Lansoprazole has the following structure: Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, polyethylene glycol, sugar spheres (contains maize starch and sucrose), talc and titanium dioxide. Components of the hypromellose capsule include carrageenan, hypromellose, potassium chloride and titanium dioxide. The capsule is printed with edible black ink containing carnauba wax, FD & C blue # 2 aluminum lake, glyceryl monooleate, red ferric oxide, shellac, yellow ferric oxide. lansoprazole-chemical-structure Amoxicillin Capsules USP Amoxicillin is a penicillin class antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-aza-bicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. The molecular formula is C 16 H 19 N 3 O 5 S • 3H 2 O and the molecular weight is 419.45. Amoxicillin has the following structure: Amoxicillin capsules are intended for oral administration. Each yellow opaque capsule contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin. Inactive ingredients: Capsule shells – yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents – cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. amoxicillin-chemical-structure Clarithromycin Tablets USP Clarithromycin is a macrolide antimicrobial. Chemically, it is 6-0-methylerythromycin. The molecular formula is C 38 H 69 NO 13 , and the molecular weight is 747.96. Clarithromycin has the following structure: Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white oval film-coated immediate-release tablet contains 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. clarithromycin_chem-structure
How Supplied
HOW SUPPLIED Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg are supplied in boxes of 14 daily administration cards, each card containing: Lansoprazole Delayed-Release Capsules USP, 30 mg: Two white hypromellose capsules with GG638 black imprint on cap and body of the capsule, containing white to off-white pellets. Amoxicillin Capsules USP, 500 mg: Four yellow, opaque, hard gelatin amoxicillin 500 mg capsules, USP, imprinted AMOX 500 on one side and GG 849 on the other side. Clarithromycin Tablets USP, 500 mg: Two white oval film-coated tablets, debossed GG C9 on one side and plain on the reverse side. NDC 0781-4054-42 Carton containing 14 daily administration cards NDC 0781-4054-32 Daily administration card Store between 20°C and 25°C (68°F and 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
Indications & Usage
INDICATIONS AND USAGE H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence The components in lansoprazole delayed-release capsules USP, 30 mg, amoxicillin capsules USP, 500 mg, and clarithromycin tablets USP, 500 mg (lansoprazole, amoxicillin, and clarithromycin) are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of lansoprazole delayed-release capsules USP, 30 mg, amoxicillin capsules USP, 500 mg, and clarithromycin tablets USP, 500 mg and other antibacterial drugs, lansoprazole delayed-release capsules USP, 30 mg, amoxicillin capsules USP, 500 mg, and clarithromycin tablets USP, 500 mg should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosage and Administration
DOSAGE AND ADMINISTRATION H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence The recommended adult oral dose is 30 mg lansoprazole, 1 g amoxicillin, and 500 mg clarithromycin administered together twice daily (morning and evening) for 10 or 14 days (see INDICATIONS AND USAGE ). Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg is not recommended in patients with creatinine clearance less than 30 mL/min.