Drug Catalog - Product Detail
LANSOPRAZOLE DR CAP/AMOXICILLIN CAP/CLARITHROMYCIN TAB CP/CP/TB 30/500/500MG 14X8
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0418-64 | PRASCO LABORATORIES | 112 | NA | NA |
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Description
DESCRIPTION Lansoprazole/amoxicillin/clarithromycin consists of a daily administration card containing two lansoprazole delayed-release 30 mg capsules, four amoxicillin 500 mg capsules, USP, and two clarithromycin 500 mg tablets, USP, for oral administration. Lansoprazole Delayed-Release Capsules The active ingredient in lansoprazole delayed-release capsules is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical 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: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. Chemical Structure Amoxicillin Capsules, USP Amoxicillin is a semi synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2 S , 5 R , 6 R )-6-[( R )-(-)-2-amino-2-( p -hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [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 capsule, with yellow opaque cap and body, contains 500 mg amoxicillin trihydrate. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide; Capsule contents – cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Chemical Structure Clarithromycin Tablets, USP Clarithromycin is a semi-synthetic macrolide antibiotic. 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 yellow oval film-coated immediate-release tablet contains 500 mg of clarithromycin and the following inactive ingredients: hypromellose, hydroxypropyl cellulose, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sorbic acid, sorbitan monooleate, titanium dioxide, and vanillin. Chemical Structure
How Supplied
HOW SUPPLIED Lansoprazole/amoxicillin/clarithromycin is supplied as an individual daily administration card, each containing: Lansoprazole Delayed-Release Capsules – Two opaque, hard gelatin, black and pink capsules with "TAP" and "PREVACID 30" imprinted on the capsules. Amoxicillin Capsules, USP – Four yellow, opaque, hard gelatin 500-mg capsules imprinted with AMOX 500 on one side and GG 849 on the other side. Clarithromycin Tablets, USP – Two yellow, oval film-coated 500-mg tablets debossed with the Abbott logo on one side and "KL" on the other side of the tablets. NDC 66993-418-64 Carton containing 14 daily administration cards NDC 66993-418-82 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/amoxicillin/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/amoxicillin/clarithromycin and other antibacterial drugs, lansoprazole/amoxicillin/clarithromycin 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/amoxicillin/clarithromycin is not recommended in patients with creatinine clearance less than 30 mL/min.