Prescription Drugs

Find Lowest Prices on Omeclamox®-Pak (omeprazole, clarithromycin, amoxicillin) Capsules and Tablets for Oral Administration DESCRIPTION Omeclamox®-Pak consists of a pack of ten individual daily administration cards, each card containing two omeprazole delayed-release 20 mg capsules, USP, two clarithromycin 500 mg tablets, USP, and four amoxicillin 500 mg capsules, USP, for oral administration. Omeprazole Delayed-Release Capsules, USP The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl) methyl] sulfinyl]1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is: Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol, and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule contains 20 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, lactose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl acetate. The capsule shells contain: D&C Red #28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Clarithromycin Tablets, USP Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. Clarithromycin has the following structural formula: 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 tablet for oral administration contains 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry II (White), povidone, stearic acid, and talc. Opadry II (White) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide and triacetin. Amoxicillin Capsules, USP Amoxicillin, a semisynthetic antibiotic, is an analogue 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. Its empirical formula is C16H19N3O5S •3H2O with a molecular weight of 419.45. Amoxicillin has the following structural formula: Amoxicillin capsules contain amoxicillin trihydrate equivalent to 500 mg of amoxicillin. Amoxicillin capsules USP also contain magnesium stearate and sodium lauryl sulfate. The capsule shell contains D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. Each 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium.

INDICATIONS To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omeclamox®-Pak and other antibacterial drugs, Omeclamox®-Pak should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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. Eradication Of Helicobacter Pylori In Patients With Active Duodenal Ulcer Or History Of Duodenal Ulcer Disease Omeprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules taken together are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [See Clinical Studies]. In patients who fail therapy with Omeclamox®-Pak, perform susceptibility testing. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, institute alternative antimicrobial therapy [See CLINICAL PHARMACOLOGY, Microbiology]. DOSAGE AND ADMINISTRATION The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg, each given twice daily, for 10 days, in the morning and evening before eating a meal. Inform patients that omeprazole, clarithromycin, and amoxicillin should not be crushed or chewed, and should be swallowed whole. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief. HOW SUPPLIED Dosage Forms And Strengths Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains: Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque, hard gelatin lavender and grey capsules, with 'R 158' and 'OMEPRAZOLE 20 mg' imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets. Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with '54 312' on one side and plain on the other side. Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin peach and orange capsules, marked 'WC 731'. Each capsule contains amoxicillin trihydrate, equivalent to 500 mg amoxicillin. Storage And Handling Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs: Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque hard gelatin lavender and grey capsules, with 'R 158' and 'OMEPRAZOLE 20 mg' imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets. Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with '54 312' on one side and plain on the other side. Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin peach and orange capsules, marked 'WC 731'. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin. NDC 65224-707-11 Carton containing 10 daily administration cards NDC 65224-707-00 Daily administration card Store at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture. Omeclamox®-Pak is distributed by CUMBERLAND PHARMACEUTICALS INC, Nashville, TN 37203. Omeprazole Delayed-Release Capsules, USP, 20 mg. Manufactured by Dr. Reddy's Laboratories, Limited, Bachepalli, 502 325, INDIA, Clarithromycin Tablets, USP, 500 mg. Manufactured by Roxane Laboratories, Inc., a division of Boehringer Ingelheim, Columbus, OH 43228, U.S.A., Amoxicillin Capsules, USP, 500 mg. Manufactured by Suir Pharma Ireland Ltd., Clonmel, IRELAND. Promoted by: For inquiries contact Cumberland Pharmaceuticals Inc. 1-877-484-2700. Revised: Dec 2014