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(lansoprazole) 30 mg Delayed-release Capsules, (amoxicillin) 500 mg Capsules, USP, and (clarithromycin) 500 mg Tablets, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PREVPAC and other antibacterial drugs, PREVPAC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED.
The individual products contained in this package should not be used alone or in combination for other purposes. The information described in this labeling concerns only the use of these products as indicated in this daily administration pack. For information on use of the individual components when dispensed as individual medications outside this combined use for treating Helicobacter pylori (H. pylori), please see the package inserts for each individual product.
PREVPAC consists of a daily administration card containing two PREVACID 30 mg delayed release capsules, four amoxicillin 500 mg capsules, USP, and two clarithromycin 500 mg tablets, USP, for oral administration.
PREVACID (lansoprazole) Delayed-Release Capsules
The active ingredient in PREVACID 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 C16H14F3N3O2S with a molecular weight of 369.37. PREVACID 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.
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 (2S, 5R, 6R)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 C16H19N3O5S • 3H2O 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.
BIAXIN Filmtab (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 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.
What are the possible side effects of amoxicillin, clarithromycin, and lansoprazole (Prevpac)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or bloody;
- signs of new infection, such as fever, chills, body aches, flu symptoms, mouth sores;
- easy bruising or bleeding, unusual weakness;
- agitation, confusion, unusual thoughts or behavior;
- dizziness, fainting, fast or pounding heartbeat;...
What are the precautions when taking lansoprazole, amoxicillin and clarithromycin (Prevpac)?
Before taking this product, tell your doctor or pharmacist if you are allergic to lansoprazole, amoxicillin, or clarithromycin; or to penicillins (such as ampicillin), cephalosporins (such as cephalexin), or macrolide antibiotics (such as erythromycin); or to dexlansoprazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including liver problems with past clarithromycin use), kidney disease, a certain type of muscle disease (myasthenia gravis), a certain type of viral infection (infectious mononucleosis).
Some symptoms may actually...
Last reviewed on RxList: 1/14/2014
This monograph has been modified to include the generic and brand name in many instances.
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