Prevacid NapraPAC
PREVACID® NapraPAC ® 500
Prevacid (lansoprazole 15 mg) Delayed-Release Capsules and
Naprosyn (naproxen 500 mg) Tablets Kit
Cardiovascular Risk
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
- PREVACID NapraPAC (lansoprazole) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal (GI) Risk
- NSAIDs cause an increased risk of serious GI adverse events including bleeding and perforation of the stomach and intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Patients with a history of gastric and/or duodenal ulcers (especially patients with a history of bleeding or perforation) and geriatric patients are at greater risk for serious GI events (see WARNINGS and Clinical Studies, Risk Reduction of NSAID-Associated Gastric Ulcer(s)).
PREVACID® NapraPAC ®500 is a combination package containing two individual drug products: PREVACID® (lansoprazole) Delayed-Release Capsules, a proton pump inhibitor (PPI), and NAPROSYN® (naproxen tablets), a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. The information described in this labeling concerns only the use of these products as indicated in this combination package and does not include all individual use information. For information on use of the components when dispensed as individual medications outside this combination package, please see the package inserts for PREVACID Delayed-Release Capsules and NAPROSYN Tablets.
DRUG DESCRIPTION
PREVACID NapraPAC (lansoprazole) 500 is a combination package containing NAPROSYN 500 mg tablets and PREVACID 15 mg capsules.
NAPROSYN
Naproxen is a proprionic acid derivative related to the arylacetic acid group of NSAIDs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and naproxen has the following structure:
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Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3.
Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.
NAPROSYN (naproxen tablets) is available as yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone, and magnesium stearate.
PREVACID
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:
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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.
Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25ºC is approximately 0.5 hour at pH 5 and approximately 18 hours at pH 7.
PREVACID Delayed-Release capsules contain enteric-coated granules consisting of 15 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, FD&C Green No. 3, and FD&C Red No. 40.
What are the possible side effects of lansoprazole and naproxen (PREVACID NapraPAC 500)?
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.
Stop using lansoprazole and naproxen and call your doctor at once if you have a serious side effect such as:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- urinating...
Read All Potential Side Effects and See Pictures of Prevacid NapraPAC »
Last reviewed on RxList: 12/19/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Prevacid NapraPAC Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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