Country: United States
Language: English
Source: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
QPharma Inc
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation) . Naproxen as naproxen tablets are indicated: Naproxen tablets are contraindicated in the following patients:
NaproxenTablets, USP, 375 mg, are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 189” on obverse and “375” on the reverse. They are available as follows: Bottles of 60: NDC 42708-061-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers as defined in the USP. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA 382220 Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 06-2016-01
Abbreviated New Drug Application
QPharma Inc ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDS: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before taking NSAIDs, Read the complete document
NAPROXEN- NAPROXEN TABLET QPHARMA INC ---------- NAPROXEN TABLETS, USP WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS CARDIOVASCULAR THROMBOTIC EVENTS • • GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) ADVERSE EVENTS INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR INTESTINES, WHICH CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND WITHOUT WARNING SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS _(SEE WARNINGS)._ DESCRIPTION Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti- inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C H O . Naproxen, USP 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, USP at pH 7.4 is 1.6 to 1.8. NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND STROKE, WHICH CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE WITH DURATION OF USE _(SEE WARNINGS)._ NAPROXEN TABLETS ARE CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY _(SEE CONTRAINDICATIONS, WARNINGS)._ 14 14 3 Naproxen, USP is available as white tablets containing 250 mg of naproxen, USP, white tablets containing 375 mg of naproxen, USP and white tablets containing 500 mg of naproxen, USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Naproxen has analgesic, anti-inflammatory, and a Read the complete document