Country: United States
Language: English
Source: NLM (National Library of Medicine)
ETODOLAC (UNII: 2M36281008) (Etodolac - UNII:2M36281008)
Apotex Corp.
ETODOLAC
ETODOLAC 400 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac tablets, USP are indicated: - For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis - Osteoarthritis - Rheumatoid arthritis - For the management of acute pain Etodolac is contraindicated in patients with known hypersensitivity to etodolac. Etodolac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Pre-existing Asthma ). - Etodolac tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Etodolac Tablets, USP are available as: 400 mg Tablets (White to off-white, oval, unscored, film-coated tablets, imprinted "APO 041" on one side and "400" on the other side.) -in bottles of 100, NDC 60505-0041-1 500 mg tablets (White to off-white, oval, unscored, film-coated tablets imprinted "APO 102" on one side and "500" on the other side.) -in bottles of 100, NDC 60505-0102-1 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Dispense with Medication Guide available at www1.apotex.com/products/us APOTEX INC. ETODOLAC TABLETS, USP 400 mg and 500 mg Apotex Inc. Toronto, Ontario Canada M9L 1T9 Apotex Corp. Weston, Florida 33326 Revised: December 2021 Rev. 9
Abbreviated New Drug Application
ETODOLAC- ETODOLAC TABLET, FILM COATED Apotex Corp. ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Medication Guide available at www1.apotex.com/products/us 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 Read the complete document
ETODOLAC- ETODOLAC TABLET, FILM COATED APOTEX CORP. ---------- ETODOLAC TABLETS, USP 400 MG AND 500 MG RX ONLY CARDIOVASCULAR THROMBOTIC EVENTS 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 and PRECAUTIONS). Etodolac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). GASTROINTESTINAL RISK NSAIDs cause an increased risk of serious gastrointestinal 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 are at a greater risk for serious gastrointestinal (GI) events (see WARNINGS). DESCRIPTION Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti- inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+]S and [-]R- enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n- octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C H NO , and it has the following structural formula: Each etodolac tablet, USP is for oral administration, contains 400 mg or 500 mg of etodolac. In addition, each tablet contains the following inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. 17 21 3 CLINICAL PHARMACOLOGY PHARMACODYNAMICS Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti- inflammatory, analgesic, and antipyretic activities in an Read the complete document