Country: United States
Language: English
Source: NLM (National Library of Medicine)
ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008)
AvKARE
ETODOLAC
ETODOLAC 200 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 capsules are indicated: • For acute and long-term use in the management of signs and symptoms of the following: - Osteoarthritis - Rheumatoid arthritis • For the management of acute pain Etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. 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 ). - In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS )
Etodolac Capsules, USP are available as: 200 mg capsules (Hard gelatin capsules with a white opaque body and a light gray cap. “APO 039” is imprinted on each capsules in black ink) - in bottles of 100, NDC 42291-404-01 300 mg capsules (Hard gelatin capsules with a white opaque body and a light gray cap. “APO 040” is imprinted on each capsules in black ink) - in bottles of 100, NDC 42291-405-01 Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant container [see USP]. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 07/16 AV 01/17 (P)
Abbreviated New Drug Application
ETODOLAC- ETODOLAC CAPSULE AvKARE ---------- 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 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 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: • at 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 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, tell your healthcare provider about all of your medi Read the complete document
ETODOLAC- ETODOLAC CAPSULE AVKARE ---------- ETODOLAC CAPSULES, USP 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 capsule, USP is for oral administration, contains 200 mg or 300 mg of etodolac. In addition, each capsule contains the following inactive ingredients: black iron oxide, black SW-9008/SW-9009, colloidal silicon dioxide, croscarmellose sodium, gelatin, lactose monohydrate, sodium lauryl sulfate, stearic acid, talc and titanium dioxide. CLINICAL PHARMACOLOGY 17 21 3 PHARMACODYNAMICS Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti- inflammatory, analgesic, and antipyretic acti Read the complete document