Country: United States
Language: English
Source: NLM (National Library of Medicine)
ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see Error! Hyperlink reference not valid. ). Etodolac tablets are indicated: Etodolac tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac tablets. Etodolac tablets 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 Error! Hyperlink reference not valid. and Error! Hyperlink reference not valid. ).
Etodolac Tablets USP, 400 mg are supplied as peach, oval shaped, film-coated tablets engraved with "AC01" on one side and plain on the other side. They are available as follows: Bottle of 20 Tablets: NDC 68788-1342-2 Bottle of 30 Tablets: NDC 68788-1342-3 Bottle of 60 Tablets: NDC 68788-1342-6 Bottle of 90 Tablets: NDC 68788-1342-9 Bottle of 100 Tablets: NDC 68788-1342-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Preserve in tight containers. Store tablets in original container until ready to use. Dispense in light-resistant container. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2021-04 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
ETODOLAC- ETODOLAC TABLET, FILM COATED Preferred Pharmaceuticals Inc. ---------- MEDICATION GUIDE 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" o increasing doses of NSAIDs o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o 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, tell your healthcare provider about all of your m Read the complete document
ETODOLAC- ETODOLAC TABLET, FILM COATED PREFERRED PHARMACEUTICALS INC. ---------- ETODOLAC TABLETS, USP (400 MG AND 500 MG) RX ONLY CARDIOVASCULAR THROMBOTIC EVENTS • • GASTROINTESTINAL RISK • DESCRIPTION Etodolac is member of the pyranocarboxylic acid group of nonsteroidal anti- inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP 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 Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac, USP. In_ _addition, each tablet contains the following inactive ingredients:_ hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. Each 400 mg tablet also contains iron oxide red and iron oxide yellow. Each 500 mg tablet also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. CLINICAL PHARMACOLOGY 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 tablets, 400 mg and 500 mg are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which c Read the complete document