Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
DICLOFENAC POTASSIUM (UNII: L4D5UA6CB4) (diclofenac - UNII:144O8QL0L1)
BLUCREST PHARMACEUTICALS, LLC
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of CATAFLAM™ ( diclofenac potassium tablets, USP) and other treatment options before deciding to use CATAFLAM . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). CATAFLAM is indicated: - For treatment of primary dysmenorrhea - For relief of mild to moderate pain - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis CATAFLAM™ is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS: Anaphylactic Reactions, Serious Skin Reactions). - History of asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see WARNIN
CATAFLAM™ (diclofenac potassium tablets, USP) 50 mg are available for oral administration as light brown, round shaped, unscored, film coated tablets, imprinted "AMI" on one side and "DP" over "50" on the other side. They are supplied as follows: Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure. Keep container tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
BLUCREST PHARMACEUTICALS, LLC ---------- 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: • any time 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 medical conditions, includ Lugege kogu dokumenti
CATAFLAM- DICLOFENAC POTASSIUM TABLET BLUCREST PHARMACEUTICALS, LLC ---------- CATAFLAM™ (DICLOFENAC POTASSIUM TABLETS, USP) TABLETS 50 MG RX ONLY BLUCREST PHARMACEUTICALS LLC. PRESCRIBING INFORMATION WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 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). CATAFLAM™ (DICLOFENAC POTASSIUM TABLETS, USP) IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (SEE CONTRAINDICATIONS, WARNINGS). 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 CATAFLAM™ (diclofenac potassium tablets, USP) are a benzeneacetic acid derivative. CATAFLAM, is available as tablets of 50 mg (light brown) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C H C NKO , and it has the following structural formula: 14 10 l2 2 Each 50 mg CATAFLAM intended for oral administration, contains 50 mg diclofenac potassium for oral administration. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, iron oxide red, magnesium stearate, methanol, polyethylene glycol, povidone, sodium bicarbonate, titanium dioxide and yellow iron oxide. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Diclofenac has analgesic, anti-inflamm Lugege kogu dokumenti