Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)
Trifluent Pharma LLC
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of ketoprofen capsules USP and other treatment options before deciding to use ketoprofen capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules USP are indicated for the management of pain. Ketoprofen capsules USP are also indicated for treatment of primary dysmenorrhea. Ketoprofen capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. Ketoprofen capsules USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to ketoprofen have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma ). Ketoprofen capsules USP are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Warnings]
Kiprofen™ Capsules are available as follows: 25 mg: Dark green color cap and body, size "4" imprinted with "KETO 25" on cap with an edible white ink and containing white to off-white crystalline powder supplied as: Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
Trifluent Pharma LLC ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Rx only What is the most important information I should know about medicines called Non-Steroidal 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" and "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, tell your healthcare provider about all of your medical conditions, Les hele dokumentet
KIPROFEN- KETOPROFEN CAPSULE TRIFLUENT PHARMA LLC ---------- KIPROFEN™ CAPSULES 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_]. Ketoprofen capsules are 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 greater risk for serious gastrointestinal (GI) events (see _Warnings_). Throughout this package insert, the term NSAID refers to a non-aspirin non- steroidal anti-inflammatory drug. DESCRIPTION Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for Ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula: C H O M.W.254.29 It has a pKa of 5.94 in methanol: water (3:1) and an n-octanol: water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Kiprofen™ Capsules contain 25 mg of Ketoprofen USP for oral administration. 1 16 14 3 INACTIVE INGREDIENTS Drug Product Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate. Capsule Shell Constituents 25 mg: D&C yellow 10, edible printing ink, FD&C blue 1, FD&C yellow 6, gelatin, sodium lauryl sulfate, and titanium dioxide. CLINICAL PHARMACOLOGY Ketoprofen is a non-steroidal anti-inflammatory dr Les hele dokumentet