Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)
Rebel Distributors Corp
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea. Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are contraindicated in patients who have sho
Ketoprofen Immediate-release Capsules are available containing 50 mg or 75 mg of ketoprofen, USP. The 50 mg capsule is a hard-shell gelatin capsule with a light celery opaque cap and a light celery opaque body filled with a white to off-white powder. The capsule is axially printed with MYLAN over 4070 in black ink on both the body and cap. They are available as follows: NDC 21695-340-72 bottles of 120 capsules The 75 mg capsule is a hard-shell gelatin capsule with a light aqua opaque cap and a light aqua opaque body filled with a white to off-white powder. The capsule is axially printed with MYLAN over 5750 in black ink on both the body and cap. They are available as follows: NDC 21695-341-21 bottles of 21 capsules NDC 21695-341-30 bottles of 30 capsules NDC 21695-341-42 bottles of 42 capsules NDC 21695-341-60 bottles of 60 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from direct light and excessive heat and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED JUNE 2009 KETO:R8mc
Abbreviated New Drug Application
Rebel Distributors Corp ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)." NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called "corticosteroids" and "anticoagulants" • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant. NSAID medicines should not Baca dokumen lengkap
KETOPROFEN- KETOPROFEN CAPSULE REBEL DISTRIBUTORS CORP ---------- KETOPROFEN CARDIOVASCULAR RISK NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see 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). 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: Its empirical formula is C H O , with a molecular weight of 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. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents: 50 mg - D&C Yello Baca dokumen lengkap