Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
STAT Rx USA LLC
MELOXICAM
MELOXICAM 7.5 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. Meloxicam tablet is contraindicated in patients with known hypersensitivity to meloxicam. Meloxicam tablets 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-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Pre-existing Asthma). Meloxicam tablet is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Meloxicam Tablets, 7.5 mg, yellow colored, circular, biconvex tablets, debossed with “512” on one side and plain on the other side are available as follows: Bottle of 30 NDC 42549-604-30 Bottle of 60 NDC 42549-604-60 Bottle of 90 NDC 42549-604-90 Bottle of 120 NDC 42549-604-12 Meloxicam Tablets, 15 mg, yellow colored, oval, biconvex tablets, debossed with “513” on one side and plain on the other side are available as follows: Bottle of 30 NDC 42549-519-30 Bottle of 60 NDC 42549-519-60 Bottle of 90 NDC 42549-519-90 Bottle of 120 NDC 42549-519-12 Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Keep Meloxicam tablets in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children. Manufactured by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive Detroit, MI 48202 C.S.No. 5481T05
Abbreviated New Drug Application
STAT Rx USA LLC ---------- 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 no Læs hele dokumentet
MELOXICAM - MELOXICAM TABLET STAT RX USA LLC ---------- MELOXICAM ATTENTION DISPENSER: ACCOMPANYING MEDICATION GUIDE MUST BE DISPENSED WITH THIS PRODUCT. WARNING CARDIOVASCULAR RISK NSAIDS MAY CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, 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 AND CLINICAL TRIALS). MELOXICAM TABLET IS CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE 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 EVENTS (SEE WARNINGS). DESCRIPTION Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti- inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-_N_-(5-methyl-2-thiazolyl)-2_H_-1,2- benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C H N O S and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) = 0.1 in _n_-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets include: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium Læs hele dokumentet