displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each yellow 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)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 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)app = 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 anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium citrate dehydrate and starch (corn).
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS).Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Meloxicam is contraindicated in patients with known hypersensitivity to meloxicam.Meloxicam 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 (seeWARNINGS, Anaphylactoid Reactions, andPRECAUTIONS, Pre-existing Asthma).Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS).
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
There is limited experience with meloxicam overdose. Four cases have taken 6 to 11 times the highest recommended dose; all recovered. Cholestyramine is known to accelerate the clearance of meloxicam.Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.Patients should be managed with symptomatic and supportive care following an NSAID overdose. In cases of acute overdose, gastric lavage followed by activated charcoal is recommended. Gastric lavage performed more than one hour after overdose has little benefit in the treatment of overdose. Administration of activated charcoal is recommended for patients who present 1-2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly. Accelerated removal of meloxicam by 4 gm oral doses of cholestyramine given three times a day was demonstrated in a clinical trial. Administration of cholestyramine may be useful following an overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet.Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet.Meloxicam Tablets 7.5 mg are available as follows:
NDC 0591-3230-01; Bottles of 100
NDC 0591-3230-05; Bottles of 500
NDC 0591-3230-10; Bottles of 1000Meloxicam Tablets 15 mg are available as follows:
NDC 0591-3231-01; Bottles of 100
NDC 0591-3231-05; Bottles of 500
NDC 0591-3231-10; Bottles of 1000Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 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 for: Watson Laboratories Inc.
Corona, CA 92880 USAManufactured by: Cipla Ltd.
Kurkumbh, INDIARevised: August 2006
SUPPLEMENTAL PATIENT MATERIAL
displayName: SUPPLEMENTAL PATIENT MATERIAL SECTION
FDA Article Code: 38056-8