Meloxicam Tablets
7.5 mg and 15 mg
Rx only

Prescribing Information

ATTENTION DISPENSER: Accompanying Medication Guide must be dispensed with this product.

     Prescribing Information

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 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 pastel 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 molecular 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: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate anhydrous.

INDICATIONS AND USAGE
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 (see WARNINGS).

Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis.

CONTRAINDICATIONS
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 (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Pre-existing Asthma).

Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

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.

HOW SUPPLIED
Meloxicam tablets 7.5 mg are pastel yellow, round compressed tablets debossed cor over 175 on one side and other side is plain. They are supplied as follows:

       Bottles of 100          (NDC 0781-5195-01)
       Bottles of 1000        (NDC 0781-5195-10)

Meloxicam tablets 15 mg are pastel yellow, round compressed tablets debossed cor over 176 on one side and other side is plain. They are supplied as follows:

       Bottles of 100          (NDC 0781-5196-01)
       Bottles of 1000        (NDC 0781-5196-10)

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Keep Meloxicam Tablets in a dry place.

Dispense tablets in a tight container.

Keep this and all medications out of the reach of children.

Meloxicam Tablets 7.5 mg and 15 mg are manufactured by:
Corepharma LLC
Middlesex, NJ 08846
Distributed by:
Sandoz Inc.
Princeton, NJ 08540

MF# 524
Rev. 07-2006

ATTENTION DISPENSER: Accompanying Medication Guide must be dispensed with this product.

Meloxicam Tablets