This should include discontinuation of meloxicam until a serious GI adverse event is ruled out. Nevertheless, during concomitant therapy with meloxicam, patients should be observed closely for signs of renal failure [see Warnings and Precautions (5.6)], as well as to ensure diuretic efficacy.In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 to 1072 mg twice daily with meloxicam 15 mg every day as compared to subjects receiving lithium alone. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.A pharmacokinetic study in patients with mild and moderate renal impairment revealed that no dosage adjustments in these patient populations are required. 0000001353 00000 n Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. )(See the end of this Medication Guide for a list of prescription NSAID medicines. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. Protect from moisture.Medication guide is found at www.fds.gov/drugs/drugsafety/ucm085729Mfg. Protein binding of meloxicam was not affected by hepatic impairment. Impairment of Fertility. [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].Meloxicam pharmacokinetics have been investigated in subjects with mild and moderate renal impairment. Therefore it is recommended that meloxicam dosage in this population not exceed 7.5 mg per day. How to consume bitter melon? Prior to 30 weeks gestation, use meloxicam during pregnancy only if the potential benefit justifies the potential risk to the fetus. This was demonstrated when oral administration of cholestyramine following a single IV dose of meloxicam decreased the AUC of meloxicam by 50%.The mean elimination half-life (t1/2) ranges from 15 hours to 20 hours. 0000000899 00000 n It is not completely understood how reduced synthesis of these compounds results in therapeutic efficacy.Meloxicam exhibits anti-inflammatory, analgesic, and antipyretic activities.The absolute bioavailability of meloxicam capsules was 89% following a single oral dose of 30 mg compared with 30 mg IV bolus injection. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. ), discontinue meloxicam [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].NSAIDs, including meloxicam tablets, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. 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 USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclooxygenase) inhibition which is involved in the initial steps of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin. WARNING: RISK OF CARDIOVASCULAR AND GASTROINTESTINAL EVENTSNonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. However, one subject showed an increase in INR from 1.5 to 2.1.
Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of meloxicam with placebo.The following adverse reactions have been identified during post approval use of meloxicam. If you are a consumer or patient please visit Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Diabetics can consume 10 – 30 ml per day. by Unichem Laboratories Ltd, Goa 403 511 IndiaMfg for Unichem Pharmaceuticals Inc. Rochelle Park, NJ 07662 Lot #Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256Keep out of reach of children. The use of meloxicam in subjects with severe renal impairment is not recommended [see Warnings and Precautions (5.6) and Use in Specific Populations (8.7)].Following a single dose of meloxicam, the free Cmax plasma concentrations were higher in patients with renal failure on chronic hemodialysis (1% free fraction) in comparison to healthy volunteers (0.3% free fraction). No pharmacokinetic interaction was detected with concomitant administration of antacids. Talk with your doctor. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms.