Scored, Oral, Tablet: 7.5 mg and 15 mg
Indication & Usage
Meloxfar is a non-steroidal anti-inflammatory drug
- Osteoarthritis (OA)
- Rheumatoid Arthritis (RA)
- Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg
Dosage & Administration
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
- OA and RA:
- Starting dose: 7.5 mg once daily
- Dose may be increased to 15 mg once daily
- 5 mg once daily in children ≥60 kg
- Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenzalike symptoms
- Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience
- Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see Warnings and Precautions]
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions]
- In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions]
- Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking Meloxifar with drugs that interfere with hemostasis. Concomitant use of Meloxifar and analgesic doses of aspirin is not generally recommended
- ACE Inhibitors, Angiotensin Receptor Blockers (ARBs) or Beta-Blockers: Concomitant use with Meloxifar may diminish the antihypertensive effect of these drugs. Monitor blood pressure
- ACE Inhibitors and ARBs: Concomitant use with Meloxifar in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function
- Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects
Warning & Precaution
- Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop
- Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure
- Heart Failure and Edema: Avoid use of Meloxifar in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure
- Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of Meloxifar in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function
- Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs
- Exacerbation of Asthma Related to Aspirin Sensitivity: Meloxifar is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity)
- Serious Skin Reactions: Discontinue Meloxifar at first appearance of skin rash or other signs of hypersensitivity
- Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation
- Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia
Pregnancy & Lactation
Use of NSAIDs, including Meloxifar, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Meloxifar, in pregnant women starting at 30 weeks of gestation (third trimester) [see Warnings and Precautions].
There are no adequate and well-controlled studies of Meloxifar in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss.
In animal reproduction studies, embryofetal death was observed in rats and rabbits treated during the period of organogenesis with meloxicam at oral doses equivalent to 0.65- and 6.5-times the maximum recommended human dose (MRHD) of Meloxifar. Increased incidence of septal heart defects were observed in rabbits treated throughout embryogenesis with meloxicam at an oral dose equivalent to 78-times the MRHD. In pre- and post-natal reproduction studies, there was an increased incidence of dystocia, delayed parturition, and decreased offspring survival at 0.08-times MRHD of meloxicam. No teratogenic effects were observed in rats and rabbits treated with meloxicam during organogenesis at an oral dose equivalent to 2.6 and 26-times the MRHD.
Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors, such as meloxicam, resulted in increased pre- and post-implantation loss.
There are no human data available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Meloxifar and any potential adverse effects on the breastfed infant from the Meloxifar or from the underlying maternal condition.
Keep out of the reach of children.
Store below 30°C and protect from moisture.
Meloxifar 7.5 mg: Carton containing 3 Blister strips of 10 tablets each.
Meloxifar 15 mg: Carton containing 10 Blister strips of 10 tablets each.
Marketing Authorization Holder