Meloxicam (meloxicam)

The lowest possible effective dosage and shortest duration of therapy consistent with the treatment goals of the patient should be employed.

Meloxicam is administered orally and by IV injection.

Meloxicam is also commercially available in fixed combination with bupivacaine or rizatriptan. For additional information, consult the prescribing information for these combination products.

No dosing information is available for this tab.

No dosing information is available for this tab.

Meloxicam is extensively metabolized by cytochrome P-450 (CYP) isoenzyme 2C9, with minor contribution by CYP3A4.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity (e.g., anaphylaxis, serious dermatologic reactions) to meloxicam or any ingredient in the formulation.

*History of asthma, urticaria, or other allergic-type reaction precipitated by aspirin or other nonsteroidal anti-inflammatory agents (NSAIAs).

*In the setting of coronary artery bypass graft (CABG) surgery.

*Parenteral meloxicam is contraindicated in patients with moderate to severe renal impairment who are at risk for renal failure because of hypovolemia.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse effects of meloxicam tablets and oral suspension (>=5% of adult patients and greater than placebo) include diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms. Adverse effects in pediatric studies were similar to adults.

The most common adverse effects of meloxicam capsules (>=2% of patients) reported in clinical trials include diarrhea, nausea, and abdominal discomfort.

The most common adverse effects of IV meloxicam (>=2% of patients and greater than placebo) reported in clinical trials include constipation, increased gamma-glutamyltransferase (GGT, gamma-glutamyltranspeptidase, GGTP) concentrations, and anemia.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of oral meloxicam have not been established in pediatric patients younger than 2 years of age. Safety and efficacy of oral meloxicam tablets and suspension have been established in pediatric patients 2-17 years of age with juvenile rheumatoid arthritis. After a single dose and at steady state, exposure was lower (by approximately 30%) in pediatric patients 2-6 years of age compared to patients 7-16 years of age. Older pediatric patients had similar (after a single dose) or lower (at steady state) exposures compared to adult patients. The mean elimination half-life of meloxicam is 15.2 hours and 13 hours in patients 2-6 and 7-16 years of age, respectively. Body weight, not age, was the single predictive variable for differences in clearance and is predictive of exposure in pediatric patients.

The manufacturers state that the safety and efficacy of meloxicam capsules and parenteral meloxicam have not been established in pediatric patients.

Use of NSAIAs during pregnancy at about 30 weeks of gestation or later can cause premature closure of the fetal ductus arteriosus, and use at about 20 weeks of gestation or later has been associated with fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, use of NSAIAs should be avoided in pregnant women at about 30 weeks of gestation or later; if NSAIA therapy is necessary between about 20 and 30 weeks of gestation, the lowest effective dosage and shortest possible duration of treatment should be used. Monitoring of amniotic fluid volume via ultrasound examination should be considered if the duration of NSAIA treatment exceeds 48 hours; if oligohydramnios occurs, the drug should be discontinued and follow-up instituted according to clinical practice. Pregnant women should be advised to avoid use of NSAIAs beginning at 20 weeks' gestation unless otherwise advised by a clinician.

Fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment has been observed, on average, following days to weeks of maternal NSAIA use, although oligohydramnios has been observed infrequently as early as 48 hours after initiation of NSAIA therapy. Oligohydramnios is often, but not always, reversible (generally within 3-6 days) following discontinuance of NSAIA therapy. Complications of prolonged oligohydramnios may include limb contracture and delayed lung maturation. A limited number of case reports have described maternal NSAIA use and neonatal renal dysfunction, in some cases irreversible, without oligohydramnios. Some cases of neonatal renal dysfunction have required treatment with invasive procedures such as exchange transfusion or dialysis. Deaths associated with neonatal renal failure have been reported. Available data on neonatal outcomes generally involved preterm infants, and the extent to which certain reported risks can be generalized to full-term infants is uncertain.

Animal data indicate that prostaglandins have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, inhibitors of prostaglandin synthesis, such as meloxicam, were associated with increased pre- and post-implantation losses. Prostaglandins also have an important role in fetal kidney development. In animal studies, inhibitors of prostaglandin synthesis impaired kidney development at clinically relevant doses.

Embryofetal deaths and an increased incidence of septal heart defects have been observed with meloxicam in animal reproduction studies.

The effects of meloxicam on labor and delivery are unknown. In studies in rats, drugs that inhibit prostaglandin synthesis, including NSAIAs, increased the incidence of dystocia, delayed parturition, and decreased pup survival.

Meloxicam is distributed into milk in rats. It is not known whether meloxicam distributes into human milk, affects milk production, or affects breast-fed infants.

The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for meloxicam and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

If anticipated benefits of meloxicam outweigh the potential risks, the manufacturers of oral meloxicam state that the drug should be initiated in geriatric patients at the low end of the dosage range and patients should be monitored for adverse effects.

Of the total number of patients in clinical trials of meloxicam capsules, 291 patients were >=65 years of age. Of the total number of patients in clinical trials of parenteral meloxicam, 197 patients were >=65 years of age. In pharmacokinetic studies with oral meloxicam, geriatric males exhibited similar pharmacokinetics to younger males. Female patients >=65 years of age had higher exposure (by 47%) and higher maximum plasma concentrations (by 32%) compared to younger females (<=55 years of age). Although results from clinical studies of meloxicam revealed no overall differences in efficacy or safety of the drug between geriatric patients and younger individuals, most of the spontaneous reports of fatal adverse GI effects with NSAIAs have been in geriatric or debilitated individuals.

Geriatric patients receiving NSAIAs are at increased risk for serious adverse cardiovascular, GI, and renal effects. If anticipated benefits of meloxicam outweigh the potential risks, the drug should be initiated at the low end of the dosing range and the patient should be monitored for adverse effects.