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metaxalone 800 mg tablet generic metaxall, skelaxin

Out of Stock Manufacturer ACTAVIS/TEVA 00591234101
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Uses

Muscular Conditions

Metaxalone is used as an adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Skeletal muscle relaxants generally appear to be more effective than placebo in providing symptomatic relief of acute low back pain, but are associated with a high incidence of adverse effects. Although comparative studies are limited, available data suggest that various skeletal muscle relaxants generally have similar efficacy for such use. Acute low back pain usually is a benign and self-limiting condition that improves spontaneously over time; if pharmacologic therapy is required, an analgesic agent such as acetaminophen or a nonsteroidal anti-inflammatory agent (NSAIA) generally is recommended as first-line therapy for most patients. Skeletal muscle relaxants (alone or in combination with analgesics) may be used as an option for short-term relief of acute low back pain; however, the possibility of adverse effects, particularly adverse CNS effects, should be considered. In general, skeletal muscle relaxants should be used with caution after weighing the potential risks against the benefits in individual patients.

Well-controlled clinical studies have not conclusively demonstrated whether relief of musculoskeletal pain by metaxalone results from skeletal muscle relaxant effects, sedative effects, or a placebo effect of the drug. Most authorities attribute the beneficial effects of metaxalone to its sedative properties. The drug is ineffective in the treatment of skeletal muscle hyperactivity secondary to chronic neurologic disorders, such as cerebral palsy, and other dyskinesias.

Dosage and Administration

Administration

Metaxalone is administered orally. Although administration of metaxalone with a high-fat meal delays absorption of the drug, increases peak plasma concentrations, and increases the extent of exposure to the drug, the clinical importance of these effects has not been established and the manufacturer makes no specific recommendation regarding administration of metaxalone with food.

Dosage

Muscular Conditions

The usual dosage of metaxalone for adults and children older than 12 years of age is 800 mg 3 or 4 times daily.

Cautions

Adverse Effects

The most frequent adverse effects of metaxalone are drowsiness, dizziness, headache, nervousness or irritability, nausea, vomiting, and GI upset. Other adverse effects include confusion, anorexia, dry mouth, and urinary retention. Exacerbation of tonic-clonic (grand mal) seizures has also been reported.

Hypersensitivity reactions and rash (with or without pruritus) have occurred in patients receiving metaxalone. Anaphylactoid reactions, leukopenia, hemolytic anemia, and jaundice have occurred rarely. Abnormalities in liver function tests, such as increased serum concentrations of AST (SGOT), ALT (SGPT), alkaline phosphatase, and bilirubin, and increased sulfobromophthalein (BSP) retention and thymol turbidity, have occurred in patients receiving metaxalone. Although a causal relationship to metaxalone has not been established, nephrotoxicity and proteinuria have occurred rarely during treatment with the drug; pyuria and nephrolithiasis have also been reported.

Precautions and Contraindications

Patients should be warned that metaxalone may impair ability to perform hazardous activities requiring mental alertness or physical coordination, such as operating machinery or driving a motor vehicle. In addition, patients should be warned that additive CNS depression may occur when the drug is administered concomitantly with other CNS depressants, including alcohol. Metaxalone should be used with caution in geriatric patients and in patients with hepatic or renal impairment. Liver function studies should be performed periodically during metaxalone therapy in patients with preexisting liver damage. The drug is contraindicated in patients with substantially impaired hepatic or renal function, known hypersensitivity to the drug or any ingredient in the formulation, or a history of drug-induced, hemolytic, or other anemias.

Pediatric Precautions

Safety and efficacy of metaxalone in children 12 years of age or younger have not been established; therefore, the drug should not be administered to children in this age group.

Carcinogenicity

The carcinogenic potential of metaxalone has not been determined.

Pregnancy, Fertility, and Lactation

Pregnancy

Safe use of metaxalone during pregnancy has not been established. Reproduction studies in rats have not revealed evidence of harm to the fetus. Although postmarketing surveillance has not revealed evidence of fetal injury in humans, the reported experience to date cannot exclude the possibility of adverse fetal effects of the drug. Therefore, metaxalone should not be used in women who are or may become pregnant unless the possible benefits outweigh the potential risks.

Fertility

Reproduction studies in rats have not revealed evidence of impaired fertility.

Lactation

It is not known whether metaxalone is distributed into milk. The drug should not be used in nursing women unless the possible benefits outweigh the potential risks.

Drug Interactions

CNS Depressants

Additive CNS depression may occur when metaxalone is administered concomitantly with other CNS depressants, including alcohol. If metaxalone is used concomitantly with other depressant drugs, caution should be used to avoid overdosage.

Pharmacokinetics

Absorption

The absolute bioavailability of orally administered metaxalone has not been determined. Following oral administration of a single 400- or 800-mg dose of the drug in the fasted state, mean peak plasma concentrations of approximately 865 or 1653 ng/mL, respectively, were attained in 3-3.3 hours. Plasma concentrations of metaxalone required for sedative, skeletal muscle relaxant, or toxic effects are not known. The onset of action is usually within 1 hour, and the duration of action is about 4-6 hours.

Administration of metaxalone with a high-fat meal delays absorption of the drug, increases peak plasma concentrations, and increases the extent of exposure to the drug; however, the clinical importance of these effects is not known. Following oral administration of a single 400- or 800-mg dose of metaxalone with a high-fat meal, peak plasma concentrations and area under the plasma concentration-time curve (AUC) were increased by about 178-194 and 115-142%, respectively. In addition, the time to peak plasma concentration was delayed by about 1-2 hours.

Distribution

It is not known whether metaxalone crosses the placenta or is distributed into milk.

Elimination

The plasma half-life of metaxalone is about 2-4 hours, and the apparent oral clearance of the drug is about 59-68 L/hour. Metaxalone is metabolized in the liver and excreted in urine as unidentified metabolites. The effect of age, gender, and renal or hepatic impairment on the elimination of metaxalone has not been established.

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