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Metaxalone
Overview
What is Metaxalone?
Metaxalone tablets are available as an 800 mg tablet.
Chemically, metaxalone is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is CH1NO, which corresponds to a molecular weight of 221.25. The structural formula is:
Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water.
Each tablet contains 800 mg metaxalone and the following inactive ingredients: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch and magnesium stearate.
What does Metaxalone look like?
What are the available doses of Metaxalone?
Sorry No records found.
What should I talk to my health care provider before I take Metaxalone?
Sorry No records found
How should I use Metaxalone?
Metaxalone tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
What interacts with Metaxalone?
Known hypersensitivity to any components of this product.
Known tendency to drug induced, hemolytic or other anemias.
Significantly impaired renal or hepatic function.
What are the warnings of Metaxalone?
As the rate of theophylline clearance may be dose-dependent (i.e., steady-state serum concentrations may increase disproportionately to the increase in dose), an increase in dose based upon a sub-therapeutic serum concentration measurement should be conservative. In general, limiting dose increases to about 25% of the previous total daily dose will reduce the risk of unintended excessive increases in serum theophylline concentration (see , Table VI).
What are the precautions of Metaxalone?
Metaxalone should be administered with great care to patients with pre-existing liver damage. Serial liver function studies should be performed in these patients.
False-positive Benedict’s tests, due to an unknown reducing substance, have been noted. A glucose-specific test will differentiate findings.
Taking metaxalone tablets with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect. (See and ).
Information for Patients
Metaxalone tablets may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with alcohol or other CNS depressants.
Drug Interactions
The sedative effects of metaxalone tablets and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of metaxalone has not been determined.
Pregnancy
Reproduction studies in rats have not revealed evidence of impaired fertility or harm to the fetus due to metaxalone. Post marketing experience has not revealed evidence of fetal injury, but such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus. Safe use of metaxalone has not been established with regard to possible adverse effects upon fetal development. Therefore, metaxalone tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless, in the judgement of the physician, the potential benefits outweigh the possible hazards.
Nursing Mothers
It is not known whether this drug is secreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
Pediatric Use
Safety and effectiveness in children 12 years of age and below have not been established.
What are the side effects of Metaxalone?
The most frequent reactions to metaxalone include:
CNS:
Digestive:
Other adverse reactions are:
Immune System:
Hematologic:
Hepatobiliary:
Though rare, anaphylactoid reactions have been reported with metaxalone.
What should I look out for while using Metaxalone?
Known hypersensitivity to any components of this product.
Known tendency to drug induced, hemolytic or other anemias.
Significantly impaired renal or hepatic function.
Metaxalone tablets may enhance the effects of alcohol and other CNS depressants.
What might happen if I take too much Metaxalone?
Sorry No Records found
How should I store and handle Metaxalone?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59".They are supplied by as follows:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Rx OnlyManufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846This Product was Repackaged By Sandhills Packaging for:Keltman Pharmaceuticals Inc.Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59".They are supplied by as follows:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Rx OnlyManufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846This Product was Repackaged By Sandhills Packaging for:Keltman Pharmaceuticals Inc.Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59".They are supplied by as follows:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Rx OnlyManufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846This Product was Repackaged By Sandhills Packaging for:Keltman Pharmaceuticals Inc.Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59".They are supplied by as follows:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Rx OnlyManufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846This Product was Repackaged By Sandhills Packaging for:Keltman Pharmaceuticals Inc.Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59".They are supplied by as follows:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Rx OnlyManufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846This Product was Repackaged By Sandhills Packaging for:Keltman Pharmaceuticals Inc.Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59".They are supplied by as follows:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Rx OnlyManufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846This Product was Repackaged By Sandhills Packaging for:Keltman Pharmaceuticals Inc.Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59".They are supplied by as follows:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Rx OnlyManufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846This Product was Repackaged By Sandhills Packaging for:Keltman Pharmaceuticals Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.
Non-Clinical Toxicology
Known hypersensitivity to any components of this product.Known tendency to drug induced, hemolytic or other anemias.
Significantly impaired renal or hepatic function.
Metaxalone tablets may enhance the effects of alcohol and other CNS depressants.
The sedative effects of metaxalone tablets and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.
Metaxalone should be administered with great care to patients with pre-existing liver damage. Serial liver function studies should be performed in these patients.
False-positive Benedict’s tests, due to an unknown reducing substance, have been noted. A glucose-specific test will differentiate findings.
Taking metaxalone tablets with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect. (See and ).
The most frequent reactions to metaxalone include:
CNS:
Digestive:
Other adverse reactions are:
Immune System:
Hematologic:
Hepatobiliary:
Though rare, anaphylactoid reactions have been reported with metaxalone.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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