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Metaxalone
Overview
What is Metaxall?
Metaxalone is available as an 800 mg, light pink to pink, capsule shaped, scored uncoated tablet.
Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is CHNO, 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: calcium carbonate, FD& C Red # 40, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, silicone dioxide, sodium starch glycol ate and sodium stearyl fumarate.
What does Metaxall look like?
What are the available doses of Metaxall?
Sorry No records found.
What should I talk to my health care provider before I take Metaxall?
Sorry No records found
How should I use Metaxall?
Metaxalone is 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 Metaxall?
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 Metaxall?
Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
What are the precautions of Metaxall?
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 with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect. (See section).
Information for Patients
Metaxalone 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 and other CNS depressants (e.g., alcohol, 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 Metaxall?
The most frequent reactions to metaxalone include:
CNS: drowsiness, dizziness, headache, and nervousness or "irritability". Digestive: nausea, vomiting, gastrointestinal upset.
Other adverse reactions are:
Immune System: hypersensitivity reaction, rash with or without pruritus; Hematologic: leukopenia; hemolytic anemia;
Hepatobiliary: jaundice.
Though rare, anaphylactoid reactions have been reported with metaxalone.
What should I look out for while using Metaxall?
Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
Metaxalone may enhance the effects of alcohol and other CNS depressants.
What might happen if I take too much Metaxall?
Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with alcohol.
When determining the LD in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD could be determined as the higher doses produced an emetic action in 15 to 30 minutes.
How should I store and handle Metaxall?
StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled RoomTemperature].StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled RoomTemperature].Metaxalone is available as an , light pink to pink, capsule shaped, scored uncoated tablet with debossing 'AN' on the left side of the scoring and '553' on the right side of the scoring. Other side of the tablet is plain.They are available as follows:Bottles of 30: NDC 51021-333-30Bottles of 60: NDC 51021-333-60Metaxalone is available as an , light pink to pink, capsule shaped, scored uncoated tablet with debossing 'AN' on the left side of the scoring and '553' on the right side of the scoring. Other side of the tablet is plain.They are available as follows:Bottles of 30: NDC 51021-333-30Bottles of 60: NDC 51021-333-60Metaxalone is available as an , light pink to pink, capsule shaped, scored uncoated tablet with debossing 'AN' on the left side of the scoring and '553' on the right side of the scoring. Other side of the tablet is plain.They are available as follows:Bottles of 30: NDC 51021-333-30Bottles of 60: NDC 51021-333-60Metaxalone is available as an , light pink to pink, capsule shaped, scored uncoated tablet with debossing 'AN' on the left side of the scoring and '553' on the right side of the scoring. Other side of the tablet is plain.They are available as follows:Bottles of 30: NDC 51021-333-30Bottles of 60: NDC 51021-333-60
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 may enhance the effects of alcohol and other CNS depressants.
The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, 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 with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect. (See section).
The most frequent reactions to metaxalone include:
CNS: drowsiness, dizziness, headache, and nervousness or "irritability". Digestive: nausea, vomiting, gastrointestinal upset.
Other adverse reactions are:
Immune System: hypersensitivity reaction, rash with or without pruritus; Hematologic: leukopenia; hemolytic anemia;
Hepatobiliary: jaundice.
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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