SKELAXIN Tablet (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

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1. Description

SKELAXIN (metaxalone) is available as an 800 mg oval, scored pink tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15 ...

2. Clinical Pharmacology

Mechanism of Action The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system (CNS) depression. Metaxalone has no direct action on the contractile ...

3. Indications and Usage

SKELAXIN (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 ...

4. Contraindications

Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.

5. Warnings

Serotonin Syndrome Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with SKELAXIN used within the recommended dosage ...

6.1. General

SKELAXIN 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 Benedicts tests, due to an ...

6.2. Information for Patients

Driving or Operating Heavy Machinery SKELAXIN may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially ...

6.4. Drug Interactions

CNS Depressants The sedative effects of SKELAXIN and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of metaxalone has not been determined.

6.7. 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 ...

6.9. 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.

6.10. Pediatric Use

Safety and effectiveness in children 12 years of age and below have not been established.

7. Adverse Reactions

The most frequent reactions to metaxalone include: CNS: drowsiness, dizziness, headache, and nervousness or irritability; Digestive: nausea, vomiting, gastrointestinal upset. Other ...

9. Overdosage

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. ...

10. Dosage and Administration

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

11. How Supplied

SKELAXIN (metaxalone) is available as an 800 mg oval, scored pink tablet inscribed with 8667 on the scored side and S on the other. Available in bottles of 100 (NDC 60793-136-01) and in bottles of 500 ...

12. Storage and Handling

Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F).