Drug Interaction:
Skeletal Muscle Relaxant include-
Carisprodal, Chlorphenesin Maleate, Chlorzoxazone, Chlormezanone, Cyclobenzaprine, Methocarbinol, Metaxalone, Dantrolenes Sodium, Orphenadrine.
Refer Orphenadrine
Drug/Lab Test interactions:
False -positive Benedicts tests,due to unknown reducing substance,have been noted. A glucose specific test will differentiate findings.
Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Metaxalone Muscle relaxant 08-10-2002
Relief of discomfort associated with acute, painful musculoskeletal conditions.
FIXED DOSE COMBINATIONS APPROVED BY DCG(I) FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Metaxalone 400mg + 22-02-2005
Diclofenac Potassium 50mg tablet
For acute painful musculoskeletal condition in adult
Skeletal Muscle Relaxant include-
Carisprodal, Chlorphenesin Maleate, Chlorzoxazone, Chlormezanone,
Cyclobenzaprine, Methocarbinol, Metaxalone, Dantrolenes Sodium, Orphenadrine.
Refer Orphenadrine
Adverse Reaction:
GI- Nausea, vomiting, GI upset.
CNS-Drowsiness, dizziness, headache, nervousness, irritability.
Miscellaneous- Hypersensitivity reaction- (light rash with or without pruritus); leukopenia, hemolytic anemia, jaundice.
Contra-Indications:
Hypersens to metaxalone, known tendency to drug induced hemolytic or other anemia,
significantly impaired renal or hepatic function.
Special precautions:
Warnings-
Hepatic function impairment- Administerr with great care to patients with preexisting liver disease and perform liver functions studies as required. Elevation in cephalin flocculation tests without concurrent changes inother liver functin parameters have been noted.
Pregnancy- Do not use during pregnancy especially during early pregnancy or in women who become pregnant unless potential benefits outweigh the potential hazards to the fetus.
Lactation- Safety for use in nursing mother has not been established.
Children- Safety and efficacy for use in children < 12 years of age has not been established.
Dosages/ Overdosage Etc:
Indications:
Musculoskeletal conditions, as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.
Dosage:
Adults and children(below 12 years): 800mg 3 to 4 times daily.
Overdosage-
Symptoms/Treatment
Employ gastric lavage and supportive theapy.
No documented case of major toxicity has been reported.
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Patient Information:
.
Refer Orphenadrine
1.May cause drowsiness or dizziness. Patients should observe caution while driving or performing tasks requiring alertness and coordination.
2. Avoid alcohol and other CNS depressants
3. Notify physician if skin rash or yellowish discoloration of the skin or eyes occur.
Pharmacology/ Pharmacokinetics:
Pharmacology:
The mechanism of action of metaxalone has not been established, but it may be due to CNS depression. The drug has no direct action on the contractile mechanism of straited muscle, and also does not not relax tense skeletal muscles.
Pharmacokinetics:
Onset of action is 1 hour and duration of action is 4 to 6 hours. Peak plasma levels of approx 300mcg/ml occur 2 hours after administration of 800mg metaxalone. The half-life is 2 to 3 hours,and the meatbolites are excreted in the urine.
Pregnancy and lactation:
Pregnancy:
Do not use during pregnancy or in women who may become pregnant, unless the
potential benefits outweigh the potential hazards to the fetus.
Lactation:
It is not known whether the drug is excreted in the breast milk. Safety for use in nursing mothers has not been established.
Children:
Safety and efficacy for use in children below 12 years of age have not been
established.
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