Composition
Somalax 250 Tablet: Each tablet contains Carisoprodol USP 250 mg. Somalax 350 Tablet: Each tablet contains Carisoprodol USP 350 mg.
Pharmacology
Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax tense skeletal muscle in man. The mode of action of Carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, Carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours.
Indication
Somalax is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.
Dosage & Administration
Adults (18 years and older): The recommended dose of Somalax is 250 mg to 350 mg 3-4 times daily (before or after meal and at bedtime) for up to 2-3 weeks or as directed by the physician.
Contraindication
Carisoprodol is contraindicated in patients with history of acute intermittent prophyria or a hypersensitivity reaction to carbamate such as Meprobamate.
Warnings & Precautions
Carisoprodol is metabolized in the liver and excreted by the kidney. To avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function & additive sedative effects is found when used with other CNS depressants including alcohol.
Side Effects
Common side effects are drowsiness, dizziness and headache.
Use in Pregnancy & Lactation
The safety of this drug in pregnancy or lactation has not been established. Therefore, use of this drug in pregnancy, in nursing mothers, or in women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to mother and child. Carisoprodol is present in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. This factor should be taken into account when use of the drug is contemplated in breast-feeding patients.
Use in Children & Adolescents
The efficacy, safety and pharmacokinetics of Carisoprodol in paediatric patients less than 16 years of age have not been established.
Drug Interactions
• Caution should be exercised with patients who take other CNS depressants (eg.- alcohol, benzodiazepines, opioids, tricyclic antidepressants) with Carisoprodol.
• Co-administration of CYP2C19 inhibitors (Omeprazole, Fluvoxamine) with Carisoprodol could result in increased exposure of Carisoprodol. Co-administration of CYP2C19 inducers (Rifampin) with Carisoprodol may result in decreased exposure of Carisoprodol.
Overdosage
Overdosage of Carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures have been reported with Carisoprodol overdosage. Basic life support measures should be instituted in Carisoprodol overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
Storage
Store below 30°C., away from light and in a dry place. Keep all medicines out of the reach of children.
Packing
Somalax 250 Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack and an insert.
Somalax 350 Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack and an insert.