Full Prescribing Info
Tolperisone hydrochloride.
Each tablet contains Tolperisone Hydrochloride 50 mg.
Pharmacology: Pharmacodynamics: BIOCALM is a centrally acting muscle relaxant. It exerts muscle relaxant activity through blocking gamma pathway descending from the brain stem and exhibiting nonspecified inhibitory activity at the spinal levels.
Pharmacokinetics: After oral administration absorption and distribution of tolperisone is rapid with large variation in AUC (area under curve) and Cmax (peak concentration). Tolperisone is mainly metabolised by p450-mediated CYP2D6 metabolic pathway into its active metabolite hydroxymethyl tolperisone. The half life of the drug is 1.5 hours, it undergoes extensive metabolism and only 0.1% of total dose appears in urine over a period of 24 hours. The inter-individual variation in the plasma concentration is due to the genetic polymorphism of the drug metabolizing enzymes.
Tolperisone is used in the symptomatic treatment of spasticity, muscle spasm.
Dosage/Direction for Use
The recommended oral dose for adults is 1-3 tablets 3 times daily or as directed by physician.
No data.
Patients with a history of hypersensitivity to Tolperisone and any other ingredients of BIOCALM.
Tolperisone is contraindicated in conditions like Myasthenia gravis.
Special Precautions
Caution need to be exercised in patients with hepatic failure and in pregnancy.
Individuals who perform potentially hazardous tasks requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle) should be warned about possible dizziness or weakness.
Use In Pregnancy & Lactation
Safety in pregnancy and lactation is not established.
Use of this medication in pregnancy and lactation is not recommended unless the therapeutic advantages of BIOCALM are judged as overweighing its risks.
Adverse Reactions
Common side effects are abdominal pain, nausea, diarrhea, dizziness, headache, weakness, tremor, muscle pain. It has been reported that it can manifest with hypersensitivity.
Drug Interactions
It has been reported that the combination use of tolperisone with methocarbamol caused accommodation disorder of eyes, exercise care in using BIOCALM in combination with methocarbamol.
Store at room temperature not exceeding 30°C.
ATC Classification
M03BX04 - tolperisone ; Belongs to the class of other centrally-acting muscle relaxants.
Double-compressed coated tab 50 mg (round, biconvex, pink) x 10 x 10's, 50 x 10's, 100 x 10's.
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