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Painful Muscle Spasms and Muscle Spasticities

The drug is well tolerated and with low incidence of adverse effects. Few adverse effects wer observed in patients like muscle pain, generalised body weakness, fatigue and dizziness, which were self-liminting.

Tolperisone has low -incidence of side efects. The drug is considered safe for use. The drug is contraindicated in pregnancy and during breast feeding. Breast feeding should be stopped during the treatment period The drug is contraindicated in patients suffering from mysthenia gravis and in patients. Since no well controlled studies have been carried out with the drug in pregnant women, tolperisone should be used with caution in such patients keeping the risk benefit ratio of the drug.

Special Precautions-

If the patient experiences uneasiness, accompanied by a feeling of burning in the extremities, skin reactions or a difficulty in breathing after the first dose of the drug, the treatment should be stopped immediately as it could be a sign of hypersensitivity. Patients on drug should be advised to observe caution while driving or operating machinery since dizziness has been reported by some patients.

Painful Muscle Spasms and Muscle Spasticities

Dosage -

Recommended based on clinical studies- Adults- 150- 1000/mg/day Childrren (age range from 3 months to 18 years ) 5-10 mg/kg/day

Low back pain- 150-400mg/day

Post-cerebral stroke spasticity - 300- 900mg/day Spinal pain- 300mg

Neuropathic diabetic foot syndrome- 150- 400mg

Painful reflux muuscle spasm - 300mg/day

Neurolathyrism - 300mg/day

Tolperisone was nitially derived from the structure of Cocaine. It is a pieridine derivative. Pharmacology- Tolperisone is a centrally acting muscle relaxant launched for tht treatment of acute and chronic back pain and spasticity of neurological origin. Being a centrally acting muscle relaxant, tolperisone acts by blocking sodium channels and also known to possess significant effect on voltage- gated calcium channels. Pharmacokinetics- Pharmacokinetic profile of tolperisone varies from individual to individual. There is a need for individualiztion of dosage of tolperisone while administering therapy to the patient. Tolperisone gets absorbed quickly in the body and peak plasma concentration is acheived usually 0.5 to 1.0 hour after ingestion Less than 1% of the dose is excreted unchanged within 24 hours in urine after I.V.administration. Total body clearance of the drug is 140.8 +/- 33.8l/hr. Interaction with food- Studies have shown that bioavailability of tolperisone is enhanced by at least 10- 30% in fasting state suggesting higher bioavailabilty is obtained when drug is administerd before meals

Studies have shown that bioavailability of tolperisone is enhanced by at least 10- 30% in fasting state suggesting higher bioavailabilty is obtained when drug is administerd before meals

The drug is contraindicated in pregnancy and during breast feeding. Breast feeding should be stopped during treatment.