Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
210. Tolperisone Hcl Tablet 50/100/150mg 26-09-08
For the relief of painful muscle spasms of the skeletal
musculature
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Tolperisone Hcl SR 450mg tablets 30-03-2010
For the Relief of Painful Muscle Spasms of the skeletal Musculalture
2.Tolperisone Hcl 450mg 12-04-2013
+ Diclofenac Sodium 100mg SR tablets
Addl.stgth
For the treatment of Patients with acute Muscule/Musculo skeletal
spasms in adult
3. Tolperisone Hcl Tablet 26-09-2008
50/100/150mg
For the relief of Painful muscle Spasms of the Skeletal Musculature
4.Tolperisone HCL IP 150mg 07-12-2011
+ Diclofenac IP 50mg Tablets
For the Treatment of Patients with Acute Muscle/musculoskeletal
spasm in adult
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Each sustained release tablet contains: 12-04-2013
Toperisone HCL 450mg +
Diclofenac sodium IP 100mg
Addl.stgth
For the treatment of Patients with acute muscle/musculo
skeletal spasm in adult
2.Tolperidone HCL 150mg + 21-10-2011
Paracetamol IP 500mg tablet
For the treatment of patients with acute painful
musculoskeletal conditions
Painful Muscle Spasms and Muscle Spasticities
Contra-Indications:
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.
Dosages/ Overdosage Etc:
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
Manufacturer Details