Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: M. K. Stavrinos ltd., 3 Irakleous Str., 1046 Nicosia, Cyprus Tel.: 22434490, Fax: 22434485, E-mail: mkstavco@cytanet.com.cy
Symptomatic treatment of post-stroke spasticity in adults.
The recommended dosage to initiate the treatment in adults is one tablet at 150 mg (Mydoflex) three times a day (i.e. a daily dose of 450 mg). In known difficult cases a dosage of four times a tablet at 150 mg (i.e. a daily dose of 600 mg) can be used. In children the daily dose to initiate the treatment must be reduced. It will be calculated to be 5 to 10 mg/kg and divided in several administrations per day. In elderly patients as well as in patients with hepatic or renal insufficiency it is also recommended to reduce the daily dose.
Maintain the initial dosage until the therapeutic effect is obtained. Then it is possible to prolong the dosing intervals (e.g. giving two doses per day).
The safety and efficacy of tolperisone in children have not been established.
Experience in patients with renal impairment is limited and a higher frequency of adverse events has been observed in this patient group. Therefore, individual titration with close monitoring of the patient’s condition and renal function is recommended in patients with moderate renal impairment. Use of tolperisone is not recommended in patients with severe renal impairment.
Experience in patients with hepatic impairment is limited and a higher frequency of adverse events has been observed in this patient group. Therefore, individual titration with close monitoring of the patient’s condition and hepatic function is recommended in patients with moderate hepatic impairment. Use of tolperisone is not recommended in patients with severe hepatic impairment.
The medicine should be taken after meals with a glass of water.
Insufficient food intake may decrease the bioavailability of tolperisone.
Adynamia and coma were the symptoms in the reported cases of accidental ingestion and suicide attempts. Gastric lavage may be helpful to eliminate tablet remains. Vital signs must be monitored and, if necessary, cardiorespiratory assistance undertaken.
Symptoms in overdose may include sommolence, gastrointestinal symptoms (nausea, vomiting, epigastric pain), tachycardia, hypertension, bradykinesia and vertigo. In severe cases seizure, respiratory depression, apnoea and coma were reported.
There is no special antidote for tolperisone, and symptomatic treatment is recommended.
Shelf life of Mydoflex as packaged for sale is 2 years.
Store Mydoflex in a dry place, in their original package (blister and carton) to protect them from moisture and light.
Aluminium/blister.
Pack sizes: 30 tablets.
No special requirements.
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