Tolec
Generic Name
Tolperisone Hydrochloride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tolec 10 mg tablet | ৳ 10.03 | ৳ 100.30 |
Description
Overview of the medicine
Tolec 10 mg Tablet contains Tolperisone, which is a centrally acting muscle relaxant. It is used to treat pathological hypertonicity of skeletal muscles, such as that caused by neurological diseases (e.g., spasticity, rigidity, muscle spasms). It helps to relieve muscle stiffness and improve movement without causing sedation.
Uses & Indications
Dosage
Adults
The usual daily dose is 50-150 mg three times daily, adjusted according to individual response and tolerability. Tolec 10 mg tablet may be used for titration, as a component of a larger total daily dose, or for specific patient groups requiring lower doses.
Elderly
Lower initial doses and careful titration may be necessary due to potential reduced renal and/or hepatic function.
Renal_impairment
Reduced dosage and careful monitoring are required in patients with moderate renal impairment. Use in severe renal impairment is not recommended.
How to Take
Tolec 10 mg Tablet should be taken orally after meals with a glass of water to maximize absorption and reduce gastrointestinal irritation. Swallow the tablet whole; do not chew or crush it.
Mechanism of Action
Tolperisone acts on the central nervous system by modulating voltage-gated sodium and calcium channels. This action leads to a decrease in the excitability of motor neurons and a reduction in muscle tone. Unlike many other muscle relaxants, it primarily acts on the spinal cord and brainstem, thereby reducing muscle hypertonicity without significant sedative effects.
Pharmacokinetics
Onset
Clinical effects typically begin within 1 hour after oral administration.
Excretion
Mainly excreted by the kidneys, almost exclusively as metabolites, within 24 hours.
Half life
Approximately 1.5-2.5 hours.
Absorption
Well absorbed from the gastrointestinal tract, but undergoes extensive first-pass metabolism, resulting in a bioavailability of about 20%. Peak plasma concentrations are reached within 0.5-1.5 hours after oral administration.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 enzymes (mainly CYP2D6 and CYP3A4), into several inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Tolperisone or to any of its excipients, or to Eperisone (a chemically related compound).
- Myasthenia gravis (a chronic autoimmune neuromuscular disease characterized by weakness of voluntary muscles).
- Breastfeeding women.
Drug Interactions
CYP2D6 inhibitors
Tolperisone is metabolized by CYP2D6; co-administration with strong CYP2D6 inhibitors may increase Tolperisone plasma levels, requiring dose adjustment.
Sedatives and alcohol
Tolperisone generally does not cause sedation, so interactions with sedatives or alcohol are less pronounced than with other muscle relaxants. However, caution is advised.
Niflumic acid and other NSAIDs
Tolperisone may increase the effect of niflumic acid and other NSAIDs; therefore, their concomitant use may require a dose reduction of the NSAID.
Other centrally acting muscle relaxants
When Tolperisone is co-administered with other centrally acting muscle relaxants, the dose of Tolperisone may need to be reduced.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, symptoms may include drowsiness, dizziness, gastrointestinal upset (nausea, vomiting), and rarely, seizures or respiratory depression. Treatment is symptomatic and supportive, focusing on maintaining vital functions.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under strict medical supervision. Tolperisone is contraindicated during breastfeeding due to lack of data on its excretion into human milk and potential harm to the infant.
Side Effects
Contraindications
- Hypersensitivity to Tolperisone or to any of its excipients, or to Eperisone (a chemically related compound).
- Myasthenia gravis (a chronic autoimmune neuromuscular disease characterized by weakness of voluntary muscles).
- Breastfeeding women.
Drug Interactions
CYP2D6 inhibitors
Tolperisone is metabolized by CYP2D6; co-administration with strong CYP2D6 inhibitors may increase Tolperisone plasma levels, requiring dose adjustment.
Sedatives and alcohol
Tolperisone generally does not cause sedation, so interactions with sedatives or alcohol are less pronounced than with other muscle relaxants. However, caution is advised.
Niflumic acid and other NSAIDs
Tolperisone may increase the effect of niflumic acid and other NSAIDs; therefore, their concomitant use may require a dose reduction of the NSAID.
Other centrally acting muscle relaxants
When Tolperisone is co-administered with other centrally acting muscle relaxants, the dose of Tolperisone may need to be reduced.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, symptoms may include drowsiness, dizziness, gastrointestinal upset (nausea, vomiting), and rarely, seizures or respiratory depression. Treatment is symptomatic and supportive, focusing on maintaining vital functions.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under strict medical supervision. Tolperisone is contraindicated during breastfeeding due to lack of data on its excretion into human milk and potential harm to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Expired/Generic available
Clinical Trials
Tolperisone has undergone various clinical trials to establish its efficacy and safety in treating muscle spasticity and hypertonicity. Ongoing research explores its potential in different neurological conditions and its non-sedative profile. Earlier studies confirm its central muscle relaxant action.
Lab Monitoring
- No specific routine laboratory monitoring is typically required for Tolperisone. However, for prolonged use or in patients with pre-existing hepatic or renal impairment, periodic assessment of liver and kidney function tests may be considered.
Doctor Notes
- Tolperisone is a valuable non-sedating muscle relaxant, particularly useful for spasticity where maintaining alertness is crucial.
- Emphasize the importance of taking Tolec after meals to patients, as bioavailability is significantly increased.
- Counsel patients on potential hypersensitivity reactions and instruct them to discontinue the drug and seek medical attention if symptoms like rash or swelling occur.
- While generally well-tolerated, consider initial lower doses in elderly or renally impaired patients and monitor response.
Patient Guidelines
- Take Tolec 10 mg Tablet exactly as prescribed by your doctor. Do not alter the dose or stop the medication without consulting your doctor.
- Always take the tablet after meals with sufficient liquid (e.g., a glass of water) to ensure better absorption.
- Report any new or worsening side effects, especially signs of an allergic reaction like rash, itching, swelling of the face/throat, or difficulty breathing, immediately to your doctor.
- Avoid driving or operating heavy machinery if you experience dizziness, drowsiness, or any other side effects that impair your concentration.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Tolec is generally non-sedating, but some individuals may experience dizziness or drowsiness, especially at the start of treatment. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Regular, gentle exercise and physical therapy, as advised by your healthcare provider, can complement the muscle relaxing effects of Tolec. Maintain a balanced diet and stay hydrated.
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