Miroflex
Generic Name
Baclofen 10 mg Tablet
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| miroflex 10 mg tablet | ৳ 35.00 | ৳ 350.00 |
Description
Overview of the medicine
Baclofen is a muscle relaxant and antispastic agent. It is used to relieve muscle spasms, cramping, and tightness caused by conditions such as multiple sclerosis, spinal cord injury, or cerebral palsy.
Uses & Indications
Dosage
Adults
Initial: 5 mg three times daily for 3 days, then increased by 5 mg increments every 3 days as needed, usually up to 10-20 mg three times daily. Maximum 100 mg/day.
Elderly
Start with lower doses (e.g., 5 mg once or twice daily) and titrate slowly due to increased sensitivity and potential for adverse effects.
Renal_impairment
Dose reduction required; 5 mg daily or every other day may be sufficient, depending on the degree of impairment.
How to Take
Administer orally with food or milk to minimize gastrointestinal irritation. Do not discontinue abruptly.
Mechanism of Action
Baclofen is a GABA-B receptor agonist. It acts centrally in the spinal cord to inhibit both monosynaptic and polysynaptic reflexes, thereby reducing muscle spasticity.
Pharmacokinetics
Onset
Onset of action typically within 1-2 hours.
Excretion
Primarily excreted unchanged by the kidneys (70-80%) within 72 hours.
Half life
Approximately 3-4 hours.
Absorption
Rapidly and extensively absorbed from the gastrointestinal tract. Peak plasma concentrations reached in 2-3 hours.
Metabolism
About 15% metabolized in the liver; main metabolite is beta-(p-chlorophenyl)-gamma-hydroxybutyric acid.
Side Effects
Contraindications
- Hypersensitivity to baclofen or any component of the formulation
- Peptic ulcer disease (relative contraindication)
- Epilepsy (relative contraindication, use with caution)
Drug Interactions
Lithium
May worsen spasticity and can lead to dyskinesia.
Antihypertensives
Enhanced hypotensive effect; monitor blood pressure and adjust antihypertensive dose if necessary.
Tricyclic Antidepressants (TCAs)
May potentiate the muscle relaxant effect of baclofen, leading to increased sedation.
CNS Depressants (e.g., alcohol, opioids, benzodiazepines)
Increased CNS depression, drowsiness, and respiratory depression. Avoid concomitant use or use with extreme caution.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe drowsiness, dizziness, confusion, decreased consciousness, respiratory depression, seizures, and coma. Management involves supportive care, gastric lavage or activated charcoal if recent ingestion, and respiratory support if needed.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefits outweigh the potential risks to the fetus. Baclofen is excreted in breast milk in small amounts; use with caution during lactation.
Side Effects
Contraindications
- Hypersensitivity to baclofen or any component of the formulation
- Peptic ulcer disease (relative contraindication)
- Epilepsy (relative contraindication, use with caution)
Drug Interactions
Lithium
May worsen spasticity and can lead to dyskinesia.
Antihypertensives
Enhanced hypotensive effect; monitor blood pressure and adjust antihypertensive dose if necessary.
Tricyclic Antidepressants (TCAs)
May potentiate the muscle relaxant effect of baclofen, leading to increased sedation.
CNS Depressants (e.g., alcohol, opioids, benzodiazepines)
Increased CNS depression, drowsiness, and respiratory depression. Avoid concomitant use or use with extreme caution.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe drowsiness, dizziness, confusion, decreased consciousness, respiratory depression, seizures, and coma. Management involves supportive care, gastric lavage or activated charcoal if recent ingestion, and respiratory support if needed.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefits outweigh the potential risks to the fetus. Baclofen is excreted in breast milk in small amounts; use with caution during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA in Bangladesh)
Patent Status
Generic available, off-patent
Clinical Trials
Baclofen has undergone extensive clinical trials demonstrating its efficacy and safety in the management of spasticity across various neurological conditions.
Lab Monitoring
- No routine lab monitoring is generally required. Liver function tests may be considered in patients with hepatic impairment or during prolonged use.
- Renal function monitoring in patients with kidney impairment.
Doctor Notes
- Caution is advised in patients with renal impairment, as dose adjustment is necessary.
- Monitor for CNS depression, especially when co-administered with other depressants.
- Emphasize the importance of gradual withdrawal to patients to prevent severe adverse effects.
- Evaluate benefits versus risks in patients with a history of epilepsy or peptic ulcer.
Patient Guidelines
- Do not stop taking Miroflex-10-mg Tablet suddenly, as this can lead to serious withdrawal symptoms. Follow your doctor's instructions for gradual tapering.
- Avoid consuming alcohol and other central nervous system depressants while on this medication.
- This medicine may cause drowsiness or dizziness. Avoid driving or operating heavy machinery until you know how it affects you.
- Take with food or milk to minimize stomach upset.
Missed Dose Advice
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Miroflex-10-mg Tablet may cause drowsiness, dizziness, and decreased alertness. Patients should be warned not to drive or operate hazardous machinery until they are reasonably certain that baclofen does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Regular physical therapy and exercise can complement baclofen treatment for spasticity. Maintain a healthy and balanced lifestyle.
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