Sedilux-M
Generic Name
Clonazepam
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sedilux m 2 mg syrup | ৳ 21.70 | N/A |
Description
Overview of the medicine
Sedilux-M (Clonazepam) is a benzodiazepine used to prevent and treat various types of seizures, panic disorder, and other anxiety-related conditions. It acts on the brain and nerves (central nervous system) to produce a calming effect.
Uses & Indications
Dosage
Adults
Initial dose for seizures: 0.5 mg orally three times daily, gradually increased by 0.5-1 mg every 3 days until seizure control is achieved or side effects preclude further increase. Max daily dose usually 20 mg. Initial dose for panic disorder: 0.25 mg orally twice daily, increasing to 1 mg/day after 3 days. Max daily dose usually 4 mg.
Elderly
Lower initial doses (e.g., 0.25 mg once daily) and slower titration are recommended due to increased sensitivity and potential for adverse effects.
Renal_impairment
No specific dose adjustment is generally required for mild to moderate renal impairment, but caution is advised. Not recommended for severe impairment.
How to Take
Take Sedilux-M syrup orally with or without food, as directed by your doctor. Use a calibrated measuring device to ensure accurate dosing. Do not stop taking it abruptly.
Mechanism of Action
Clonazepam enhances the activity of gamma-aminobutyric acid (GABA), a major inhibitory neurotransmitter in the brain. It binds to specific benzodiazepine receptors on the GABA-A receptor complex, leading to increased chloride ion influx and hyperpolarization of neurons, thereby reducing neuronal excitability.
Pharmacokinetics
Onset
Within 20-60 minutes for oral administration.
Excretion
Excreted primarily in the urine as metabolites (approximately 50-70%) and a small amount in feces (10-30%). Less than 2% is excreted unchanged.
Half life
Approximately 30-40 hours (range: 19-60 hours).
Absorption
Rapidly and completely absorbed after oral administration. Peak plasma concentrations are reached within 1-4 hours.
Metabolism
Extensively metabolized in the liver, primarily by nitroreduction, forming 7-amino-clonazepam (inactive metabolite).
Side Effects
Contraindications
- Known hypersensitivity to clonazepam or other benzodiazepines.
- Acute narrow-angle glaucoma.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
Drug Interactions
CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin)
May decrease clonazepam plasma concentrations and reduce its effectiveness.
CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, fluvoxamine)
May increase clonazepam plasma concentrations and enhance its effects.
CNS Depressants (e.g., alcohol, opioids, barbiturates, antihistamines)
Increased CNS depressant effects, leading to profound sedation, respiratory depression, and hypotension.
Storage
Store at room temperature (below 30°C). Protect from light and moisture. Do not freeze. Keep the bottle tightly closed.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves supportive care, maintaining a patent airway, and monitoring vital signs. Flumazenil, a benzodiazepine receptor antagonist, may be considered in severe cases, but caution is advised due to the risk of precipitating withdrawal symptoms or seizures in dependent patients.
Pregnancy & Lactation
Pregnancy Category D: Clonazepam may cause fetal harm when administered to a pregnant woman. It is excreted in breast milk and may cause sedation and feeding difficulties in nursing infants. Use with caution during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding.
Side Effects
Contraindications
- Known hypersensitivity to clonazepam or other benzodiazepines.
- Acute narrow-angle glaucoma.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
Drug Interactions
CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin)
May decrease clonazepam plasma concentrations and reduce its effectiveness.
CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, fluvoxamine)
May increase clonazepam plasma concentrations and enhance its effects.
CNS Depressants (e.g., alcohol, opioids, barbiturates, antihistamines)
Increased CNS depressant effects, leading to profound sedation, respiratory depression, and hypotension.
Storage
Store at room temperature (below 30°C). Protect from light and moisture. Do not freeze. Keep the bottle tightly closed.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves supportive care, maintaining a patent airway, and monitoring vital signs. Flumazenil, a benzodiazepine receptor antagonist, may be considered in severe cases, but caution is advised due to the risk of precipitating withdrawal symptoms or seizures in dependent patients.
Pregnancy & Lactation
Pregnancy Category D: Clonazepam may cause fetal harm when administered to a pregnant woman. It is excreted in breast milk and may cause sedation and feeding difficulties in nursing infants. Use with caution during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture when stored under recommended conditions.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Patent expired
WHO Essential Medicine
YesClinical Trials
Clonazepam has undergone extensive clinical trials for its efficacy and safety in various seizure disorders and panic disorder, leading to its widespread approval and use since the 1970s.
Lab Monitoring
- Periodic blood counts and liver function tests are recommended during long-term therapy.
Doctor Notes
- Emphasize the importance of gradual withdrawal to prevent severe withdrawal symptoms.
- Monitor for signs of depression, suicidality, and paradoxical reactions, especially in pediatric and elderly patients.
- Caution patients about the risks of concomitant use with opioids and alcohol.
Patient Guidelines
- Do not stop taking Sedilux-M abruptly without consulting your doctor, as this can lead to withdrawal symptoms.
- Avoid alcohol and other CNS depressants while taking this medication.
- Report any unusual mood or behavior changes, or thoughts of self-harm, to your doctor immediately.
- Do not drive or operate heavy machinery until you know how this medication affects you.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Sedilux-M can cause drowsiness, dizziness, and impaired coordination, which may affect your ability to drive or operate machinery. Avoid such activities until you are certain of its effects on you.
Lifestyle Advice
- Maintain a regular sleep schedule to support overall well-being.
- Practice stress-reducing techniques such as meditation or deep breathing exercises.
- Engage in regular physical activity to help manage anxiety and improve mood.
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