Sedilux-M
Generic Name
Clonazepam
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sedilux m 4 mg tablet | ৳ 0.20 | N/A |
Description
Overview of the medicine
Clonazepam is a benzodiazepine derivative. It is used to prevent and control seizures, panic disorder, and certain movement disorders. It works by calming the brain and nerves.
Uses & Indications
Dosage
Adults
Seizure disorders: Initial dose 0.5 mg three times daily. May be increased by 0.5 mg every 3 days until seizures are controlled or side effects prohibit further increase. Maximum daily dose 20 mg. Panic disorder: Initial dose 0.25 mg twice daily. May be increased to 1 mg/day after 3 days. Maximum daily dose 4 mg.
Elderly
Elderly patients may be more sensitive to the effects of benzodiazepines. Lower initial doses (e.g., 0.25 mg once or twice daily) are recommended, with careful titration.
Renal_impairment
No specific dose adjustment is generally required for renal impairment, but caution is advised due to potential accumulation of metabolites in severe cases.
How to Take
Take Sedilux-M tablet orally with or without food. Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet unless specifically advised by a doctor for dispersion.
Mechanism of Action
Clonazepam enhances the effect of gamma-aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. This leads to increased chloride ion influx, neuronal hyperpolarization, and decreased neuronal excitability, resulting in anxiolytic, anticonvulsant, sedative, and muscle relaxant effects.
Pharmacokinetics
Onset
Oral: 20-60 minutes.
Excretion
Primarily excreted in the urine (around 50-70%) as metabolites, with a smaller portion excreted in feces (around 10-30%). Less than 2% is excreted as unchanged drug.
Half life
18-50 hours.
Absorption
Rapidly and completely absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are reached within 1-4 hours. Bioavailability is approximately 90%.
Metabolism
Extensively metabolized in the liver, primarily via nitroreduction by CYP3A4 to 7-aminoclonazepam, followed by acetylation. Other metabolic pathways also exist.
Side Effects
Contraindications
- Known hypersensitivity to clonazepam or any component of the formulation, or to other benzodiazepines.
- Acute narrow-angle glaucoma.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
Drug Interactions
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death.
Antiepileptic drugs
May lead to additive CNS depression. Monitoring of plasma levels of co-administered antiepileptic drugs may be beneficial.
Alcohol and other CNS depressants
Enhances sedative effects, leading to increased drowsiness and impaired coordination.
CYP3A4 inducers (e.g., rifampin, carbamazepine)
May decrease clonazepam plasma concentrations, reducing its therapeutic effect.
CYP3A4 inhibitors (e.g., ketoconazole, fluconazole)
May increase clonazepam plasma concentrations, potentially leading to increased adverse effects.
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 somnolence, confusion, diminished reflexes, ataxia, and coma. Management is primarily supportive: maintain airway, monitor vital signs, and provide symptomatic treatment. Flumazenil, a benzodiazepine receptor antagonist, may be used but carries risks, especially in patients on chronic benzodiazepine therapy or with co-ingestions.
Pregnancy & Lactation
Pregnancy Category D. Clonazepam can cause fetal harm when administered to a pregnant woman. It is not recommended during pregnancy, especially during the first trimester. Excreted into breast milk; therefore, not recommended for use during breastfeeding.
Side Effects
Contraindications
- Known hypersensitivity to clonazepam or any component of the formulation, or to other benzodiazepines.
- Acute narrow-angle glaucoma.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
Drug Interactions
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death.
Antiepileptic drugs
May lead to additive CNS depression. Monitoring of plasma levels of co-administered antiepileptic drugs may be beneficial.
Alcohol and other CNS depressants
Enhances sedative effects, leading to increased drowsiness and impaired coordination.
CYP3A4 inducers (e.g., rifampin, carbamazepine)
May decrease clonazepam plasma concentrations, reducing its therapeutic effect.
CYP3A4 inhibitors (e.g., ketoconazole, fluconazole)
May increase clonazepam plasma concentrations, potentially leading to increased adverse effects.
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 somnolence, confusion, diminished reflexes, ataxia, and coma. Management is primarily supportive: maintain airway, monitor vital signs, and provide symptomatic treatment. Flumazenil, a benzodiazepine receptor antagonist, may be used but carries risks, especially in patients on chronic benzodiazepine therapy or with co-ingestions.
Pregnancy & Lactation
Pregnancy Category D. Clonazepam can cause fetal harm when administered to a pregnant woman. It is not recommended during pregnancy, especially during the first trimester. Excreted into breast milk; therefore, not recommended for use during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Clonazepam has been extensively studied in numerous clinical trials demonstrating its efficacy and safety for various seizure disorders and panic disorder. These studies have led to its approval for these indications worldwide.
Lab Monitoring
- Periodic monitoring of liver function tests (LFTs) is recommended during long-term therapy.
- Complete blood count (CBC) may be monitored periodically.
Doctor Notes
- Prescribe the lowest effective dose for the shortest duration possible to minimize risks of dependence and adverse effects.
- Counsel patients thoroughly about the risks of concomitant use with opioids, alcohol, and other CNS depressants.
- Emphasize the importance of gradual tapering when discontinuing treatment to prevent severe withdrawal symptoms.
- Assess for a history of substance abuse prior to initiating therapy.
Patient Guidelines
- Do not abruptly stop taking Sedilux-M, as it can cause withdrawal symptoms. Always consult your doctor for gradual dose reduction.
- Avoid alcohol and other central nervous system depressants while taking this medicine.
- Inform your doctor about all other medications you are taking, including herbal supplements and over-the-counter drugs.
- Report any unusual mood or behavior changes to your doctor immediately.
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 with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Sedilux-M may cause drowsiness, dizziness, or impaired coordination. Do not drive or operate heavy machinery until you know how this medicine affects your ability to perform such tasks safely.
Lifestyle Advice
- Maintain a consistent sleep schedule to support overall well-being.
- Avoid activities that require high mental alertness until you know how the medication affects you.
- Engage in stress-reducing activities like meditation or light exercise.
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