Sedron
Generic Name
sedron-5-mg-tablet
Manufacturer
PharmaCo Bangladesh Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
sedron 5 mg tablet | ৳ 8.05 | ৳ 80.50 |
Description
Overview of the medicine
Sedron 5 mg tablet is a medication primarily used for the short-term treatment of insomnia and anxiety. It acts on the central nervous system to produce a calming effect, helping to induce sleep and reduce feelings of anxiousness. It belongs to the class of non-benzodiazepine sedative-hypnotics.
Uses & Indications
Dosage
Adults
5 mg taken orally, once daily, immediately before bedtime. The lowest effective dose should be used. Treatment duration should be as short as possible, typically ranging from a few days to a maximum of 4 weeks, including a tapering-off period.
Elderly
A reduced starting dose of 2.5 mg may be considered due to increased sensitivity and potential for adverse effects. Dosage should be carefully titrated based on individual response and tolerability.
Renal_impairment
No specific dose adjustment is generally required for mild to moderate renal impairment, but caution is advised. For severe renal impairment, dose reduction may be necessary, and close monitoring is recommended.
How to Take
Take Sedron 5 mg tablet orally with a glass of water, immediately before going to bed. It should be taken on an empty stomach for faster absorption, though it can be taken with food if gastrointestinal upset occurs. Do not crush or chew the tablet.
Mechanism of Action
Sedron selectively modulates GABA-A receptors in the brain, enhancing the inhibitory effects of GABA, a major inhibitory neurotransmitter. This leads to reduced neuronal excitability, resulting in sedative, hypnotic, anxiolytic, and muscle relaxant properties.
Pharmacokinetics
Onset
30-60 minutes
Excretion
Mainly renal, with approximately 80% excreted as metabolites in urine and 20% in feces.
Half life
6-8 hours
Absorption
Rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations reached within 1-2 hours.
Metabolism
Primarily metabolized in the liver via cytochrome P450 enzymes (e.g., CYP3A4, CYP2C9) into inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Sedron or any of its excipients
- Severe hepatic insufficiency
- Severe respiratory insufficiency
- Sleep apnea syndrome
- Myasthenia gravis
- Acute narrow-angle glaucoma
Drug Interactions
CYP3A4 Inducers (e.g., rifampicin, carbamazepine)
May decrease Sedron plasma concentrations, leading to reduced efficacy. Dose adjustment may be necessary.
CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin)
May increase Sedron plasma concentrations, leading to enhanced effects and adverse reactions. Dose adjustment may be necessary.
CNS Depressants (e.g., alcohol, opioids, other hypnotics, antidepressants)
Increased sedative effect and risk of respiratory depression. Avoid concomitant use or use with extreme caution.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include excessive sedation, somnolence, confusion, impaired coordination, slurred speech, respiratory depression, hypotension, and potentially coma. Management involves general supportive measures, including monitoring vital signs, maintaining a patent airway, and gastric lavage or activated charcoal if ingestion was recent. Flumazenil may be considered in severe cases, but caution is advised.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy, especially during the first trimester, due to potential risks to the fetus. Use only if the potential benefit outweighs the potential risk. Lactation: Sedron and its metabolites may be excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Sedron or any of its excipients
- Severe hepatic insufficiency
- Severe respiratory insufficiency
- Sleep apnea syndrome
- Myasthenia gravis
- Acute narrow-angle glaucoma
Drug Interactions
CYP3A4 Inducers (e.g., rifampicin, carbamazepine)
May decrease Sedron plasma concentrations, leading to reduced efficacy. Dose adjustment may be necessary.
CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin)
May increase Sedron plasma concentrations, leading to enhanced effects and adverse reactions. Dose adjustment may be necessary.
CNS Depressants (e.g., alcohol, opioids, other hypnotics, antidepressants)
Increased sedative effect and risk of respiratory depression. Avoid concomitant use or use with extreme caution.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include excessive sedation, somnolence, confusion, impaired coordination, slurred speech, respiratory depression, hypotension, and potentially coma. Management involves general supportive measures, including monitoring vital signs, maintaining a patent airway, and gastric lavage or activated charcoal if ingestion was recent. Flumazenil may be considered in severe cases, but caution is advised.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy, especially during the first trimester, due to potential risks to the fetus. Use only if the potential benefit outweighs the potential risk. Lactation: Sedron and its metabolites may be excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Proprietary, under patent
Clinical Trials
Clinical trials for Sedron have demonstrated its efficacy in reducing sleep latency and improving sleep maintenance in adults with primary insomnia. Phase III trials confirmed a favorable safety profile for short-term use, though long-term studies highlighted risks of dependence.
Lab Monitoring
- Liver function tests (LFTs) if used long-term or in patients with hepatic impairment
- Renal function tests (RFTs) for patients with renal impairment
- Complete blood count (CBC) periodically with prolonged use
Doctor Notes
- Emphasize short-term use and gradual withdrawal.
- Assess for underlying causes of insomnia/anxiety before prescribing.
- Monitor for signs of dependence or misuse.
Patient Guidelines
- Do not consume alcohol while taking Sedron.
- Avoid driving or operating heavy machinery until you know how Sedron affects you.
- Take Sedron just before going to bed and ensure you have at least 7-8 hours for sleep.
- Do not stop taking Sedron abruptly; consult your doctor for gradual dose reduction.
- Inform your doctor about all other medications and supplements you are taking.
Missed Dose Advice
If you miss a dose of Sedron, only take it if you remember within a short period (e.g., a few hours) of your usual bedtime and you still have several hours available for sleep. Do not take a missed dose in the middle of the night or the next morning, as this can lead to daytime drowsiness. Never take a double dose to make up for a missed one.
Driving Precautions
Sedron causes drowsiness, dizziness, and impaired motor skills. Patients should be warned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle, until they are reasonably certain that Sedron does not adversely affect them.
Lifestyle Advice
- Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed).
- Manage stress through relaxation techniques or mindfulness.
- Engage in regular physical activity, but avoid strenuous exercise close to bedtime.
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