Restonix
Generic Name
Alprazolam
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| restonix 05 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Restonix 0.5 mg Tablet contains Alprazolam, which is a benzodiazepine medication used to treat anxiety disorders and panic disorder. It works by enhancing the activity of certain neurotransmitters in the brain.
Uses & Indications
Dosage
Adults
Initial dose 0.25 mg to 0.5 mg three times daily, gradually increasing up to a maximum of 4 mg daily in divided doses for anxiety; for panic disorder, initial dose 0.5 mg three times daily, increasing up to a maximum of 10 mg daily in divided doses.
Elderly
Initial dose 0.25 mg two or three times daily, gradually adjusted based on response and tolerability.
Renal_impairment
Use with caution. Dosage adjustments may be necessary, starting with lower doses.
How to Take
Orally, with or without food. Swallow the tablet whole with water. Do not crush, chew, or break.
Mechanism of Action
Alprazolam binds to GABA-A receptors in the brain, enhancing the effects of gamma-aminobutyric acid (GABA), a major inhibitory neurotransmitter. This leads to sedative, anxiolytic, muscle relaxant, and anticonvulsant effects.
Pharmacokinetics
Onset
Within 15-30 minutes for anxiolytic effects.
Excretion
Excreted predominantly in the urine as metabolites, with only small amounts of unchanged drug.
Half life
Approximately 11-15 hours (range 6.3-26.9 hours) in healthy adults.
Absorption
Rapidly and well absorbed after oral administration. Peak plasma concentrations are achieved within 1-2 hours.
Metabolism
Primarily metabolized in the liver by cytochrome P450 3A (CYP3A) enzymes, mainly to alpha-hydroxyalprazolam and a benzophenone derivative.
Side Effects
Contraindications
- Known hypersensitivity to alprazolam or other benzodiazepines
- Acute narrow-angle glaucoma
- Concomitant use with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole)
Drug Interactions
Digoxin
Increased digoxin plasma levels have been reported with concomitant use of alprazolam.
Fluoxetine
Increases alprazolam plasma levels and may require dosage adjustment.
CYP3A inhibitors
Increases alprazolam concentration (e.g., ketoconazole, itraconazole, fluoxetine, nefazodone, fluvoxamine, cimetidine, erythromycin, clarithromycin, diltiazem, verapamil, oral contraceptives).
Imipramine/Desipramine
Increased steady-state plasma concentrations of imipramine and desipramine have been reported with concomitant use of alprazolam.
CNS depressants (e.g., opioids, alcohol, antihistamines, other benzodiazepines)
Increased risk of sedation, respiratory depression, coma, and death.
Storage
Store at controlled room temperature (20°C to 25°C), away from moisture and direct light. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves supportive care, gastric lavage/activated charcoal if appropriate, and monitoring of vital signs. Flumazenil may be used as an antidote, but caution is advised in patients on chronic benzodiazepine therapy.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Alprazolam is excreted in human milk; avoid use during lactation due to potential adverse effects on the infant.
Side Effects
Contraindications
- Known hypersensitivity to alprazolam or other benzodiazepines
- Acute narrow-angle glaucoma
- Concomitant use with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole)
Drug Interactions
Digoxin
Increased digoxin plasma levels have been reported with concomitant use of alprazolam.
Fluoxetine
Increases alprazolam plasma levels and may require dosage adjustment.
CYP3A inhibitors
Increases alprazolam concentration (e.g., ketoconazole, itraconazole, fluoxetine, nefazodone, fluvoxamine, cimetidine, erythromycin, clarithromycin, diltiazem, verapamil, oral contraceptives).
Imipramine/Desipramine
Increased steady-state plasma concentrations of imipramine and desipramine have been reported with concomitant use of alprazolam.
CNS depressants (e.g., opioids, alcohol, antihistamines, other benzodiazepines)
Increased risk of sedation, respiratory depression, coma, and death.
Storage
Store at controlled room temperature (20°C to 25°C), away from moisture and direct light. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves supportive care, gastric lavage/activated charcoal if appropriate, and monitoring of vital signs. Flumazenil may be used as an antidote, but caution is advised in patients on chronic benzodiazepine therapy.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Alprazolam is excreted in human milk; avoid use during lactation due to potential adverse effects on the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies and hospitals
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available
Clinical Trials
Alprazolam's efficacy and safety have been established through numerous clinical trials for anxiety and panic disorders. Ongoing post-marketing surveillance continues to monitor its long-term effects and safety profile.
Lab Monitoring
- No routine laboratory monitoring is typically required.
- Liver and kidney function tests may be considered in patients with pre-existing hepatic or renal impairment.
Doctor Notes
- Educate patients about the risks of dependence and withdrawal. Emphasize gradual tapering of dosage when discontinuing.
- Monitor for signs of abuse or misuse, especially in patients with a history of substance abuse.
- Caution patients about additive CNS depressant effects with alcohol or other medications.
Patient Guidelines
- Take exactly as prescribed by your doctor. Do not increase or decrease the dose without consulting your doctor.
- Do not stop taking this medicine abruptly, as it can lead to withdrawal symptoms. Your doctor will gradually reduce your dose.
- Avoid alcohol and other CNS depressants while taking Restonix 0.5 mg Tablet.
- Be cautious when driving or operating machinery until you know how this medicine affects you.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next 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
May cause drowsiness, dizziness, or impaired coordination, which can affect your ability to drive or operate machinery safely. Avoid such activities until you are certain this medicine does not impair your abilities.
Lifestyle Advice
- Practice relaxation techniques and stress management.
- Maintain a regular sleep schedule.
- Avoid excessive caffeine intake.
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