Xolam-XR
Generic Name
Alprazolam Extended Release
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xolam xr 05 mg tablet | ৳ 2.00 | ৳ 20.00 |
Description
Overview of the medicine
Xolam-XR 0.5 mg tablet is an extended-release benzodiazepine used to treat panic disorder with or without agoraphobia, and generalized anxiety disorder. It works by enhancing the activity of a certain natural chemical (GABA) in the brain.
Uses & Indications
Dosage
Adults
Panic Disorder: Initially 0.5-1 mg once daily. May increase by no more than 1 mg/day every 3-4 days up to a maximum of 3-6 mg/day. GAD: Initially 0.5 mg once daily. Max 4 mg/day.
Elderly
Initially 0.5 mg once daily. Use with caution due to increased sensitivity and risk of adverse effects.
Renal_impairment
Use with caution. Dosage adjustments may be necessary. Start with lower doses.
How to Take
Take orally, once daily, preferably in the morning. Swallow the tablet whole; do not crush, chew, or break. Can be taken with or without food.
Mechanism of Action
Alprazolam binds to specific benzodiazepine receptors on GABA-A receptors in the central nervous system, enhancing the inhibitory effects of GABA. This leads to CNS depression, resulting in anxiolytic, sedative, hypnotic, muscle relaxant, and anticonvulsant effects.
Pharmacokinetics
Onset
Clinical effects may be noticeable within hours, but steady-state concentrations are reached after several days of dosing.
Excretion
Mainly excreted in the urine as metabolites.
Half life
Approximately 10-15 hours for the parent compound, slightly longer with XR formulation.
Absorption
Well absorbed from the gastrointestinal tract; peak plasma concentrations occur within 5-11 hours due to extended-release formulation.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4, to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to alprazolam or other benzodiazepines
- Acute narrow-angle glaucoma
- Concomitant use with potent CYP3A inhibitors (e.g., ketoconazole, itraconazole)
Drug Interactions
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death.
CNS Depressants (alcohol, other sedatives)
Additive CNS depressant effects.
CYP3A Inducers (e.g., carbamazepine, rifampin)
Decreased alprazolam plasma concentrations, potentially reducing efficacy.
CYP3A Inhibitors (e.g., ketoconazole, itraconazole, fluoxetine, nefazodone)
Increased alprazolam plasma concentrations, potentially leading to increased adverse effects.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves general supportive measures, monitoring vital signs, and gastric lavage if ingested recently. Flumazenil may be used as an antidote, but with caution, especially in patients on chronic benzodiazepine therapy or with a history of seizures.
Pregnancy & Lactation
Pregnancy Category D: Alprazolam may cause fetal harm when administered to pregnant women. Avoid during pregnancy, especially in the first trimester. Lactation: Alprazolam is excreted in breast milk and may cause sedation and feeding difficulties in infants. Not recommended during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to alprazolam or other benzodiazepines
- Acute narrow-angle glaucoma
- Concomitant use with potent CYP3A inhibitors (e.g., ketoconazole, itraconazole)
Drug Interactions
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death.
CNS Depressants (alcohol, other sedatives)
Additive CNS depressant effects.
CYP3A Inducers (e.g., carbamazepine, rifampin)
Decreased alprazolam plasma concentrations, potentially reducing efficacy.
CYP3A Inhibitors (e.g., ketoconazole, itraconazole, fluoxetine, nefazodone)
Increased alprazolam plasma concentrations, potentially leading to increased adverse effects.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves general supportive measures, monitoring vital signs, and gastric lavage if ingested recently. Flumazenil may be used as an antidote, but with caution, especially in patients on chronic benzodiazepine therapy or with a history of seizures.
Pregnancy & Lactation
Pregnancy Category D: Alprazolam may cause fetal harm when administered to pregnant women. Avoid during pregnancy, especially in the first trimester. Lactation: Alprazolam is excreted in breast milk and may cause sedation and feeding difficulties in infants. Not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date.
Availability
Available in pharmacies
Approval Status
Approved (e.g., FDA, DGDA)
Patent Status
Off-patent (for generic Alprazolam XR)
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of alprazolam extended-release in the treatment of panic disorder and generalized anxiety disorder, showing sustained anxiolytic effects and improved tolerability compared to immediate-release formulations.
Lab Monitoring
- No routine laboratory monitoring is typically required.
- Monitor liver and kidney function in patients with impairment or on long-term therapy.
Doctor Notes
- Counsel patients on the risks of dependence, abuse, and withdrawal, and the importance of gradual tapering.
- Strongly advise against concomitant use with opioids due to severe respiratory depression risk.
- Monitor for signs of paradoxical reactions, especially in psychiatric patients.
Patient Guidelines
- Do not stop taking this medicine abruptly without consulting your doctor, as it can lead to severe withdrawal symptoms.
- Avoid alcohol and other CNS depressants while on this medication.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- This medicine may cause drowsiness or dizziness; avoid driving or operating heavy machinery until you know how it 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 two doses at once to make up for a missed dose.
Driving Precautions
Xolam-XR may cause drowsiness, dizziness, or impaired coordination, which can impair your ability to drive or operate machinery. Do not drive or operate heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Avoid situations requiring mental alertness, such as driving or operating machinery, especially when initiating therapy or after a dose increase.
- Inform family members about potential risks of dependence and withdrawal.
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