Xolam-0.5 XR Tablet: Each extended release tablet contains Alprazolam USP 0.5 mg.
Alprazolam is a triazolo analogue of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam produces its effects via interacting with the Gamma Aminobutyric Acid (GABA) - benzodiazepine receptor complex. Like all benzodiazepines, it has dose related CNS depressant activity.
1. Anxiety disorder
2. Anxiety associated with depression
3. Panic disorder, with or without agoraphobia
Dosage & Administration
Xolam XR Tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed or broken. Xolam XR should be initiated with a dose of 0.5 mg to 1 mg once daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The suggested total daily dose ranges from 3 to 6 mg/day for most patients but some patients may require doses as much as 10 mg/day.
In elderly patients & in patients with advanced liver disease or debilitating disease, the usual starting dose of Xolam XR is 0.5 mg once daily.
Switch from Alprazolam (Immediate-release) tablets to Xolam XR tablets :
Patients who are currently being treated with divided doses of Alprazolam (Immediate-release) tablets, for example 3 to 4 times a day, may be switched to Xolam XR (Alprazolam XR) tablets at the same total daily dose taken once daily.
1. Acute narrow angle glaucoma
2. Acute pulmonary insufficiency
3. With ketoconazole and itraconazole
4. In known hypersensitivity to this drug or other benzodiazepines
Warning & Precautions
Prolonged use of Alprazolam may cause the development of physical dependence, tolerance. As a result benzodiazepines withdrawal symptoms may occur during rapid dose reduction or sudden cessation of therapy after long term treatment. Therefore, the dosage of Xolam XR should be reduced or discontinued gradually. It is suggested that the daily dosage be decreased by no more than 0.5 mg every three(3) days. Some patients may require an even slower dosage reduction.
In general the side effect profile of Alprazolam is benign. Some side effects may disappear with continued treatment. However, the most frequent side effects are fatigue, somnolence, muscle weakness, ataxia, dizziness, impairment of memory, confusion etc.
The initial step in Alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of Alprazolam. They may increase effects of Alprazolam, producing excessive sedation and impaired psychomotor function.
Consequently, alprazolam should be avoided in patients receiving very potent inhibitors of CYP3A e.g., Azole antifungal agents - ketoconazole and itraconazole etc.
Caution and consideration of appropriate Alprazolam dose reduction are recommended during coadministration with moderate inhibitors of CYP3A e.g., nefazodone, fluvoxamine, cimetidine, propoxyphene, fluoxetine & oral contraceptives.
Caution is recommended during coadministration of following weak CYP3A inhibitors with Alprazolam - diltiazem, isoniazid, macrolide antibiotics, sertraline, paroxetine, ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine.
Being inducer of CYP3A, carbamazepine can increase Alprazolam metabolism and therefore can decrease plasma levels of Alprazolam.
Because of producing additive CNS depressant effects, Alprazolam should be used with caution with other psychotropic medications, anticonvulsants, antihistaminics, ethanol and other CNS depressants
Use in special groups
Use in pregnancy: FDA Pregnancy Category D. Use of Alprazolam in pregnant women requires careful consideration of risk benefit ratio.
Use in lactation: Alprazolam is likely to appear in breast milk. Mothers receiving Alprazolam should not breast-feed their infants.
Use in children: Safety and efficacy have not been established for children less than 18 years.
Xolam-0.5 XR Tablet : Each box contains 50's tablets in alu-PVDC pack.