Trade Name: SERELAM TABLET 0.25 MG
Generic Name: Alprazolam USP 0.5mg

Presentation:

Serelam 0.25 : Each tablet contains Alprazolam USP 0.25 mg
Serelam 0.5 : Each tablet contains Alprazolam USP 0.5mg

Indications:

Alprazolam is used in the treatment of  

• Generalized anxiety disorders,

• Anxiety associated with depression, and

• Panic disorder.

• Insomnia

Dosage and administration:

Anxiety: The usual initial adult dosage of Alprazolam for the management of anxiety disorder is 0.25 mg 3 times daily. Dosage may be gradually increased at intervals of 3 or 4 days to a maximum dosage of 4 mg daily, given in divided dosage.

In geriatric or debilitated patients: Alprazolam therapy for anxiety should be initiated with 0.25 mg 2 or 3 times daily.

Children: Safety or efficacies have not been established for children under 18 years.

Panic disorder: Initial doses are 0.5mg 3 times daily. Depending on response, increase dose at intervals of 3 to 4 days in increments of no more than 1 mg/day.

Side effects: Side effects to Alprazolam tablets, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patients, the most frequent side effects are likely to be an extension of the pharmacological activity of Alprazolam. eg, drowsiness, light-headedness, muscle weakness, ataxia, impairment of memory, confusion, depression and changes in libido.

Precautions: If Alprazolam tablets are to be combined with other psychotropic agents or anticonvulsant drugs or compounds, which might potentiate the action of benzodiazepines, careful consideration should be given. It is recommended that the dosage be limited to the smallest effective dose to preclude the development of ataxia or over sedation, which may be particular problem in elderly or debilitated patients. The usual precausion in treating patients with impaired renal, hepatic or pulmonary function should be observed. Seizures, delirium and withdrawal symptoms have occurred in some patients following rapid dosage reduction and/ or abrupt discontinuance of Alprazolam. Alprazolam should be withdrawn gradually.

Contraindications:
Alprazolam tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines, acute pulmonary insufficiency, acute narrow angel glaucoma. Alprazolam is contraindicated with ketoconazole and itraconazole.

Drug interactions:

Inhibitors of microsomal oxidation, such as cimetidine, propoxyphene,  macrolide, antibiotics, fluvoxamine and fluoxetin  feduces the clearance of Alprazolam. Alprazolam potentiates the effects of slcohol and other CNS depressants.

In pregnancy and lactation:

The safety of Alprazolam in pregnancy has not been established and its use in women of childbearing potential requires careful consideration of risk/benefit. Mother receiving Alprazolam should not breast-feed their infants.

Overdose:

Alprazolam in over dosage causes drowsiness, sedation, confusion, ataxia, and coma. There are minimal respiratory or cardiovascular effects unless large dosage are combined with alcohol or other CNS depressant agents.

Packaging Quantities:

Serelam 0.25: Each box contains 10 alu-alu blister  Strips of 10 tablets.
Serelam: 0.5: Each box contains 10 alu-alu blister strips of 10 tablets.