Presentation

Zolium 0.25: Each tablet contains Alprazolam BP 0.25 mg

Zolium 0.5: Each tablet contains Alprazolam BP 0.5 mg

Zolium XR 1: Each tablet contains Alprazolam BP 1 mg

Description

Alprazolam is a triazolo analogue of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA) – benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose related CNS depressant activity varying from mild impairment of task performance to hypnosis.

Indications

* Anxiety disorder

* Short term relief of anxiety

* Anxiety associated with depression

* Panic disorder, with or without agoraphobia.

Dosage & Administration

Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may

be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. The maximum dose should not

exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a

successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.

Dosage should be individualized for maximum beneficial effect with a lowest possible dose. If side-effects occur at

starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more

than 0.5 mg every three days.

In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times

daily and may be gradually increased if needed and tolerated. Safety and effectiveness of Alprazolam in individuals

below 18 years of age have not been established.

Zolium XR 1 should be administered once daily, preferably in the morning by patients who are on multiple dosage

regimen of Zolium 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.

Side Effects

Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation etc.

Precautions

Because Alprazolam may produce psychological and physical dependence, increment of dose or abrupt discontinuation of Alprazolam therapy should not be done without physician’s advice. Duration of therapy must be determined by the physicians. Alprazolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency or sleep apnea.

Use in Pregnancy & Lactation

Pregnancy: Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy.

Lactation: Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.

Drug Interaction

The CNS-depressant action of Alprazolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral contraceptives.

Over Dose

Manifestations of Alprazolam over dosage include somnolence, confusion, impaired coordination, diminished reflexes and coma. In such cases of over dosage general supportive measures should be employed along with immediate gastric lavage.

Commercial Pack

Zolium 0.25: Each box contains 10 blister strips of 10 tablets.

Zolium 0.5: Each box contains 10 blister strips of 10 tablets.

Zolium XR 1: Each box contains 3 blister strips of 10 tablets.