Zolium Tablet 0.25 mg

Zolium Tablet

Generic Name: Alprazolam

Strength: 0.25 mg

Dosage Form: Tablet

Manufacturer: Incepta Pharmaceuticals Ltd

Indications

Zolium is indicated in-

• Anxiety disorder
• Short term relief of anxiety
• Anxiety associated with depression
• Panic disorder, with or without agoraphobia.

Pharmacology

Alprazolam is a triazole analog 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.

Dosage Information

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/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 the 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.

Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 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 Zolium may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Zolium therapy should not be done without the physician’s advice. The duration of therapy must be determined by the physicians. Zolium should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.

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/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 the 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.

Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.

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.

Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.

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

The safety and effectiveness of Zolium in individuals below 18 years of age have not been established.

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