Zolium(Alprazolam)
Therapeutic Group: Drugs of Nervous System
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
Zolium XR 2: Each tablet contains Alprazolam BP 2 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 tablet (1 mg & 2 mg):
Treatment should be initiated with 1 mg once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken. Depending on the response, dose increments should not more than 1 mg/day at intervals of 3 to 4 days. The usual daily dose for panic disorders ranges between 3 mg/day to 6 mg/day. Occasional patients required as much as 10 mg /day to achieve a successful response.
Switch from Zolium Tablet to Zolium XR Tablet:
Patients who are currently being treated with divided doses of Zolium tablets, may be switched to Zolium XR tablets at the same total daily dose taken once daily. If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above.
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.
Storage
Do not store above 30 C. Keep away from light and out of the reach of children.
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.
Zolium XR 2: Each box contains 3 blister strips of 10 tablets.