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Each tablet contains: Alprazolam 0.5mg

Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics)
1. Alprazolam is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name is 8-chloro-1-methyl-6-phenyl-4H-striazolo (4,3-α)(1,4) benzodiazepine.

2. Alprazolam is readily absorbed from the gastrointestinal tract following oral administration with peak plasma concentrations being achieved within 1-2 hours. The mean half-life in plasma is 12 to 15 hours. Alprazolam is 70-80% bound to plasma protein. It is metabolized in the liver primarily to alpha-hydroxyalprazolam, which is reported to be approximately half as active as the parent compound, and to an inactive benzophenone. Plasma concentrations of metabolites are very low. Alprazolam and its metabolites are excreted primarily in the urine.

3. Alprazolam did not affect the prothrombin times or plasma warfarin levels in male volunteers administered sodium warfarin orally.

Anxiety States: Symptoms include anxiety, tension, agitation, insomnia, apprehension, irritability and/or autonomic hyperactivity resulting in a variety of somatic complaints.


Mixed Anxiety-Depression: Symptoms of both anxiety and depression occur simultaneously. Neurotic or Reactive Depression: Patients show a depressed mood or a pervasive loss of interest or pleasure. Symptoms include anxiety, psychomotor agitation and insomnia. Other characteristics are appetite disturbances, changes in weight, somatic complaints, cognitive disturbances, decreased energy, feeling of worthlessness or guilt or thoughts of death or suicide.

Alprazolam should not be used in patients whose primary symptom of depression is psychomotor retardation, with a diagnosis of bipolar depression, with psychotic symptoms. Anxiety states, mixed anxiety-depression or neurotic depression associated with other diseases, eg the chronic phase of alcohol withdrawal and functional or organic disease, particularly certain gastrointestinal, cardiovascular or dermatological disorders.

Alprazolam is also indicated for the treatment of panic disorder, with or without agoraphobia. The effectiveness of Alprazolam for long-term use exceeding 6 months has not been established.

The physician should reassess the usefulness of the drug for the individual patient from time to time.

Dosage and Administration
The optimum dosage of Alprazolam should be individualized based on the severity of the symptoms and patient response for maximum beneficial effect.

The usual daily dosage (refer table) will meet the needs of most patients. Dosage should be increased cautiously to avoid adverse effects. The evening dose should be increased before the daytime doses.

Patients who have not previously received psychotropic medications will require lower doses than those previously treated with minor tranquilizers, antidepressants or hypnotics or those with a history of chronic alcoholism. The general principle of using the lowest effective dosage should be followed to preclude the development of oversedation or ataxia.



Usual Starting Dosage*

Usual Dosage Range


0.25-0.5 mg given 3 times daily

0.5-4 mg daily, given in divided dose


0.5 mg given 3 times daily

1.5-4.5 mg daily, given in divided dose

Geriatric patients

or in the presence of

debilitating disease

0.25 mg, given 2-3 times daily

0.5-0.75 mg daily, given in divided dosage; to be gradually increased if needed and tolerated

Panic-related disorders

0.5-1 mg, given at bedtime

The dose should be adjusted to patient response. Dosage adjustments should be in increments no greater than 1mg every 3-4 days. additional doses can be added until 3 or 4 times daily schedule is achieved. The mean dose in a large multi-clinic study was 5.7 2.3 mg/day with rare patients requiring a maximum of 10 mg daily.

* If side effects occur, the dose should be lowered


Patients with known sensitivity to the benzodiazepines.

Side Effect(s) / Adverse Reaction(s)
Side effects are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage. The most common adverse reaction to Alprazolam was drowsiness. Other less common adverse reactions include lightheadedness, blurred vision, coordination disorders, various gastrointestinal symptoms and autonomic manifestations.

Withdrawal symptoms have occurred following rapid decrease or abrupt discontinuance of alprazolam. These can range from mild dysphoria and insomnia to a major syndrome, which may include abdominal and muscle cramps, vomiting, sweating, tremor and convulsions. In addition, withdrawal seizures have occurred upon rapid decrease or abrupt discontinuation of therapy with alprazolam.


Anterograde amnesia may occur at therapeutic dosages and the risk increasing at higher dosages.


Amnesic effects may be associated with inappropriate behaviour.

Pre-existing depression may be unmasked during benzodiazepam use.

Paradoxical reactions, eg stimulation, agitation, concentration difficulties, confusion, hallucinations or other adverse behavioural effects, may occur in rare instances and in a random fashion. They are more likely to occur in children and the elderly. Patients who have borderline personality disorder, a prior history of violent or aggressive behaviour, or alcohol or substance abuse may be at risk of adverse behavioural effects. Instances of irritability, hostility and intrusive thoughts have been reported during discontinuance of alprazolam in patients with post-traumatic stress disorder.


Use of alprazolam (even at therapeutic doses) may lead to the development of physical dependence. Discontinuation of the therapy may result in withdrawal or rebound phenomena. Psychic dependence may also occur.


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