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Asolan

DESCRIPTION

ASOLAN TABLET 0.25 MG: A round light blue, 7 mm diameter tablet with marking "DUOMA/DUOMA" and "DUO 2"

ASOLAN TABLET 0.5 MG: A round pink, 7 mm diameter tablet with marking "DUOMADUOMA" and "DUO 2"

ASOLAN TABLET 1 MG: A round apple green, 7 mm diameter tablet with marking "DUOMA/DUOMA" and "DUG' 2

COMPOSITION

ASOLAN TABLET 0.25 MG: Each tablet contains Alprazolam 0.25 mg

ASOLAN TABLET 0.5 MG: Each tablet contains Alprazolam 0.5 mg

ASOLAN TABLET 1 MG: Each tablet contains Alprazolam 1 mg

PHARMACODYNAMICS

In general, benzodiazepines act as depressants of the central nervous system (CNS). producing all levels of CNS depression from mild sedation to hypnosis to coma depending on dose. The precise sites and mechanisms of action have not been completely established. Although various mechanisms of action have been proposed, it is believed that benzodiazepines enhance or facilitate the inhibitory neurotransmitter action of gamma-aminobutyric acid (GABA). which is one of the major inhibitory neurotransmitters in the brain and mediates both pre- and post-synaptic inhibition in all regions of the CNS, following interaction between the benzodiazepine and a specific neuronal membrane receptor.

Pharmacological properties of alprazolam in animals appear similar to those of other benzodiazepines. that is. it produces significant anxiolytic, muscle relaxant, sleep promoting and anticonvulsant effects in appropriate animal models.

PHARMACOKINETICS

Following oral administration to fasting subjects, alprazolam is rapidly absorbed with nearly complete bioavailability. Alprazolam exhibits linear kinetics; after single dose administration of 0.5 - 3.0 mg plasma levels of 8.0 p 40 mg/mL were observed; during multiple dose administration of 1.5 -10 mg/day in divided doses, steady state plasma levels of 18.3 -100 mg/mL were observed.

Peak plasma levels showed a two- to three-fold variation within individual treatment groups. The plasma half life of alprazolam after single doses in health subjects has ranged from 6 to 25 hours. The mean half life of individual treatment groups ranged only from 10 to 14 hours. Alprazolam and its metabolites are excreted primarily in the urine. About 50 percent of the dose is excreted within 24 hours. and 94 percent after 72 hours. With chronic dosing, the apparent elimination half life increases by about 50 percent, possibly because of compartmentalization effects.

Plasma levels of drug reach steady state within 7 days after starting or altering dosage size. The steady state level is 3 to 4 times that achieved with a single dose.

Some 21 metabolites of alprazolam were detected in man. In addition to alprazolam, the major drug-related materials excreted in urine are alpha-hydroxyalprazolam, and a benzophenone analog. The biological activity of alpha-hydroxyalprazolam is approximately one-half that of alprazolam. The benzophenone metabolite is essentially inactive. Plasma level of these metabolites are extremely low. However, their half-lives appear to be of the same order of magnitude as that of alprazolam. In vitro alprazolam is bound (80%) to human serum protein. When alprazolam-¹⁴C was administered to pregnant mice, drugrelated materials appeared uniformly distributed in the foetus with ¹⁴C concentration approximately the same as in the blood and skeletal muscle of the mother.

Of the known alprazolam metabolites, only alpha-hydroxy-alprazolam shows significant pharmacologic activity (in animals); however, only very low levels of this metabolite are found in human plasma. Alprazolam tablets did not affect the prothrombin times or plasma warfarin levels in male volunteers administered sodium warfarin orally.

INDICATIONS

Anxiety States (Anxiety Neuroses): Symptoms which occur in such patients 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 in such patients.

Neurotic or Reactive Depression: Such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure. Symptoms of anxiety. psychomotor agitation and insomnia are usually present. Other characteristics include 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.

The effectiveness of alprazolam for long-term use exceeding 6 months has not been established by systematic clinical trials. The physician should periodically reassess the usefulness of the drug for the individual patient.

RECOMMENDED DOSAGE

Dosage and Administration:
The optimum dosage of Alprazolam tablets should be individualised, based upon the severity of the symptoms and individual patient response. The daily dosage (see Table) will meet the needs of most patients. In the few patients who require higher doses, dosage should be increased cautiously to avoid adverse effects. When higher dosage is required, the evening dose should be increased before the daytime doses. In general, patients who have not previously received psychotropic medication will require lower doses than those previously treated with minor tranquillisers, antidepressants, or hypnotics or those with a history of chronic alcoholism. It is recommended that the general principle of using the lowest effective dosage be followed to preclude the development of oversedation or ataxia. In patients who experience early morning anxiety and emergence of anxiety symptoms, it is recommended that the same total daily dose be given divided as more frequent administration. Patients should be periodically assessed and dosage adjustments made, as appropriate:

Administration of Alprazolam tablets immediately after meals does not affect the extent of Alprazolam tablets' absorption compared to administration on an empty stomach. Food does, however, delay the onset of absorption and decrease the rate of absorption of alprazolam tablets. As a direct consequence, side effects, such as somnolence, are less pronounced.

Discontinuation therapy: The dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam tablets be decreased by 0.25 to 0.5 mg every three days. It is important that this rate of dosage reduction does_ not exceed 0.5 mg every 3 days in order to minimize any possible withdrawal symptoms. Some patients may require an even slower dosage reduction (see Precautions.)

CONTRAINDICATIONS

Hypersensitivity to benzodiazepines; myasthenia gravis; chronic obstructive airways disease with incipient respiratory failure.

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