(and dosage form):
Tablets containing 0,25 mg, 0,5 mg or 1,0 mg alprazolam.
A 2.6 Tranquillizers
Alprazolam is a benzodiazepine with anxiolytic properties. It is rapidly absorbed from the gastro-intestinal tract following oral administration with peak plasma concentrations being achieved within 1 to 2 hours of a dose. The half-life of alprazolam in plasma is 12 to 15 hours and it is 70 to 80% bound to plasma protein. Alprazolam is metabolised chiefly in the liver and excreted in the urine as unchanged drug and metabolites.
Anxiety disorders. Alprazolam is also used in the treatment of anxiety associated with depression.
The effectiveness of alprazolam in the treatment of anxiety disorders and anxiety associated with depression for long term use exceeding six months has not been established. The doctor should periodically re-assess the usefulness of alprazolam for the individual patient.
Alprazolam is contra-indicated in patients with porphyria and in patients with known hypersensitivity to benzodiazepines. It should be avoided in patients with pre-existing central nervous system depression or coma, acute pulmonary insufficiency or sleep apnoea. It should be used with care in patients with chronic pulmonary insufficiency.
Do not administer during pregnancy or lactation. Use of alprazolam in the first trimester of pregnancy has been associated with various congenital malformations in the infant, but no clear relationship has been established. Administration of alprazolam in late pregnancy has been associated with intoxication of the neonate. Alprazolam should not be used for the treatment of chronic psychosis or for phobic or obsessional states.
There is a potential for abuse and dependence. Withdrawal symptoms may occur after periods of ordinary therapeutic doses. Individuals who are prone to abuse drugs, such as alcoholics and drug addicts or patients on other central nervous system depressants should be under careful surveillance while receiving alprazolam because of the predisposition of such patients to habituation and dependence. Use with extreme caution in patients with a history of alcohol or medicine abuse.
Patients receiving alprazolam should be advised not to operate motor vehicles or dangerous machinery, or climb dangerous heights until it is established that they do not become drowsy or dizzy while receiving alprazolam. In these situations, impaired decision making could lead to accidents.
DOSAGE AND DIRECTIONS FOR USE'
Treatment of anxiety: 0,25 mg - 0,5 mg three times daily, increased where necessary up to a total daily dose of 3 to 4 mg.
In elderly or debilitated patients an initial dose of 0,25 mg twice or three times daily is suggested.
Treatment of panic attacks and depression: Doses of up to 10 mg daily.
The optimum dosage of alprazolam should be individualised based upon the severity of symptoms and individual patient response. If higher dosages are required the increase should be done gradually and cautiously.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Drowsiness, sedation, and ataxia are the most frequent adverse effects of alprazolam. They generally decrease on continued administration and are a consequence of central nervous system depression. Less frequent effects include vertigo, headache confusion mental depression slurred speech or dysarthria, changes in libido, tremor, visual disturbances, changes in salivation, amnesia and paradoxical excitation and disinhibition. Jaundice, blood disorders, and hypersensitivity reactions have been reported. Respiratory depression and hypotension occasionally occur with high dosage. Rebound anxiety and insomnia may be a result of tolerance to the effects of alprazolam or part of a withdrawal syndrome.
Alprazolam should be given with care to elderly or debilitated patients who may be more prone to adverse effects. Caution is required in patients with impaired liver or kidney function. The sedative effects of alprazolam are most marked during the first few days of administration; affected patients should not drive or operate machinery. Sedation or respiratory and cardiovascular depression may be enhanced by other agents with central nervous system depression properties; these include alcohol, antidepressants, antihistamines, general anaesthetics, other hypnotics or sedatives, neuroleptics and opioid analgesics.
Alprazolam-induced disinhibition may precipitate suicide or aggressive behaviour. Caution is required in patients with organic brain changes, particularly arteriosclerosis. In cases of bereavement, psychological adjustment may be inhibited by alprazolam. Alprazolam has provoked seizures in epileptic patients; seizures may also occur on abrupt withdrawal of therapy.
Dependence characterised by a withdrawal syndrome may develop after regular use of alprazolam, even in therapeutic doses for short periods Alprazolam should not be discontinued abruptly after regular use for even a few weeks but withdrawn by gradual reduction of the dose over a period of weeks. Withdrawal symptoms include anxiety, insomnia, headache, dizziness, tinnitus, loss of appetite, tremor, perspiration, irritability, perceptual disturbances such as hypersensitivity to visual and auditory stimuli and a metallic taste, nausea, vomiting, abdominal cramps, palpitations and orthostatic hypotension. Rare and more serious symptoms include muscle twitching, confusional or paranoid psychosis, convulsion, hallucinations, and delirium tremens.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of alprazolam can produce CNS depression and coma. Following recent ingestion of an overdose the stomach may be emptied by gastric lavage. Treatment is symptomatic and supportive although the specific benzodiazepine antagonist, flumazenil, may be indicated in emergencies.
0,25 mg - A white tablet with bevelled edges, bisected on one side and a mortar and pestle on the other side.
0,5 mg - A pale pink tablet with bevelled edges bisected on one side and a mortar and pestle on the other side.
1,0 mg - A pale lavender tablet with bevelled edges, bisected on one side and a mortar and pestle on the other side.
Securitainers of 30 and 100 tablets.
Store in airtight containers below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
Azor-0,25 mg Tablets - 29/2.6/0180
Azor-0,5 mg Tablets - 29/2.6/0181
Azor-1,0 mg Tablets - 29/2.6/0182
NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Updated on this site: January 2003
Source: Hospital Pharmacy
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