INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ALZAM 0,25 mg (tablet)
ALZAM 0,5 mg (tablet)
ALZAM 1,0 mg (tablet)

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

ALZAM 0,25 mg (tablet)
ALZAM 0,5 mg (tablet)
ALZAM 1,0 mg (tablet)

COMPOSITION:
Each tablet contains 0,25 mg, 0,5 mg or 1,0 mg alprazolam.

PHARMACOLOGICAL CLASSIFICATION:
A: 2.6 Tranquillisers.

PHARMACOLOGICAL ACTION:
Alzam (alprazolam) is an anxiolytic agent of the benzodiazepine group. Following oral administration, alprazolam is readily absorbed. Peak concentrations in plasma occur in one to two hours following administration. Plasma levels are proportionate to the dose given; over the dose range of 0,5 mg to 3,0 mg, peak levels of 8,0 to 37 ng/mL were observed. The mean half-life of alprazolam is 12-15 hours. Alprazolam and its metabolites are excreted primarily in the urine. The predominant metabolites are alpha-hydroxy-alprazolam and a benzophenone derived from alprazolam. In vitro, alprazolam is bound 70-80% to human serum protein.

INDICATIONS:
Alzam (alprazolam) is indicated for the treatment of anxiety disorders, or the short-term relief of symptoms of anxiety. Anxiety associated with depression is responsive to Alzam. Alzam is also indicated for the treatment of panic disorders for up to eight months. The doctor should periodically re-assess the usefulness of Alzam (alprazolam) in the treatment of anxiety disorders; anxiety associated with depression, for long term use exceeding six months has not been established.
Alzam is only indicated when the disorder is severe, disabling or subjecting the individuals to extreme stress.

CONTRA-INDICATIONS:
The safety of Alzam (alprazolam) in pregnancy has not been established. Alzam should not be administered during pregnancy. Do not administer during labour. Given during labour it crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking.
Alzam (alprazolam) should not be administered to nursing mothers, since alprazolam is excreted in human breast milk.
Alzam (alprazolam) is contraindicated in patients with known sensitivity to the benzodiazepines.
Alzam (alprazolam) is not recommended for use in patients whose primary diagnosis is schizophrenia.
Psychotic patients and patients suffering from mental depression or suicidal tendencies, unless there is a marked component of anxiety in their illness.

WARNINGS:
There is a potential for abuse and dependence. Withdrawal symptoms may occur after periods of ordinary therapeutic doses. Individuals who are prone to abuse medicines, such as alcoholics and drugs addicts or patients on other CNS depressants, should be under careful surveillance while receiving a benzodiazepine because of the predisposition of such patients to habituation and dependence.
Patients receiving Alzam (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 Alzam. In these situations, impaired decision-making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
The maximum recommended dosage should not be exceeded.
The optimum dosage of Alzam (alprazolam) should be individualized based upon the severity of the symptoms and individual patient response. In 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 medications will require lower doses than those previously treated with minor tranquillizers, antidepressants, or hypnotics or those with a history of chronic alcoholism.
It is recommended that the general principle of using the lowest effective dose be followed. Patients should be periodically re-assessed and dosage adjustments made, as appropriate.

	USUAL STARTING DOSAGE*	USUAL DOSAGE RANGE
Anxiety	0,25 to 0,5 mg given three times daily	0,5 to 4,0 mg daily, given in divided doses
Anxiety associated with depression	0,5 mg given three times daily	1,5 to 4,0 mg daily, given in divided doses
Geriatric patients or in the presence of debilitating disease	0,25 mg given two to three times daily	0,5 to 0,75 mg daily, given in divided doses; to be gradually increased if needed and tolerated.
Panic related Disorders	0,5 - 1,0 mg given at bedtime	The dose should be adjusted to patient response. Dosage adjustments should be in increments no greater than 1 mg every 3 to 4 days. Additional doses can be added until a three times daily or four times daily schedule is achieved. Maximum of 10 mg daily

* If side effects occur, the dose should be lowered.
Treatment Period:
Treatment should be as short as possible. The patient should be re-assessed regularly and the need for continued treatment should be evaluated, especially in the case of a patient being symptom free.
The overall duration of treatment should, generally, not be more than 8 - 12 weeks, including a tapering-off process. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status.
Discontinuation Therapy:
The dosage should be reduced slowly to minimise withdrawal symptoms. It is suggested that the daily dosage of Alzam be decreased by no more than 0,5 mg every three days. Some patients may require an even slower dosage reduction.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Side effects, are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage. In patients treated for anxiety, anxiety associated with depression, the most common side-effects to Alzam (alprazolam) were drowsiness, sedation and ataxia. Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses.
Less common side-effects are:
Co-ordination disorders, tremor, lethargy, ataxia, blurred vision, memory impairment/amnesia, insomnia, nervousness/anxiety, depression, headache, autonomic manifestations, change in mass and various gastrointestinal symptoms.
The following side-effects have also been reported:
Stimulation, agitation, irritability, concentration difficulties, confusion, hallucinations, other adverse behavioural effects, musculoskeletal weakness, dystonia, fatigue, slurred speech, anorexia, changes in salivation, changes in libido, menstrual irregularities, incontinence, urinary retention, abnormal liver function, jaundice, blood disorders, increased intra-ocular pressure and hypersensitivity reactions.
Amnesia and paradoxical excitation may occur. In the case of acute, hyperexcitability states, the medicine should be discontinued.
Precautions:
The usual precautions for treating patients with impaired renal or hepatic function, pulmonary disease and limited pulmonary reserve should be observed.
The safety and efficacy of Alzam (alprazolam) has not been established in children under the age of 18 years. Paradoxical reactions such as excitement and irritability may occur in children. Smaller children are more prone to these reactions.
Alzam is not recommended for the primary treatment of psychotic illness. Alzam should of be used alone to treat depression or anxiety with depression; suicide may be precipitated in such patients. Alzam should be used with extreme caution in patients with a history of alcohol or drug abuse.
Dependence:
There is a potential for abuse and the development of physical and psychic dependence, especially with prolonged use and high doses. The risk of dependence is also greater in patients with a history of alcohol or drug abuse.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, mild dysphoria, insomnia, muscle and abdominal pain, extreme anxiety, tension, restlessness, confusion, irritability, vomiting, sweating and tremor.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
These signs, and symptoms, especially the more serious ones are generally more common in those patients who have received excessive doses over an extended period of time. However, withdrawal symptoms have also been reported following abrupt discontinuance of benzodiazepines taken at recommended therapeutic levels. Consequently abrupt discontinuation should be avoided and a gradual tapering in dosage followed. Special care may be needed in epileptic patients in whom the initiation or abrupt withdrawal has provoked seizures.
Particular caution should be exercised with the elderly and debilitated who are at special risk of oversedation, respiratory depression and ataxia (the initial oral dosage should be reduced in these patients).
Reboundeffects:
A transient syndrome, whereby the symptoms that led to treatment with Alzam recur in an enhanced form, may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.
Duration of treatment:
The duration of treatment should be as short as possible (see Dosage), but should not exceed eight to twelve weeks in case of anxiety, including the tapering-off process. Extension beyond these periods should not take place without re-evaluation of the situation. It may be useful to inform the patient, when treatment is started, that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.
Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms, should they occur while the product is being discontinued.
Interactions:
Alzam (alprazolam) produces additive Central Nervous System depressant effects when co-administered with medicines such as barbiturates, alcohol or other central nervous system depressants. Patients should be cautioned regarding the additive effect of alcohol.
The steady state plasma concentrations of imipramine and desipramine have been reported to be increased with the concomitant administration of Alzam (alprazolam). Pharmacokinetic interactions of Alzam with other medications have been reported. The clearance of Alzam can be delayed by the co-administration of cimetidine or macrolide antibiotics.
Alzam (alprazolam) did not affect the prothrombin times of plasma warfarin levels in male volunteers who received sodium warfarin orally.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF IT TREATMENT:
Manifestations of Alzam (alprazolam) overdosage include extensions of its pharmacological activity, namely ataxia and somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.
Treatment is symptomatic and supportive.

IDENTIFICATION:

Alzam 0,25 mg:	Round, white, biconvex tablets bisected on one side with "WC" and "787" debossed above and below the bisect respectively.
Alzam 0,5 mg:	Round, peach, biconvex tablets bisected on one side with "WC" and "786" debossed above and below the bisect respectively.
Alzam 1,0 mg:	Round, pale blue, biconvex tablets bisected on one side with "WC" and "785" debossed above and below the bisect respectively.

PRESENTATION:
Securitainers of 30's, 100's and 250's.

STORAGE INSTRUCTIONS:
Store in tightly closed containers below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

Alzam 0,25 mg:	30/2.6/0212
Alzam 0,5 mg:	30/2.6/0211
Alzam 1,0 mg:	30/2.6/0213

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 February 1996

                16641-01/2005
                Britepak

Current: October 2005
Source: Community Pharmacy
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