INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BENZOPIN 2 mg Tablets
BENZOPIN 5 mg Tablets

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

BENZOPIN 2 mg Tablets
BENZOPIN 5 mg Tablets

COMPOSITION:
Each tablet contains 2 mg (5 mg) of
Diazepam.
The 5 mg tablet contains TARTRAZINE.

PHARMACOLOGICAL CLASSIFICATION:
A 2.6 Tranquillizers.

PHARMACOLOGICAL ACTION:
It has been found that the major locus of Central Nervous System depressant action of diazepam on spinal reflexes is the brain stem reticular system. After oral administration peak plasma concentrations are reached in 1 to 4 hours. Drug elimination follows a biphasic pattern, with a rapid phase (plus-minus ½ - 2 to 3 hours) followed by a slow decay with a half-life of 2 to 8 days. Diazepam is metabolised to active products including oxazepam. One third is excreted as oxazepam and 70% of the metabolites appear in the urine. Metabolites have been found in the urine and in the plasma 14 days after a 10 mg dose.

INDICATIONS:
Diazepam is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.
Diazepam is used in the treatment of anxiety in neurotic patients, and for pre-operative medication. It may be effective in relieving the acute symptoms of the alcohol withdrawal syndrome, but has no specific usefulness in the treatment of psychotic patients.

CONTRA-INDICATIONS:
Diazepam is contra-indicated in infants and in patients with known hypersensitivity to diazepam. Caution should be observed when giving diazepam to patients with impaired hepatic or renal function. In elderly and debilitated patients and patients with impaired obstructive airways disease large doses may produce syncope. The effects of diazepam may be enhanced by alcohol, barbiturates, narcotics, MAO inhibitors and other depressants of the central nervous system. The response to treatment with oral anticoagulants may be variable in patients taking diazepam.

WARNING:
Benzopin 5 mg tablets contain FD & C Yellow No. 5 (TARTRAZINE) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low it is frequently seen in patients who have aspirin-sensitivity.
Caution should be observed when giving diazepam to patients with impaired hepatic or renal function.

DOSAGE AND DIRECTIONS FOR USE:
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
The usual dose for mild anxiety states in ambulant patients is 2 mg three times daily and in severe anxiety and other psychiatric disorders 15 mg to 30 mg daily in divided doses. For sleep disturbances 5 mg to 30 mg should be given in the evening. Elderly and debilitated patients and patients with obstructive airways disease should be given half the usual adult dose.
Treatment should be as short as possible. The patients should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. The overall duration of treatment generally should 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.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Diazepam is not recommended for the primary treatment of psychotic illness. Diazepam should not be used alone to treat depression or anxiety with depression (suicide may be precipitated in such patients). Diazepam should be used with extreme caution in patients with history of alcohol or drug abuse.
The toxic effects most frequently encountered with diazepam are drowsiness, dizziness, fatigue, apathy, constipation, irritability and ataxia. Less frequently, depression, diarrhoea, indigestion and impairment of sexual function may occur. Diazepam may modify the patient's reactions (driving ability, operating machinery, etc.) to a varying extent depending on dosage, administration and individual susceptibility. Large doses may produce syncope. Other side-effects occasionally reported are skin rashes, headaches, frequency of urination, and menstrual irregularities. Blood dyscrasias and hepatic dysfunction have occasionally been reported. Care should be taken when administered in obstetrics during labour because of the possible effect of central respiratory depression, hypothermia and hypotonia and an increase in foetal heart rate in the infant. In severely disturbed patients treatment with diazepam may result in paradoxical reactions provoking excitement instead of sedation. There is risk of dependency of the barbiturate-alcohol type withdrawal reactions including convulsions have been observed in patients receiving large doses for prolonged periods when the drug was stopped abruptly. Ambulant patients receiving diazepam should take special care when driving a car particularly in traffic and when operating machinery.
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, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
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.
Rebound effects:
A transient syndrome whereby the symptoms that led to treatment with diazepam 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 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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Sedation is the most prominent symptom of overdosage. This usually follows symptoms of dizziness, fatigue, apathy or irritability. Large doses may produce syncope.

Treatment: In severe overdosage the stomach should be emptied by aspiration or lavage. There is no specific treatment and recovery usually follows symptomatic treatment.

IDENTIFICATION:
2 mg - White tablets.
5 mg - Yellow tablets.

PRESENTATION:
Containers of 100 and 1000 tablets.

STORAGE INSTRUCTIONS:
Keep in a well-closed container, protected from light and moisture.
Store in a cool place (below 25°C).
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
2 mg - L/2.6/90
5 mg - L/2.6/91

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABORATORIES (PTY) LIMITED
Co. Reg. No. 93/05259/07
17 Faraday Street
Village Main
Johannesburg 2091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1979

                                PM 0544-7/97

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