INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BRAZEPAM-3 and BRAZEPAM-6 TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

BRAZEPAM-3 and BRAZEPAM-6 TABLETS

COMPOSITION:
Each tablet contains 3 or 6 mg bromazepam per tablet.

PHARMACOLOGICAL CLASSIFICATION:
A 2.6 Tranquillizers.

PHARMACOLOGICAL ACTION:
Bromazepam is a benzodiazepine which has anxiolytic, sedative, muscle relaxant and anticonvulsant properties.
In low doses it diminishes anxiety and tension. In higher doses the sedative and muscle-relaxant properties appear.

INDICATIONS:
Bromazepam is used in the treatment of patients suffering from anxiety disturbances.
Bromazepam is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.

CONTRA-INDICATIONS:
Brazepam is contra-indicated in children and in patients with a known hypersensitivity to bromazepam and should not be given to patients with acute closed-angle glaucoma and myasthenia gravis.
Bromazepam should not be used for the treatment of chronic psychosis or for phobic or obsessional states.
Caution should be observed when giving bromazepam 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.
Use of bromazepam in the first trimester of pregnancy has been associated with various congenital malformations in the infant and in the last trimester it has been associated with drowsiness, respiratory depression and intoxication in the new born infant. For these reasons bromazepam is contra-indicated in pregnancy.
Bromazepam is exerted in breast milk and is contra-indicated by nursing mothers because of the side-effects it can cause in the breastfed infant such as drowsiness, slow heartbeat and breathing problems.

WARNINGS:
There is potential for abuse. Prolonged use may lead to the development of dependence of the barbiturate-alcohol type.
Withdrawal of bromazepam from patients who have been receiving it for prolonged periods of time should be gradual.
Bromazepam may enhance the effects of central nervous system depressants.
Bromazepam may cause drowsiness. If affected, patients should not drive or operate machinery.
Alcoholic drinks should be avoided.
KEEP OUT OF THE REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
The usual dose is 3 mg twice or thrice daily. In severe conditions up to 6 –12 mg twice or thrice daily.
Treatment should be as short as possible. The patient 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:
The side-effects most commonly encountered are drowsiness and oversedation. Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses. Less common are depression of mood, disorientation or confusion, lethargy and ataxia.
Paradoxical reactions such as acute hyperexcitable states with hostility and rage, may occur. If these occur the medicine should be discontinued.
Other side-effects observed include hypotension, respiratory depression, gastro-intestinal disturbances such as nausea and constipation, changes in salivation, visual disturbances such as blurred vision and diplopia, dysarthria, skin rashes, urinary retention, incontinence, tremor, headache, slurred speech, vertigo, confusion and changes in libido. There have been reports of blood disorders and jaundice. During long-term treatment regular blood counts and liver function tests should be performed. The product can induce amnesia.
Bromazepam should not be used in patients with pre-existing central nervous system depression or coma, acute pulmonary insufficiency, or sleep apnoea, and used with care in those with chronic pulmonary insufficiency.
Special Precautions:
Particular caution should be exercised in:

-	the elderly and debilitated - who are at a particular risk of oversedation, respiratory depression and ataxia. (The initial oral dosage should be reduced in these patients).
-	patients with pulmonary disease and limited pulmonary reserve;
-	patients suffering from impairment of renal or hepatic function;
-	patients suffering from anxiety accompanied by an underlying depressive disorder;
-	patients receiving barbiturates or other central nervous system depressants since there is an additive risk of central nervous depression when these medicines are taken together;
-	patients should be cautioned regarding the additive effect of alcohol;
-	patients with myasthenia gravis on account of pre-existing muscle weakness;
-	patients with organic brain changes particularly arteriosclerosis.

Given during labour it crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking.
Bromazepam is not recommended for the primary treatment of psychotic illness. Bromazepam should not be used alone to treat depression or anxiety with depression (suicide may be precipitated in such patients). Bromazepam should be used with extreme caution in patients with 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, 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 bromazepam 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 this period 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 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 WITH OTHER MEDICINES:
The effects of bromazepam may be enhanced by alcohol, barbiturates, narcotics. mono-amine oxidase (MAO) inhibitors and other depressants of the central nervous system.
The response to treatment with oral anticoagulants may be variable in patients taking bromazepam.
Cimetidine may inhibit the metabolism of bromazepam.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Manifestations of overdosage include somnolence, confusion, coma, respiratory depression and hypotension. In acute severe overdosage the stomach should be emptied with aspiration and lavage. Treatment is symptomatic and supportive.

IDENTIFICATION:
3 mg Tablet A flat, round, pink tablet with bevelled edges, scored on one side.
6 mg Tablet A flat, round, green tablet with bevelled edges, scored on one side.

PRESENTATION:
Blister PVC/Foil packs of 30 and Securitainers 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Bromazepam - 3 Tablets: W/2.6/407
Bromazepam - 6 Tablets: W/2.6/408

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH 6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 October 1990

                G863
        A & S PRINTERS.

Updated on this site: May 2000
Current: September 2004
Source: Community Pharmacy
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