Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa
BETAPAM 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.
BETAPAM is only indicated when the disorder is severe, disabling or when the individual is subject to extreme stress.
BETAPAM is indicated for the following conditions:
Anxiety: symptomatic relief of anxiety, tension and other somatic or psychological complaints associated with the anxiety syndrome. It can also be used as an adjunct to the treatment of anxiety or excitation associated with psychiatric disorders.
Muscle relaxation: as an adjunct for the relief of reflex muscle spasm due to local trauma (injury, inflammation). It can also be used to combat spasticity arising from damage to spinal and supraspinal interneurons such as cerebral palsy and paraplegia, as well as athetosis and stiff-man syndrome.
Treatment should be as short as possible. The patient should be assessed regularly and the need for continued treatment should be re-evaluated especially when the patient is symptom-free. The overall duration of treatment of anxiety should not be more than 8 to 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.
The duration of treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment evaluated, especially if the patient is symptom free. It should not exceed 2-3 months, including the tapering-off period. 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 explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms, should they occur during withdrawal.
There is evidence that, in case of short-acting benzodiazepines, withdrawal phenomena can become manifest within the dosage interval especially when the dosage is high. When long-acting benzodiazepines such as diazepam are being used, it is important to warn against changing to short acting benzodiazepines as withdrawal symptoms may develop.
For optimal effect, the dosage should be carefully individualised. Treatment should begin at the lowest effective dose appropriate to the particular condition and the maximum dose should not be exceeded.
Average adult dosage for oral administration: Initial dose: 5-10 mg. Depending on symptom severity, the usual dose is 5-20 mg daily. The maximum single oral dose for adults should not exceed 10 mg.
Elderly and debilitated patients who are at particular risk of over sedation, respiratory depression and ataxia should be given half of the usual adult dose. These patients should be checked regularly at the start of treatment in order to minimise the dosage and/or frequency of administration to prevent overdose due to accumulation.
Patients with impaired hepatic function should be given a reduced dose.
The usual precautions in treating patients with impaired renal function should be observed.
0,1-0,3 mg/kg bodyweight daily.
BETAPAM should not be given to children without careful assessment of the indication; the duration of treatment must be kept to a minimum.
Safety and efficacy have not been demonstrated in children below 6 months of age.
Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.
BETAPAM commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of BETAPAM may be life-threatening if the medicine is taken alone, and may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. BETAPAM’s respiratory depressant effects are more serious in patients with respiratory disease. BETAPAM increases the effects of other central nervous system depressants, including alcohol.
Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects.
Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off.
Flumazenil is to be used with extreme caution in the presence of medicines that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this medicine.
24 Months: Amber PVC containers of 30,100, 500, and 1000 tablets, polypropylene containers of 100 and 500 tablets and H.D.P.E. bucket of 5000 tablets.
15 Months: Patient ready packs of different pack sizes.
Store at or below 25°C in a cool, dry place. Protect from light and moisture.
Amber PVC containers of 30,100, 500, and 1000 tablets.
Polypropylene containers of 100 and 500 tablets.
H.D.P.E. Bucket of 5000 tablets.
Patient ready packs of different pack sizes.
Not applicable.
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