BETAPAM Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
BETAPAM Tablets.
2. Qualitative and quantitative composition
Each tablet contains 5 mg diazepam. Contains sugar (lactose monohydrate): 145,7 mg per tablet. Contains Tartrazine. For full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Yellow, biconvex, scored tablets.
4.1. Therapeutic indications
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 ...
4.2. Posology and method of administration
Duration of treatment 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 ...
4.3. Contraindications
BETAPAM is contraindicated in patients with: a known history of hypersensitivity to benzodiazepines; severe respiratory insufficiency; severe hepatic insufficiency; sleep apnoea syndrome; myasthenia gravis; ...
4.4. Special warnings and precautions for use
Concomitant use of alcohol/CNS depressants The concomitant use of BETAPAM with alcohol or/and CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacodynamic Interactions Enhanced effects of sedation, respiration, and haemodynamics may occur when BETAPAM is coadministered with other centrally acting depressants such as antipsychotics, anxiolytics ...
4.6. Fertility, pregnancy and lactation
Pregnancy The safety of diazepam for use in pregnancy has not been established. An increased risk of congenital malformation associated with the use of benzodiazepines during the first trimester of pregnancy ...
4.7. Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration and impaired muscle function may adversely affect the ability to drive or operate machinery. Patients should be advised, particularly at the initiation of therapy, ...
4.8. Undesirable effects
System Organ Class Frequency Adverse Reaction <b>Psychiatric disorders</b> Less frequent Drowsiness, confusion, numbed emotions, depression, reduced alertness, increase or decrease in libido. Paradoxical ...
4.9. Overdose
Symptoms Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension. BETAPAM commonly cause drowsiness, ataxia, dysarthria and nystagmus. ...
5.1. Pharmacodynamic properties
<b>Category and class:</b> A 2.6 Tranquilisers <b>Pharmacotherapeutic group: ATC code:</b> N05BA01 Diazepam is a long-acting benzodiazepine hypnotic with anxiolytic, sedative, muscle-relaxant, anticonvulsant ...
5.2. Pharmacokinetic properties
Absorption Diazepam is rapidly and completely absorbed from the gastrointestinal tract, peak plasma concentrations appearing 30 to 90 minutes after oral ingestion. Distribution Diazepam and its metabolites ...
6.1. List of excipients
Certolake Tartrazine (C.I. 19140) Lactose monohydrate Magnesium stearate Microcrystalline cellulose Starch Maize
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
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. ...
6.4. Special precautions for storage
Store at or below 25°C in a cool, dry place. Protect from light and moisture.
6.5. Nature and contents of container
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.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa
8. Marketing authorization number(s)
L/2.6/185 (S.A)
9. Date of first authorization / renewal of the authorization
18 April 1979
10. Date of revision of the text
19 January 2022
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