BETAPAM Tablet Ref.[50672] Active ingredients: Diazepam

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa

Product name and form

BETAPAM Tablets.

Pharmaceutical Form

Tablet.

Yellow, biconvex, scored tablets.

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.

Active Ingredient Description
Diazepam

Diazepam is a psychotropic substance from the class of 1,4-benzodiazepines with marked properties of suppression of tension, agitation and anxiety as well as sedative and hypnotic effects. In addition, diazepam demonstrates muscle relaxant and anticonvulsive properties. It is used in the short-term treatment of anxiety and tension states, as a sedative and premedicant, in the control of muscle spasm and in the management of alcohol withdrawal symptoms.

List of Excipients

Certolake Tartrazine (C.I. 19140)
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Starch Maize

Pack sizes and marketing

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.

Marketing authorization holder

RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

L/2.6/185 (S.A)

18 April 1979

Drugs

Drug Countries
BETAPAM South Africa

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