BETAMOX Capsule, Suspension Ref.[50348] Active ingredients: Amoxicillin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext. 1, Roodepoort 1724, South Africa

Product name and form

BETAMOX 250 capsules.
BETAMOX 500 capsules.
BETAMOX S 125 mg/5 ml suspension.
BETAMOX SF 250 mg/5 ml suspension.

Pharmaceutical Form

BETAMOX 250: Capsules Size 2 capsule, with an opaque maroon cap and an opaque flesh coloured body. The name BETAMOX 250 mg is imprinted on the flesh body, and the Be-Tabs logo on the maroon cap.

BETAMOX 500: Capsules Size 0 capsule, with an opaque maroon cap and an opaque flesh coloured body. The name BETAMOX 500 mg is imprinted on the flesh body, and the Be-Tabs logo on the maroon cap.

BETAMOX S: Suspension Free-flowing, slightly pink powder, purple suspension when reconstituted.

BETAMOX SF: Suspension Free-flowing, slightly pink powder, purple suspension when reconstituted.

Qualitative and quantitative composition

BETAMOX 250: Each capsule contains amoxycillin trihydrate equivalent to 250 mg amoxycillin.

Sugar free.

BETAMOX 500: Each capsules contains amoxycillin trihydrate equivalent to 500 mg amoxycillin.

Sugar free.

BETAMOX S: Each 5 ml of the reconstituted suspension contains amoxycillin trihydrate equivalent to 125 mg amoxycillin.

Contains sugar: Sucrose (Pharmagrade sugar) 3,031 g.

BETAMOX SF: Each 5 ml of the reconstituted suspension contains amoxycillin trihydrate equivalent to 250 mg amoxycillin.

Contains sugar: Sucrose (Castor sugar) 2,873 g.

For full list of excipients, see section 6.1.

Active Ingredient Description
Amoxicillin

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bactericidal peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.

List of Excipients

BETAMOX 250 and BETAMOX 500

Capsule contents: Magnesium stearate, purified talc and sodium lauryl sulphate

Capsule shell: Flesh opaque body: erythrosine (CI no. 45430), gelatin, quinoline yellow (CI no. 47005), titanium dioxide (CI no. 77891)

Maroon cap: brilliant blue (CI no. 42090), erythrosine (CI no. 45430), gelatin, sunset yellow (CI no. 15985), titanium dioxide (CI no. 77891)

Capsule printing ink:

Yellow printing ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, yellow iron oxide (CI no. 77492)

Black printing ink: absolute alcohol, black iron oxide (CI no. 77499), butyl alcohol, isopropyl alcohol, propylene glycol, shellac

BETAMOX S

Hexacol grape A B 100 concentration (grape colour): hexacol brilliant blue FCF supra (CI no. 42090) and hexacol carmoisine (red) (CI no. 14720), sodium acid citrate, sodium carboxymethyl cellulose, sodium citrate, sucrose (pharmagrade sugar), Trusil grape concord (F1526) (grape flavour)

BETAMOX SF

Castor sugar (starch free), Hexacol grape A B 100 concentration (grape colour): hexacol brilliant blue FCF supra (CI no. 42090) and hexacol carmoisine (red) (CI no. 14720), sodium acid citrate, sodium carboxymethyl cellulose, sodium citrate, sucrose (pharmagrade sugar), Trusil grape concord (F1526) (grape flavour)

Pack sizes and marketing

BETAMOX 250: Canisters containing 15, 100 or 500 × 250 mg amoxycillin capsules.

Patient ready packs of different pack sizes.

BETAMOX 500: Canisters containing 15, 100 or 500 × 500 mg amoxycillin capsules.

Patient ready packs of different pack sizes.

BETAMOX S: Bottles containing powder for reconstitution to 75 ml and to 100 ml of 125 mg/5 ml suspension.

BETAMOX SF: Bottles containing powder for reconstitution to 100 ml of 250 mg/5 ml suspension.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext. 1, Roodepoort 1724, South Africa

Marketing authorization dates and numbers

BETAMOX 250: Y/20.1.2/127 (S.A.), Botswana: S2 BOT0500765, Namibia: NS2 04/20.1.2/1625
BETAMOX 500: Y/20.1.2/128 (S.A.), Namibia: NS2 04/20.1.2/1626
BETAMOX S: Y/20.1.2/129 (S.A.), Botswana: S2 BOT0500763, Namibia: NS2 04/20.1.2/1623
BETAMOX SF: Y/20.1.2/130 (S.A.), Botswana: S2 BOT0500764, Namibia: NS2 04/20.1.2/1624

May 1991

Drugs

Drug Countries
BETAMOX Hong Kong, Singapore, South Africa

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