CEPODEM Film-coated tablet / Suspension Ref.[51081] Active ingredients: Cefpodoxime

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, a Sun Pharma Company, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa

Product name and form

Cepodem 100 Tablets (Film-coated tablets).

Cepodem 200 Tablets (Film-coated tablets).

Cepodem Suspension 40 mg/5 ml (Powder for Oral Suspension).

Pharmaceutical Form

Film-coated tablets

Cepodem 100 Tablets: White coloured, capsule shaped, film coated tablets imprinted with ‘RX520’ on one side in black edible ink.

Cepodem 200 Tablets: White coloured, capsule shaped, film coated tablets imprinted with ‘RX521’ on one side in black edible ink.

Suspension

Cepodem Suspension 40 mg/5 ml: Off-white to yellow granular powder forming an off-white to yellow suspension on constitution with water. The resulting suspension has a characteristic fruity flavour.

Qualitative and quantitative composition

Cepodem 100 Tablets

Each film coated tablet contains: Cefpodoxime proxetil equivalent to cefpodoxime 100 mg.

Contains sugar: Lactose anhydrous 10,0 mg.

Cepodem 200 Tablets

Each film coated tablet contains: Cefpodoxime proxetil equivalent to cefpodoxime 200 mg.

Contains sugar: Lactose anhydrous 20,0 mg.

For the full list of excipients, see section 6.1.

Cepodem Suspension 40 mg/5 ml

Each 5 ml of the constituted suspension contains: Cefpodoxime proxetil equivalent to cefpodoxime 40 mg.

Preservative: Sodium benzoate 0,2% m/v.

Contains sugar: Sucrose 2,7 g; lactose anhydrous 7, 23 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cefpodoxime

Like other beta-lactam drugs, cefpodoxime exerts antibacterial activity by binding to and inhibiting the action of certain bacterial cell wall synthetic enzymes, namely the penicillin binding proteins.

List of Excipients

Cepodem Tablets

Tablet core:

Carboxymethyl cellulose calcium
Hydroxypropylcellulose
Lactose anhydrous
Magnesium stearate
Sodium lauryl sulphate

Film-coat:

Propylene glycol

Opadry White 03H58987 consisting of:

Hypromellose
Titanium dioxide
Propylene glycol

Printing Ink:

Opacode-S-1-17823 consisting of:

Shellac Glaze
Iron oxide black
N-Butyl Alcohol
Propylene glycol

Cepodem Suspension 40 mg/5 ml

Carboxymethyl cellulose sodium
Carrageenan
Citric acid
Colloidal anhydrous silica
Croscarmellose sodium
Hydroxypropyl cellulose
Lactose anhydrous
Microcrystalline cellulose sodium
Sodium benzoate
Sodium citrate
Sucrose
Flavourant: Flavour Cherry; Flavour Fruit Gum
Colourant: Ferric Oxide Yellow

Pack sizes and marketing

Cepodem 100 Tablets: Aluminium strip pack of 10 tablets.

Cepodem 200 Tablets: Aluminium strip pack of 10 tablets.

Cepodem Suspension 40 mg/5 ml: Natural translucent HDPE bottle pack of 50 ml and 100 ml.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, a Sun Pharma Company, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

Cepodem 100 Tablets: 36/20.1.1/0225
Cepodem 200 Tablets: 36/20.1.1/0226
Cepodem Suspension 40 mg/5 ml: 36/20.1.1/0227

11 December 2003

Drugs

Drug Countries
CEPODEM Nigeria, South Africa

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