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
Cepodem 100 Tablets and Cepodem 200 Tablets are indicated for use in the short-term treatment of upper and lower respiratory tract infections due to susceptible micro-organisms (sensitivity tests must be performed):
Acute bronchitis and acute exacerbations of chronic bronchitis due to: Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis.
Pharyngitis and tonsillitis due to: Streptococcus pyogenes
Bacterial pneumonia and community-acquired bronchopneumonia due to: Haemophilus influenza, Streptococcus pneumoniae, Moraxella catarrhalis.
Acute sinusitis due to: Haemophilus influenzae (non-typeable), Streptococcus pneumoniae, Methicillin-sensitive Staphylococcus aureus, Moraxella catarrhalis.
Cepodem Suspension 40 mg/5 ml is indicated for use in the short-term treatment of infections due to susceptible micro-organisms:
Upper and lower respiratory tract infections
Otitis media due to: Haemophilus influenzae (non-typeable), Streptococcus pneumoniae, Moraxella catarrhalis.
Tonsillitis and pharyngitis due to: Streptococcus pyogenes.
Pneumonia due to: Haemophilus influenza, Streptococcus pneumoniae, Moraxella catarrhalis.
Each film-coated tablet contains 100 mg or 200 mg of cefpodoxime.
The dosage of Cepodem 100 Tablets and Cepodem 200 Tablets depends on the condition being treated.
One Cepodem 100 Tablet (100 mg) every 12 hours with meals (200 mg/day). In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.
One Cepodem 200 Tablet (200 mg) every 12 hours with meals (400 mg/day).
Where renal function is normal, it is not necessary to adjust the dose.
No dosage adjustment necessary.
When the creatinine clearance is above 40 ml/min, it is not necessary to adjust the dose.
For values below 40 ml/min, the daily dosage regimen should be reduced by half and administered as a single daily dose for values 10-39 ml/min, every second day for values below 10 ml/min, and after each dialysis session for haemodialysis patients.
Each 5 ml of the constituted suspension contains 40 mg of cefpodoxime.
Preservative: Sodium benzoate 0,2% m/v.
The dosage depends on the weight of the child being treated. The average dose is 8 mg/kg/day administered in two doses at 12 hourly intervals withmeals. Shake the bottle before use.
The following table may be used as a dosage guide:
| Weight (kg) | Dose |
|---|---|
| Between 10 and 15 kg | 5 ml (40 mg) every 12 hours |
| ≥15 kg | 10 ml (80 mg) every 12 hours |
Cepodem Suspension 40 mg/5 ml is currently not indicated for use in children under one year of age since insufficient clinical data is available at present (see section 4.3).
Oral.
Cepodem 100/200 film-coated tablet taken with meals.
CEPODEM Suspension 40 mg/5 ml administered with meals.
Directions for reconstitution of the suspension: Shake the bottle to loosen the granules. Add 33 ml and 66 ml water for 50 ml and 100 ml packs respectively in two divided portions to the dry mixture in the bottle. Shake well after each addition.
Overdosage with Cepodem may manifest in any of the symptoms described under section 4.8.
Treatment is symptomatic and supportive.
Convulsions and other signs of CNS toxicity have been associated with high doses, especially in patients with renal impairment.
Cepodem 100 Tablets / Cepodem 200 Tablets: 24 months.
Cepodem Suspension 40 mg/5 ml: 18 months.
Store at or below 25°C, protected from light and moisture.
After constitution of the suspension, the pack must be stored at 2-8°C in a refrigerator. The constituted suspension should be consumed within 10 days of preparation. Discard any unused portion of the constituted suspension after 10 days. Shake well before dosing.
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.
No special requirements.
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