Source: Health Products Regulatory Authority (ZA) Publisher: sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand, 1685, South Africa
In adults:
Orelox 100 and Orelox 200 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):
In children:
Orelox Junior is indicated for use in the short-term treatment of infections due to susceptible micro-organisms:
Upper and lower respiratory tract infections:
Each film-coated tablet contains 100 mg or 200 mg of cefpodoxime. The dosage depends on the condition being treated.
One ORELOX 100 tablet (100 mg) every 12 hours with meals (200 mg/day) As is the case with all beta-lactam antibiotics in the treatment of beta-haemolytic streptococcal infections, a therapeutic dose has to be administered for at least 10 days.
One ORELOX 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 suspension contains 40 mg of cefpodoxime.
Preservative: Potassium sorbate 0,17%.
Contains aspartame 20 mg/5ml.
ORELOX JUNIOR must not be given to children with phenylketonuria, since the formulation contains aspartame (see CONTRAINDICATIONS).
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 with meals. 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 |
The use of ORELOX JUNIOR in children under one year of age is currently not indicated since insufficient clinical data is available at present (see CONTRAINDICATIONS).
Remove the screw-cap by simultaneously pushing and turning it. Remove the desiccant plug by pulling the tear-tab, and discard. The indented calibration mark represents the final volume. Half fill the bottle with water and shake vigorously (about 30 seconds). Fill up with water to the calibration mark and shake again to disperse all granules. A total of 45 ml water is required to make up the 50 ml suspension and a total of 90 ml water is required to make up the 100 ml suspension.
Treatment should be symptomatic and supportive.
In cases of overdosage, particularly in patients with renal insufficiency, there is a risk of encephalopathy.
Convulsions have also been reported with very high doses especially in patients with renal impairment.
ORELOX 100: film-coated tablets are available in polyamide/aluminium/polyvinyl chloride/aluminium blister packs, inserted into an outer printed cardboard carton containing 10 tablets (1 strip x 10 tablets).
ORELOX 200: film-coated tablets are available in polyamide/aluminium/polyvinyl chloride/aluminium blister packs, inserted into an outer printed cardboard carton containing 10 tablets (1 strip x 10 tablets) or 20 tablets (2 strips x 10 tablets).
ORELOX JUNIOR: is packed into a 75 ml or 150 ml type lll amber glass bottle, fitted with a dehydrating capsule. The closure is a child-proof white opaque plastic screw-cap fitted with a white polyethylene joint and a pilfer proof ring.
The bottle is inserted into an outer printed cardboard carton.
The 75 ml or 150 ml bottles contain granules for reconstitution up to 50 ml or 100 ml of suspension, respectively.
ORELOX 100 and ORELOX 200:
Store in a cool, dry place, at or below 25°C.
Protect from light and humidity.
Keep blister pack in carton until required for use.
KEEP OUT OF REACH OF CHILDREN.
ORELOX JUNIOR:
Before reconstitution: Store in a cool, dry place at or below 25°C. Protect from light and humidity.
After reconstitution: Use within 10 days. Store in a refrigerator (+2 to +8°C). Shake before use.
KEEP OUT OF REACH OF CHILDREN.
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