Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Macleods Pharmaceuticals SA (Pty) Ltd., Ground Floor, Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock Ext 12, Alberton, Gauteng
AFARIS PAED 75/50 is indicated for pulmonary tuberculosis in children.
AFARIS PAED 75/50 is recommended in the continuation phase of the treatment of pulmonary tuberculosis. During this phase AFARIS PAED 75/50 should be administered on a continuous daily basis.
The total dosage requirement is as follows:
Daily | Maximum daily dose | |
---|---|---|
Rifampicin | 15 mg/kg (10 to 20) | 600 mg |
Isoniazid | 10 mg/kg (7 to 15) | 300 mg |
The daily dosage is calculated from the recommended daily requirement given above and to closely regulate dosage according to body mass.
Table 1. Dosage calculation:
Number of tablets | For infants/children with body mass (kg) |
---|---|
1 tablet | 4-7 |
2 tablets | 8-11 |
3 tablets | 12-15 |
4 tablets | 16-24 |
Adult dosages recommended | 25+ |
Oral use.
The tablets can either be dispersed in as little as 5 ml of water, or chewed, and should preferably be taken on an empty stomach as a single dosage.
AFARIS PAED 75/50 should be taken at least 1 hour before aluminium containing antacids are used.
Acute overdosage with rifampicin has produced a characteristic bright-red discolouration of the skin and mucous membranes, sometimes referred to as “the red-man syndrome”, mental obtundation, periorbital or facial oedema and generalised pruritus.
Symptoms are more likely to be related to isoniazid. These include hyperglycaemia and metabolic acidosis, slurred speech, convulsions, coma, hallucinations, respiratory distress, central nervous system depression; fatalities can occur.
In cases of overdosage with AFARIS PAED 75/50 activated charcoal slurry into the stomach may help absorb any remaining medicine from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting. Intensive supportive measures should be instituted and individual symptoms treated as they arise. Further treatment is symptomatic and supportive.
If acute overdose is suspected, even in asymptomatic patients, the administration of intravenous pyridoxine (vitamin B6) should be considered. In patients with seizures not controlled with pyridoxine, anticonvulsant therapy should be administered. Sodium bicarbonate should be given to control metabolic acidosis. Haemodialysis is advised for refractory cases: if this is not available, peritoneal dialysis can be used along with forced diuresis.
AFARIS PAED 75/50: 24 months.
Store at or below 25°C. Protect from moisture and light.
Keep the aluminium sachet in the HDPE container until required for use.
Keep the blister in the carton until required for use.
KEEP OUT OF REACH OF CHILDREN.
HDPE Container:
Tablets are packed in a transparent, self-sealing LDPE polybag and further packed in a silver coloured triple laminated aluminium sachet (LDP/PET/AL), kept in a white plastic container (HDPE), which is sealed at the mouth with an aluminium tagger and is closed with a white HDPE screw-on lid. Pack sizes include 100 tablets.
Alu-alu strip pack:
Tablets are packed in silver-metallic coloured aluminium foil (soft tempered) laminated with low density polyethylene film as the lidding and forming material. The blister is packed in a pre-printed carton. Pack sizes include 28, 56, 84 and 100 tablets.
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