AFARIS PAED 75/50 Tablet Ref.[115239] Active ingredients: Isoniazid Rifampicin

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

Therapeutic indications

AFARIS PAED 75/50 is indicated for pulmonary tuberculosis in children.

Posology and method of administration

Posology

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+

Method of administration

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.

Overdose

Symptoms of overdose

Rifampicin

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.

Isoniazid

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.

Treatment of overdose

General

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.

Shelf life

AFARIS PAED 75/50: 24 months.

Special precautions for storage

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.

Nature and contents of container

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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