Source: Health Products Regulatory Authority (ZA) Revision Year: 2020 Publisher: Strides Pharma SA (Pty) Ltd, 106 16<sup>th</sup> Road, Building 2, Midrand, 1686
OSELFLU is indicated in the following conditions:
OSELFLU may be taken with or without food (see section 5.2). However, OSELFLU taken with food may enhance tolerability in some patients.
Treatment should begin within the first or second day of onset of symptoms of influenza.
Adults and adolescents:
The recommended oral dose of OSELFLU in adults and adolescents ≥13 years is a 75 mg capsule twice daily, for 5 days.
Children:
Children >40 kg or ≥8 years who are able to swallow capsules, may also receive treatment with a 75 mg capsule twice daily.
The recommended oral dose of OSELFLU for prophylaxis of influenza following close contact with an infected individual is 75 mg once daily for at least 7 days.
Therapy should begin within two days of exposure.
The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily.
The duration of protection lasts for as long as dosing is continued.
Treatment of influenza: No dose adjustment is necessary for patients with creatinine clearance above 30 ml/min. In patients with a creatinine clearance of 10-30 ml/min, it is recommended that the dose be reduced to 75 mg of OSELFLU once daily for 5 days. No dosing recommendation is available for patients undergoing routine haemodialysis and continuous peritoneal dialysis with end stage renal disease and for patients with creatinine clearances 10 ml/min (see Special populations and section 4.4).
Prophylaxis of influenza: No dose adjustment is necessary for patients with creatinine clearance above 30 ml/min. In patients with creatinine clearance between 10 and 30 ml/min receiving OSELFLU it is recommended that the dose be reduced to 75 mg of OSELFLU every other day. No dosing recommendation is available for patients undergoing routine haemodialysis and continuous peritoneal dialysis with end stage renal disease and for patients with creatinine clearance ≤10 ml/min (see Special populations and section 4.4).
No dose adjustment is required for patients with hepatic dysfunction in the treatment or prophylaxis of influenza (see Special populations and section 4.4).
No dose adjustment is required for elderly patients in the treatment or prophylaxis of influenza (see Special populations and section 4.4).
The safety and efficacy of OSELFLU in children under 1 year has not been established (see Special populations and section 4.4). OSELFLU should not be used in children under 1 year of age.
Administration of 100 mg of oseltamivir twice daily for five days to patients with various degrees of renal impairment showed that exposure to the active metabolite is inversely proportional to declining renal function.
Treatment of influenza: No dose adjustment is necessary for patients with creatinine clearance above 30 ml/min. In patients with a creatinine clearance of 10-30 ml/min, it is recommended that the dose be reduced to 75 mg of oseltamivir once daily for 5 days. No dosing recommendation is available for patients undergoing routine haemodialysis and continuous peritoneal dialysis with end stage renal disease and for patients with creatinine clearances ≤10 ml/min (see sections 4.2 and 4.4).
Prophylaxis of influenza: In patients with creatinine clearance between 10 and 30 ml/min receiving oseltamivir it is recommended that the dose be reduced to 75 mg of oseltamivir every other day. No dosing recommendation is available for patients undergoing routine haemodialysis and continuous peritoneal dialysis with end stage renal disease and for patients with creatinine clearance ≤10 ml/min (see sections 4.2 and 4.4).
In vitro studies have shown that exposure to oseltamivir is not expected to be increased significantly, nor is exposure to the active metabolite expected to be significantly decreased in patients with hepatic impairment (see section 4.2).
Exposure to the active metabolite at steady state was 25-35% higher in elderly (age range 65-78) compared to young adults who were given comparable doses of oseltamivir. Half-lives observed in the elderly were similar to those seen in young adults. On the basis of medicine exposure and tolerability, dosage adjustments are not required for elderly patients for either the treatment or prophylaxis of influenza (see section 4.2).
The pharmacokinetics of oseltamivir have been evaluated in single dose pharmacokinetic studies in children aged 1 to 16 years. Younger children cleared both the pro-medicine and the active metabolite faster than adults resulting in lower exposure for a given mg/kg dose. Doses of 2 mg/kg give oseltamivir carboxylate exposures comparable to those achieved in adults receiving a single 75 mg capsule dose (approximately 1 mg/kg). The pharmacokinetics of oseltamivir in children over 12 years of age are similar to those in adults.
Oral.
At present there has been no experience with overdose, however, the anticipated manifestations of acute overdose would be nausea, with or without accompanying emesis.
Not applicable.
Not applicable.
2 Years. Store at or below 25°C.
Protect from light.
Keep blister in outer carton until required for use.
Carton containing 10 capsules in blister pack. Blister packs are composed of plastic (PVC/PE/PVDC) and aluminium foil.
No special requirements.
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