Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: SONKE PHARMACEUTICALS (PTY) LTD, Ground Floor, Tugela House, Riverside Office Park, 1303 Heuwel Avenue, Centurion
ATENEF is indicated for use alone as a complete regimen or in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults.
The dose of ATENEF is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms.
ATENEF is not recommended for use in patients less than 18 years of age.
Because ATENEF is a fixed-dose combination, it should not be prescribed for patients requiring dosage adjustment such as those with moderate or severe renal impairment (creatinine clearance less than 50 ml/min).
Oral use.
ATENEF tablets should be swallowed whole once daily.
600 mg twice daily have been reported to increase nervous system symptoms.
Limited clinical experience is available at doses higher than the therapeutic dose of emtricitabine.
Haemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1,5 hours of emtricitabine dosing (blood flow rate of 400 ml/min and a dialysate flow rate of 600 ml/min). It is not known whether emtricitabine can be removed by peritoneal dialysis.
Limited clinical experience at doses higher than the therapeutic dose of tenofovir DF 300 mg is available. The effects of higher doses are not known.
Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir DF, a 4-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.
If overdose occurs, the patient should be monitored for evidence of toxicity, including monitoring of vital signs and observation of the patient’s clinical status; standard supportive treatment should then be applied as necessary. Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz. Haemodialysis can remove both emtricitabine and tenofovir DF but is unlikely to significantly remove efavirenz from the blood.
36 months.
Store at or below 25°C in the original package, protected from moisture.
28, 30, 84 or 90 Tablets packed in a white opaque HDPE bottle. The HDPE bottle is packed with or without an outer cardboard carton.
HDPE bottle pack for 28 and 30: The HDPE bottle is a white, opaque 100 ml HDPE bottle with a white polypropylene, round cylindrical 38 mm cap with a heat seal liner.
HDPE bottle pack for 84 and 90: The HDPE bottle is a white, opaque 250 ml HDPE bottle with a white polypropylene, round cylindrical 38 mm cap with a heat seal liner.
The cap is a white polypropylene, round cylindrical cap with a heat seal liner and printed with “SEALED for YOUR PROTECTION” in black. The bottle also contains a desiccant.
No special requirements.
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