Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685
RIZENE 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.
Take one RIZENE film-coated tablet daily on an empty stomach.
Dosing at bedtime may improve the tolerability of nervous system symptoms.
RIZENE is not recommended for use by patients under the age of 18 years.
RIZENE is a fixed dose combination and should not be used by patients that require dose adjustment, such as those with moderate or severe renal impairment resulting in a creatinine clearance of less than 50 ml/min.
Standard supportive treatment should be applied for patients who have overdosed on RIZENE. Treatment is based on evidence of toxicity and monitoring of vital signs as well as observation of the patient’s clinical status.
Accidental intake of 600 mg of efavirenz has resulted in nervous system symptoms such as involuntary muscle contractions.
Unabsorbed efavirenz may be removed by activated charcoal. Efavirenz is not effectively removed by haemodialysis.
There is no data of severe side effects for emtricitabine and tenofovir disoproxil fumarate. The available studies are at the prescribed doses and therefore data is limited.
Emtricitabine and tenofovir may be removed by haemodialysis.
A 3-hour haemodialysis period starting 1,5 hours post-dosing (blood flow rate of 400 ml/min and a dialysate flow rate of 600 ml/min) may be able to remove around 30 % of the emtricitabine dose. It is not known whether emtricitabine can be removed by peritoneal dialysis.
The extraction coefficient of 54% for tenofovir results in efficient removal. A 4-hour haemodialysis session following a 300 mg single-dosing of tenofovir disoproxil fumarate may be able to remove approximately 10% of the administered dose.
36 months.
Store at or below 30°C. Keep well closed.
RIZENE is packed as 28’s, 30’s, 60’s, 84’s, 90’s, 120’s, 180’s and 500’s in white opaque, heavy weight high density polyethylene (HDPE) bottles with child-resistant closures and a silica gel desiccant sachet.
Not all packs sizes may be marketed.
No special precautions.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
