Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530 Phone: +27 21 943 4200 Customer Care: 080 222 6662 E-mail: info@cipla.co.za
DALIDUO is indicated for the treatment of immunodeficiency virus-1(HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA ˂50 copies/ml), for at least 6 months on a stable PI, NI or NNRTI plus NRTI based regimens, without known or suspected resistance to either antiretroviral component. Co-administration with any other NNRTI medicines is not recommended (see section 4.5).
DALIDUO should be initiated by a medical practitioner experienced in the management of HIV infection.
The recommended dose is one DALIDUO tablet once a day.
There is limited data available for the use of dolutegravir, an active component in DALIDUO in patients aged 65 years and over. There is therefore no dose adjustments required for DALIDUO in elderly patients.
The safety and efficacy of rilpivirine, an active component in DALIDUO has not been proven in adolescents and children. Treatment with rilpivirine, an active component in DALIDUO is not recommended for use in children and adolescents ≤18 years.
No dose adjustment of DALIDUO is required in patients with renal impairment.
No dosage adjustment of DALIDUO is required in patients with mild hepatic impairment (Child-Pugh score A). DALIDUO is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B and C), see sections 4.3 and 5.2.
Rifampicin decreases the blood levels of dolutegravir.
DALIDUO should be taken orally with food.
Management should be as clinically indicated or as recommended by the national poisons centre, where available. There is no specific treatment for an overdose of DALIDUO. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary such as monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. DALIDUO is highly bound to plasma proteins, it is unlikely that it will be significantly be removed by dialysis. If indicated, elimination of unabsorbed rilpivirine may be removed by administration of activated charcoal.
24 months.
Store at or below 25°C.
Keep the bottle tightly closed.
Keep away from children.
DALIDUO is packed in a 50 cc white round HDPE Bottle consisting of a Silica Gel Bag 2 gm Stripax (Multisorb) R/F and closed with a 33 mm Blue Child Resistant Cap. The HDPE bottle is packed into an outer cardboard carton. Pack sizes are 28 and 30 tablets.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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