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Therapeutic action
- Antiretroviral, HIV protease inhibitor
Indications
- HIV infection, in combination with ritonavir (booster) and other antiretrovirals
Forms and strengths
- 75 mg, 300 mg, 400 mg and 600 mg tablets
Dosage
Patients with no previous use of protease inhibitors
- Child 14 to < 35 kg: 600 mg once daily (+ 100 mg ritonavir once daily)
- Child ≥ 35 kg and adult: 800 mg once daily (+ 100 mg ritonavir once daily)
Patients with previous use of protease inhibitors
- Child 14 to < 25 kg: 375 mg 2 times daily (+ 50 mg ritonavir 2 times daily)
- Child 25 to < 35 kg: 400 mg 2 times daily (+ 100 mg ritonavir 2 times daily)
- Child ≥ 35 kg and adult: 600 mg 2 times daily (+ 100 mg ritonavir 2 times daily)
Duration
- The duration of treatment depends on the efficacy and tolerance of darunavir and ritonavir.
Contra-indications, adverse effects, precautions
- Do not administer in children under 3 years; in case of severe hepatic impairment, history of allergy to sulfonamides or in combination with rifampicin.
- Administer with caution and monitor use in patients with haemophilia (increased bleeding) or in patients with mild or moderate hepatic impairment.
- May cause:
- gastrointestinal disturbances, headache, insomnia, fatigue, dizziness, peripheral neuropathy, renal disorders, myocardial infarction, hypertension, tachycardia, hyperglycaemia, hyperlipidaemia, lipodystrophy;
- skin rash sometimes severe, hepatic disorders; in this event, stop treatment immediately.
- Darunavir in combination with ritonavir reduces the efficacy of oral contraceptives: use a non-hormonal contraception or injectable medroxyprogesterone or an oral contraceptive containing 50 micrograms of ethinylestradiol per tablet.
- Pregnancy: no contra-indication
Remarks
- Take with meals together with ritonavir.
Storage
- Below 25 °C