Drug Interaction:
See contraindications- Rifabutin, Lopinavir, Retronavir, Saquinavir, Indinavir, Atazanavir, Efavirinz, Didasonine Trazodone, Despramine, Antihistamines Neuroliptics,Sedatives Digoxin
Clarithromycin Risperidone,Thioridazine Warfarin Phenobarbital Phenytoin, Carbamazioine Azole antifungals Calcium antagonists, beta blockers Immunosuppressants Buprenorphine,
methadone Sidenafil, tadalafil Sertraline, paroxtine Ethyl osetradiol, norethindrone, steroids
Indication:
Treatment of HIV infections
In combination with low dose ritronavir together with other antiretrovirals
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Darunavir as Ethanolate Tablet 300mg 19-03-2009
For the treatment of Human Immnological deficiency (HIV) infection
in antiretroviral treatment exprienced adult patients such as those
with HIV - 1 strains resistent to more than one protease inhibitor
when co-administered with 100mg Ritonavir and other antiretroviral
agents.
Adverse Reaction:
Severe rash discontinue if it develops
GI upset, anorexia Headache, dizziness, asthenia, fatigue, prurituis, insomnia
Peripheral neuropathy, Hyperglycemia Hyperlipidaemia and other metabolic abnormalites
Lipodystrophy Increased CPK, pancreatic enzymes Arthalgia, osteoporosis, musculoskeletal and joint stiffness,myalgia
Hepatitis, Myosistis Drug- induced hepatitis
Rarely rhabomyolysis
Contra-Indications:
Severe hepatic impairment Concomitant rifampicin, Alfuzosin St.johns wart, ergot derivatives Cisapride, statins, Pimozide, Midazolam,Triazolam Antiarrhythmics Lactation
Special precautions-
Mild to moderate hepatic impairment, severe renal impairment Sulfonamide allergy/chronic hepatitis B or C haemophilia,
Diabetes Fat redistribution Risk of immune reactivation syndrome in patients with severe immune deficiency within first few weeks or months of starting combination of antiretroviral theapy
Risk of osteonecrosis Monitor for liver enzymes, signs of joint pain or immobility
Elderly, Pregnancy
Dosages/ Overdosage Etc:
For the treatment of Human Immnological deficiency (HIV) infection in antiretrovir to more than one protease inhibitor when co-administered with 100mg Ritonavir and other antiretroviral agents.
Anti-retroviral -
Dosage-
experienced patients- 600mg twice daily with retronavir 100mg twice daily
Children - under 6 years and <20kg not recommended
Anti-retroviral experienced children- 20-29 kg - 375mg twice daily with retronvir, 50mg twice daily
30-39kg - 450mg twice daily with retronavir,
60mg twice daily > 40kg - 600mg twice daily with retronavir, 100mg twice daily
All to be taken with food with other antiretrovirals
Interaction with Food:
To be taken with food with other antiretrovirals
Pregnancy and lactation:
Pregnancy and Lactation- Use Contraindicated