Generic Medicine Info
Hypersensitivity. Lactation. Concomitant administration with drugs in which inhibition of CYP3A4 can result in elevated serum concentration of these drugs, potentially causing serious adverse reactions; St. John's wort.
Special Precautions
Patient with diabetes, haemophilia A or B. Hepatic impairment. Pregnancy. Patients taking delavirdine, itraconazole, ketoconazole or rifabutin. Patient Counselling Ensure adequate hydration. Monitoring Parameters Monitor viral load, CD4 count, triglycerides, cholesterol, glucose, LFTs, CBC, urinalysis; signs of gastrointestinal disturbances that can result in dehydration and weight loss, hyperlipidaemia, redistribution of body fat, rash, CNS effects (e.g. insomnia, malaise, abnormal thinking), electrolyte imbalance.
Adverse Reactions
Significant: Fat redistribution (e.g. buffalo hump, peripheral wasting with increased abdominal girth, cushingoid appearance), indirect hyperbilirubinaemia, immune reconstitution syndrome; nephrolithiasis or urolithiasis (sometimes associated with renal impairment, acute renal failure or pyelonephritis), tubulointerstitial nephritis (in patients with asymptomatic severe leukocyturia); new-onset diabetes mellitus or hyperglycaemia, or exacerbation of pre-existing diabetes mellitus, diabetic ketoacidosis. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhoea, dysgeusia, dyspepsia, acid regurgitation, flatulence, dry mouth. General disorders and administration site conditions: Asthenia, fatigue. Investigations: Increased ALT and AST, decreased neutrophil counts, increased mean corpuscular volume (MCV). Musculoskeletal and connective tissue disorders: Myalgia. Nervous system disorders: Headache, dizziness, hypoaesthesia, paraesthesia. Psychiatric disorders: Insomnia. Renal and urinary disorders: Dysuria, crystalluria, haematuria, proteinuria. Skin and subcutaneous tissue disorders: Pruritus, dry skin, rash.
Potentially Fatal: Acute haemolytic anaemia; hepatitis (which may result in hepatic failure).
Drug Interactions
May increase serum concentration with CYP3A4 inhibitors, delavirdine, itraconazole, ketoconazole. May decrease serum concentration with other CYP3A4 inducers (e.g. phenobarbital, phenytoin, carbamazepine, dexamethasone), didanosine, efavirenz, nevirapine, rifabutin, venlafaxine. May increase risk of nephrolithiasis with ritonavir. May increase serum concentration of ciclosporin, tacrolimus, sirolimus, CYP3A4 inhibitors, Ca channel blockers, trazodone, parenteral midazolam, other drugs metabolised by CYP3A4. May increase risk of myopathy with other HMG-CoA reductase inhibitors (e.g. rosuvastatin, atorvastatin, pravastatin, fluvastatin). May increase risk of phosphodiesterase type 5 (PDE5) inhibitor-associated adverse effects (e.g. hypotension, visual changes, priapism) with PDE5 inhibitors (e.g. tadalafil, vardenafil, sildenafil).
CIMS Class
ATC Classification
J05AE02 - indinavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
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