Telura – Tenofovir disoproxil fumarate, Lamivudine & Efavirenz Tablets IP 300mg/300mg/600mg

Description

Why Is it Used ?

TENOFOVIR DISOPROXIL FUMARATE :

Adult: PO HIV infection; Chronic hepatitis B =18 yr: 300 mg once daily.

2What are the Side Effects ?

TENOFOVIR DISOPROXIL FUMARATE :

Diarrhoea, nausea, vomiting, abdominal pain, flatulence, dyspepsia, anorexia, skin rash, peripheral neuropathy, headache, dizziness, insomnia, depression, dyspnoea, asthenia, sweating, myalgia, myopathy, body fat redistribution, osteomalacia. Hypophosphataemia, raised amylase and liver enzymes, hepatitis, hypertriglyceridaemia, hyperglycaemia, neutropenia, nephritis, nephrogenic diabetes insipidus, renal impairment, proximal tubulopathy, Fanconi syndrome, immune reconstitution syndrome. Potentially Fatal: Lactic acidosis with severe hepatomegaly with steatosis; severe acute exacerbations of hepatitis B. Acute renal failure.

3What Precautions should be taken ?

TENOFOVIR DISOPROXIL FUMARATE :

Renal impairment, hepatomegaly or at risk for liver disease. Elderly and pregnancy. Discontinue therapy if there is a rapid rise in aminotransferase concentrations, progressive hepatomegaly or steatosis, metabolic or lactic acidosis of unknown cause. Monitor creatinine clearance and serum phosphorus routinely in patients at risk of renal impairment. Bone monitoring for patients with history of pathologic bone fracture or at risk of osteopenia. Test for presence of chronic hepatitis B virus (HBV) before initiating therapy. If tenofovir is discontinued in patients co-infected with HIV and HBV, monitor hepatic function for several mth for exacerbation of hepatitis. Monitor child exposed in utero to combination drug for possible mitochondrial dysfunction.

4Do not take this if you have any of the below …

TENOFOVIR DISOPROXIL FUMARATE :

Lactation. Not for treatment for chronic hepatitis B virus infection. Do not co-administer with fixed dose combinations containing tenofovir.

5Interaction with other medicines…

TENOFOVIR DISOPROXIL FUMARATE :

Decreased atazanavir concentration with tenofovir unless also co-administered with ritonavir. Increased serum concentration of tenofovir or co-administered drug if taken with drugs that are eliminated by active tubular secretion. Potentially Fatal: Increased risk of renal impairment with recent or concurrent use of nephrotoxic agents (e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2); monitor renal function wkly if unavoidable. Increased didanosine levels and thereby increasing risk of pancreatitis and peripheral neuropathy, with a high treatment failure rate with concurrent use; avoid concurrent use.