Viread Tablets / Film-coated
Tenofovir Disoproxil Fumarate
300mg
GILEAD SCIENCES LIMITED
| Pack size | 30's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | IRELAND |
| Agent | QUADRI PHARMACEUTICALS STORE L.L.C. |
| Retail Price | 2477.00 AED |
Indications
Viread Tablets / Film-coated is used for:
HIV-1 infection, Chronic hepatitis B
Adult Dose
Oral
Chronic hepatitis B; HIV infection (Indicated in combination with other antiretroviral agents for treatment of HIV-1 infection)
Adult: 300 mg once daily.
Child Dose
HIV Infection
<2 years: Safety and efficacy not established
>2 years: 8 mg/kg PO qDay; not to exceed 300 mg/day
Hepatitis B Infection
<12 years: Safety and efficacy not established
>12 years; <35 kg: Safety and efficacy not established
>12 years; >35 kg: 300 mg PO qDay
Renal Dose
Renal impairment: Haemodialysis patients: 300 mg once every 7 days or after a cumulative total of 12 hr of dialysis.
CrCl (ml/min) Dosage Recommendation
10-29 300 mg 72-96 hrly.
30-49 300 mg 48 hrly.
Administration
May be taken with or without food. Take consistently either always w/ or always w/o food.
Contra Indications
Tenofovir is contraindicated in patients with previously demonstrated hypersensitivity to Tenofovir or any component of the product.
Precautions
Patient w/ hepatomegaly or other risk factors for liver disease. Renal impairment. Pregnancy. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor renal function and serum phosphate concentrations before start of therapy, 4 wkly during the 1st wk, and then 3 mthly; hepatic function for several mth following discontinuation. Determine HIV status in all hepatitis B virus (HBV) infected patients prior to treatment.
Lactation: HIV+ women are advised not to breastfeed
Pregnancy-Lactation
Pregnancy
Human data
Available prospective reported data from the APR shows no increase in the overall risk of major birth defects with first trimester exposure for tenofovir DF compared with US rate for major birth defects
Data from 3 controlled clinical trials in 327 pregnant women with chronic HBV infection did not observe an increased risk of adverse pregnancy related outcomes with tenofovir DF use during the third trimester
Animal data
In animal reproduction studies, no adverse developmental effects were observed when tenofovir DF was administered at doses >14 (TDF) and 2.7 (tenofovir) times those of the recommended daily dose
Lactation
Based on published data, tenofovir shown to be present in human breast milk
Unknown if tenofovir DF affects milk production or has effects on the breastfed child
HIV-infected mothers: Breastfeeding in HIV-1 infected mothers is not recommended owing to potential for HIV-1 transmission
HBV-infected mothers: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
In a study of 50 HIV-uninfected, breastfeeding women on a tenofovir-containing regimen initiated between 1 and 24 weeks postpartum (median 13 weeks), drug was undetectable in plasma of most infants after 7 days of treatment in mothers
Interactions
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.
Adverse Effects
Side effects of Tenofovir Disoproxil Fumarate :
>10%
Asthenia (11%), Diarrhea (16%), Nausea (11%), Pain (12%)
1-10%
Anorexia, Depression, Myalgia, Peripheral neuropathy, Dyspepsia, Rash, Headache, Vomiting, Flatulence, Abdominal pain, Neutropenia, Increased transaminases
Mechanism of Action
Tenofovir disoproxil fumarate, a diester prodrug of tenofovir, is a nucleotide reverse transcriptase inhibitor. After oral absorption, tenofovir disoproxil fumarate is rapidly converted to tenofovir and then undergo subsequent phosphorylation by cellular enzymes to the active tenofovir diphosphate, which inhibits the activity of HIV-1 reverse transcriptase.
Note
Viread 300mg Tablets / Film-coated manufactured by GILEAD SCIENCES LIMITED. Its generic name is Tenofovir Disoproxil Fumarate. Viread is availble in United Arab Emirates.
Farmaco UAE drug index information on Viread Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.