Vironil 300 mg Tab. 300 mg

Tablet

Pack Size : 5 Tablet x 1 strip

Generics : Tenofovir Disoproxil Fumarate

Manufacturer : Unimed & Unihealth Manufacturers Ltd.

Best Price * TK 475.00

* Delivery will be done in Dhaka city only.

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More Information About - Vironil 300 mg Tab. 300 mg

Description

Generic Name

Tenofovir Disoproxil Fumarate

Precaution

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

Indication

HIV-1 infection, Chronic hepatitis B

Contra Indication

Tenofovir is contraindicated in patients with previously demonstrated hypersensitivity to Tenofovir or any component of the product.

Dose

N/A

Side Effect

>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

Pregnancy Category

Name : Not Classified

Description

FDA has not yet classified the drug into a specified pregnancy category.

Mode 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.

Interaction

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.

Pregnancy Category Note

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

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.

Disclaimer

The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.