Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)
Avera McKennan Hospital
TENOFOVIR DISOPROXIL FUMARATE
TENOFOVIR DISOPROXIL FUMARATE 300 mg
ORAL
PRESCRIPTION DRUG
VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. The following points should be considered when initiating therapy with VIREAD for the treatment of HIV-1 infection: - VIREAD should not be used in combination with ATRIPLA® , COMPLERA® , STRIBILD® , or TRUVADA® [See Warnings and Precautions (5.4)] . VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection: - The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Studies (14.2)]. - VIREAD was evalua
VIREAD tablets, 300 mg, are almond-shaped, light blue, film-coated tablets containing 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, are debossed with "GILEAD" and "4331" on one side and with "300" on the other side. Each bottle contains 30 tablets, a desiccant (silica gel canister or sachet), and closed with a child-resistant closure. (NDC 61958-0401-1) NDC 69189-0401-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Oral Powder VIREAD oral powder consists of white, coated granules containing 40 mg of tenofovir disoproxil fumarate, which is equivalent to 33 mg of tenofovir disoproxil, per gram of powder and is available in multi-use bottles containing 60 grams of oral powder, closed with a child-resistant closure, and co-packaged with a dosing scoop. (NDC 61958-0403-1) Store VIREAD tablets and oral powder at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature). Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.
New Drug Application
VIREAD- TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VIREAD SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIREAD. VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLETS, FOR ORAL USE VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER, FOR ORAL USE INITIAL U.S. APPROVAL: 2001 WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS AND POST TREATMENT EXACERBATION OF HEPATITIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGS, INCLUDING VIREAD. (5.1) SEVERE ACUTE EXACERBATIONS OF HEPATITIS HAVE BEEN REPORTED IN HBV-INFECTED PATIENTS WHO HAVE DISCONTINUED ANTI-HEPATITIS B THERAPY, INCLUDING VIREAD. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY IN THESE PATIENTS. IF APPROPRIATE, RESUMPTION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED. (5.2) INDICATIONS AND USAGE VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1) VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. (1) DOSAGE AND ADMINISTRATION Recommended dose for the treatment of HIV-1 or chronic hepatitis B in adults and pediatric patients 12 years of age and older (35 kg or more): 300 mg once daily taken orally without regard to food. (2.1) Recommended dose for the treatment of HIV-1 in pediatric patients (2 to less than 12 years of age): Tablets: for pediatric patients weighing greater than or equal to 17 kg who can swallow an intact tablet, one VIREAD tablet (150, 200, 250 or 300 mg based on body weight) once daily taken orally without regard to food. (2.2) Oral powder: 8 mg/kg VIREAD or Perskaitykite visą dokumentą