Entavec Entecavir Oral Solution
Product Name : Entavec Entecavir Oral Solution
Trade Name : Entavec
Available Strength : 0.05 mg/ ml
Packing : 210 ml
Pack Insert/Leaflet : yes
Therapeutic use : treatment of chronic hepatitis B virus infection in adults and pediatric patients
Production Capacity : 1 million bottle/month
Inquire about Entavec Entecavir Oral SolutionWhat is entecavir used to treat?
Entecavir Tablets USP are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease
Entecavir Dosage and Administration
Professionals FDA PI Entecavir Print Save Entecavir Package insert / prescribing information Dosage form: tablet, film coated Drug class: Nucleoside reverse transcriptase inhibitors (NRTIs) Medically reviewed by Drugs.com. Last updated on Nov 1, 2021. On This Page Boxed Warning Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions/Side Effects Drug Interactions Use In Specific Populations Overdosage Description Clinical Pharmacology Nonclinical Toxicology Clinical Studies How Supplied/Storage and Handling Patient Counseling Information WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions(5.1)]. Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if Entecavir tablets are used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with Entecavir tablets are not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions (5.2)]. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals [see Warnings and Precautions (5.3)]. Related/similar drugs tenofovir, lamivudine, Vemlidy, Viread, Epivir, Pegasys Indications and Usage for Entecavir Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir Dosage and Administration Timing of Administration Entecavir tabelts should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). Recommended Dosage in Adults Compensated Liver Disease The recommended dose of Entecavir tablets for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily. The recommended dose of Entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily. Decompensated Liver Disease The recommended dose of Entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.