سعر باراكلود 0.5 مجم 30 قرص 2022

Baraclude (entecavir 0.5 mg) film-coated tablets by Bristol-Myers Squibb, an oral nucleoside analogue HBV polymerase inhibitor for chronic hepatitis B; pack of 30 tablets (listed in Egypt at a net price).

• Chronic hepatitis B virus infection with active viral replication and persistently elevated aminotransferases or histologically active diseasePopulation: Adults and children 2 years and olderDailyMed (U.S. National Library of Medicine)
• Chronic hepatitis B virus infection in adults with compensated liver disease (active replication, elevated ALT, histological inflammation/fibrosis) or decompensated liver diseasePopulation: AdultsEuropean Medicines Agency (EPAR product information)
• Chronic hepatitis B in nucleoside-naive paediatric patients 2 to <18 years with compensated liver diseasePopulation: Children 2 to <18 yearsEuropean Medicines Agency (EPAR product information)

• Most common adverse reactions in adults (3% or more, all grades): headache, fatigue, dizziness and nausea; reactions in paediatric patients were consistent with adults.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Common: insomnia, headache, dizziness, somnolence, vomiting, diarrhoea, nausea, dyspepsia, increased transaminases, fatigue; uncommon: rash, alopecia; rare: anaphylactoid reaction; exacerbations of hepatitis during and after discontinuation.International label, same formulation · European Medicines Agency (EPAR product information)

• None (US label).International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Hypersensitivity to entecavir or to any of the excipients.International label, same formulation · European Medicines Agency (EPAR product information)

• Boxed warning: severe acute exacerbations of hepatitis B have been reported after discontinuation of anti-hepatitis B therapy, including entecavir; monitor hepatic function closely for at least several months after stopping.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Boxed warning: not recommended for HIV/HBV co-infected patients not receiving HAART because of potential HIV nucleoside reverse transcriptase inhibitor resistance; offer HIV antibody testing before starting.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Boxed warning: lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues; suspend treatment if clinical or laboratory findings suggest lactic acidosis or pronounced hepatotoxicity; patients with decompensated liver disease may be at higher risk.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Drugs that reduce renal function or compete for active tubular secretionEntecavir is mainly renally eliminated; co-administration may increase serum concentrations of either drug; monitor closely for adverse events.DailyMed (U.S. National Library of Medicine)
• Lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarateNo significant drug interactions observed on co-administration.DailyMed (U.S. National Library of Medicine)
• CYP450 substrates, inducers or inhibitorsEntecavir is not a substrate, inducer or inhibitor of CYP450 enzymes, so CYP450-mediated interactions are unlikely.European Medicines Agency (EPAR product information)

• Antiretroviral Pregnancy Registry data are insufficient to assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes; no adverse developmental effects in animal studies at clinically relevant exposures (embryofetal toxicity only at exposures hundreds to thousands of times human exposure).International label, same formulation · DailyMed (U.S. National Library of Medicine)
• No adequate data in pregnant women; animal studies showed reproductive toxicity at high doses; should not be used during pregnancy unless clearly necessary; women of childbearing potential should use effective contraception; appropriate interventions should be used to prevent neonatal HBV acquisition.International label, same formulation · European Medicines Agency (EPAR product information)
• Unknown whether entecavir is present in human milk; it is excreted in rat milk (about 25% of plasma AUC); weigh the benefits of breastfeeding against the mother's clinical need and potential adverse effects on the infant.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Entecavir: Guanosine nucleoside analogue that, after phosphorylation to the triphosphate, competes with deoxyguanosine triphosphate and inhibits HBV polymerase base priming, reverse transcription of the negative strand and synthesis of the positive strand of HBV DNA.