Entecavir Manufacturers Directly Supply High Content Raw Powder With 99% Quality Assurance
The main ingredient of this product is Entecavir
Chemical name: 2 - amino - 9 - [(1 s, 3 r, 4 s) - 4 - hydroxy - 3 - hydroxy methyl - 2 - methylene cyclopentyl] 1, 9 - dihydro - 6 h - purines - - ketone - hydrates.
Molecular formula: C12H15N5O3·H2O
Molecular weight: 295.3
Broadcasting of indications
This product is indicated for the treatment of chronic hepatitis B in adults with active viral replication, persistent elevated serum alanine aminotransferase (ALT) or active liver histology.
It is also suitable for treatment from age 2 to < Evidence of active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis was present in an 18-year-old pediatric patient initially treated with nucleoside for chronic HBV infection with compensatory liver disease. For the specific use method, see [Usage and Dosage]
Specifications to broadcast
1) 0.5 mg 
2) 1 mg 
Broadcasting of usage and dosage
Patients should take this product under the guidance of an experienced physician. Tablets and oral solutions are bioequivalent in healthy subjects, so the two dosage forms can be used interchangeably. For more information about the oral solution, see the Oral Solution manual. This product should be taken on an empty stomach (at least 2 hours before or after a meal).
Adults: Take 0.5mg orally once a day. Patients with viremia or lamivudine-resistant mutations on lamivudine therapy were given 1mg once a day (two 0.5mg tablets).
Children: Already suitable for age 2 to < Entecavir oral solution and entecavir tablets in an 18-year-old child patient. Treatment decisions for pediatric patients should carefully consider the needs of the individual patient and refer to current pediatric treatment guidelines. In children with HBeAg-positive chronic hepatitis B compensatory liver disease, serum ALT should be elevated for at least 6 months before treatment. HBeAg negative children were at least 12 months old. The daily dose for patients weighing 32.6kg or more should be 0.5mg tablet or 10ml(0.5mg) oral solution, with or without food. Patients weighing less than 32.6kg should be given an oral solution.
No dose adjustment is required for patients with liver insufficiency.
Time of treatment
The optimal duration of treatment and its relationship with long-term treatment outcomes, such as cirrhosis and liver cancer, are not yet known.
Adverse reaction broadcast
The evaluation of adverse reactions was based on four global clinical trials: AI463014, AI463022, AI463026, AI463027 and three clinical trials conducted in China (AI463012, AI463023, AI463056). A total of 2596 patients with chronic hepatitis B were enrolled in the seven studies. Adverse reactions and laboratory abnormalities of Entecavir were similar to those of Lamivudine in a control study.
In foreign studies, the most common adverse reactions of this product are: headache, fatigue, dizziness, nausea. Common adverse reactions in patients treated with lamivudine were headache, fatigue and vertigo. In each of the four studies, 1% of entecavir patients and 4% of lamivudine patients dropped out of the study due to adverse reactions and abnormal laboratory markers.
Taboo to broadcast
Patients allergic to entecavir or any component of the preparation should not be allowed.
Patients should take entecavir under the direction of their physician and inform their physician of any new symptoms and drug combinations. Patients should be informed that they may sometimes experience liver exacerbation if they stop taking the medication, so they should change their treatment under the guidance of their doctor.
Treatment with entecavir does not reduce the risk of HBV transmission through sexual contact or contaminated blood sources. Therefore, appropriate protective measures need to be taken.
Pregnant women and lactating women medication report
The effects of Entecavir on pregnant women are not well studied. This product should only be used when the potential risks and benefits to the fetus have been adequately weighed.
There is no evidence that this product can affect mother-to-child transmission of HBV. Therefore, appropriate interventions should be taken to prevent neonatal infection of HBV.
Entecavir can be secreted from rat milk. However, it is still unclear whether there is secretion in human milk, so it is not recommended to take this product for mothers to breastfeed.
Children's Medication Bulletin
2 - to & lt; For the clinical data of children aged 18, please refer to the section of Children in foreign clinical Trials under [Clinical Studies].
Report on medication for the elderly
Since there are not enough elderly patients aged 65 and older to participate in clinical studies of this product, it is unclear how older patients respond differently to this product than younger patients. Other clinical trials have reported no difference between older and younger patients. Entecavir is excreted primarily by the kidneys and may be at higher risk of toxic reactions in patients with renal impairment. Since most elderly patients have decreased renal function, attention should be paid to the choice of drug dosage and monitoring of renal function.
Report on drug interactions
The metabolism of Entecavir was evaluated in vivo and in vitro. Entecavir is not a substrate, inhibitor, or inducer of the cytochrome P450 (CYP450) enzyme system. Entecavir does not inhibit any of the major human CYP450 enzymes: 1A2, 2C9, 2C19, 2D6, 3A4, 2B6, and 2E1 at concentrations up to about 10,000 times human concentrations. Entecavir does not induce human CYP450 enzymes: 1A2, 2C9, 2C19, 3A4, 3A5, and 2B6 at concentrations of about 340 times human concentrations. Concurrent administration of drugs metabolized by inhibiting or inducing the CYP450 system had no effect on the pharmacokinetics of entecavir. Moreover, simultaneous administration of entecavir had no effect on the pharmacokinetics of known CYP substrates.
The steady-state pharmacokinetics of entecavir and its interaction with lamivudine, adefovir and tenofovir were not changed.
Since entecavir is primarily cleared by the kidney, taking a drug that reduces renal function or competes with secretion by active glomeruli may increase the blood concentration of both drugs. Simultaneous administration of entecavir with lamivudine, adefovir and tenofovir did not cause significant drug interactions. The interaction of simultaneous administration of entecavir with other drugs that clear through the kidneys or are known to affect kidney function has not been studied. Patients should be closely monitored for adverse reactions while taking entecavir with these drugs.