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Enviral
Opsonin Pharma Limited
Generic: Entecavir
Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Enviral. Please consult your doctor.
CONSULT YOUR DOCTOR
Enviral may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Enviral is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
UNSAFE
Enviral may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
CAUTION
Enviral should be used with caution in patients with kidney disease. Dose adjustment of Enviral may be needed. Please consult your doctor.
SAFE IF PRESCRIBED
Enviral is safe to use in patients with liver disease. No dose adjustment of Enviral is recommended.
Medicine Overview of Enviral 0.25mg/5ml Oral Solution
Introduction
Enviral is used in the treatment of HIV infection and chronic hepatitis B virus (HBV) infection. It prevents the multiplication of virus in human cells. This stops the virus from producing new viruses and clears up your infection. Enviral is not a cure for HIV or AIDS and only helps to decrease the amount of HIV in your body. This helps to lower your risk of getting HIV-related complications and improves your lifespan. It is prescribed in combination with other HIV medicines. Your doctor will recommend the best medicines for you and will decide the doses that you need. Follow...
... Show moreUses of Enviral
- Chronic hepatitis B virus (HBV) infection
Side effects of Enviral
Common
- Headache
- Dizziness
- Tiredness
- Nausea
How to use Enviral
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Enviral is to be taken empty stomach.
How Enviral works
Enviral is an antiviral medication. It prevents the multiplication of virus in human cells. This stops the virus from producing new viruses and clears up your infection.
What if you forget to take Enviral?
If you miss a dose of Enviral, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
- You have been prescribed Enviral for the treatment of chronic hepatitis B virus (HBV) infection.
- Take it on an empty stomach, at least 2 hours after or before a meal.
- Enviral may cause dizziness or sleepiness. Do not drive or do anything requiring concentration until you know how it affects you.
- You may still develop infections or other illnesses associated with viral infection while taking this medication.
- During treatment and for at least six months after stopping this medicine, regular blood tests are needed to monitor your liver function, level of hepatitis B virus and blood cells in your blood.
Brief Description
Indication
Chronic hepatitis B
Administration
Should be taken on an empty stomach. Take at least 2 hr after a meal & 2 hr before the next meal. Use oral solution when needed for renal impairment dosage adjustments.
Adult Dose
Chronic Hepatitis B
Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease
Nucleoside inhibitor treatment-naïve with compensated liver disease (adults and adolescents ?16 yr): 0.5 mg PO qDay
Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (adults and adolescents ?16 yr): 1 mg PO qDay
Decompensated liver disease (adults): 1 mg PO qDay
Child Dose
Chronic Hepatitis B
Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease in children ?2 years and weigh at least 10 kg
16 years: As adult
Renal Dose
Renal Impairment
Usual daily dose (0.5 mg)
CrCl ?50 mL/min: No dosage adjustment required
CrCl 30-49 mL/min: Reduce to 0.25 mg/day or 0.5 mg q48hr
CrCl 10-29 mL/min: Reduce to 0.15 mg/day or 0.5 mg q72hr
CrCl <10 mL/min, hemodialysis, or CAPD: 0.05 mg/day or 0.5 mg q7days
Lamivudine-refractory/decompensated liver disease daily dose (1 mg)
CrCl ?50 mL/min: No dosage adjustment required
CrCl 30-49 mL/min: Reduce to 0.5 mg/day or 1 mg q48hr
CrCl 10-29 mL/min: Reduce to 0.3 mg/day or 1 mg q72hr
CrCl <10 mL/min, hemodialysis, or CAPD: 0.1 mg/day or 1 mg q7days
Contraindication
Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.
Mode of Action
Selective HBV DNA polymerase inhibitor; inhibition blocks reverse transcriptase activity, which in turn reduces viral DNA synthesis
Precaution
Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.
Lactation: excretion in milk unknown/not recommended
Side Effect
1-10%
Fatigue (1-3%),Headache (2-4%),Dizziness,Nausea
<1%
Diarrhea,Dyspepsia,Vomiting,Somnolence,Insomnia
Pregnancy Category Note
Pregnancy Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes; use during pregnancy has been evaluated in a limited number of individuals reported to APR and number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population; rate of miscarriage is not reported in APR; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes Lactation Not known whether drug is present in human breast milk, affects human milk production, or has effects on the...
... Show moreInteraction
Drugs that reduce renal function or compete for active tubular secretion may increase serum conc of either entecavir or co-administered drug.
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