Entavir 1 mg Tablet

Entavir 1 mg tablet by Drug International Ltd. contains Entecavir, an antiviral medicine used in Bangladesh for the treatment of chronic hepatitis B virus infection when prescribed by a doctor.

Entecavir works by blocking hepatitis B virus DNA polymerase, reducing viral replication in the liver. A key caution is that stopping treatment can cause a serious flare of hepatitis B, so it should not be stopped without medical advice.

• Treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and liver disease.
• Treatment of chronic hepatitis B virus infection in suitable paediatric patients when prescribed by a specialist.
• May be used in patients with compensated or decompensated liver disease under specialist supervision.

Entecavir is usually taken once daily by mouth on an empty stomach, at least 2 hours after a meal and 2 hours before the next meal. The exact dose and duration depend on previous hepatitis B treatment, liver condition, age, weight, kidney function, and the prescribed dosage form. Patients with kidney impairment may need dose adjustment. Take it exactly as prescribed and do not stop treatment unless the doctor advises.

• Common side effects may include headache, tiredness, dizziness, nausea, indigestion, diarrhoea, and sleep disturbance.
• Blood tests may show changes in liver enzymes or kidney function.
• Serious but uncommon risks include severe worsening of hepatitis B after stopping treatment, lactic acidosis, enlarged fatty liver, and severe allergic reaction.
• Seek urgent medical help for severe weakness, trouble breathing, persistent vomiting, severe abdominal pain, yellowing of the eyes or skin, dark urine, or swelling of the face or throat.

Use Entecavir with care in people with kidney disease, decompensated liver disease, previous lamivudine-resistant hepatitis B, HIV infection, or a history of liver transplant. HIV testing may be needed before treatment because Entecavir should not be used alone to treat HIV infection. Regular monitoring of liver function, kidney function, and hepatitis B viral response is important. Use this medicine only under the guidance of a registered doctor or pharmacist.

• Food can reduce absorption; it is generally taken on an empty stomach as directed.
• Medicines that affect kidney function or are cleared by the kidneys may increase exposure to Entecavir; examples include aminoglycoside antibiotics, high-dose or prolonged NSAID use, cyclosporine, tacrolimus, and some antivirals.
• Using Entecavir alone in a person with unrecognised or untreated HIV infection may contribute to HIV drug resistance.
• Tell the doctor or pharmacist about all prescription medicines, over-the-counter medicines, herbal products, and supplements being used.

• Known hypersensitivity or serious allergic reaction to Entecavir or any component of the formulation.
• It should not be used as the only antiviral medicine in patients with HIV infection who are not receiving effective antiretroviral therapy.

During pregnancy, Entecavir should be used only when the expected benefit justifies the potential risk, and hepatitis B management should be planned with a specialist. Data in pregnancy are more limited than for some other hepatitis B antivirals. It is not known whether Entecavir passes into human breast milk; breastfeeding decisions should consider the mother’s need for treatment, the infant’s safety, and local medical advice.

Store tablets and oral solution at room temperature, away from excess heat, moisture, and direct sunlight. Keep the bottle tightly closed, use the oral solution measuring device if supplied, and keep all medicines out of the reach of children. Do not use after the expiry date.