Description

Centaurus 0.5 mg Tablets contain entecavir, an antiviral medicine used to suppress hepatitis B virus replication. It is a prescription medicine intended for use under specialist medical supervision.

• Manufacturer Name: Ferozsons
• Drug Class: Nucleoside analogue antiviral
• Dosage Form: Immediate-Release Tablet
• Storage: Store at controlled room temperature, generally 20°C to 25°C. Protect from moisture and keep out of reach of children.
• Pack Size: Pack of 30 Tablets

Ingredients

• Entecavir 0.5 mg

Benefits

• Treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication.
• May help reduce hepatitis B viral load and improve liver inflammation and liver-function markers.
• Use is determined by the prescriber based on viral load, liver status, resistance history, and kidney function.

Usage & Safety

For Adult

• Usual adult dose for previously untreated chronic hepatitis B with compensated liver disease: 0.5 mg orally once daily.
• For lamivudine-resistant infection or decompensated liver disease, the usual prescribed dose may be 1 mg once daily; specialist supervision is required.
• Take on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal.
• Dosage reduction is required in patients with reduced kidney function; follow the prescriber's instructions.
• Do not stop treatment without medical advice because hepatitis B may worsen after discontinuation.

For Children

• May be used in children and adolescents at least 2 years old and weighing at least 10 kg when prescribed by a specialist.
• Pediatric dosing is weight-based and may range from 0.15 mg to 0.5 mg once daily for treatment-naive patients; the maximum dose is generally 0.5 mg daily.
• Children with lamivudine-resistant infection may require specialist-adjusted dosing up to 1 mg daily.
• Safety and effectiveness have not been established for children younger than 2 years or weighing less than 10 kg.

Side Effects

• Common effects may include headache, tiredness, dizziness, nausea, abdominal discomfort, and indigestion.
• Abnormal liver-function tests or increased liver enzymes may occur.
• Seek urgent medical help for severe weakness, persistent vomiting, abdominal pain, rapid breathing, breathing difficulty, unusual muscle pain, yellowing of the skin or eyes, or marked swelling of the abdomen.
• Serious but uncommon reactions include lactic acidosis, hepatomegaly with steatosis, severe hepatitis flare, and allergic reactions.

Contraindications

• Do not use in patients with a known allergy to entecavir or any tablet ingredient.
• Use cautiously in patients with kidney impairment, liver decompensation, or a history of treatment with nucleoside or nucleotide antivirals.
• Patients should be tested for HIV before treatment when clinically appropriate; entecavir should not be used as the sole treatment for HIV infection.
• Monitor for lactic acidosis and severe liver enlargement with fatty liver, particularly in patients with liver disease or other risk factors.
• Stopping treatment can cause a serious flare or worsening of hepatitis B and requires medical monitoring.

Precautions & Warnings

• Medicines that reduce kidney function or compete for renal tubular secretion may increase entecavir or co-administered medicine levels.
• Tell the prescriber about nephrotoxic medicines, including certain antivirals, antibiotics, chemotherapy medicines, and other drugs that may affect kidney function.
• Use with lamivudine, emtricitabine, or other medicines active against hepatitis B or HIV requires specialist review to avoid ineffective or duplicate therapy.
• Food reduces absorption when taken with a meal; take the tablet on an empty stomach as directed.
• Entecavir has limited metabolism through liver enzyme pathways, but all prescription, non-prescription, and herbal medicines should still be disclosed.

Pregnancy

• Human pregnancy data are limited; use during pregnancy only when specifically recommended by a physician after considering benefits and risks.
• Patients who are pregnant or planning pregnancy should discuss hepatitis B treatment options with a specialist; an alternative antiviral may be preferred in some situations.
• Entecavir has not been adequately studied in breastfeeding mothers, and an alternative may be preferred, especially when nursing a newborn or premature infant.
• Breastfeeding decisions should consider the mother's need for treatment and prevention of hepatitis B transmission; the infant should receive hepatitis B vaccine and immune globulin at birth when indicated.