📋 Indications & Clinical Dosage
*Prophylaxis against hepatitis B infection for individuals exposed to the Hepatitis B virus:*
BY IM INJ: Adult: 500 units, dose to be administered as soon as possible after exposure; ideally within 12-48 hours, but no later than 7 days after exposure.
*Prevention of hepatitis B re-infection more than 6 months after liver transplantation in stable HBV-DNA negative patients:*
BY SC INJ: Adult (body-weight up to 75 kg): 500 units once weekly, increased if necessary up to 1000 units once weekly;(body-weight 75 kg and above): 1000 units once weekly, dose to be started 2-3 weeks after last dose of intravenous hepatitis B immunoglobulin.
*Prevention of hepatitis B in haemodialysed patients, Prophylaxis against re-infection of transplanted liver:*
BY IV INF: Adult: (consult product literature).
*Perinatal exposure of infants born to HbS Ag - positive mothers:*
Neonate: 0.5 ml to infants within 12 hr after birth.
⚠️ Precautions & Warnings
Selective IgA deficiencies, anti-IgA antibodies, interference with live virus vaccines, risk factors for thrombotic events or acute renal failure. Monitor for adverse reactions and anaphylactoid reactions during infusion.
🔄 Drug Interactions
Hydantoins; e.g. Phenytoin, Virus vaccines, Live/measles, mumps, rubella vaccines, inactivated vaccines e.g. DPI, Hib, OPV, rabies vaccine, immunosuppressants.
⚠️ Adverse Reactions / Side Effects
Injection site reactions, abdominal pain, anaphylaxis, arthralgia, buccal ulceration, chest pain, dizziness, dyspnea, glossitis, headache, tremor
Side-effects with IV use: abdominal distension, blood pressure fluctuations, deep vein thrombosis, haemolytic anaemia, injection site reactions, myocardial infarction, pulmonary embolism, stroke, thromboembolic events
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.