HYDRALAZINE Powder for concentrate for solution for injection/infusion Ref.[8220] Active ingredients: Hydralazine

Posology

Elderly

Clinical evidence would indicate that no special dosage regime is necessary. Advancing age does not affect either blood concentration or systemic clearance. Renal elimination may however be affected in so far as kidney function diminishes with age.

Adults

Initially 5 to 10 mg by slow intravenous injection, to avoid precipitous decreases in arterial pressure with a critical reduction in cerebral or utero-placental perfusion. If necessary a repeat injection can be given after an interval of 20-30 minutes, throughout which blood pressure and heart rate should be monitored. A satisfactory response can be defined as a decrease in diastyloic blood pressure to 90/100 mmHg. The contents of the vial should be reconstituted by dissolving in 1 ml of water for injection BP. This should then be further diluted with 10 ml of Sodium Chloride injection BP 0.9% and be administered by slow intravenous injection. The injection must be given immediately and any remainder discarded. Hydralazine may also be given by continuous intravenous infusion, beginning with a flow rate of 200-300µg/min. Maintenance flow rates must be determined individually and are usually within the range 50-150µg/min. The product reconstituted as for direct iv injection may be added via the infusion container to 500 ml of Sodium Chloride Injection BP 0.9% and given by continuous infusion. The addition should be made immediately before administration and the mixture should not be stored. Hydralazine for infusion can also be used with 5% sorbitol solution or isotonic inorganic infusion solutions such as Ringers solution.

Paediatric population

The safety and efficacy of Apresoline Ampoules 20 mg/ Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion in children have not yet been established.

Signs and Symptoms

Symptoms include hypotension, tachycardia, myocardial ischaemia dysrhythmias and coma.

Treatment

Supportive measures including intravenous fluids are also indicated. If hypotension is present, an attempt should be made to raise the blood pressure without increasing the tachycardia. Adrenaline should therefore be avoided.

Five years.

The ampoules should be protected from light and stored below 30°C. Single use only. Use immediately after reconstitution.

Medicines should be kept out of reach of children.

Colourless Type I glass 2ml ampoule. Five ampoules are packed in a cardboard printed carton.

None.