Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Hydralazine is indicated for:
See “Precautions” before use.
The dose should be adjusted to the individual requirements of the patient. Treatment should begin with low doses of hydralazine which, depending on the patient’s response, should be increased stepwise to achieve optimal therapeutic effect whilst keeping unwanted effects to a minimum. Initially 25mg twice daily. This can be increased gradually to a dose not exceeding 200mg daily.
The dose should not be increased beyond 100mg daily without first checking the patient’s acetylator status.
Treatment with hydralazine should always be initiated in hospital, where the patient’s individual haemodynamic values can be reliably determined with the help of invasive monitoring. It should then be continued in hospital until the patient has become stabilised on the requisite maintenance dose. Doses vary greatly between individual patients and are generally higher than those used for treating hypertension. After progressive titration (initially 25mg 3-4 times daily increasing every second day) the maintenance dosage averages 50-75mg four times daily.
Not recommended for this age group.
Clinical evidence indicates 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.
For oral administration.
Symptoms including hypotension, tachycardia, myocardial ischaemia, dysrrhythmias and coma.
Gastric lavage or, in the absence of coma, emetic treatment should be given as soon as possible. Supportive measures such as intravenous fluids and elevation of foot of bed are also indicated. If hypotension is present, an attempt should be made to raise blood pressure without increasing tachycardia, hence adrenaline (epinephrine) should be avoided. Cautious administration of angiotensin or noradrenaline (norepinephrine) intravenously may be of use.
3 years.
Polypropylene and polyethylene containers: Do not store above 25°C. Store in the original container.
Blister packs: Do not store above 25°C. Keep container in the outer carton.
The product containers are rigid injection moulded polypropylene containers and snap-on polyethylene lids.
The product may also be supplied in blister packs and cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: 250µm white rigid PVC. Surface printed 20µm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.
Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.
Polyethylene container with a polypropylene lid.
Pack size: 56s
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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