HYDRALAZINE

Posology Older people (over 65 years) No studies in the elderly have been performed. The safety and efficacy of Hydralazine is not established in the elderly population. Elderly 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. Adults Hypertension 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 50mg once 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. 4).

Chronic congestive heart failure:

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 50mg twice daily increasing every second day) the maintenance dosage averages 50-75mg four times a day.

Paediatric population Not recommended for this age group. 4). Method of administration For oral administration.

g. tachycardia, palpitations, angina symptoms, flushing, headache, dizziness, nasal congestion and gastro-intestinal disturbances are commonly seen at the start of treatment, especially if the dose is raised quickly. However such effects generally subside in the further course of treatment.

System organ class Very common (≥1/10) Common (≥1/100 to <1/10) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Frequency not known (cannot be estimated from the available data). 4) hypersensitivity reactions such as pruritus, urticaria, rash Musculoskeletal and connective tissue disorders arthralgia, joint swelling, myalgia Renal and Urinary disorders proteinuria, blood creatinine increased, haematuria sometimes in association with glomerulonephritis acute renal failure, urinary retention, General disorders and administration site conditions pyrexia, malaise exophthalmos Investigations weight decrease Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Warnings The overall 'hyperdynamic' state of the circulation induced by hydralazine may accentuate certain clinical conditions. Myocardial stimulation may provoke or aggravate angina pectoris. Patients with suspected or confirmed coronary artery disease should therefore be given hydralazine only under beta-blocker cover or in combination with other suitable sympatholytic agents.

It is important that the beta- blocker medication should be commenced a few days before the start of treatment with hydralazine. Patients who have survived a myocardial infarction should not receive hydralazine until a post-infarction stabilisation phase has been achieved.

Prolonged treatment with hydralazine may provoke a systemic lupus erythematosus (SLE)-like syndrome. First symptoms are likely to be similar to rheumatoid arthritis (arthralgia, sometimes associated with fever, anaemia, leucopenia, thrombocytopenia and rash) and are reversible after withdrawal of the drug.

In its more severe form it resembles acute SLE (similar manifestations as the milder form plus pleurisy, pleural effusions and pericarditis), and in rare cases renal and ocular involvement have been reported. e. treatment discontinuation and possibly long-term treatment with corticosteroids may be required to reverse these changes) are of utmost importance in this life-threatening illness to prevent more severe complications, which may sometimes be fatal.

Since such reactions tend to occur more frequently the higher the dose and the longer its duration, and since they are more common in slow acetylators, it is recommended that for maintenance therapy the lowest effective dose should be used.

If 100 mg daily fails to elicit an adequate clinical effect, the patient's acetylator status should be evaluated. Slow acetylators and women run greater risk of developing the SLE-like syndrome and every effort should therefore be made to keep the dosage below 100 mg daily and a careful watch kept for signs and symptoms suggestive of this syndrome.

1. • Idiopathic systemic lupus erythematosus (SLE) and related diseases. g. in thyrotoxicosis). g. in the presence of aortic or mitral stenosis or constrictive pericarditis). e. cor pulmonale). • Dissecting aortic aneurysm. • Porphyria.