HYDRALAZINE

See “Precautions” before use.

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 25 mg bid. This can be increased gradually to a dose not exceeding 200 mg daily. The dose should not be increased beyond 100 mg daily without first checking the patient’s acetylator status.

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 25 mg tid or qid increasing every second day) the maintenance dosage averages 50-75 mg qid.

Paediatric population:

Not recommended 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.

Method of administration For Oral use only The dose of hydralazine should be reduced or the dosage interval prolonged in patients with hepatic or renal impairment.

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.

001%). System Organ Class Frequency Adverse effects Rare Anaemia, leucopenia, neutropenia, thrombocytopenia with or without purpura. eosinophilia Blood and lymphatic system disorders Isolated cases Haemolytic anaemia, leucocytosis, lymphadenopathy, pancytopenia, splenomegaly, agranulocytosis Metabolism and nutrition disorders Rare Decreased appetite Rare Agitation, anxietyPsychiatric disorders Isolated cases Depression, hallucinations Very common Headache Rare Dizziness Nervous system disorders Isolated cases Peripheral neuritis, polyneuritis, paraesthesia (these unwanted effects may be reversed by administering pyridoxine).

Eye disorders Rare Conjunctivitis, lacrimation increased Very common Tachycardia, palpitations Common Anginal symptoms Cardiac disorders Rare Oedema, heart failure Common Flushing, hypotensionVascular disorder Isolated cases Paradoxical pressor responses Respiratory, thoracic and mediastinal disorders Rare Nasal congestion, Dyspnoea, pleuritic pain Common Gastrointestinal disturbances, diarrhoea, nausea, vomiting Gastrointestinal disorders Isolated cases Paralytic ileus.

Hepatobiliary disorders Rare Jaundice, hepatomegaly, abnormal liver function sometimes in association with hepatitis. 4 Special warnings and precautions for use) Skin and subcutaneous tissue disorders Rare Hypersensitivity reactions such as pruritus, urticaria, vasculitis, rash Musculoskeletal and connective tissue disorders Common Arthralgia, joint swelling, myalgia Rare Proteinuria, Blood creatinine increased, haematuria sometimes in association with glomerulonephritis.

Renal and urinary disorders Isolated cases Acute kidney failure, urinary retention. General disorders and administration site conditions Isolated cases Exophthalmos Investigations Rare Weight decrease Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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 Tablets only under cover of beta- blocker 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 Tablets. Patients who have survived a myocardial infarction should not receive Hydralazine Tablets until a post-infarction stabilisation state has been achieved.

e. usually for more than 6 months) may provoke a systemic lupus erythematosus (SLE)-like syndrome, especially where doses exceed 100 mg daily. First symptoms are likely to be similar to rheumatoid arthritis (arthralgia, sometimes associated with fever, anaemia, leukopenia, 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 also 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). Isolated right ventricular failure due to pulmonary hypertension.

Porphyria.