ALPHAPRESS

What it is

ALPHAPRESS is a film coated tablet containing hydralazine hydrochloride, available in strengths of 25 mg or 50 mg.

Approved indications

— Hypertension (drug resistant, moderate to severe) as supplementary medication for use together with other antihypertensives such as beta-blockers and diuretics.

Dosing overview

Treatment should begin with low doses, which should be increased stepwise according to patient response. The usual starting dosage is 25 mg twice daily. This dosage can be increased as required within the effective maintenance dosage range of 50 to 200 mg daily. However, the dose should not be increased above 100 mg daily without determining the acetylator phenotype. Safety and efficacy of hydralazine have not been established in children.

Key safety warnings

Myocardial stimulation may provoke or aggravate angina pectoris or provoke myocardial infarction. Hydralazine can cause anginal attacks and ECG changes indicative of myocardial ischaemia. It must be used with caution in patients with suspected coronary artery disease, and patients with suspected or confirmed coronary artery disease should only receive ALPHAPRESS under cover of a beta-blocker or in combination with other suitable sympatholytic agents. Prolonged treatment with hydralazine (usually more than 6 months) may provoke a systemic lupus erythematosus (SLE)-like syndrome, especially where dosages exceeding 100 mg daily are prescribed. In its mild form this syndrome is reminiscent of rheumatoid arthritis and proves reversible after withdrawal of the drug. In its more severe form it resembles acute SLE. Slow acetylators and women run a greater risk of developing an SLE-like syndrome. In such patients every effort should be made not to exceed a dosage of 100 mg daily, and a careful watch should be kept for clinical signs and symptoms suggestive of an SLE-like syndrome. During long-term treatment it is advisable to determine the antinuclear factors (ANF) and carry out full blood count and urine analyses at intervals of approximately 6 months. Treatment with hydralazine may induce systemic vasculitis, including ANCA-positive vasculitis, leading to pulmonary renal syndrome which is a combination of diffuse alveolar haemorrhage and rapidly progressive glomerulonephritis. Patients may present with severe respiratory and/or renal failure requiring treatment in an intensive care unit. The syndrome is characterised by a fulminant course if left untreated and may sometimes be fatal. Adverse haematological effects such as a reduction in haemoglobin and red cell count, leucopenia, agranulocytosis and purpura have been reported. If such abnormalities develop, therapy should be discontinued.

Contraindications

ALPHAPRESS is contraindicated in patients with known hypersensitivity to hydralazine or dihydralazine; idiopathic systemic lupus erythematosus (SLE) and related diseases; severe tachycardia and heart failure with a high cardiac output (such as in thyrotoxicosis); myocardial insufficiency due to mechanical obstruction (such as in aortic or mitral stenosis or constrictive pericarditis); isolated right ventricular heart failure due to pulmonary hypertension (cor pulmonale); dissecting aortic aneurysm; and porphyria.

PBS listing

Information regarding PBS listing for ALPHAPRESS is not available in the provided source documents.

Regulatory history

ALPHAPRESS 25 was first listed on the ARTG on 20 September 1991, and ALPHAPRESS 50 was first listed on 4 July 1997. The current ARTG registrations are AUST R 17575 for ALPHAPRESS 25 and AUST R 60380 for ALPHAPRESS 50.