Apreszine 25/Apreszine 50 Warnings

Apreszine 50: The "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 be given Hydralazine only under cover of a beta-blocker or in combination with other suitable sympatholytic agents. Beta-blocker medication should be started a few days prior to commencing treatment with Hydralazine.
Patients who have survived a myocardial infarction should not receive Hydralazine until a post-infarction stabilization phase has been achieved.
Prolonged treatment with Hydralazine (i.e. usually for more than 6 months) may provoke a systemic lupus erythematosus (SLE) like syndrome, especially with doses exceeding 100 mg daily. Initial symptoms are likely to be similar to rheumatoid arthritis (arthralgia, sometimes associated with rash, anaemia, leucopenia, thrombocytopenia and fever) and are reversible upon 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. Early detection and a timely diagnosis with appropriate therapy (i.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 with higher doses and longer duration of treatment and since they are also more common in slow acetylators, the lowest effective dose should be used for maintenance therapy. If 100 mg daily fails to elicit an adequate response, the patient's acetylator status should be evaluated. Slow acetylators and women are at greater risk of developing the SLE-like syndrome and every effort should therefore be made to keep the dosage below 100 mg daily. The patient should be watched for signs and symptoms of the syndrome and if such symptoms develop, the drug should be gradually withdrawn. Rapid acetylators often respond inadequately even to doses of 100 mg daily and therefore the dose may be raised with only a slightly increased risk of an SLE-like syndrome.
During long-term treatment with Hydralazine, it is advisable to determine the antinuclear factors and conduct urine analysis at intervals of approximately 6 months. Microhaematuria and/or proteinuria, in particular along with positive ANF titres, may be initial signs of immune-complex glomerulonephritis associated with the SLE-like syndrome. If overt clinical signs or symptoms develop, hydralazine should be withdrawn immediately.
Skin rash, febrile reactions and change in blood count occur rarely and the drug should be withdrawn. Peripheral neuritis in the form of paraesthesia has been reported and may respond to pyridoxine administration or withdrawal of the drug.