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HYDRALAZINE is a brand name for Hydralazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indicated in adults for: - Moderate to severe hypertension as an adjunct to other antihypertensive agents. - Moderate to severe chronic congestive heart failure as supplementary medication for use in combination along with long-acting nitrates in patients whose optimal doses of diuretics and cardiac glycosides have…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage should be adjusted to the individual requirements of the patient. Treatment should commence with low doses which, depending on the patient’s response, should be increased stepwise to achieve optimal therapeutic effect, whilst minimising unwanted effects.
Due to the complementary mechanism of action, the combination of hydralazine with beta-blockers and diuretics may enable antihypertensive efficacy at lower dose levels and counteract accompanying hydralazine effects such as reflex tachycardia and oedema.
Adults Hypertension: the initial dose is 25 mg twice daily. This may be increased gradually to a maximum dose of 200 mg daily. The patient’s acetylator status must be checked prior to increasing the daily dose beyond 100 mg. 4).
Chronic congestive heart failure:
Doses vary greatly between individual patients and are generally higher than those used to treat hypertension. Treatment should be initiated in hospital where the patient’s individual haemodynamic values can be determined with the help of invasive monitoring.
Treatment should continue in hospital until the patient has been established on the required maintenance dose. After progressive titration (initially 25 mg three or four times daily, increasing every second day) maintenance dosage averages 50-75 mg four times daily.
Paediatric population Hydralazine is not recommended. Elderly There is no special dosage requirement. Systemic clearance and blood concentration of hydralazine are not affected by advanced age, though renal elimination may be affected due to diminished kidney function with age.
The elderly may also be more sensitive to the hypotensive effects of hydralazine. 4). Method of administration For oral administration only. Swallow the tablets with a glass of water.
Some side effects of hydralazine such as palpitations, tachycardia, angina symptoms, flushing, headaches, dizziness, gastrointestinal disturbances and nasal congestion are commonly seen at the start of therapy especially if the dose is raised quickly but generally subside as treatment continues.
Adverse reactions are categorised by frequencies as follows: very common (≥1/10), common (≥1/100 to <1/10), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). 4) Renal and urinary disorders: Rare: proteinuria, haematuria sometimes associated with glomerulonephritis Very rare: acute renal failure and urinary retention General disorders and administration site conditions: Rare: fever, weight loss, malaise, oedema Investigations: Rare: increased plasma creatinine 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 “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 stabilisation phase has been achieved.
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. 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.
g. in thyrotoxicosis) - Myocardial insufficiency due to mechanical obstruction (eg. in the presence of mitral or aortic stenosis or constrictive pericarditis) - Cor pulmonale - Dissecting aortic aneurysm - Porphyria
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
In high (cyto-) toxic concentrations, hydralazine induces gene mutations in single cell organisms and in mammalian cells in vitro. No unequivocally mutagenic effects have been detected in vivo in a great number of test systems. Hydralazine in lifetime carcinogenicity studies, caused, towards the end of the experiments, small but statistically significant increases in lung tumours in mice and in hepatic and testicular tumours in rats.
These tumours also occur spontaneously with fairly high frequency in aged rodents. With due consideration of these animals and in-vitro toxicological findings, hydralazine in therapeutic doses does not appear to bear risk that would necessitate a limitation of its administration.
Many years of clinical experience have not suggested that human cancer is associated with hydralazine use. 5 mg/ 100 ml) in order to avoid accumulation of the drug. Hydralazine should be used with caution in patients with coronary artery disease (since it may increase angina) or cerebrovascular disease.
Patients on Hydralazine who undergo surgery, may show a fall in blood pressure. Adrenaline should not be used to correct the hypotension since it enhances the cardiac-accelerating effects of hydralazine. Treatment with hydralazine may induce systemic vasculitis.
There have also been a small number of reported cases of suspected antineutrophil cytoplasmic antibody ANCA(+) vasculitis in some patients also receiving hydralazine, 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 and require early diagnosis, discontinuation of the medicine and prompt hospital treatment. The syndrome is characterised by a fulminant course if left untreated, and may sometimes be fatal.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.