Hydinin 10 10 mg Tablets

HYDININ is indicated for the treatment of hypertension.

Posology
The usual oral dose is 100 mg to 200 mg per day, starting with 10 mg or 20 mg two to four times daily. This is increased gradually until the desired effect is obtained or unacceptable side effects develop. The dose should not exceed 300 mg per day.
Special populations
Reduced doses of hydralazine should be given to patients who are slow acetylators. Hypotension may occur during anaesthesia in patients being treated with hydralazine.
Paediatric population
No data are available.
Method of administration
HYDININ is for oral use.

HYDININ is contraindicated in:
u2022 Hypersensitivity to hydralazine or to any of the excipients of HYDININ (see section 6.1).
u2022 Patients with tachycardia.
u2022 Used with caution in patients with a history of coronary disease.

Chronic administration of hydralazine, particularly in doses of 400 mg or more per day, can produce an acute rheumatoid state. A syndrome indistinguishable from disseminated lupus erythematosus, including glomerulonephritis, may develop. The symptoms regress after hydralazine is discontinued but relatively long-term treatment with adrenocorticosteroids (steroids) may be required.
Reduced doses of hydralazine should be given to patients who are slow acetylators and women.
Myocardial stimulation produced by hydralazine can cause anginal attacks and ECG changes of myocardial ischemia. Hydralazine must be used with caution in patients with suspected coronary artery disease.
The u201chyperdynamicu201d circulation caused by hydralazine may accentuate specific cardiovascular inadequacies. For example, hydralazine may increase pulmonary artery pressure in patients with mitral valvular disease.
Postural hypotension may result from hydralazine but is less common than with ganglionic blocking medicines. It should be used with caution in patients with cerebral vascular accidents.
In hypertensive patients with normal kidneys who are treated with hydralazine, there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. Hydralazine should be used with caution in patients with advanced renal damage.
Hypotension may occur during anaesthesia in patients being treated with hydralazine.
Adrenaline should not be given to antagonise the hypotensive effects of hydralazine since it enhances the cardiac-accelerating effects.
Caution should be observed if hydralazine is administered concurrently with monoamine oxidase inhibitors or tricyclic antidepressants (see section 4.5).

The following medicine enhance the hypotensive effects of hydralazine:
u2022 Other antihypertensives (diuretics, ACE inhibitors, calcium channel blockers, vasodilators)
u2022 Anaesthetics
u2022 Tricyclic antidepressants
u2022 Major tranquillisers
u2022 Nitrates or drugs exerting central depressant actions (including alcohol)
MAO inhibitors and tricyclic antidepressants should be used with caution in patients receiving hydralazine.
When other potent parenteral antihypertensive medicines, such as diazoxide, are used in combination with hydralazine, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydralazine are used concomitantly.

The safety of hydralazine for use during pregnancy and lactation have not been established.

HYDININ has no or negligible influence on the ability to drive and use machines. However, undesirable effects may occur (e.g. allergic reaction, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8).

a. Summary of the safety profile
Adverse reactions with hydralazine are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue use. Common side effects are headache, anorexia, nausea, vomiting, diarrhoea, palpitations, tachycardia, angina pectoris.
b. Tabulated summary of adverse reactions

System Organ Class Frequency Undesirable effect
Blood and the lymphatic system disorders Less frequent Blood dyscrasias, consisting of reduction in haemoglobin and red cell count, leukopenia, agranulocytosis, purpura, lymphadenopathy; splenomegaly, eosinophilia
Metabolism and nutrition disorders Frequent Anorexia
Nervous system disorders Frequent Sweating, severe headache Less frequent Peripheral neuritis, evidenced by paraesthesia, numbness, and tingling, tremors; muscle cramps; chills, fever, flushing, psychotic reactions characterized by depression, disorientation, or anxiety
Eye disorders Less frequent Conjunctivitis, lacrimation
Ear and labyrinth disorders Less frequent Vertigo, dizziness
Cardiac disorders Frequent Tachycardia, palpitations, angina Less frequent Hypotension, paradoxical pressor response, oedema
Respiratory, thoracic and mediastinal disorders Frequent Nasal congestion Less frequent Dyspnoea and pleural pain
Gastrointestinal disorders Frequent Nausea, vomiting, diarrhoea Less frequent Constipation, paralytic ileus
Hepato-biliary disorders Frequency unknown Hepatitis
Skin and subcutaneous tissue disorders Less frequent Rash, urticaria, pruritus
Renal and urinary disorders Less frequent Proteinuria, haematuria sometimes associated with glomerulonephritis Frequency unknown Acute renal failure, urinary retention

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Symptoms: Tachycardia, palpitations, severe headache. anorexia, nausea, vomiting, postural hypotension, lacrimation, nasal congestion and peripheral neuritis.
Treatment for tachycardia and relative hypovolaemia may be indicated.