Source: Health Products and Food Branch (CA) Revision Year: 2019
APRESOLINE (hydralazine hydrochloride Injection Mfr. Std) is indicated for the emergency treatment of severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure (e.g. toxemia of pregnancy or pre-eclampsia).
The dose of APRESOLINE (hydralazine hydrochloride USP) must always be individualized and adjusted according to the patient’s blood pressure response.
The injection solution should be used immediately after the vial is opened. It should not be added to infusion solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Patients should be hospitalized. The parenteral administration of APRESOLINE should always be carried out cautiously and under strict medical supervision.
Blood pressure and heart rate should be checked frequently (i.e., every 5 minutes). Blood pressure levels may begin to fall within a few minutes after injection, with an average maximal decrease occurring in 10 to 80 minutes. In cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. A satisfactory response can be defined as a decrease in diastolic blood pressure to 90 to 100 mmHg.
The initial dose is 5 to 10 mg, administered by slow intravenous injection in order to avoid precipitous decreases in mean arterial pressure with a critical reduction in cerebral or uteroplacental perfusion. Geriatric patients or patients with marked renal damage may require a lower dosage. In hypertensive crises other than preeclampsia/eclampsia, usual doses of 20-40 mg have been used, repeated as necessary. If it is necessary to repeat the injection, this should be done after an interval of 20 to 30 minutes, throughout which blood pressure and heart rate should be monitored.
Most patients can be transferred to an oral anti-hypertensive within 24 to 48 hours.
Symptoms include hypotension, tachycardia, accompanied by headache, generalized skin flushing, sweating, nausea and dizziness. Also possible are myocardial ischemia with angina pectoris, and cardiac arrhythmia. Further signs may include impairment of consciousness, headache and vomiting, as well as possible tremor, convulsions, oliguria, hypothermia, profound shock and coma.
Further signs may include impairment of consciousness, vomiting, tremor, convulsions, oliguria, and hypothermia.
There is no known specific antidote. Supportive measures including intravenous fluids are also indicated. If hypotension is present, an attempt should be made to raise the blood pressure without increasing the tachycardia. Adrenaline should not be used to correct the hypotension, since it enhances the cardiac-accelerating effects of hydralazine.
Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia. The ECG should be monitored while the vasopressors are being administered. Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required. The use of dopamine to elevate systolic blood pressure to 90 mmHg may be considered in an emergency.
No experience has been reported with extracorporeal or peritoneal dialysis.
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