Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The name of your medicine is Hydralazine Injection.
The active ingredient is hydralazine hydrochloride in the form of a powder.
Hydralazine hydrochloride belongs to a group of medicines called antihypertensives.
Hydralazine Injection is used to treat adults with very high blood pressure, particularly when this condition occurs in pregnancy or in people with kidney disease.
It works by relaxing blood vessels which increases the supply of blood and oxygen to the heart.
You should not be given this medicine: • if you are allergic to hydralazine or any of the other ingredients in this medicine (listed in section 6) (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);
• if you are allergic to dihydralazine ;
• if you have or have ever had a condition called Systemic Lupus Erythematosus (SLE), an autoimmune condition which causes joint pain, skin rashes and fever;
• if you suffer from severe tachycardia or right sided heart failure due to increased pressure in the blood vessels of the lungs (cor pulmonale);
• if you suffer from thyrotoxicosis (an excess of thyroid hormones in the blood that can cause a fast heartbeat, sweating, trembling, anxiety, increased appetite, loss of weight and intolerance of heat);
• if you heart function impaired (myocardial insufficiency);
• if you have a condition known as porphyria.
• if you have a condition called dissecting aortic aneurysm.
Warnings and precautions: Talk to your doctor or pharmacist or nurse before using Hydralazine Injection
• if you have had a heart attack in the past three months;
• if you have coronary heart disease:
• if you have angina pectoris, which causes pain in the chest with exercise;
• if you have cerebrovascular disease (narrowing of the blood vessels in the brain);
• if you have been told you are a slow acetylator (this means that your body handles some medicines more slowly than other people);
• if you suffer from any serious liver or kidney problems;
• if you are experiencing fever, loss of appetite, weight loss, tiredness, general body pain, coughing which may produce tarry black deposits or blood, swelling of arms, hands, legs, feet and ankles, blood in urine while on treatment with Hydralazine. Talk to your doctor or nurse or pharmacist immediately.
• if you have blockage of one or more arteries that supply blood to the heart (coronary heart disease).
• if you have had blood tests before starting treatment
Children Hydralazine Injection is not recommended for use in children. In rare cases Hydralazine Injection may be used with extreme caution to treat children.
Other medicines and Hydralazine Injection Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important that you tell your doctor if you are taking:
• medicines for high blood pressure, such as vasodilators (e.g. minoxidil, diazoxide);
• ACE inhibitors (e.g. enalapril, lisinopril, captopril);
• beta-blockers (e.g. propranolol);
• calcium antagonists (e.g. nifedipine, diltiazem);
• medicines for water retention (e.g. diuretics);
• medicines for problems such as depression, including monoamine oxidase inhibitors (MAOls) (e.g. moclobemide, phenelzine, isocarboxazid, tranylcypromine); tricyclic antidepressants (e.g. amitriptyline, clomipramine) or tranquillisers (e.g. diazepam);
• medicines to control pain and inflammation (a group of medicines known as non-steroidal anti-inflammatory drugs (NSAlDs));
• corticosteroids (e.g. prednisolone or prednisone);
• medicines to control psychoses;
• a specific group of medicines known as nitrates, used to control blood pressure;
• oestrogens (a group of female sex hormones used in contraception and in treating the menopause).
If you are going to have a general anaesthetic you should tell the doctor or dentist in charge that you are taking Hydralazine Injection.
Hydralazine Injection with food , drink and alcohol It is advisable not to drink alcohol whilst taking Hydralazine Injection as it may affect you more than usual.
Taking Hydralazine Injection with food may decrease the amount of the medicine in your system, therefore, take it before food.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines You can drive while being treated with Hydralazine Injection but do not drive until you know how it affects you. It may make you feel dizzy or impair your reactions. If it affects you in this way, do not drive or operate any machinery.
This medicine will be given to you in hospital. Your doctor will decide when and how to treat you with this medicine. It can be given to you in one of 2 ways:
• usually it is injected slowly into your vein using a syringe, this is called an intravenous injection or;
• it may be diluted further and injected very slowly into your vein through a drip (intravenous infusion).
The recommended dose is 5 to 10 mg by intravenous injection, and will be repeated if necessary after 20 to 30 minutes.
Your blood pressure will be taken whilst you are receiving treatment and the dose adjusted to make sure that you have gradual fall in your blood pressure to normal levels.
Use in children
In the rare cases where rapid treatment proves indispensable in a child, Hydralazine injection should be used with extreme caution. The initial dose is 0.1-0.5 mg/kg body weight administered intravenously over 1-2 min with repeat doses every 30-90 min as required, up to a maximum daily dose of 3.5 mg/kg body weight
If you are given more Hydralazine Injection than you should Symptoms of overdose include a faster or irregular heartbeat, low blood pressure, feeling sick, dizziness, and sweating. Chest pain, headache, vomiting and losing consciousness are also possible symptoms. As this medicine is given to you in hospital it is very unlikely that an overdose will happen. Should an overdose occur, the doctor will treat any symptoms that follow.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking the medicine and seek immediate medical advice if you notice the following: • Fever, loss of appetite, weight loss, coughing which may produce dark tarry black deposits or blood, swelling of arms, hands, legs, feet and ankles, blood in urine
• SLE-type syndrome, which can cause symptoms such as joint pain, fever, change in blood count and skin rash.
• Allergic reactions including itching, skin rash, inflammation of the walls of small blood vessels and difficulty in breathing.
• Yellowing of the skin and whites of the eyes, which may indicate problems with the liver such as jaundice and hepatitis.
• Kidney failure (e.g. changes in urine, swelling of legs, ankles or feet, shortness of breath, tiredness and nausea).
Other side effects may include: Very common (may affect more than 1 in 10 people)
• Abnormal heartbeat (palpitations);
• An unusually fast heartbeat;
• Headaches.
Common (may affect up to 1 in 10 people)
• Chest pains;
• Swelling and/or pain in joints, muscle pain;
• Low blood pressure;
• Feeling sick and being sick, particularly at the beginning of the treatment or after an increase in dose;
• Diarrhoea;
• Flushing.
Rare (may affect up to 1 in 1,000 people)
• Heart failure, swelling;
• Increased levels of a substance called creatinine in the blood;
• Breathlessness, breathing difficulties or pain when breathing;
• Liver enlargement
• Skin rash;
• Blood in the urine which may be associated with a disease of the kidneys;
• Presence of protein in the urine;
• Inflammation or the abnormal functioning of the liver;
• Watering or sore itchy eyes (conjunctivitis);
• A reduction in the number of platelets in the blood which can cause unexplained bruising or rashes;
• A reduction in red blood cells, which can make you feel tired or breathless with physical exertion;
• A reduction in certain white blood cells which may make you more susceptible to infections;
• Fever;
• Anxiety;
• Restlessness;
• Blocked or stuffy nose;
• Loss of appetite;
• Weight loss;
• Dizziness;
• Generally feeling unwell.
Isolated cases
• A change in the amount of urine produced;
• A restriction of movement in part of the intestine;
• A deficiency of certain white blood cells which can result in fever and ulceration of the mouth and throat;
• An increased number of white blood cells;
• Enlargement of the spleen and liver;
• A reduction in the number of red and white blood cells and platelets in the blood;
• Depression;
• Seeing or hearing things which are not really there (hallucinations);
• Inflammation of the nerves which may cause weakness or numbness especially in your fingers and toes;
• Tingling (pins and needles) in your hands or feet;
• Disease of the lymph nodes;
• Enlarged eye balls;
• The inability to completely or partially empty the bladder;
• Opposite effect of medical treatment (episodes of high blood pressure); • An increase in other kinds of white blood cells.
Not known (frequency cannot be estimated from the available data)
• Involuntary shaking or movement (tremors)
• Inflammation of veins and arteries (Systemic vasculitis) which may lead to a rare medical syndrome involving bleeding in the lungs and kidney damage (Pulmonary renal syndrome).
If you feel very tired, experience unexpected bruising or bleeding, or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
The Vials will be stored in the hospital and they will follow the instructions below.
Store the Vials in the original package in order to protect from light. Store below 25°C.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month. The solution will be used as soon as it has been made up.
What Hydralazine Injection contains Each vial contains 20 mg of the active ingredient, hydralazine hydrochloride as a powder. They also contain hydrochloric acid , water for injection and nitrogen (as an inactive ingredient).
What Hydralazine Injection looks like and contents of the pack Hydralazine Injection is provided as a white to yellow powder in 3 ml clear glass Vials.
Each pack contains 5 Vials.
Marketing Authorisation Holder Amdipharm UK Limited
Dashwood House
69 Old Broad Street
London
EC2M 1QS
United Kingdom
Alternate Manufacturer FAMAR HEALTH CARE SERVICES
MADRID S.A.U.
Avda. de Leganés
62 - 28923
Alcorcón (Madrid)
España
This leaflet was last revised in June 2026.
ADVANZ Pharma
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Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion Vial comes as powder containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion Vial is hydralazine hydrochloride.
Medicines with the same active substance include: Apresoline Tablets 25 mg, Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion, Hydralazine 25 mg Film-coated Tablets, Hydralazine 25 mg Tablets, Hydralazine 25 mg tablets, Hydralazine 50 mg Film-coated Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion Vial, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
1. Apresoline is indicated in adults for the treatment of hypertensive emergencies, particularly those associated with pre-eclampsia and toxaemia of pregnancy.
2. Apresoline is indicated in adults for the treatment of hypertension with renal complications
Posology
Elderly:
Clinical evidence would indicate that no special dosage regime is necessary. Advancing age does not affect either blood concentration or systemic clearance. Renal elimination may however be affected in so far as kidney function diminishes with age.
Adults:
Initially 5 to 10 mg by slow intravenous injection, to avoid precipitous decreases in arterial pressure with a critical reduction in cerebral or utero-placental perfusion. If necessary a repeat injection can be given after an interval of 20-30 minutes, throughout which blood pressure and heart rate should be monitored. A satisfactory response can be defined as a decrease in diastolic blood pressure to 90/100 mmHg.
Method of Administration
The contents of the vial should be reconstituted by dissolving in 1 ml of water for injection BP. This should then be further diluted with 10 ml of Sodium Chloride injection BP 0.9% and be administered by slow intravenous injection. The injection must be given immediately and any remainder discarded. Hydralazine may also be given by continuous intravenous infusion, beginning with a flow rate of 200-300µg/min. Maintenance flow rates must be determined individually and are usually within the range 50-150µg/min. The product reconstituted as for direct iv injection may be added via the infusion container to 500 ml of Sodium Chloride Injection BP 0.9% and given by continuous infusion. The addition should be made immediately before administration and the mixture should not be stored. Hydralazine for infusion can also be used with 5% sorbitol solution or isotonic inorganic infusion solutions such as Ringers solution.
Paediatric population :
The safety and efficacy of Apresoline 20 mg
/ Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion in children have not yet been established.
Method of administration
For Intravenous use only.
Special Populations
Renal impairment and hepatic impairment (all indications)
In patients with moderate to severe renal impairment (creatinine clearance < 30 mL/min or serum creatinine concentration > 2.5 mg/100 mL or 221 μ mol/L) or hepatic dysfunction, the dosage or the dosing interval must be adapted according to the clinical response to avoid accumulation of the “apparent” active substance (see section 4.4).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Known hypersensitivity to dihydralazine.
Idiopathic systemic lupus erythematosus (SLE) and related diseases.
Severe tachycardia and heart failure with a high cardiac output (e.g. in thyrotoxicosis).
Myocardial insufficiency due to mechanical obstruction (e.g. in the presence of aortic or mitral stenosis or constrictive pericarditis).
Isolated right ventricular failure due to pulmonary hypertension (cor pulmonale).
Dissecting aortic aneurysm.
Porphyria
Potentiation of effects: Concurrent therapy with other antihypertensives (vasodilators, calcium antagonists, ACE inhibitors, diuretics), anaesthetics, tricyclic antidepressants, major tranquillisers, 1nitrates or drugs exerting central depressant actions (including alcohol).
Administration of Hydralazine shortly before or after diazoxide may give rise to marked hypotension.
MAO inhibitors should be used with caution in patients receiving Hydralazine.
Concurrent administration of Hydralazine with beta-blockers subject to a strong first pass effect (e.g. propranolol) may increase their bioavailability. Download adjustment of these drugs may be required when they are given concomitantly with Hydralazine.
There is potential for the hypotensive effect of hydralazine to be antagonised when used concomitantly with oestrogens, corticosteroids or non-steroidal anti-inflammatory drugs.
Women of child-bearing potential
Women planning to become pregnant should not take Apresoline. When pregnancy is confirmed in women taking Apresoline, the treatment should be discontinued immediately (see subsection Pregnancy).
Pregnancy
Use of Hydralazine in pregnancy, before the third trimester should be avoided but the drug maybe employed in later pregnancy if there is no safer alternative or when the disease itself carries serious risks for the mother or child e.g. pre-eclampsia and /or eclampsia.
No serious adverse effects in human pregnancy have been reported to date with Hydralazine, although experience in the third trimester is extensive. However, studies have shown teratogenic potential in mice but not in other animal species . Hydralazine crosses the placenta.
Breast-feeding
Hydralazine passes into breast milk but reports available so far have not shown adverse effects on the infant. Mothers in whom use of Hydralazine proves unavoidable may breast feed their infant provided that the infant is observed for possible adverse effects.
Fertility
No data available.
Dizziness or hypotension may occur with Apresoline, it is therefore advisable to exercise caution when driving or operating machinery.
Symptoms
The chief manifestations are cardiovascular disorders such as pronounced tachycardia and hypotension, which are accompanied by nausea, dizziness, and sweating, and which can result in circulatory collapse; also possible are myocardial ischaemia with angina pectoris and cardiac arrhythmias. Further signs and symptoms may include impairment of consciousness, headache, and vomiting, as well as possibly tremor, convulsions, oliguria, and hypothermia.
Management
Since no specific antidote is known, - in addition to attempts to eliminate the drug from the gastrointestinal tract (early induction of vomiting, later gastric lavage; administration of activated charcoal and possibly laxatives) - treatment should be supportive including use of a plasma expander or intravenous fluids as indicated
If hypotension is present, an attempt should be made to raise the blood pressure without increasing the tachycardia. Adrenaline should therefore be avoided.
Ask anything about Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion Vial. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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