What is hydralazine used for. How does hydralazine work to lower blood pressure. What are the potential side effects of taking hydralazine. Who should not take hydralazine. How is hydralazine typically prescribed and dosed. What drug interactions are important to know with hydralazine. When is hydralazine used during pregnancy.

What is Hydralazine and How Does it Work?

Hydralazine is a medication primarily used to treat high blood pressure (hypertension). It belongs to a class of drugs called vasodilators. Hydralazine works by relaxing and widening blood vessels, which allows blood to flow more easily through the body. This action helps reduce blood pressure and decrease the workload on the heart.

Some key points about how hydralazine functions:

• It directly relaxes the smooth muscles in the walls of arteries and arterioles
• This vasodilation increases blood supply and oxygen to the heart
• The reduced vascular resistance leads to lower blood pressure
• It does not typically affect heart rate or cardiac output

By lowering blood pressure, hydralazine can help prevent complications of hypertension like heart attack, stroke, and kidney problems. It’s often prescribed when other blood pressure medications haven’t been effective enough on their own.

Medical Uses and Indications for Hydralazine

While primarily used for hypertension, hydralazine has several important medical applications:

Treatment of Chronic Hypertension

Hydralazine is frequently prescribed to manage chronic high blood pressure, especially when other medications have not adequately controlled blood pressure levels. It’s often used in combination with other antihypertensive drugs for enhanced effectiveness.

Management of Hypertensive Emergencies

In cases of severe, acute elevations in blood pressure (hypertensive crisis), hydralazine may be administered intravenously in hospital settings to rapidly lower dangerously high blood pressure.

Pregnancy-Related Hypertension

Hydralazine is one of the few antihypertensive medications considered relatively safe for use during pregnancy. It’s commonly used to manage pre-eclampsia and eclampsia, conditions characterized by high blood pressure during pregnancy that can be dangerous for both mother and baby.

Heart Failure

In some cases, hydralazine may be prescribed in combination with nitrates to treat heart failure, particularly in African American patients who may not respond as well to ACE inhibitors.

Dosage and Administration of Hydralazine

The dosage of hydralazine can vary significantly depending on the individual patient, the condition being treated, and the severity of hypertension. Always follow your doctor’s instructions precisely.

Typical dosing guidelines for adults include:

• Initial dose: 10 mg orally four times daily
• Maintenance dose: 25 to 100 mg four times daily
• Maximum daily dose: Usually not exceeding 300 mg

For hypertensive emergencies, hydralazine may be given intravenously or intramuscularly under close medical supervision.

It’s important to note that the full effects of hydralazine may not be apparent for several days to a few weeks after starting treatment. Regular blood pressure monitoring is essential to ensure the medication is working effectively and the dosage is appropriate.

Potential Side Effects and Risks of Hydralazine

Like all medications, hydralazine can cause side effects. While not everyone experiences these, it’s important to be aware of potential adverse reactions:

Common Side Effects

• Headache
• Dizziness or lightheadedness
• Flushing or warmth in the face, neck, or chest
• Nausea
• Rapid heartbeat
• Loss of appetite

Less Common but Serious Side Effects

While rare, some patients may experience more severe side effects that require immediate medical attention:

• Lupus-like syndrome (joint pain, fever, chest pain, skin rash)
• Numbness or tingling in extremities
• Unusual bleeding or bruising
• Severe dizziness or fainting
• Symptoms of heart failure (shortness of breath, swelling in ankles/feet)

It’s crucial to inform your healthcare provider if you experience any persistent or concerning side effects while taking hydralazine.

Drug Interactions and Precautions with Hydralazine

Hydralazine can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects. Some important interactions to be aware of include:

Medications That May Interact with Hydralazine

• Beta-blockers (e.g., metoprolol, atenolol): May enhance the blood pressure-lowering effects
• Monoamine oxidase inhibitors (MAOIs): Can cause severe hypotension when used with hydralazine
• Diuretics: May increase the risk of orthostatic hypotension
• NSAIDs (e.g., ibuprofen, naproxen): Can reduce the effectiveness of hydralazine

Always inform your healthcare provider about all medications, supplements, and herbal products you’re taking to avoid potential interactions.

Precautions and Contraindications

Certain conditions may increase the risks associated with hydralazine use or make it unsuitable for some patients:

• Coronary artery disease: Hydralazine can potentially worsen angina in some patients
• Mitral valve rheumatic heart disease: Increased risk of adverse effects
• Lupus or a history of lupus: Hydralazine may trigger or exacerbate lupus symptoms
• Kidney or liver disease: May require dosage adjustments

Patients with these conditions should discuss the risks and benefits of hydralazine use with their healthcare provider.

Hydralazine Use During Pregnancy and Breastfeeding

Hydralazine is one of the few antihypertensive medications considered relatively safe for use during pregnancy, particularly in the management of severe hypertension, pre-eclampsia, and eclampsia. However, its use should always be under close medical supervision.

Pregnancy Considerations

• Hydralazine is classified as FDA Pregnancy Category C, meaning that while risks cannot be ruled out, the potential benefits may warrant use in pregnant women despite potential risks
• It’s often preferred over other antihypertensives due to its long history of use in pregnancy and relatively low risk of fetal harm
• Regular monitoring of both maternal and fetal well-being is essential when using hydralazine during pregnancy

Breastfeeding Considerations

Hydralazine does pass into breast milk in small amounts. While it’s generally considered compatible with breastfeeding, some precautions should be taken:

• Monitor the infant for potential side effects such as increased heart rate or decreased blood pressure
• Consider the timing of doses in relation to breastfeeding sessions to minimize infant exposure
• Discuss the risks and benefits with a healthcare provider to make an informed decision about breastfeeding while taking hydralazine

Long-Term Effects and Monitoring for Hydralazine Therapy

While hydralazine can be an effective long-term treatment for hypertension, ongoing monitoring is crucial to ensure its continued safety and efficacy.

Regular Medical Check-ups

Patients on long-term hydralazine therapy should have regular follow-up appointments with their healthcare provider. These visits typically include:

• Blood pressure measurements to assess the medication’s effectiveness
• Blood tests to monitor kidney and liver function
• Evaluation for potential side effects or complications

Long-Term Side Effects to Watch For

Some potential long-term effects of hydralazine use that require monitoring include:

• Drug-induced lupus erythematosus: A reversible condition that can develop after prolonged use
• Peripheral neuropathy: Numbness or tingling in extremities
• Changes in blood cell counts: Rare but possible effects on white blood cells or platelets

If any concerning symptoms develop during long-term use, it’s important to consult with a healthcare provider promptly.

Alternatives to Hydralazine for Hypertension Management

While hydralazine can be an effective treatment for hypertension, it’s not always the first-line choice. There are several other classes of antihypertensive medications that may be considered, depending on the individual patient’s needs and medical history:

Other Antihypertensive Medication Classes

• ACE inhibitors (e.g., lisinopril, enalapril)
• Angiotensin II receptor blockers (ARBs) (e.g., losartan, valsartan)
• Calcium channel blockers (e.g., amlodipine, nifedipine)
• Beta-blockers (e.g., metoprolol, atenolol)
• Diuretics (e.g., hydrochlorothiazide, furosemide)

Each of these medication classes works differently to lower blood pressure, and the choice of treatment depends on factors such as the patient’s age, race, other medical conditions, and potential side effects.

Non-Pharmacological Approaches

In addition to or instead of medication, lifestyle modifications can play a crucial role in managing hypertension:

• Maintaining a healthy weight
• Regular physical activity
• Reducing sodium intake
• Limiting alcohol consumption
• Quitting smoking
• Managing stress

These lifestyle changes can significantly impact blood pressure levels and may reduce or eliminate the need for medication in some cases.

In conclusion, hydralazine remains an important tool in the management of hypertension, particularly in specific clinical scenarios such as pregnancy-related hypertension or resistant hypertension. However, its use should always be carefully considered and monitored by healthcare professionals, taking into account the individual patient’s needs, potential risks, and alternative treatment options. As with any medication, the goal is to achieve optimal blood pressure control while minimizing side effects and improving overall cardiovascular health.

Hydralazine (Oral Route) Description and Brand Names

Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

1. Apresoline

Descriptions

Hydralazine is used to treat high blood pressure (hypertension). It is also used to control high blood pressure in a mother during pregnancy (pre-eclampsia or eclampsia) or in emergency situations when blood pressure is extremely high (hypertensive crisis).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can decrease the risk of heart attacks and strokes.

Hydralazine works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

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Hydralazine dosing, indications, interactions, adverse effects, and more

Hydralazine for high blood pressure

About hydralazine

Although many people with high blood pressure (hypertension) do not feel unwell, it is still important that high blood pressure be treated. If left untreated, high blood pressure is a risk factor that can increase your chance of developing heart disease, a stroke, and other serious conditions. Hydralazine will be prescribed alongside other medicines to control high blood pressure.

Hydralazine works by relaxing the muscles in the walls of your blood vessels. This means that your blood vessels widen, which reduces your blood pressure and allows blood and oxygen to circulate more freely around your body. Hydralazine will only be prescribed for you if other treatments are not suitable or effective, as it can increase the amount of water and salt in your body and can increase your heart rate. The other medicines you are prescribed to take alongside it will help to control these side-effects.

Hydralazine is occasionally prescribed by hospital doctors for other heart conditions. If you have been prescribed it for a reason other than high blood pressure, speak with your doctor if you have any questions about your treatment.

Before taking hydralazine

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking hydralazine it is important that your doctor knows:

• If you have a condition called systemic lupus erythematosus. This is an inflammatory condition also called lupus, or SLE.
• If you have any problems with the way your liver works, or if you have any problems with the way your kidneys work.
• If you have a problem with your blood vessels, such as coronary artery disease or cerebrovascular disease.
• if you have a heart condition or have recently had a heart attack.
• If you are pregnant or breastfeeding.
• If you have a rare inherited blood disorder called porphyria.
• If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
• If you have ever had an allergic reaction to any medicine.

How to take hydralazine

• Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about hydralazine and will provide you with a full list of the side-effects which you could experience from taking the tablets.
• Take hydralazine exactly as your doctor tells you to. It is usual to take one tablet twice a day. Try to take your doses at similar times of day each day, as this will help you to remember to take them regularly. There are two strengths of hydralazine tablet – it is usual to take the 25 mg strength tablet to begin with, but this may later be increased to the higher 50 mg strength tablet. Increasing your dose gradually allows your doctor to make sure that you have the dose that best helps your condition, but also keeps unwanted side-effects to a minimum.
• Swallow the tablet whole with a drink of water. You can take hydralazine either with or without food.
• If you forget to take a dose at your usual time, take it as soon as you remember unless your next dose is due. If your next dose is due then take the dose which is due but leave out the forgotten one. Do not take two doses together to make up for a missed dose. 

Getting the most from your treatment

• Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. You will need to have regular blood pressure measurements, and also some blood and urine tests from time to time.
• Your doctor will advise you on what lifestyle changes you can make to help your condition. These could include losing weight if you are overweight, taking regular physical activity, eating a healthy diet, cutting back on the amount of alcohol you drink, stopping smoking, and reducing the amount of salt in your meals and caffeine in your drinks. It is important that you follow any advice you are given.
• If you buy any medicines, check with a pharmacist that they are suitable for you to take. This is because some medicines (particularly some anti-inflammatory painkillers) can interfere with the way hydralazine works.
• Treatment with hydralazine is usually long-term unless you experience an adverse effect. Continue to take the tablets unless you are advised otherwise by your doctor.
• If you are having an operation or dental treatment, tell the person carrying out the treatment that you are taking hydralazine. This is because some anaesthetics can affect your blood pressure.

Can hydralazine cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the more common ones associated with hydralazine. The best place to find a full list of the side-effects which can be associated with your medicine, is from the manufacturer’s printed information leaflet supplied with the medicine. Alternatively, you can find an example of a manufacturer’s information leaflet in the reference section below. Speak with your doctor or pharmacist if any of the following continue or become troublesome.

If you experience any other symptoms which you think may be due to the tablets, please speak with your doctor or pharmacist for further advice.

How to store hydralazine

• Keep all medicines out of the sight and reach of children.
• Store in a cool, dry place, away from direct heat and light. 

Important information about all medicines

Hydralazine – an overview | ScienceDirect Topics

Hydralazine

Hydralazine entered the therapeutic armamentarium shortly after the ganglian-blocking agents and was one of the most effective drugs in the 1950s.²⁸ Usage declined rapidly in the 1960s but hydralazine returned to regular usage in stepped-care regimens of the late 1960s, in combination with a beta blocker and diuretic. Hydralazine has largely been replaced by other peripherally acting drugs and is now not widely used, although the drug remains effective and safe in specialist hands.

Hydralazine is usually administered three or four times daily, preferably starting with an individual dose of 12.5 to 25 mg. A lower dose (10 mg) may be used if there are side effects. The dose is then increased as necessary to a maximum of 200 to 300 mg daily. Slow acetylators show greater lowering of blood pressure.¹¹ The daily dose should not exceed 200 mg. High doses are more likely to be associated with development of anti-nuclear antibodies (ANA) and a lupus-like syndrome.¹¹ The acetylator phenotype can be determined readily by a simple urinary test of sulphonamide acetylation.²⁹ Periodic full blood count and ANA titers are recommended during chronic hydralazine therapy. Because hydralazine undergoes hepatic metabolism, dose adjustment is unnecessary in renal impairment.

Pretreatment with a beta blocker prevents sympathetic activation, reduces side effects, and potentiates the antihypertensive action.³⁰ Hydralazine is used with a beta blocker and diuretic to control moderate to severe hypertension. Where renal function is seriously impaired, a loop diuretic rather than a thiazide is needed to avoid edema. A multicenter trial³¹ evaluated hydralazine, labetalol, methyldopa, prazosin, and placebo for value as a third drug when added to ongoing beta-blocker and diuretic treatment. Overall, hydralazine was the most generally suitable third drug.

Much of the early information demonstrating that antihypertensive therapy can diminish morbidity and mortality involved hydralazine-treated patients.^25,26,32,33 A combination of reserprine, hydrochlorothiazide, and hydralazine was used in the landmark Veterans Administration Cooporative Study Group Trials,²⁵ which demonstrated unequivocally the merits of antihypertensive therapy not only in severe but in moderate hypertension.

For urgent control of blood pressure, hydralazine can be given parenterally. Onset of action is in 15 minutes,² but the dose and frequency of administration required for blood pressure control are highly variable, the long duration of action makes dose titration difficult, and many patients do not respond adequately to any dose of hydralazine. Therefore, hydralazine is not an ideal drug for hypertensive emergencies. Sodium nitroprusside is more effective if continuous monitoring in an intensive therapy unit is available.

Although there have been no formal studies in pregnancy, and although the drug is teratogenic in some animals, hydralazine is widely used in pregnant women.³⁴ The main contraindication is coronary artery disease because increased cardiac output increases cardiac work and may provoke angina and myocardial ischemia or infarction. However, if hypertension is severe reduction in blood pressure and cardiac work will more than compensate. In mitral valve disease, hydralazine may increase pulmonary artery pressure and induce congestive heart failure. Endralazine lowers blood pressure over 24 hours with once-daily dosing.³⁵

Hydralazine tablets

What is this medicine?

HYDRALAZINE (hye DRAL a zeen) is a type of vasodilator. It relaxes blood vessels, increasing the blood and oxygen supply to your heart. This medicine is used to treat high blood pressure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Apresoline

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood vessel disease
• heart disease including angina or history of heart attack
• kidney or liver disease
• systemic lupus erythematosus (SLE)
• an unusual or allergic reaction to hydralazine, tartrazine dye, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• medicines for high blood pressure
• medicines for mental depression

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Check your blood pressure and pulse rate regularly. Ask your doctor or health care professional what your blood pressure and pulse rate should be and when you should contact him or her.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or pain while you are taking this medicine without asking your doctor or health care professional for advice. Some ingredients may increase your blood pressure.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• chest pain, or fast or irregular heartbeat
• fever, chills, or sore throat
• numbness or tingling in the hands or feet
• shortness of breath
• skin rash, redness, blisters or itching
• stiff or swollen joints
• sudden weight gain
• swelling of the feet or legs
• swollen lymph glands
• unusual weakness

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea, or constipation
• headache
• loss of appetite
• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Hydralazine 25 mg Tablets – Summary of Product Characteristics (SmPC)

This information is intended for use by health professionals

Apresoline Tablets 25 mg

Hydralazine 25 mg Tablets

The active ingredient is 1-hydrazinophthalazine hydrochloride (hydralazine hydrochloride).

One coated tablet contains 25 mg hydralazine hydrochloride B.P.

Excipient(s) with known effects

Each tablet contains 22.931 mg of sucrose

For the full list of excipients, see section 6.1

For the treatment of moderate to severe hypertension as an adjunct to other anti-hypertensive agents.

Due to the complementary mechanism of action the combination of hydralazine with b-blockers and diuretics may enable antihypertensive efficacy at lower dose levels and counteract accompanying hydralazine effects such as reflex tachycardia and oedema.

As supplementary medication for use in combination with long-acting nitrates in moderate to severe chronic congestive cardiac failure in patients in whom optimal doses of conventional therapy have proved insufficient.

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:

Hypertension: the dose should be adjusted to the individual requirements of the patient. Treatment should begin with low doses of Apresoline which, depending on the patient’s response should be increased stepwise to achieve optimal therapeutic effect whilst keeping unwanted effects to a minimum.

Initially 25 mg bid. This can be increased gradually to a dose not exceeding 200 mg daily. The dose should not be increased beyond 100 mg daily without first checking the patient’s acetylator status.

Chronic congestive heart failure: Treatment with Apresoline should always be initiated in hospital, where the patient’s individual haemodynamic values can be reliably determined with the help of invasive monitoring. It should then be continued in hospital until the patient has become stabilised on the requisite maintenance dose. Doses vary greatly between individual patients and are generally higher than those used for treating hypertension. After progressive titration (initially 25 mg tid or qid increasing every second day) the maintenance dosage averages 50-75 mg qid.

Paediatric population:

Not recommended

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

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.

Porphyria

Warnings

The overall ‘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 therefore be given Apresoline/Hydralazine Tablets only under cover of beta-blocker or in combination with other suitable sympatholytic agents. It is important that the beta-blocker medication should be commenced a few days before the start of treatment with Apresoline/Hydralazine Tablets.

Patients who have survived a myocardial infarction should not receive Apresoline/ Hydralazine Tablets until a post-infarction stabilisation state 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 where doses exceed 100 mg daily. First symptoms are likely to be similar to rheumatoid arthritis (arthralgia, sometimes associated with fever, anaemia, leucopenia, thrombocytopenia and rash) and are reversible after 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 the higher the dose and the longer its duration, and since they are also more common in slow acetylators, it is recommended that for maintenance therapy the lowest effective dose should be used. If 100 mg daily fails to elicit an adequate clinical effect, the patient’s acetylator status should be evaluated. Slow acetylators and women run greater risk of developing the SLE-like syndrome and every effort should therefore be made to keep the dosage below 100 mg daily and a careful watch kept for signs and symptoms suggestive of this syndrome. If such symptoms do develop the drug should be gradually withdrawn.

Rapid acetylators often respond inadequately even to doses of 100 mg daily and therefore the dose can be raised with only a slightly increased risk of an LE like syndrome.

During long term treatment with Apresoline/Hydralazine Tablets it is advisable to determine the antinuclear factors and conduct urine analysis at intervals of approximately 6 months. Microhaematuria and / or proteinuria, in particular together with positive titres of ANF, may be initial signs of immune-complex glomerulonephritis associated with the SLE like syndrome. If overt clinical signs or symptoms develop, the drug should be withdrawn immediately.

Skin rash, febrile reactions and change in blood count occur rarely and drug should be withdrawn. Peripheral neuritis in the form of paraesthesia has been reported, and may respond to pyridoxine administration or drug withdrawal.

Precautions

In patients with renal impairment (creatinine clearance < 30 ml/min or serum creatinine concentrations > 2.5 mg / 100 ml or 221 μmol/l) and in patients with hepatic dysfunction the dose or interval between doses should be adjusted according to clinical response, in order to avoid accumulation of the ‘apparent’ active substance.

Apresoline/Hydralazine Tablets should be used with caution in patients with coronary artery disease (since it may increase angina) or cerebrovascular disease.

When undergoing surgery, patients treated with Apresoline/Hydralazine Tablets may show a fall in blood pressure, in which case one should not use adrenaline to correct the hypotension, since it enhances the cardiac-accelerating effects of hydralazine.

When initiating therapy in heart failure, particular caution should be exercised and the patient kept under surveillance and/or haemodynamic monitoring for early detection of postural hypotension or tachycardia. Where discontinuation of therapy in heart failure is indicated, Apresoline/Hydralazine Tablets should be withdrawn gradually (except in serious situations, such as SLE-like syndrome or blood dyscrasias) in order to avoid precipitation and/or exacerbation of heart failure.

This medicine contains sucrose

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Potentiation of effects: Concurrent therapy with other antihypertensives (vasodilators, calcium antagonists, ACE inhibitors, diuretics), anaesthetics, tricyclic antidepressants, major tranquillisers, nitrates or drugs exerting central depressant actions (including alcohol).

Administration of Apresoline/Hydralazine Tablets shortly before or after diazoxide may give rise to marked hypotension.

MAO inhibitors should be used with caution in patients receiving Apresoline/Hydralazine Tablets.

Concurrent administration of Apresoline/Hydralazine Tablets with beta-blockers subject to a strong first pass effect (e.g. propranolol) may increase their bioavailability. Downward adjustment of these drugs may be required when they are given concomitantly with Apresoline/Hydralazine Tablets.

There is potential for the hypotensive effect of hydralazine to be antagonised when used concomitantly with oestrogens or non-steroidal anti-inflammatory drugs.

Pregnancy

Use of Apresoline in pregnancy, before the third trimester should be avoided but the drug may be 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 Apresoline, although experience in the third trimester is extensive.

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 Apresoline is unavoidable may breast feed their infant provided that the infant is observed for possible adverse effects.

Apresoline may impair the patient’s reactions especially at the start of the treatment.

The patient should be warned of the hazard when driving or operating machinery.

Some of the adverse effects listed below e.g. tachycardia, palpitations, angina symptoms, flushing, headache, dizziness, nasal congestion and gastro-intestinal disturbances are commonly seen at the start of treatment, especially if the dose is raised quickly. However such effects generally subside in the further course of treatment.

(The following frequency estimates are used: frequent > 10 %, occasional 1-10%, rare 0.001-1%, isolated cases < 0.001%)

Cardiovascular system:

Frequently: tachycardia, palpitations.

Occasionally: flushing, hypotension, anginal symptoms.

Rarely: oedema, heart failure.

Isolated cases: paradoxical pressor responses.

Central and peripheral nervous system:

Frequently: headache.

Rarely: dizziness.

Isolated cases: peripheral neuritis, polyneuritis, paraesthesiae (these unwanted effects may be reversed by administering pyridoxine).

Musculo-skeletal system:

Occasionally: arthralgia, joint swelling, myalgia.

Skin and appendages:

Rarely: rash.

Urogenital system:

Rarely: proteinuria, increased plasma creatinine, haematuria sometimes in association with glomerulonephritis.

Isolated cases: acute renal failure, urinary retention.

Gastrointestinal tract:

Occasionally: gastro-intestinal disturbances, diarrhoea, nausea, vomiting.

Rarely: jaundice, liver enlargement, abnormal liver function sometimes in association with hepatitis.

Isolated cases: paralytic ileus.

Blood:

Rarely: anaemia, leucopenia, neutropenia, thrombocytopenia with or without purpura.

Isolated cases: haemolytic anaemia, leucocytosis, lymphadenopathy, pancytopenia, splenomegaly, agranulocytosis.

Psychiatric reactions:

Rarely: agitation, anorexia, anxiety.

Isolated cases: depression, hallucinations.

Sense organs:

Rarely: increased lacrimation, conjunctivitis, nasal congestion.

Hypersensitivity reactions:

Occasionally: SLE-like syndrome (sometimes resulting in a fatal outcome see section 4.4 Special warnings and precautions for use).

Rarely: hypersensitivity reactions such as pruritus, urticaria, vasculitis, eosinophilia, hepatitis.

Respiratory tract:

Rarely: dyspnoea, pleural pain.

Miscellaneous:

Rarely: fever, weight decrease, malaise.

Isolated cases: exophthalmos.

Reporting 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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Signs and symptoms

Symptoms include hypotension, tachycardia, myocardial ischaemia dysrhythmias and coma.

Treatment

Gastric lavage should be instituted as soon as possible. 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.

Pharmacotherapeutic group: Hydrazinophthalazine derivatives; ATC code: C02DB02

Mechanism of action

Hydralazine is a direct acting vasodilator which exerts its effects principally on the arterioles. Its precise mode of action is not known.

Pharmacodynamic effects

Administration of hydralazine produces a fall in peripheral resistance and a decrease in arterial blood pressure, effects which induce reflex sympathetic cardiovascular responses. The concomitant use of a beta-blocker will reduce these reflex effects and enhance the anti-hypertensive effect. The use of hydralazine can result in sodium and fluid retention, producing oedema and reduced urinary volume. These effects can be prevented by concomitant administration of a diuretic.

Absorption

Orally administered Apresoline is rapidly and completely absorbed but is subject to a dose dependent first pass effect (systemic bioavailability: 26-55%) which is dependent upon the individual’s acetylator status. Peak plasma concentrations are attained after 0.5 to 1.5 hours.

Distribution

Apresoline is rapidly distributed in the body and displays a particular affinity for the blood vessel walls. Plasma protein binding is of the order of 90%. Within 24 hours after an oral dose, the quantity recovered in the urine averages 80% of the dose.

Biotransformation

Nil

Elimination

Apresoline appears in the plasma chiefly in the form of a readily hydrolysable conjugate with pyruvic acid. Plasma half-life averages 2-3 hours but is prolonged up to 16 hours in severe renal failure (creatinine clearance less than 20 ml/mm) and shortened to approximately 45 minutes in rapid acetylators.

The bulk of the dose is excreted as acetylated and hydroxylated metabolites, some of which are conjugated with glucoronic acid.

Characteristics in patients

None relevant.

Hydralazine has been found to be teratogenic in mice producing a small incidence of cleft palate and certain other bony malformations, in oral doses ranging from 20-120 mg / kg i.e. 20-30 times the maximum human daily dose. It was not teratogenic in rats or rabbits.

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.

Sugar-coated tablets of 25 mg contain silicon dioxide, microcrystalline cellulose, magnesium stearate, polyvinylpyrrolidone, maize starch, hydroxypropylmethylcellulose, povidone, talc, titanium dioxide, polyethylene glycol, sucrose, yellow iron oxide ,water, shellac glaze, black iron oxide (E172) and propylene glycol (E1520) ,Red iron oxide (E172), Ammonium Hydroxide (E527).

Protect from moisture and heat. Store below 30°C.

Securitainers of 84 or 56 or 100 tablets.

Amdipharm UK Limited

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

United Kingdom.

Hydralazine: Uses, Interactions, Mechanism of Action

90,000 hydralazine is … What is hydralazine?

90,000 What is hydralazine?

Hydralazine is a high strength prescription drug used to treat high blood pressure.It can be given to patients who are at risk of heart attacks due to high blood pressure, as well as to patients recovering from heart failure. Hydralazine is very effective in most cases, although it can cause potentially serious side effects and secondary health problems. Most doctors prefer to try other less potent drugs before prescribing hydralazine.

High blood pressure, or hypertension, can be caused by a number of different factors.Possible causes include obesity, diabetes, high cholesterol, blood clots, and congenital heart or vascular defects. Depending on the underlying cause of the hypertension, the patient may need to take other medications in combination with hydralazine to manage symptoms. Hydralazine helps to improve blood flow by relaxing the smooth muscles surrounding the arteries in the body. The arterial walls expand when they are relaxed, allowing more blood to flow through an adjustable rate.

Exact doses are calculated based on the patient’s specific condition, underlying health problems and age. Most adult patients, however, are given 10 milligrams of tablets four times daily at the start of treatment. The doctor may gradually increase the dosage up to 50 mg four times a day depending on the patient’s response. Doctors try to find the lowest effective dose to limit the risk of adverse reactions. Hydralazine is intended to be taken daily indefinitely, even if acute symptoms improve, to prevent further complications from developing.

The risk of side effects with hydralazine is relatively high compared to many other drugs for hypertension. A person may experience headaches, dizziness, lightheadedness, and nausea shortly after taking a dose. Digestive problems such as diarrhea and vomiting are less common but possible. The drug can also increase your heart rate, which can lead to shortness of breath, fatigue, and weakness. Rarely, fever, hot flashes, hives, and severe breathing problems may develop if the person is allergic to the drug.

Most side effects and health complications can be avoided if patients follow their doctors’ instructions on medication use and lifestyle adjustments. Doctors usually recommend that people check their blood pressure at home at least once a day during treatment to make sure it is stable. Dietary restrictions, such as limiting caffeine, alcohol, salt, and fatty foods, can also help prevent future heart problems. In addition, patients are usually asked to exercise regularly and attend scheduled appointments to track changes in health.

OTHER LANGUAGES

Hydralazine: description, recipe, instruction

Hydralazine

Analogs (generics, synonyms)

Active ingredient

Hydralazinum

Pharmacological group

Vasodilators

Recipe

International:

Rp .: Tab. Hydralazini 0.025 No. 10
D.S. 1 tablet 3r / day

Russia:

Prescription form 107-1 / y

Pharmacological action

Hydralazine has a vasodilating, hypotensive effect.Reduces afterload on the heart. Changes intracellular calcium metabolism, suppresses the contractility of vascular smooth muscles, dilates arterioles and (to a small extent) veins, reduces peripheral resistance.
Absorbed 90%. Bioavailability ranges from 10 (for “fast acetylators”) to 31% (for “slow acetylators”). The connection with plasma proteins is 87%. Vd- 1.5 ± 1 l / kg. Biotransformed in the liver to active metabolites. The half-life is 3-7 hours; in chronic renal failure (with creatinine clearance less than 20 ml / min) – up to 16 hours; increases in chronic heart failure.Clearance – 56 ± 13 ml / (min ± kg), decreases in chronic heart failure. 52-90% is eliminated by the kidneys (2-4% of the substance is excreted unchanged when taken orally, 11-14% when administered intravenously), with feces about 10%.

Pharmacodynamics

There is no data for this section. We are currently processing information, please come back later.

Pharmacokinetics

There is no data for this section. We are currently processing information, please come back later.

Method of application

For adults:

Inside, after meals, starting from 10-25 mg 2-4 times a day, with a gradual increase to 100-200 mg per day (in 4 divided doses). Higher doses: single – 100 mg, daily – 300 mg.

Readings

– Arterial hypertension, hypertensive crisis, congestive heart failure with high afterload, eclampsia.

Contraindications

– Hypersensitivity, severe atherosclerosis, mitral heart disease.

Special instructions

There is no data for this section. We are currently processing information, please come back later.

Side effects

– Allergic reactions
– Cutaneous vasculitis
– Angina pectoris
– Edema
– Lupus syndrome
– Anorexia
– Nausea, vomiting, constipation, diarrhea
– Lymphadenopathy
– Peripheral neuritis
– Headache, tachycardia, hypotension of the face
– Shortness of breath
– Lachrymation
– Nasal congestion

Overdose

There is no data for this section.We are currently processing information, please come back later.

Drug interactions

There is no data for this section. We are currently processing information, please come back later.

Form of issue

Tablets 10 mg and 25 mg.

Vasodilators for heart failure

What are they doing

Vasodilators cause your blood vessels to dilate or relax and thus reduce the resistance in them.This lowers blood pressure and allows blood to flow more easily through the body, improving symptoms.

Some vasodilators are taken regularly. However, some short-acting vasodilators (such as glycerin trinitrate / nitroglycerin) can be taken as a spray or pill under the tongue as needed to relieve chest pain (angina). There are other types of vasodilators (not only based on nitrates ) used in heart failure; they can also be prescribed in the form of patches and ointments, which are applied to the skin with angina .

What is the expected benefit?

Nitrates reduce the frequency and intensity of chest pain (angina) and are therefore used to relieve symptoms. Other vasodilators such as hydralazine and minoxidil can be used to improve symptoms such as shortness of breath.

Side effects

Vasodilators can lower blood pressure, which can make you feel lightheaded and dizzy if you sit down or get up quickly.

Other side effects include headaches, flushing, heart palpitations , and nasal congestion. Headaches are especially common with long-acting vasodilators such as nitrates.

Most Important Tips

Dizziness usually accompanies any medication that lowers blood pressure, but your heart functions better when your blood pressure is low.

If you feel dizzy in the morning, try doing about ten back and forth movements with your legs before standing up.Or, you may find it helpful to hang your legs off the bed before sitting down and then sit on the edge of the bed for about a minute before getting up. Avoid getting up quickly, both from a sitting position and from an inclined position, as this can cause dizziness. Take your time and allow your body to adjust.

Vasodilators:

• Nitroglycerin preparations
  (Coro-Nitro Pump Spray®, Glytrin Spray®, Nitrolingual Pumpspray®, Nitromin®, Suscard®, Deponit®, Minitran®, Nitro-Dur®, Percutol®, Transiderm-Nitro®), 9000
• Isosorbide dinitrate (
  Angitak®, Isoket Retard®)
• Isosorbide mononitrate (
  Angeze®, Angeze SR®, Chemydur 60X®, Elantan®, Ismo®, Elantan LA®, Imdur®, Isib 60XL®, Ismo Retard®, Isodur®, Isotard®, Modisal LA®, Modisal XL®, Monomax®, Monomil X®, Monosorb XL 60®, Zemon®)
• Hydralazine
  (Aprezolin®)
• Minoxidil
  (Simdax®)

Return to the section “Medicines for heart failure”

instructions for use, dosage, composition, analogs, side effects / Pillintrip

Special warnings and precautions

WARNINGS

In several patients, hydralazine can give a clinical picture that mimics systemic lupus erythematosus, including glomerulonephritis.In these patients, hydralazine should be discontinued unless the determination of benefit-for-risk warrants continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued, but remnants were found many years later. Long-term steroid treatment may be necessary. (See PRECAUTIONS, Laboratory Tests.)

PRECAUTIONS

General

Hydralazine (hydralazine) induced myocardial stimulation may cause angina attacks and ECG changes in myocardial ischemia.The drug has been implicated in the production of myocardial infarction. Therefore, it should be used with caution in patients with suspected coronary artery disease.

“Hyperdynamic” circulation caused by hydralazine (hydralazine) can exacerbate specific cardiovascular disorders. For example, hydralazine (hydralazine) can increase pulmonary artery pressure in patients with mitral valvular disease. The drug may decrease the response of the pressor to epinephrine. Postural hypotension may result from hydralazine (hydralazine) but is less common than with ganglion blocking agents.Use with caution in patients with cerebrovascular disease.

In hypertensive patients with normal kidneys who are treated with hydralazine (hydralazine), there are signs of increased renal blood flow and maintenance of glomerular filtration rate. In some cases, when the control values ​​were below normal, improved renal function was noted after the administration of hydralazine (hydralazine). However, as with any antihypertensive agent, hydralazine (hydralazine) should be used with caution in patients with advanced kidney damage.

Peripheral neuritis is observed, as evidenced by paresthesia, numbness and tingling. Published evidence suggests an antipyridoxine effect and that pyridoxine should be added to the regimen when symptoms develop. Hydralazine (hydralazine) tablets (100 mg) contain FD&C Yellow No. 5 (tartrazine), which may cause allergic reactions (including bronchial asthma) in some susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, this is often seen in patients who are also hypersensitive to aspirin.

Information for patients

Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

Laboratory tests

Complete blood counts and antinuclear antibody titers are indicated before and periodically during long-term hydralazine therapy, even if the patient is asymptomatic. These tests are also indicated if a patient develops arthralgia, fever, chest pain, ongoing malaise, or other unexplained signs or symptoms.

A positive antinuclear antibody titer requires the clinician to carefully weigh the implications of test results against the benefits of hydralazine antihypertensive therapy.

Blood dyscrasias, consisting of decreased hemoglobin and erythrocyte count, leukopenia, agranulocytosis, and purpura have been reported. If such disorders develop, therapy should be discontinued.

Drug / Drug Interactions

MAO inhibitors should be used with caution in patients receiving hydralazine.

When other potent parental antihypertensive drugs, such as diazoxide, are used in combination with hydralazine, patients should be monitored continuously for several hours for any excessive drop in blood pressure. Deep hypotensive episodes can occur with the simultaneous use of diazoxide infection and hydralazine (hydralazine).

Drugs / Food Interactions

Dietary administration of hydralazine results in an increase in plasma levels.

Carcinogenesis, mutagenesis, impaired fertility

Throughout the life of the study on Swiss albino mice, a statistically significant increase in the incidence of lung tumors (adenoma and adenocarcinoma) was observed in male and female mice, who were continuously given hydralazine in drinking water in a dose about 250 mg / kg per day (about 80 times the maximum recommended human dose). In a P-year carcinogenicity study of rats treated with hydralazine lavage at dose levels of 15, 30, and 60 mg / kg / day (about 5-20 times the recommended daily dose for humans) microscopic examination of the liver revealed a small but statistically significant increase in benign tumor nodules in male and female rats from the high dose group and in female rats from the intermediate dose group.Benign testicular interstitial cell tumors were also significantly increased in the high-dose male rats. The observed tumors are common in elderly rats, and a significantly increased incidence was not observed until 18 months of treatment. Hydralazine has been shown to be mutagenic in bacterial systems (gene mutation and DNA repair) and in one of two rat and one rabbit DNA repair studies in vitro. Additional vim and in vitro studies using lymphoma cells, germ cells and fibroblasts in mice, Chinese hamster bone marrow cells, and fibroblasts from human cell lines did not demonstrate the mutagenic potential of hydralazine.

The extent to which these findings indicate a risk to humans is uncertain. Although long-term clinical observations do not suggest that human cancer is associated with hydralazine use, epidemiological studies are still insufficient to reach any conclusion.

Pregnancy Category C

Animal studies show that hydralazine is teratogenic in mice 20-30 times the maximum daily dose for humans from 200 to 300 mg and possibly 10-15 times the maximum daily intake in rabbits. doses in humans, but non-teratogenic in rats.The teratogenic effects observed were cleft palate and malformations of the facial and cranial bones.

There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydralazine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Nursing mothers

It has been shown that hydralazine is excreted in breast milk.

Pediatric Use

Safety and efficacy in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of Hydralazinee (hydralazine) in these patients. The usual recommended oral starting dose is 0.75 mg / kg body weight per day in four divided doses. The dosage may be gradually increased over the next 3-4 weeks to a maximum of 7.5 mg / kg or 200 mg per day.

Drugs for treating very high blood pressure during pregnancy

Pregnant women with high blood pressure (hypertension) can lower their blood pressure with antihypertensive drugs, but the most effective antihypertensive drug during pregnancy is unknown.The goal of antihypertensive therapy is to rapidly lower blood pressure, but safely for both the mother and her baby, avoiding sudden drops in blood pressure that can cause dizziness or fetal distress.

During pregnancy, a woman’s blood pressure drops in the first few weeks, then slowly rises again in the middle of pregnancy, reaching the pressure level observed before pregnancy. Pregnant women with very high blood pressure (systolic> 160 mmHg)Art., diastolic 110 mm Hg. or more) are at risk of developing preeclampsia associated with renal failure and preterm labor or stroke. A review of 35 randomized controlled trials involving 3573 women (in the middle and late stages of pregnancy, where indicated) found that while antihypertensive drugs are effective in lowering blood pressure, there is insufficient evidence to determine which drug is most effective.Fifteen different comparisons of antihypertensive drugs were included in these 35 clinical trials, which means that some comparisons were made in one trial. Only one trial involved a large number of people. A clinical study comparing nimodipine and magnesium sulfate showed that high blood pressure persisted in 47% and 65% of women, respectively. Calcium channel blockers have been associated with less persistent hypertension than hydralazine and possibly fewer side effects than labetalol.There is some evidence that diazoxide can cause blood pressure to drop too rapidly in women and that ketanserin may not be as effective as hydralazine. Further research is needed on the effects of antihypertensive drugs during pregnancy.

Hydralazine – Chemist’s Handbook 21

Synonyms hydralazine, apresolin. fp White crystalline powder, odorless, soluble in water, plo-Yr – in alcohol, practically insoluble in ether. [c.241]

Storage. Hydralazine hydrochloride should be stored in a well-closed container, protected from light. [c.170]

Additional information. Hydralazine hydrochloride melts with decomposition at a temperature of about 275 ° C. Even in the dark, it gradually decomposes in a humid atmosphere, with destruction accelerating as the temperature rises. [c.170]

General requirement.Hydralazine hydrochloride contains not less than 98.0% and not more than 101.0% of gH8N4-H l, calculated with reference to the dried substance. [c.170]

The metabolism of hydralazine was studied in vivo and in vitro. peaks for the analysis by the method of selective ionic detection The obtained data made it possible to establish the scheme of metabolism of hydrolazine [p.184]

Hydralazine-induced OGE Hashimoto’s thyroiditis Pernicious anemia Juvenile rheumatoid arthritis predominant affection of small joints all cases [c.269]

In conclusion, it is necessary to note a specific type of interaction – the effect of drugs on laboratory results. For example, propranolol increases the level of thyroxine in the blood (Tr, lowers glucose and can prolong hypoglycemia caused by insulin. The results of urine tests, for example, quinine, quinidine, nicotinic acid, riboflavin, tetracyclines, isoproterenol, In the urine of catecholamines, the excretion of catecholamines is increased, for example, nitroglycerin, calcium channel blockers, hydralazine, glucagon. [c.57]

Hydralazine and diazoxide bind to blood plasma proteins (85 and 90%, respectively), in contrast to minoxidil, which practically does not bind to proteins. [c.125]

Indications and dosage regimen. Hydralazine and endralazine are prescribed for hypertension of various etiologies. Hydralazine may be effective for eclampsia. [c.126]

Diazoxide is used only for the relief of urgent hypertensive conditions.Minoxidil is prescribed for hypertension with high stable blood pressure values ​​that respond poorly to treatment with other drugs, such as hydralazine. Sometimes minoxidil is given in combination with cardiac glycosides and diuretics to treat congestive heart failure. The developing activation of the sympathetic nervous system and reflex tachycardia significantly limit the use of minoxidil. [c.126]

Contraindications. Hydralazine and endralazine are contraindicated in gastric ulcer and duodenal ulcer, peripheral neuropathy.They should be used with caution in patients with angina pectoris. Hydralazine is contraindicated in SLE. [c.126]

Side effects. Hydralazine and endralazine cause reflex tachycardia, palpitations (especially at the beginning of treatment), throbbing headache, edema.