Isosorbide Dinitrate and Hydralazine (Oral)

Overview

Isosorbide Dinitrate and Hydralazine is a combination drug that's marketed under the brand name BiDil and contains the drugs Isosorbide dinitrate and Hydralazine.

It's normally used by African Americans to help treat heart failure, which is likely to affect the population at a much younger age. Compared with other ethnic or racial groups, African Americans are more likely to suffer heart failure sooner and die earlier.

Isosorbide dinitrate is in a group of medicines known as nitrates. It widens the blood vessels, allowing blood to easily flow through them so that the heart can also easily pump blood.

Hydralazine is in a group of medicines known as vasodilators. It relaxes the arteries and veins, allowing blood to be pumped more easily by the heart.

BiDil became the first prescription medication to be approved for treating one racial group, which generated a little bit of an uproar in the medical sector.

BiDil was approved by the FDA in 2005. It's sold by Arbor Pharmaceuticals.

Conditions Treated

  • Chronic heart failure

Type Of Medicine

  • Vasodilator

Side Effects

Aside from its useful effects, Isosorbide Dinitrate/Hydralazine may bring on some adverse effects. While not all the effects below may happen, if they do happen they may require medical intervention.

See your doctor promptly if you suffer any of the effects below while using Isosorbide Dinitrate/Hydralazine:

More common:

  • Confusion
  • Blurred vision
  • Sweating
  • Unusual tiredness/weakness

Less common:

  • Fainting
  • Irregular, pounding, or fast heartbeat or pulse

Incidence unknown:

  • Dark urine
  • Diarrhea
  • Chest discomfort or pain
  • Abdominal/stomach pain or cramps
  • Black, tarry stools
  • Bloating/swelling of the arms, hands, face, feet, or lower legs
  • Labored or difficult breathing
  • Pale skin
  • Painful/difficult urination
  • Pain in the legs or arms
  • Muscle stiffness, aches, or cramps
  • Light-colored stools
  • Joint pain
  • Fever or chills
  • Severe, throbbing headache
  • Side or lower back pain
  • Mental/mood changes
  • Shortness of breath
  • Yellow skin and eyes
  • Unusual weight loss or gain
  • Unusual bruising/bleeding
  • Ulcers, white spots, or sores inside the mouth or on the lips
  • Unusual behavior, including disorientation to place or time, failure to recognize others, restlessness, or hyperactivity

Some Isosorbide Dinitrate/Hydralazine side effects may happen that normally don't need to be medically treated. These side effects can disappear during treatment as you get used to the drug. In addition, your doctor may be able to recommend ways to relieve or prevent some of the effects below. Check with your healthcare provider if any of the effects below persist, bother you, or you've got questions about them.

More common:

Less common:

  • Runny/stuffy nose
  • Tenderness or pain around the cheekbones and eyes
  • Cough
  • Numbness, crawling, burning, itching, prickling, tingling, or œpins and needles feelings

Incidence unknown:

  • Stomach discomfort or soreness
  • Sensation of spinning
  • Feeling of warmth
  • Inability to keep or have an erection
  • Feeling of continuous movement of surroundings or self
  • Change in color of urine
  • Continuing buzzing, ringing, or other unusual noise in ears
  • Pinpoint purple or red spots on skin
  • Redness of the neck, arms, face, and at times upper chest

These aren't all the possible Isosorbide Dinitrate/Hydralazine side effects that can occur. If you've got questions about these side effects, give your physician a call. For medical advice regarding side effects, call your physician.

Dosage

Take Isosorbide Dinitrate/Hydralazine exactly as ordered by your healthcare professional. Don't use less or more of it, don't use it more often than directed, and don't use it beyond the prescribed period of time.

The dose of Isosorbide Dinitrate/Hydralazine will vary with patients. Please follow the instructions on the label or your doctor's directions. The information below only includes the regular doses of Isosorbide Dinitrate/Hydralazine. If you've been prescribed a different dose, don't adjust it unless you're told to by your doctor.

The amount of Isosorbide Dinitrate/Hydralazine you use depends on its strength. Moreover, the number of Isosorbide Dinitrate/Hydralazine doses you take daily, the time permitted between doses, as well as the duration in which you take Isosorbide Dinitrate/Hydralazine depend on the condition for which you're taking the medication.

For treating heart failure, adults should start with one tablet taken thrice a day. Your healthcare professional may alter your dose if necessary. Each tablet has 37.5 milligrams of Hydralazine and 20 milligrams of Isosorbide Dinitrate.

As for children, the dose and use of Isosorbide Dinitrate/Hydralazine must be decided by your doctor.

Take any missed dose as soon as you can. Don't take double doses to compensate for missed ones.

Symptoms of an Isosorbide Dinitrate/Hydralazine overdose can include severe dizziness, chest pain, confusion, throbbing headache, fast heartbeats, and tingling or warmth under the skin.

If you think there has been an overdose, contact an emergency room or poison control facility as soon as possible at 1-800-222-1222.

Interactions

Some products that might interact with Isosorbide Dinitrate/Hydralazine include: Riociguat, certain medications for treating migraine headaches (e.g. ergot alkaloids like Ergotamine), drugs for treating pulmonary hypertension (e.g. Tadalafil, Sildenafil) or erectile dysfunction (ED), and MAO inhibitors (e.g. Methylene Blue, Linezolid, Moclobemide, Procarbazine, Phenelzine, Rasagline, Tranylcypromine, Selegiline, Safinamide).

This medication can also interact with these medications:

Medicines for treating mental depression
Medicines for treating high blood pressure
Other medicines for treating heart failure or angina

Some products contain ingredients that may make your heart failure worse. Report all products you're using to your pharmacist, and ask how you can safely use them (especially diet aids, cold and cough products, or NSAIDs like naproxen or ibuprofen).

Isosorbide Dinitrate works almost like Isosorbide Mononitrate. While taking Isosorbide Dinitrate/Hydralazine, don't take medicines containing Isosorbide Mononitrate.

This medicine may interfere with some lab tests (such as cholesterol levels in the blood), possibly producing incorrect test results. Be sure to let your doctor and lab personnel know you use Isosorbide Dinitrate/Hydralazine.

Warnings

Before taking Isosorbide Dinitrate/Hydralazine, tell your healthcare professional if you:

If you suffer from any of the above conditions, you may need special monitoring or an adjustment of dosage during treatment. You may also be advised to not take Isosorbide Dinitrate/Hydralazine.

It's unclear whether Isosorbide Dinitrate/Hydralazine will affect a fetus. Don't take this drug without first consulting your healthcare professional if you're pregnant.

It's also unclear whether Isosorbide Dinitrate/Hydralazine passes into human milk. Please talk to your healthcare professional first before using Isosorbide Dinitrate/Hydralazine while breastfeeding.

If you're older than 60, you're more likely to suffer dizziness after using Hydralazine. You may need special monitoring during treatment or a lower dose.

It's vital that your healthcare professional checks your progress regularly to ensure that Isosorbide Dinitrate/Hydralazine is working well and to test for adverse effects.

Have your blood pressure and heart rate checked regularly while you're using Isosorbide Dinitrate/Hydralazine. Ask your healthcare professional or doctor what your blood pressure and heart rate should be as well as when to contact him/her. Inform your healthcare professional or doctor if you feel that this medication isn't working anymore.

Don't take Riociguat (Adempas), Avanafil (Stendra), Sildenafil (Viagra), Vardenafil (Levitra), or Tadalafil (Cialis) while you're using Isosorbide Dinitrate/Hydralazine. Using any of these medications together with Isosorbide Dinitrate/Hydralazine can cause severe dizziness, blurred vision, fainting, or lightheadedness. If you're using these medications and you suffer an angina attack, you'll need to make your way to the hospital straight away.

Faintness, lightheadedness, or dizziness may happen, especially when you quickly get up from a sitting/lying position. It may be wise to get up slowly.

Faintness, lightheadedness, or dizziness is also highly likely to happen if you take alcohol, work out, stand for prolonged periods, or stay in hot weather. While you're taking Isosorbide Dinitrate/Hydralazine, carefully limit your alcohol intake. Also exercise extra caution in hot weather or during exercise or if you need to stand for extended periods of time.

Call up your doctor straight away if you suffer fever, joint pain, chest pain, or unusual tiredness/weakness. These symptoms may indicate an autoimmune disease known as systemic lupus erythematosus.

Isosorbide Dinitrate/Hydralazine may cause nerve issues. Give your doctor a call at once if you have itching, burning, crawling, numbness, tingling, prickling, or œpins and needles feelings.

Don't treat yourself for colds, coughs, or pain while you're using Isosorbide Dinitrate/Hydralazine without seeking advice from your healthcare professional. Some ingredients in Isosorbide Dinitrate/Hydralazine may raise your blood pressure.

You may suffer a headache while taking Isosorbide Dinitrate/Hydralazine, but don't stop using the medication. To treat your headache, take Acetaminophen or Aspirin. Ask your doctor about which medication is right for you. Headaches usually disappear with continued treatment with Isosorbide Dinitrate/Hydralazine.

Don't stop using Isosorbide Dinitrate/Hydralazine suddenly. Before you stop using the medication completely, consult your doctor.

Your doctor may decide to decrease or increase your dose of Isosorbide Dinitrate/Hydralazine, or even discontinue treatment with Isosorbide Dinitrate/Hydralazine if any severe side effects occur, which would make your problem worse or if your problem doesn't improve.

Inform your healthcare professional about any allergy you have to any type of drug, prescription or nonprescription. This is vital because Isosorbide Dinitrate/Hydralazine may have inactive ingredients that may bring about certain interactions.

Losing fluids (due to vomiting, diarrhea, or sweating) or not taking enough fluids while taking Isosorbide Dinitrate/Hydralazine may cause fainting or low blood pressure. Ask your doctor how much fluid you should take each day.

Storage

Keep Isosorbide Dinitrate/Hydralazine at room temperature in a sealed container. Keep it away from direct light, moisture, and heat.

Keep Isosorbide Dinitrate/Hydralazine out of children's reach. Don't keep medicine you no longer need or outdated medicine.

Ask your healthcare provider how you should safely throw away any medication you don't use.

Summary

Isosorbide Dinitrate/Hydralazine may cause lightheadedness or dizziness. These effects could be more serious if you take Isosorbide Dinitrate/Hydralazine with certain medications or alcohol. Use this medication carefully. Don't drive or carry out other potentially hazardous tasks until you're aware of how you respond to Isosorbide Dinitrate/Hydralazine.

Don't use medicines that can cause drowsiness (e.g. muscle relaxers, sleep aids) or drink alcohol while using Isosorbide Dinitrate/Hydralazine; it may worsen their effects. If you've got any questions about which medications may cause drowsiness, ask your pharmacist and doctor.

Isosorbide Dinitrate/Hydralazine may cause fainting, lightheadedness, or dizziness. Hot weather, exercise, alcohol, fever, diarrhea, excessive sweating, vomiting, or low fluid intake can worsen these effects. Please stand slowly or sit up to prevent these effects, particularly in the morning. As soon as you experience dizziness, weakness, or lightheadedness, lie down or sit. If fainting happens, promptly notify your doctor.

Isosorbide Dinitrate/Hydralazine may cause a deficiency of vitamin B. For more information, speak to your healthcare professional or doctor.

Before you undergo any dental or medical care, surgery, or emergency care, tell your dentist or doctor that you take Isosorbide Dinitrate/Hydralazine.

Lab tests, e.g. blood pressure tests, may be carried out while you use Isosorbide Dinitrate/Hydralazine. These tests can be used to test for side effects or monitor your condition. Be sure to honor all your lab and doctor appointments.

Use Isosorbide Dinitrate/Hydralazine carefully in older adults as they could be more vulnerable to its effects.

If you get pregnant, inform your healthcare professional. You'll need to discuss the pros and cons of using Isosorbide Dinitrate/Hydralazine while you're pregnant. It's unclear whether Isosorbide Dinitrate/Hydralazine gets into human milk. If you're going to breastfeed while using this medication, consult your doctor first.

Resources
Last Reviewed:
March 26, 2018
Last Updated:
April 16, 2018