BiDil contains a combination of hydralazine and isosorbide dinitrate. Hydralazine is a vasodilator. It relaxes (widens) veins and arteries, which makes it easier for your heart to pump. Isosorbide dinitrate is in a group of drugs called nitrates. Isosorbide dinitrate dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

BiDil is used to treat heart failure in certain patients.

BiDil may also be used for purposes not listed in this medication guide.

Do not use BiDil if you are taking medicine to treat erectile dysfunction or pulmonary arterial hypertension (PAH). This includes sildenafil (Viagra, Revatio), avanafil (Stendra), tadalafil (Cialis, Adcirca), vardenafil (Levitra, Staxyn), and riociguat (Adempas). Serious, life-threatening side effects may occur.

You may develop a headache caused by BiDil, but do not stop taking it. Take aspirin or acetaminophen to treat the headache. Ask your doctor which is best for you. This side effect usually goes away with continued BiDil treatment.

Do not stop taking BiDil suddenly. Talk to your doctor before you stop taking the drug completely. Do not drink alcohol while taking this medication. Use caution when driving, operating machinery, or performing other hazardous activities. BiDil may cause dizziness. If you experience dizziness, avoid these activities.

Before taking this medicine

You should not use BiDil if you are allergic to hydralazine, isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin.

To make sure BiDil is safe for you, tell your doctor if you have:

• lupus;

• low blood pressure; or

• pulmonary arterial hypertension.

It is not known whether BiDil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether hydralazine and isosorbide dinitrate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Take BiDil exactly as directed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You should not stop using BiDil suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose of BiDil for Congestive Heart Failure:

Initial dose: Hydralazine 37.5 mg-Isosorbide dinitrate 20 mg orally three times a day
Maximum dose: Hydralazine 75 mg-Isosorbide dinitrate 40 mg orally three times a day

Comments:
-May titrate up every 3 to 5 days, but some patients may experience side effects and take longer to reach their maximum tolerated dose.
-May decrease as low as hydralazine 18.75 mg-isosorbide dinitrate 10 mg three times a day if intolerable side effects occur; should titrate up as soon as side effects subside.

Use: Treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure, and improve patient-reported functional status. Experience in patients with New York Heart Association (NYHA) class IV heart failure is limited.

You should not use BiDil if you are allergic to hydralazine, isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin.

To make sure BiDil is safe for you, tell your doctor if you have:

• lupus;

• low blood pressure; or

• pulmonary arterial hypertension.

It is not known whether BiDil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether hydralazine and isosorbide dinitrate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include warmth or tingly feeling under your skin, confusion, severe dizziness, throbbing headache, fast heartbeats, and chest pain.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol with BiDil can cause side effects.

Get emergency medical help if you have signs of an allergic reaction to BiDil: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine can cause headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use the medicine. Do not stop taking BiDil. Call your doctor before using any headache pain medication.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• numbness or tingling in your hands or feet;

• joint pain or swelling;

• fever, chest pain, general ill feeling;

• fast heart rate;

• shortness of breath that is worse than usual; or

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Some side effects may be more likely in older adults.

Common BiDil side effects may include:

• headache; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with hydralazine and isosorbide dinitrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.