Hydralazine and isosorbide dinitrate

Hydralazine is a vasodilator. It relaxes (widens) veins and arteries, making it easier for your heart to pump.

Isosorbide dinitrate belongs to a group of drugs called nitrates. Isosorbide dinitrate widens blood vessels, allowing blood to flow more easily and helping the heart pump more easily.

Hydralazine and isosorbide dinitrate is a combination medicine used to treat heart failure.

Hydralazine and isosorbide dinitrate may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label. Your doctor may change your dose from time to time to ensure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than what is recommended.

You should not stop using hydralazine and isosorbide dinitrate suddenly. Stopping suddenly may make your condition worse.

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

Do not use hydralazine and isosorbide dinitrate if you are taking medicine for 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 happen.

Do not use hydralazine and isosorbide dinitrate if you are taking medicine for 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 should not use hydralazine and isosorbide dinitrate if you are allergic to hydralazine, isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin.

To ensure hydralazine and isosorbide dinitrate is safe for you, inform your doctor if you have:

• lupus;
• low blood pressure; or
• pulmonary arterial hypertension.

It is not known if this medicine can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known if 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.

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

hydralazine and isosorbide dinitrate 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 hydralazine and isosorbide dinitrate. Call your doctor before using any headache pain medication.

Hydralazine and isosorbide dinitrate may cause serious side effects. 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 side effects of hydralazine and isosorbide dinitrate 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.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: Hydralazine 37.5 mg-Isosorbide dinitrate 20 mg orally three times a dayMaximum dose: Hydralazine 75 mg-Isosorbide dinitrate 40 mg orally three times a dayComments:-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.

Follow all instructions on your prescription label. Your doctor may sometimes adjust your dose to ensure you achieve the best results. Do not use hydralazine and isosorbide dinitrate in larger or smaller amounts or for longer than advised.

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

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

hydralazine and isosorbide dinitrate 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 this medicine can cause side effects.

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