Isosorbide Dinitrate-Hydralazine

Isosorbide Dinitrate-Hydralazine is a prescription medication  is a combination of a nitrate and a vasodilator used to treat heart failure.

• Isosorbide Dinitrate-Hydralazine is available under the following different brand names: BiDil

Adult and geriatric dosage

Tablet

• 20 mg / 37.5 mg

Heart Failure

Adult and geriatric dosage

• 1 tablet every 8 hours; titrate dose to effect; not to exceed 2 tablets orally every 8 hours; may decrease dose to as little as 1/2 tab every 8 hours if intolerable side effects occur; as soon as side effects subside, effort should be made to titrate up

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Isosorbide Dinitrate-Hydralazine include:

• headache,
• dizziness,
• light-headedness,
• weakness,
• nausea,
• vomiting,
• fast heartbeat,
• swollen ankles, and
• flushing (redness of the face, neck, and chest)

Serious side effects of Isosorbide Dinitrate-Hydralazine include:

• numbness and tingling,
• severe tiredness,
• aching/swollen joints,
• rash on the nose and cheeks,
• swollen glands,
• change in the amount of urine,
• bloody or pink urine,
• signs of infection (such as fever, chills, persistent sore throat),
• easy bruising or bleeding,
• fainting, or
• irregular or pounding heartbeat.

Rare side effects of Isosorbide Dinitrate-Hydralazine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Isosorbide Dinitrate-Hydralazine has severe interactions with the following drugs:

• avanafil
• riociguat
• sildenafil
• tadalafil
• vardenafil

Isosorbide Dinitrate-Hydralazine has serious interactions with the following drugs:

• abametapir
• apalutamide
• cabergoline
• carbamazepine
• ergoloid mesylates
• ergotamine
• fexinidazole
• fosphenytoin
• idelalisib
• ivosidenib
• levoketoconazole
• lofexidine
• lonafarnib
• methylergonovine
• pexidartinib
• phenobarbital
• phenytoin
• pretomanid
• tucatinib

Isosorbide Dinitrate-Hydralazine has moderate interactions with at least 129 other drugs.

Isosorbide Dinitrate-Hydralazine has minor interactions with the following drugs:

• acetylcysteine (Antidote)
• agrimony
• brimonidine
• celiprolol
• cornsilk
• diazoxide
• forskolin
• maitake
• pyridoxine
• pyridoxine (Antidote)
• reishi
• rifampin
• rifapentine
• ruxolitinib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Allergy to organic nitrates
• Concomitant use with PDE-5 inhibitors (e.g., avanafil, sildenafil, tadalafil, or vardenafil)
• Concomitant use with soluble guanylate cyclase (sGC) stimulators (e.g., riociguat)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Isosorbide Dinitrate-Hydralazine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Isosorbide Dinitrate-Hydralazine?”

Cautions

• Paradoxical bradycardia may occur
• Use caution in pulmonary hypertension
• Caution in patients with coronary artery disease or tachycardia
• Caution is suspected right ventricular infarction or acute MI
• Even small doses may cause symptomatic hypotension, particularly with upright posture; most likely to occur in patients who have been volume or salt depleted; correct before initiation of therapy
• Hydralazine may cause symptomatic lupus erythematosus syndromes; consider discontinuation if clinically appropriate
• May cause tachycardia and hypotension, potentially leading to myocardial ischemia and angina, particularly in patients with hypertrophic cardiomyopathy
• Associated with peripheral neuritis, which may cause paresthesia, numbness, and tingling that may result from an antipyridoxine effect; add pyridoxine to therapy if such symptoms develop

Pregnancy and Lactation

• There are no data on use in pregnant women, and insufficient data on its components (hydralazine and isosorbide dinitrate) to assess a drug-associated risk of major birth defects or miscarriage with first-trimester use; available published data on hydralazine use in pregnancy during second and third trimesters have not shown an association with adverse pregnancy-related outcomes
• Pregnant women with heart failure are at increased risk for preterm birth; clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth
• Lactation
  • There are no data on the presence the of the drug in human or animal milk, effects on the breastfed infant, or milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from the drug or underlying maternal condition