Isosorbide dinitrate and hydralazine

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take isosorbide dinitrate and hydralazine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to isosorbide dinitrate and hydralazine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

• Antihypertensive
• Vasodilator

Hypersensitivity to organic nitrates or any component in the formulation; concomitant use with phosphodiesterase 5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil); concomitant use with riociguat

Heart failure: Oral:

Initial: One tablet 3 times daily.

Maintenance: May titrate in 3 to 5 days to a maximum dose of 2 tablets 3 times daily.

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

The following events were reported in the A-HeFT Study using the combination isosorbide dinitrate/hydralazine product. See individual drug monographs for additional information.

>10%:

Cardiovascular: Chest pain (16%)

Central nervous system: Headache (50%), dizziness (32%)

Neuromuscular & skeletal: Weakness (14%)

1% to 10%:

Cardiovascular: Hypotension (8%), palpitations (4%), ventricular tachycardia (4%), tachycardia (2%)

Central nervous system: Paresthesia (4%), drowsiness (1%), malaise (1%)

Dermatologic: Alopecia (1%), diaphoresis (1%)

Endocrine & metabolic: Hyperglycemia (4%), hyperlipidemia (3%), hypercholesterolemia (1%)

Gastrointestinal: Nausea (10%), vomiting (4%), cholecystitis (1%)

Hypersensitivity: Angioedema (1%), hypersensitivity reaction (1%)

Neuromuscular & skeletal: Arthralgia (1%), myalgia (1%), tendon disease (1%)

Ophthalmic: Amblyopia (3%)

Respiratory: Bronchitis (8%), rhinitis (4%), sinusitis (4%)

Blood pressure (standing and sitting/supine), heart rate; CBC and antinuclear antibody (ANA) titers (if symptoms of systemic lupus erythematosus occur)

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea. Have patient report immediately to prescriber signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), severe headache, severe dizziness, passing out, angina, tachycardia, burning or numbness feeling, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.