Isosorbide Dinitrate/Hydralazine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat heart failure. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Using some medicines while you take this one may cause severe or life-threatening low blood pressure. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: vasodilator; antihypertensive

Generic and brand names: isosorbide dinitrate/hydralazine, oral; BiDil

What is this medicine used for?

This medicine is taken by mouth to treat heart failure. It is used along with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA), or head injury
• Anemia
• Glaucoma
• Heart attack, heart valve disease, or angina
• Kidney or liver disease
• Lupus
• Low or high blood pressure

Also, tell your healthcare provider if you are on a low-sodium diet.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Take it regularly, even if you feel better.

Talk with your healthcare provider about how much liquid you should drink each day while taking this medicine. Follow your provider's instructions about exercise, diet, and taking vitamin supplements.

Check with your healthcare provider before using this medicine in children under age 18.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: weakness, fainting, lightheadedness, dizziness, fast heartbeat, flushing, headache, confusion, chest pain.

What should I watch out for?

Do not take sildenafil (Viagra, Revatio), tadalafil (Adcirca, Cialis), or vardenafil (Levitra, Staxyn) while you are taking this medicine. Using these medicines together may cause severe or life-threatening low blood pressure. Taken with high blood pressure medicines, this medicine may cause extreme low blood pressure. Tell your provider about all the medicines you take.

This medicine may cause nerve problems. Tell your healthcare provider if you have numbness or tingling. Your healthcare provider may recommend you take pyridoxine (vitamin B6).

Your healthcare provider may want to see you regularly to check your blood pressure.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. If you feel dizzy or faint while you are standing, lie down for a while and then get up slowly. Do not drive or operate machinery unless you are fully alert.

You may get a headache when you first start taking this medicine. This is a sign that the medicine is starting to work. If the headache is severe, contact your healthcare provider. Headaches should go away as your body adjusts to the medicine. Ask your healthcare provider whether you should take aspirin or acetaminophen (Tylenol) to relieve these headaches.

This medicine may increase the risk of dizziness or fainting if you drink alcohol, exercise, stand for a long time, have fluid loss from vomiting or diarrhea, or are active in hot weather. Do not drink alcohol unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist that you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): New or worsening chest pain; joint pain or swelling; sore throat; fever; unusual tiredness or weakness; numbness, tingling, pain, or weakness in hands or feet; fast or irregular heartbeat; severe dizziness or lightheadedness; fainting; severe thirst; unusual bruising or bleeding; yellowing of your skin or eyes; trouble urinating; blurred vision or other vision problems; confusion; severe or ongoing headache.

Other: Diarrhea, mild headache, nausea, vomiting, mild dizziness, drowsiness, runny or stuffy nose, weakness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antibiotics such as chloramphenicol, clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as desipramine (Norpramin) and nefazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, sotalol (Betapace, Sorine), and timolol
• Bosentan (Tracleer)
• Calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and obinutuzumab (Gazyva)
• Cimetidine (Tagamet)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Diazoxide (Proglycem)
• Diuretics (water pills) such as amiloride, amiloride/hydrochlorothiazide, bumetanide, chlorthalidone, eplerenone (Inspra), furosemide (Lasix), hydrochlorothiazide (Microzide), metolazone (Zaroxolyn), spironolactone (Aldactone), spironolactone/hydrochlorothiazide (Aldactazide), torsemide (Demadex), triamterene (Dyrenium), and triamterene/hydrochlorothiazide (Dyazide, Maxzide)
• Dronedarone (Multaq)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Haloperidol (Haldol)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Isoxsuprine
• Levodopa/carbidopa (Duopa, Rytary, Sinemet)
• Lomitapide (Juxtapid)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat pulmonary hypertension such as riociguat (Adempas), sildenafil (Revatio), and tadalafil (Adcirca)
• Methyldopa
• Natural remedies such as bayberry, black cohosh, blue cohosh, California poppy, dong quai, ephedra, ginger, ginseng, goldenseal, hawthorn, licorice, mistletoe, shepherd's purse, St. John's wort, and yohimbe
• Nitrate medicines such as isosorbide (Dilatrate, Isordil, Monoket) and nitroglycerin (Minitran, Nitro-Dur, Nitrostat)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Procarbazine (Matulane)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rosiglitazone (Avandia)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.