Isosorbide dinitrate belongs to a class of drugs called nitrates and is specifically categorized as a nitrate vasodilator. Nitrates work to dilate blood vessels and improve blood flow.

BiDil is used to treat heart failure in certain people as an adjunct therapy (a drug used in combination with the primary treatment).

BiDil is available in an oral tablet form.

What Is BiDil Used For?

BiDil is prescribed for the treatment of heart failure as an addition to primary therapy in self-identified Black people. The treatment therapy with BiDil improves the quality of life and survival in African American people with heart failure.

Brand Name: BiDil

Drug Availability: Prescription

Therapeutic Classification: Antianginal

Available Generically: Yes

Controlled Substance: No

Administration Route: Oral

Active Ingredient: Hydralazine hydrochloride and isosorbide dinitrate

Dosage Form(s): Tablet

How to Take BiDil

Follow the prescription label carefully and ask your healthcare provider or pharmacist about anything you do not understand. Take one tablet, three times a day with or without food or as directed by your healthcare provider. 

To avoid missing the doses, take it at the same time each day. Do not stop taking BiDil without consulting your healthcare provider. Sudden discontinuation of the drug may worsen the condition. Your healthcare provider may gradually decrease your dose to ensure you do not get any withdrawal symptoms. Do not use hydralazine and isosorbide dinitrate more or less than prescribed or for longer than recommended.

Storage

Store BiDil at room temperature away from heat, light, and moisture in the container it came in. Keep all the medication out of reach of children. To protect children from poisoning, always lock safety caps and place the medication safely out of their sight and reach after use. Do not use expired medicines.

Discard all the unneeded medications. Do not flush the medication down the toilet; throw it in the bin; or dispose of it in the drain. Instead, dispose of your unnecessary medication through a medicine take-back program. Contact your pharmacist or your local waste control department to talk about medicine take-back programs in your community.

What Are the Side Effects of BiDil?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

As with all medications, BiDil can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

Common Side Effects

Common side effects of BiDil include:

Headache Dizziness Feelings of bodily weakness (asthenia) Nausea Low blood pressure (hypotension) Sinus infection (sinusitis) Body tingling (paresthesia) Lazy eye (amblyopia)

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

Severe lethargy  Serious rash on nose and/or cheeks Swollen lymph nodes Excessive urination  Blood in the urine (hematuria)  Signs of an infection (fever, chills, or sore throat) Random bruising  Fainting (syncope)  Irregular heartbeat (heart palpitations) Chest, jaw, or left arm pain

A severe allergic reaction to BiDil is rare. However, if you notice any symptoms of a severe allergic reaction, such as rash, itching/swelling of the face/tongue/throat, severe dizziness, or trouble breathing, get medical help right away.

Dosage: How Much BiDil Should I Take?

Modifications

Due to the possible effects of this medication, there may be changes to how BiDil is used. Users should be aware of the following before taking BiDil:

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For treatment of heart failure: For oral dosage form (tablets): Adults—At first, one tablet three times a day. Your doctor may adjust your dose as needed. Each tablet contains 20 milligrams (mg) of isosorbide dinitrate and 37. 5 mg of hydralazine. Children—Use and dose must be determined by your doctor.

Severe allergic reaction: Avoid using BiDil if you have a known allergy to it or any of its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you’re unsure.

Pregnancy: ​​There are no data on BiDil use in pregnant people, and insufficient data on its ingredients (hydralazine and isosorbide dinitrate) to assess a drug-associated risk of major birth defects or miscarriage with first-trimester use. 

Available published data on BiDil use in pregnancy during the second and third trimesters have not shown negative pregnancy-related outcomes. Regardless, if you are pregnant or planning to be pregnant, consult your healthcare provider before taking BiDil.

Breastfeeding: Caution is recommended with breastfeeding as there are limited data available on its effects. Talk with your healthcare provider if you plan to breastfeed, weigh the benefits and risks of taking BiDil while nursing, and the different ways available to feed your baby.

Adults over 65: The combination of hydralazine hydrochloride and Isosorbide dinitrate may be eliminated more slowly in older adults. The therapy should be initiated at low doses because of the possibility of decreased renal and hepatic function, diseases, and accompanying use of other medications.

Missed Dose

If you missed a dose of BiDil, take it as soon as you remember. If it is nearly the time for your next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses at one time to make up for the missed one.

Overdose: What Happens If I Take Too Much BiDil?

If someone has accidentally overdosed on BiDil, immediately contact the Poison Control Center. If the person feels like passing out, faints, or has difficulty breathing, call 911 right away for help. 

The overdose symptoms may include:

Fast heart rhythms (tachycardia) Sharp heart pain (angina) Confusion Dizziness Severe headache

If not treated, complications of overdose may include lack of oxygen to the heart (myocardial ischemia), heart attack (myocardial infarction), and irregular heart rhythm (atrial fibrillation) leading to shock, coma, and death.

Precautions

What Are Reasons I Shouldn’t Take BiDil?

BiDil is not appropriate for everyone. You should not take this medication if you are allergic to any of the inactive ingredients in BiDil.

If someone collapses or isn’t breathing after taking BiDil, call 911 immediately.

Do not take avanafil (Stendra®), riociguat (Adempas®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, severe dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Call your doctor right away if you have chest pain, fever, joint pain, or unusual tiredness or weakness. These may be symptoms of an autoimmune disease called systemic lupus erythematosus.

This medicine may cause nerve problems. Call your doctor right away if you have burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings.

BiDil may be used with caution in some people only if the healthcare provider determines it is safe. This includes people who are:

Allergic to organic nitrates Taking erectile dysfunction (ED) (PDE5) inhibitor drugs such as Stendra (avanafil), Viagra (sildenafil), or Cialis (tadalafil) Taking the soluble guanylate cyclase (sGC) stimulator Adempas (riociguat) as the concomitant use can cause hypotension

What Other Medications May Interact With BiDil?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter (OTC) medicines and vitamins or supplements.

BiDil interacts with some drugs when taken together. It may change how certain medications work and can increase the risk for serious side effects. 

Drugs that may interact negatively with BiDil include:

Tylenol (acetaminophen) Brompheniramine Codeine Veletri (epoprostenol) Amaryl (glimepiride) Glumetza (metformin)  Afrin nasal spray (oxymetazoline)

If taking any of the above medications, talk to your healthcare provider before using BiDil. You may need to avoid the medication or use a lower dose.

What Medications Are Similar?

BiDil is a relatively unique drug, combining two drugs from two different drug classes for specific people.

Consult your healthcare provider or pharmacist if you are trying to find a suitable OTC option to treat your symptoms. There are many products with similar names and ingredients, so you’ll want to ensure you pick the safest medication for you.

How Can I Stay Healthy While Taking BiDil?

BiDil is a combination drug having drugs from two different classes to improve the additional benefit in self-identified people of African descent with advanced heart failure. This subgroup has shown up a favorable response to this therapy.

Be careful while using a machine or driving unless you know how this drug affects you. Keep yourself affirmed and steady when standing up from a sitting or lying position to avoid dizziness. Keep all the appointments with your healthcare provider to get the maximum benefit from the therapy.