Bidil

(Isosorbide Dinitrate/Hydralazine Hydrochloride)

The active ingredients in BiDil are isosorbide dinitrate and hydralazine hydrochloride.

Isosorbide dinitrate is a nitrate that relaxes and widens blood vessels, lowering the workload on the heart. Hydralazine is a vasodilator that helps the arteries open, improving blood flow and reducing strain on the heart muscle. When used together, these ingredients help improve symptoms of heart failure and support better blood pressure control.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using BiDil. However, the following is a synopsis of the general guidelines for the use of BiDil:

• BiDil is taken by mouth, usually three times a day.
• Take each dose at the same time every day to keep the medication in your system consistently.
• Swallow the tablets with a full glass of water.
• Your doctor may gradually adjust your dose to find the right amount for you.
• If you miss a dose, take it as soon as you remember, unless it is close to the time of your next dose. Skip the missed dose; do not double up.
• Keep taking BiDil even if you feel well unless your healthcare provider tells you to stop.
• Your doctor may monitor your blood pressure, symptoms, and other medications to ensure BiDil remains safe and effective.

Some mild or common side effects of BiDil seen in clinical trials as compared to placebo include:

• Headache.
• Dizziness or lightheadedness.
• Flushing.
• Low blood pressure.
• Rapid heartbeat.
• Nausea.
• Nasal congestion.

Some individuals may experience serious side effects while using BiDil. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Fainting.
• Chest pain or signs of a heart attack.
• Severe drop in blood pressure.
• Signs of an allergic reaction, such as hives, swelling, or difficulty breathing.
• Worsening heart failure symptoms such as swelling, shortness of breath, or sudden weight gain.

These are not all of the possible side effects of BiDil. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting BiDil, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Low blood pressure or a history of fainting.
• Coronary heart disease or angina.
• Heart attack history.
• Congestive heart failure.
• Hypertrophic cardiomyopathy.
• Liver disease.
• Kidney disease.
• Anemia.
• Any allergies to nitrates, hydralazine, or other medications.
• Erectile dysfunction medications (you must disclose these).
• A history of lupus-like symptoms from hydralazine.
• Any supplements or over-the-counter medicines you routinely take.

BiDil should not be used in individuals who:

• Are taking PDE-5 inhibitors such as sildenafil, tadalafil, vardenafil, or avanafil. These combinations can cause life-threatening low blood pressure.
• Are taking riociguat.
• Have a known allergy to isosorbide dinitrate, hydralazine, or any component of the tablets.
• Have severe low blood pressure.

Some people may notice improvement in symptoms such as shortness of breath or fatigue within a few weeks. However, full benefits often develop over several weeks to months as the heart responds to treatment. Your healthcare provider will assess your progress and may adjust your dose based on your response.

When BiDil is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Sildenafil, tadalafil, vardenafil, or avanafil. These combinations may cause severe, dangerous drops in blood pressure.
• Riociguat. This medicine also affects blood vessels and can increase the risk of life-threatening hypotension.
• Other nitrates or nitroglycerin products. May cause dangerously low blood pressure.
• Taking any erectile dysfunction or pulmonary hypertension drugs like Viagra ® or Revatio ™ (sildenafil), Levitra ® (vardenafil), or Cialis ® (tadalafil).

BiDil is available as a fixed-dose combination dosage form, tablets containing:

• 20 mg isosorbide dinitrate and 37.5 mg hydralazine hydrochloride.

Your healthcare provider will determine the right number of tablets per day.

Store at room temperature and keep out of reach of children.

BiDil is manufactured by Arbor Pharmaceuticals..

There is no FDA-approved generic version of BiDil currently available.

Do not stop taking BiDil without speaking with your healthcare provider. Suddenly stopping the medication may cause your symptoms to worsen or increase your risk of chest pain or heart-related complications. If you experience side effects or feel BiDil is not helping, talk to your doctor before making any changes.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Hydralazine has been used during pregnancy, but isosorbide dinitrate should be used only if the potential benefits outweigh the risks.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. Small amounts of hydralazine may pass into breast milk.