Pronunciation:

eye-soe-SOR-bide dye-NYE-trate, hye-DRAL-a-zeen hye-droe-KLOR-ide

Brand Names:

• BiDil

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antianginal

Chemical—

Nitrate

Uses of This Medicine:

Isosorbide dinitrate and hydralazine combination is used to treat heart failure in black patients.

Isosorbide dinitrate belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load.

Hydralazine works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of isosorbide dinitrate and hydralazine combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of isosorbide dinitrate and hydralazine combination in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients receiving isosorbide dinitrate and hydralazine combination.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Avanafil
• Riociguat
• Sildenafil
• Tadalafil
• Vardenafil

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Enteral Nutrition

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic reaction to nitrates, history of—Should not be used in patients with these condition.

• Hypertrophic cardiomyopathy (a heart disease) or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

unusual tiredness or weakness

Less common

Fainting

fast, pounding, or irregular heartbeat or pulse

Incidence not known

Abdominal or stomach cramps or pain

black, tarry stools

bloating or swelling of the face, arms, hands, lower legs, or feet

chest pain or discomfort

dark urine

diarrhea

difficult or labored breathing

fever or chills

headache, severe and throbbing

joint pain

light-colored stools

lower back or side pain

mood or mental changes

muscle aches, cramps, or stiffness

pain in the arms or legs

painful or difficult urination

pale skin

shortness of breath

sores, ulcers, or white spots on the lips or inside the mouth

unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness

unusual bruising or bleeding

unusual weight gain or loss

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

headache

nausea or vomiting

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

cough

pain or tenderness around the eyes and cheekbones

stuffy or runny nose

Incidence not known

Change in urine color

continuing ringing, buzzing or other unexplained noise in the ears

feeling of constant movement of self or surroundings

feeling of warmth

inability to have or keep an erection

pinpoint red or purple spots on the skin

redness of the face, neck, arms and occasionally, upper chest

sensation of spinning

stomach soreness or discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.