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Isosorbide dinitrate and hydralazine (Oral route)

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.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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
  • food

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.


Last Updated: 9/15/2016
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