Isosorbide dinitrate and hydralazine (Oral)

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

Isosorbide dinitrate is part of a group of medicines called nitrates. It helps by relaxing blood vessels, which increases the blood and oxygen supply to the heart and lowers its workload.

Hydralazine also works by relaxing blood vessels, increasing the blood and oxygen supply to the heart, and reducing its workload.

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

It is important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to look for unwanted effects.

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

Dizziness, lightheadedness, or faintness may happen, especially when getting up quickly from a lying or sitting position. Getting up slowly may help.

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

Call your doctor immediately if you experience chest pain, fever, joint pain, or unusual tiredness or weakness. These may be signs 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.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as those to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how isosorbide dinitrate and hydralazine combination affects children. Safety and effectiveness have not been established.

Geriatric

So far, studies have not shown any specific problems in elderly patients that would limit the usefulness of isosorbide dinitrate and hydralazine combination. However, older adults are more likely to have liver or kidney problems related to age, which may require caution and a dose adjustment for those taking isosorbide dinitrate and hydralazine combination.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together with caution. If you are taking this medicine, it is very important for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions are significant but not a complete list.

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

• Avanafil
• Riociguat
• Sildenafil
• Tadalafil
• Vardenafil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco may also cause interactions. The following interactions are significant but not a complete list.

Using this medicine with any of the following may increase the chance of certain side effects, but it may be unavoidable in some cases. If used together, your doctor may need to adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Enteral Nutrition

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor about any other medical issues, especially:

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

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

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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
• Severe and throbbing headache
• 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. Your healthcare professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your healthcare 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.

In the U.S.

• BiDil

Available Dosage Forms:

• Tablet

Therapeutic Class: Antianginal

Chemical Class: Nitrate

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.