Isosorbide dinitrate and hydralazine (oral route)

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.

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.

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.

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.

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

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

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.

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

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