BiDil. Complete Information.
Brand Name
BiDil
Generic Ingredients
Isosorbide Dinitrate Hydralazine Hydrochloride Type of Drug
Vasodilator combination. Prescribed For
Heart failure in black patients, in combination with other heart-failure treatments.
General Information
BiDil is a combiRatiZ0 101 Iwo drugs that dilate (open) both arter-
2nd veins. It is the first drug product to be specifically approved for people in a single racial group for any indication. The 2 ingredients in BiDil have been available generically for years and are prescribed for a variety of uses. Isosorbide dinitrate is prescribed for angina, heart failure, and spasms of the esophagus. Hydralazine hydrochloride is prescribed to treat high blood pressure and heart failure. When people with heart failure take this drug combination, it makes it easier for the heart to pump blood throughout the body by widening arteries and veins.
Cautions and Warnings
Do not take BiDil if you are allergic or sensitive to any of its ingredients.
Do not use erectile dysfunction drugs with BiDil.
This drug may be inappropriate for you if you have had a recent heart attack or have cardiomyopathy (loss of blood-pumping ability due to damaged heart muscle) or low blood pressure, especially postural low blood pressure (symptoms include dizziness or fainting when rising from a sitting or lying position).
Long-term administration of more than 200 mg a day of hydralazine may produce symptoms of lupus erythematosus (a chronic condition affecting the body’s connective tissue), including muscle and joint pain, skin reactions, fever, kidney inflammation, and anemia, although they usually disappear when the drug is discontinued. Report any fever, chest pain, feelings of ill health, or other unexplained symptoms to your doctor. The risk of developing lupus increases with higher dosages; approximately 5 out of 100 and 10% of people taking 200 mg a day of hydralazine develop lupus. The daily dosage of hydralazine when you take BiDil can be as high as 225 mg.
Hydralazine may cause a very rapid heartbeat, potentially leading to angina pain or a heart attack.
Taking pyridoxine (vitamin B6) may relieve tingling or numbness in the hands or feet caused by hydralazine.
Possible Side Effects
✓ Most common: headache and flushing—which should disappear after your body adjusts to the drug—nausea, dizziness, weakness, and chest pain.
✓ COmmQR*, k(a% UM16 pressure.
✓ Less common: blurred vision and dry mouth; sinus irritation, rapid heartbeat, heart palpitations, high blood sugar, runny nose, numbness or tingling in the hands or feet, vomiting, and high blood-fat levels.
Possible Side Effects (continued)
V Rare-. flushing, tearing, itching, or redness of the eyes, trem-
ors, muscle cramps, depression, disorientation, anxiety,
itching, rash, fever, chills, occasional hepatitis (symptoms
include yellowing of the skin or whites of the eyes), con-
stipation, urinary difficulties, and adverse effects on nor-
mal blood composition. Other side effects may affect any
organ or organ system. Contact your doctor if you experi-
ence any side effect not listed above.
Drug Interactions
• Do not take sildenafil, vardenafil, or taldenafil with Bidil. The combination can result in a rapid and potentially fatal drop in blood pressure.
• Taking this drug with a monoamine oxidase inhibitor antidepressant may increase the blood-pressure-lowering effect of the hydralazine component of BiDil. This combination should be used with caution.
• Do not self-medicate with over-the-counter appetite suppressants and cough, cold, and allergy remedies, since many contain ingredients that may aggravate heart disease.
• Taking this drug with large amounts of alcohol may rapidly lower blood pressure, resulting in weakness, dizziness, and fainting.
Food Interactions
Take this drug on an empty stomach. It is unknown how food affects BiDil.
Usual Dose
Adult: 1 or 2 tablets 3 times a day, 1 hour before or 2 hours after eating.
Overdosage
There have been no reports of BiDil overdose. Symptoms of INID11
overdose would be related to the Specific effects of each active in-
2ind can include reduced oxygen supply to heart muscle,
leading to a heart attack, abnormal heart rhythms, and profound
shock. Fainting, coma, and death may follow unless the victim is
treated. Overdose victims must be taken to a hospital emergency
room at once. ALWAYS bring the prescription bottle or container.
Special Information
Avoid alcohol. headache, dizzi-
Call your doctor if you develop a persistent hea ,
ness, facial flushing, blurred vision, or dry mouth.
It is important to make sure you drink plenty of fluids every day and pay attention to hot weather and exercise situations in which you might lose unusual amounts of fluids and salts. Fluid loss may lead to low blood pressure, dizziness, and possibly fainting.
If you forget to take a dose of BiDil, take it as soon as you remember. If it is almost time for your next dose, skip the dose you forgot and continue with your regular schedule. Never take a double dose.
Special Populations
PregnancylBreast-feeding., Isosorbide dinitrate crosses into the fetal circulation, and hydralazine can cause low blood pressure in pregnant women and their babies. The potential benefits of B01 must be carefully weighed against its risks when your doctor considers this drug crucial.
it is not known if BiDil passes into breast milk. Nursing mothers who must take it should consider using infant formula. Seniors: Specifics about how seniors react to this drug are not
known. The lowest effective dose of BiDil should always be used, especially in people with reduced kidney and/or liver function.