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(isosorbide dinitrate and hydralazine hydrochloride) Tablets for Oral Administration
BiDil is a fixed-dose combination of isosorbide dinitrate, a vasodilator with effects on both arteries and veins, and hydralazine hydrochloride, a predominantly arterial vasodilator.
Isosorbide dinitrate is described chemically as 1,4:3,6-dianhydro-D-glucitol dinitrate and its structural formula is:
Isosorbide dinitrate is a white to off-white, crystalline powder with the empirical formula C6H8N2O8 and a molecular weight of 236.14. It is freely soluble in organic solvents such as alcohol, chloroform and ether, but is only sparingly soluble in water.
Hydralazine hydrochloride is described chemically as 1-hydrazinophthalazine monohydrochloride, and its structural formula is:
Hydralazine hydrochloride is a white to off-white, crystalline powder with the empirical formula C8H8N4•HCl and a molecular weight of 196.64. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether.
Each BiDil Tablet for oral administration contains 20 mg of isosorbide dinitrate and 37.5 mg of hydralazine hydrochloride.
The inactive ingredients in BiDil tablets include: anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, hypromellose, FD&C Yellow No. 6 aluminum lake, polyethylene glycol, titanium dioxide, polysorbate 80.
What are the possible side effects of hydralazine and isosorbide dinitrate (BiDil)?
If you experience any of the following serious side effects, stop taking hydralazine and isosorbide dinitrate and seek emergency medical attention:
- an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
- blurred vision and dry mouth;
- irregular heartbeat; or
- blood in your urine or stools;
- numbness, tingling, pain, or weakness of your arms or legs;
Other, less serious side effects may be more likely to occur. If you experience any of the...
What are the precautions when taking isosorbide dinitrate and hydralazine hcl (BiDil)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to either isosorbide dinitrate or hydralazine; or to similar drugs (such as isosorbide mononitrate, nitroglycerin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other heart problems (such as recent heart attack, rheumatic heart disease of the mitral valve), previous stroke, low blood pressure, blood vessel problems, loss of too much body water (dehydration), recent head injury, anemia, kidney problems.
This drug may make you dizzy. Do not drive, use machinery, or...
Last reviewed on RxList: 5/27/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional BiDil Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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