Bidil label

Bidil

Bidil Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors such as sildenafil, vardenafil, or tadalafil could result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Reasonable supportive care should consist of those measures used to treat a nitrate overdose with elevation of the extremities and central volume expansion.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.

History

There is currently no drug history available for this drug.

Other Information

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-2,5-dinitrate and its structural formula is:

Chemical Structure

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:

Chemical Structure

Hydralazine HCl 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.

Bidil Manufacturers

  • Arbor Pharmaceuticals
    Bidil | Arbor Pharmaceuticals
    No Recall

    Bidil | Arbor Pharmaceuticals

    Bidil | Arbor Pharmaceuticals

    Treatment with BiDil should be initiated at a dose of one BiDil Tablet, 3 times a day. BiDil may be titrated to a maximum tolerated dose, not to exceed two BiDil Tablets, 3 times a day.

    There is no adequate experience in heart failure with doses of BiDil other than those recommended and no experience with use of individual components.

    Although titration of BiDil can be rapid (3-5 days), some patients may experience side effects and may take longer to reach their maximum tolerated dose. The dosage may be decreased to as little as one-half BiDil Tablet 3 times a day if intolerable side effects occur. Efforts should be made to titrate up as soon as side effects subside.

  • Bidil | Pharmacia And Upjohn Company
    No Recall

    Bidil | Pharmacia And Upjohn Company

    Bidil | Pharmacia And Upjohn Company

    Prior to initiating DEPO-Testosterone (testosterone cypionate), confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

    DEPO-Testosterone Injection is for intramuscular use only.

    It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.

    The suggested dosage for DEPO-Testosterone Injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient's response and the appearance of adverse reactions.

    Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.

    For replacement in the hypogonadal male, 50–400 mg should be administered every two to four weeks.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.

  • Remedyrepack Inc.
    Bidil | Remedyrepack Inc.
    No Recall

    Bidil | Remedyrepack Inc.

    Bidil | Remedyrepack Inc.

    BiDil should be initiated at a dose of one BiDil Tablet, three times a day. Titrate to a maximum of two tablets three times daily, if tolerated.

    Although titration of BiDil can be rapid (3-5 days), some patients may experience side effects and may take longer to reach their maximum tolerated dose. The dosage may be decreased to as little as one-half BiDil Tablet three times a day if intolerable side effects occur. Efforts should be made to titrate up as soon as side effects subside.