What is BiDil, and how does it work?
BiDil (isosorbide dinitrate and hydralazine hcl) is a combination of a nitrate and a vasodilator used to treat heart failure.
What are the side effects of BiDil?
Common side effects of BiDil include:
- headache,
- dizziness,
- lightheadedness,
- weakness,
- nausea,
- vomiting,
- fast heartbeat,
- swollen ankles, and
- flushing (redness of the face, neck, and chest) as your body adjusts to the medication.
Tell your doctor if you have unlikely but serious side effects of BiDil including:
- numbness and tingling,
- severe tiredness,
- aching/swollen joints,
- rash on nose and cheeks,
- swollen glands,
- change in the amount of urine,
- bloody or pink urine,
- signs of infection (such as fever, chills, persistent sore throat),
- easy bruising or bleeding,
- fainting, or
- irregular or pounding heartbeat.
What is the dosage for BiDil?
- 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.
What drugs interact with BiDil?
Phosphodiesterase Inhibitors
- BiDil is contraindicated in patients who are using a selective inhibitor
of cyclic guanosine monophosphate (cGMP)- specific phosphodiesterase type 5
(PDE5), PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and
tadalafil have been shown to potentiate the hypotensive effects of organic
nitrates. - Do not use BiDil in patients who are taking the soluble guanylate
cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension.
Is BiDil safe to use while pregnant or breastfeeding?
- There are no studies using BiDil in pregnant women.
- A meta-analysis of randomized controlled trials comparing hydralazine hydrochloride with other antihypertensive agents for severe hypertension in pregnancy found that hydralazine hydrochloride was associated with significantly more
- maternal hypotension,
- placental abruption,
- caesarean sections and
- oliguria, with more adverse effects on fetal heart rate and with lower Apgar scores.
- A combination of propranolol and hydralazine hydrochloride was administered to 13 patients with longstanding hypertension during 15 pregnancies.
- These pregnancies resulted in 14 live births and one unexplained stillbirth.
- The only neonatal complications were two cases of mild hypoglycemia.
- Hydralazine hydrochloride and its metabolites have been detected using a non-selective assay in maternal and umbilical plasma in patients treated with the drug during pregnancy.
- Isosorbide dinitrate has been used for effective acute and sub-chronic control of hypertension in pregnant women, but there are no studies using it in a chronic regimen and assessing its effects on pregnant women and/or the fetus.
- No studies have been performed with BiDil.
- It is not known if either hydralazine or isosorbide dinitrate is excreted in human milk.