Dosing and uses of BiDil (isosorbide-dinitrate-hydralazine)
Adult dosage forms and strengths
isosorbide dinitrate/hydralazine
tablet
- 20mg/37.5mg
Heart Failure
1 tab PO q8hr; titrate dose to effect; not to exceed 2 tab PO q8hr
Heart failure in self-identified African Americans as Adjunct Therapy
1 tab PO q8hr; titrate dose to effect; not to exceed 2 tab PO q8hr
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
Heart failure
1 tab PO q8hr; titrate dose to effect; not to exceed 2 tab PO q8hr
BiDil (isosorbide-dinitrate-hydralazine) adverse (side) effects
Frequency not defined
Isosorbide Dinatrate
- Flushing
- Hypotension/orthostatic hypotension
- Lightheadedness
- Palpitations
- Rebound hypertension (uncommon)
- Syncope
- Unstable angina tachyarrhythmia
- Dizziness
- Headache
- Restlessness
- Weakness
- Nausea
- Methemoglobinemia (infrequent)
Hydralazine
- Hypotension
- Palpitations
- Tachycardia
- Headache
- Neuropathy
- Anorexia
- Diarrhea
- Nausea
- Vomiting
- Agranulocytosis
- Leukopenia
- Hepatotoxicity
- Chest pain
- Dyspnea
- Nasal congestion
Warnings
Contraindications
Allergy to organic nitrates
Concomitant use with PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, or vardenafil)
Concomitant use with soluble guanylate cyclase (sGC) stimulators (eg, riociguat)
Cautions
Hydralazine may cause symptomatic lupus erythematosus syndromes; consider discontinuation if clinically appropriate
May aggravate myocardial ischemia and angina
Peripheral neuritis may be treated with pyridoxine
Symptomatic hypotension may occur
Paradoxical bradycardia may occur
Use caution in pulmonary hypertension
Caution in patients with coronary artery disease or tachycardia
Caution in in suspected right ventricular infarction or acute MI
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk; use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
