Adult Dosing

Congestive heart failure

• 37.5 mg/20 mg PO tid, may be titrated to a maximum tolerated dose
• Max: 75 mg/40 mg PO tid

Note:

• Decrease the dose to one-half tablet tid if intolerable side effects occur; titrate up as soon as side effects subside

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of heart failure as an adjunct to standard therapy in African American patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status

• Hypersensitivity to any of the ingredients of the product
• Severe hypotension

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; caution advised

See Supplemental Patient Information

• Concomitant administration of phosphodiesterase inhibitors including sildenafil, tadalafil, or vardenafil amplifies the vasodilatory effects of isosorbide dinitrate resulting in severe hypotension. Treat this condition as nitrate overdose with elevation of the extremities and central volume expansion
• Therapy with hydralazine may produce clinical features similar to systemic lupus erythematosus including glomerulonephritis. Suspend therapy if such symptoms occur after a thorough benefit-to-risk assessment
• Symptomatic hypotension, particularly with upright posture, may occur with even small doses of the product. Administer with caution in patients who are volume depleted or are already hypotensive
• Myocardial ischemia and anginal attacks may occur due to hydralazine as a result of tachycardia
• Carefully administer in patients with acute myocardial infarction to avoid the hazards of hypotension and tachycardia
• Use pyridoxine concurrently if peripheral neuritis, evidenced by paresthesia, numbness, and tingling occur during therapy
• Isosorbide dinitrate may aggravate angina associated with hypertrophic cardiomyopathy

Cautions: Use cautiously in

• Hepatic impairment
• CAD

Supplemental Patient Information

• Instruct patients to consult their physician regarding dose adjustment if headache continues with repeated dosing
• Inform patients that therapy may be associated with lightheadedness on standing, particularly after rising from a recumbent or seated position
• Caution patients that inadequate fluid intake or excessive fluid loss from diarrhea or vomiting may produce an extreme drop in blood pressure that may cause lightheadedness or syncope. Excessive fall in blood pressure may provoke chest pain or a heart attack

Pregnancy Category:C

Breastfeeding: Safety unknown. Hydralazine is an acceptable antihypertensive in nursing mothers, even in those nursing newborns. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 13 June 2011). Manufacturer advises caution.

• CNS: Dizziness, headache, asthenia
• CV: Tachycardia, angina, arrhythmias, severe orthostatic hypotension, syncope, chest pain
• NEURO: Peripheral neuritis, paresthesia
• EENT: Rhinitis/sinusitis, amblyopia
• RESP: Bronchitis
• GI: Diarrhea, nausea, vomiting
• DERM: Lupus erythematosus
• METABOLIC: Methemoglobinemia, hyperglycemia, hyperlipidemia
• MUSC: Arthralgias
• HEMA: Neutropenia, blood dyscrasias
• HYPERSENSITIVITY: Angioedema
• MISC: Drug-induced lupus syndrome, flushing

Hydralazine

• Antihypertensive agent; exact mechanism of action unknown; directly relaxes vascular smooth muscle, reduces arterial BP and peripheral vascular resistance by exerting a peripheral vasodilating effect
• Extensively metabolized by liver; CYP450: Unknown
• Excreted in urine
• Half-life: 3-7 hrs

Isosorbide

• Vasodilator agent; relaxes the vascular smooth muscle and consequent dilatation of peripheral arteries and veins, resulting in peripheral pooling of blood and reduced venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure
• Metabolized in the liver to 2-mononitrate and 5-mononitrate
• Renally excreted
• Half-life:
• isosorbide dinitrate: 1 hr
• 2-mononitrate: 2 hrs
• 5-mononitrate: 5 hrs

US Trade Name(s)

• BiDil

US Availability

BiDil (hydralazine/isosorbide dinitrate)

• TABS: 37.5 mg/20 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Cardiovascular

Antihypertensive Combinations

Pricing data from www.DrugStore.com in U.S.A.

• BiDil 20-37.5 MG TABS [Bottle] (ARBOR PHARMACEUTICALS)
  30 mg = $72.13
  90 mg = $197.29

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.