Heart failure with reduced ejection fraction (off-label use):
Note: Alternative therapy for patients with persistent NYHA class III or IV heart failure with reduced ejection fraction (HFrEF) who cannot tolerate an angiotensin II receptor-neprilysin inhibitor, angiotensin-converting enzyme inhibitor, or angiotensin II receptor blocker or additional therapy in patients who have residual hypertension despite an optimal medical regimen for HFrEF (ACC [Maddox 2021]; ACCF/AHA [Yancy 2013]; Colucci 2021).
Oral: Initial: 25 mg 3 times daily in combination with isosorbide dinitrate; titrate dose as tolerated every 2 to 4 weeks; target dose: 75 mg 3 times daily (ACC [Maddox 2021]; ACCF/AHA [Yancy 2013]).
Hypertension, chronic (alternative agent):
Note: Not recommended for initial management but may be considered as additional therapy for resistant hypertension in patients who do not respond adequately to combination therapy with preferred agents (ACC/AHA [Whelton 2018]).
Oral: Initial: 10 mg 4 times daily for 2 to 4 days, then 25 mg 4 times daily for the remainder of the week followed by titration based on response to 50 mg 4 times daily (manufacturer's labeling); usual dosage range: 100 to 200 mg/day in divided doses (ACC/AHA [Whelton 2018]). Maximum dose: 300 mg/day (manufacturer's labeling); however, doses >200 mg/day are generally avoided due to increased risk of lupus-like reaction. Consider combining with a beta-blocker and/or diuretic since hydralazine is associated with reflex tachycardia and fluid retention (ACC/AHA [Whelton 2018]).
Hypertensive emergency (alternative agent):
Note: For severe elevation in blood pressure associated with new or worsening target-organ damage. Hydralazine is generally not recommended due to unpredictable and prolonged antihypertensive effects (Marik 2007):
IM, IV: 10 to 20 mg every 4 to 6 hours as needed; may increase dose to a maximum of 40 mg/dose if necessary; some experts recommend a maximum of 20 mg/dose. Consider combining with a beta-blocker since hydralazine is associated with reflex tachycardia (ACC/AHA [Whelton 2018]; Elliott 2022; Rhoney 2009; manufacturer's labeling).
Hypertensive emergency in pregnancy or postpartum (including acute-onset hypertension in preeclampsia/eclampsia) (off-label use):
Note: For acute-onset, severe, persistent (eg, ≥15 minutes) hypertension (ACOG 2019a).
IV: Initial: 5 or 10 mg; repeat with 5 to 10 mg doses every 20 minutes if blood pressure continues to exceed thresholds (ACOG 2019a; Magee 2014; Too 2013). If systolic blood pressure or diastolic blood pressure remains above threshold after a total cumulative dose of 20 to 30 mg, another agent should be used (ACOG 2019a; August 2020).
Perioperative hypertension (alternative agent):
Note: For patients with chronic hypertension prior to surgery, restart oral therapies as soon as appropriate once hemodynamically stable. The antihypertensive effects of hydralazine are less predictable than other parenteral antihypertensives and can cause reflex tachycardia. Some experts suggest doses in the low end of the dosing range (Broussard 2022; Lien 2012).
IV: 5 to 20 mg every 4 to 6 hours as needed (Broussard 2022; Lien 2012)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: There are no dosage adjustments provided in the manufacturer's labeling. Limited data suggest concentrations of hydralazine and/or its metabolites are increased in patients with CrCl <50 mL/minute; however, results vary and there is no evidence of increased adverse effects (Ludden 1982; Talseth 1976).
Altered kidney function (Aronoff 2007; expert opinion derived from Levin 2010):
GFR ≥10 mL/minute: IM, IV, Oral: No dosage adjustment necessary.
GFR <10 mL/minute:
IM, IV: No dosage adjustment necessary when used short term; use with caution (expert opinion).
Oral: Administer usual dose every 8 to 12 hours (Aronoff 2007; Levin 2010; expert opinion).
Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed (St Peter 1998).
IM, IV: No dosage adjustment necessary when used short term; use with caution (expert opinion).
Oral: Administer usual dose every 8 to 12 hours (expert opinion). Avoid administering predialysis in patients who are prone to intra-dialytic hypotension (Georgianos 2016).
Peritoneal dialysis: Unlikely to be significantly dialyzed (St Peter 1998).
IM, IV: No dosage adjustment necessary when used short term; use with caution (expert opinion).
Oral: Administer usual dose every 8 to 12 hours (Aronoff 2007; expert opinion).
There are no dosage adjustments provided in the manufacturer's labeling; however, hydralazine undergoes extensive hepatic metabolism.
(For additional information see "Hydralazine: Pediatric drug information")
Note: Individualize dose; titrate to patient response.
Heart failure, afterload reduction: Limited data available (Artman 1987; Friedman 1985; Park 2021): Note: May cause reflex tachycardia; use in combination with beta-blocker therapy has been suggested (Park 2021).
IV:
Infants: 0.1 to 0.5 mg/kg/dose every 6 to 8 hours; maximum dose: 2 mg/kg/dose.
Children and Adolescents: 0.15 to 0.2 mg/kg/dose every 4 to 6 hours; maximum dose: 20 mg/dose.
Oral: Infants, Children, and Adolescents: 0.75 to 3 mg/kg/day divided every 6 to 12 hours; maximum daily dose: 7 mg/kg/day or 200 mg/day, whichever is less.
Hypertension, chronic: Children and Adolescents: Oral: Initial: 0.75 mg/kg/day in 2 to 4 divided doses; maximum initial adult dose: 10 mg/dose; may increase gradually over 3 to 4 weeks; maximum daily dose: 7.5 mg/kg/day not to exceed 200 mg/day (NHBPEP [Flynn 2004]; NHLBI [Daniels 2012]; Park 2021; manufacturer's labeling).
Hypertension, acute severe : Note: Oral therapy should be used in patients with less severe symptoms; IV and IM therapy should be reserved for use in patients with life-threatening symptoms (AAP [Flynn 2017]): Infants, Children, and Adolescents:
Oral: 0.25 mg/kg/dose every 6 to 8 hours as needed; maximum dose: 25 mg/dose (AAP [Flynn 2017]).
IM, IV: Initial: 0.1 to 0.2 mg/kg/dose every 4 to 6 hours, titrate as needed; usual dosage range: 0.2 to 0.6 mg/kg/dose every 4 to 6 hours; maximum dose: 20 mg/dose (AAP [Flynn 2017]; NHBPEP [Flynn 2004]; Park 2014; Thomas 2011).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; however, the following adjustments have been recommended (Aronoff 2007). Note: Renally adjusted dose recommendations are based on doses: Oral: 0.75 to 1 mg/kg/day divided every 6 to 12 hours; maximum daily dose: 200 mg/day; IV: 0.1 to 0.2 mg/kg/dose every 6 hours; maximum dose: 20 mg/dose.
GFR >50 mL/minute/1.73 m2: No adjustment necessary.
GFR 10 to 50 mL/minute/1.73 m2: Administer every 8 hours.
GFR <10 mL/minute/1.73 m2: Administer every 12 to 24 hours.
Intermittent hemodialysis: Administer every 12 to 24 hours.
Peritoneal dialysis (PD): Administer every 12 to 24 hours.
Continuous renal replacement therapy (CRRT): Administer every 8 hours.
There are no dosage adjustments provided in the manufacturer's labeling; however, hydralazine undergoes extensive hepatic metabolism.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection, as hydrochloride:
Generic: 20 mg/mL (1 mL)
Tablet, Oral, as hydrochloride:
Generic: 10 mg, 25 mg, 50 mg, 100 mg
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection, as hydrochloride:
Apresoline: 20 mg/mL (1 mL)
Tablet, Oral, as hydrochloride:
Generic: 10 mg, 25 mg, 50 mg
Oral: Administer without regard to meals. However, food enhances bioavailability; administer consistently with regard to meals.
Injection: Response may be delayed and unpredictable in some patients; titrate cautiously to response.
IM: Administer undiluted as IM injection.
IV: Administer undiluted as slow IV push.
Oral: May administer without regard to meals. However, food enhances bioavailability; administer consistently with regard to meals.
Parenteral:
IM: Administer undiluted as IM injection.
IV: Administer undiluted (20 mg/mL) as slow IV push over 1 to 2 minutes (Artman 1984; Beekman 1982); maximum rate: 5 mg/minute (Klaus 1989).
Hypertension, chronic: Management of moderate to severe hypertension. Note: Not recommended for the initial treatment of hypertension (ACC/AHA [Whelton 2018]).
Heart failure with reduced ejection fraction; Hypertensive emergency in pregnancy or postpartum (including acute-onset hypertension in preeclampsia/eclampsia)
HydrALAZINE may be confused with hydroCHLOROthiazide, hydrOXYzine
Hydralazine-induced lupus-like syndrome (HILS) has occurred in up to 10% of patients on doses ≥200 mg for ≥3 months (Ref) and is reversible upon discontinuation. HILS commonly results in nonadherence or discontinuation and may lead to multi-organ involvement (pericarditis, hepatosplenomegaly); severe malaise/myalgias; acute joint pain and swelling; blood dyscrasias (leukopenia, thrombocytopenia); and positive serologies (antinuclear antibodies, antihistone antibodies, elevated erythrocyte sedimentation rate) (Ref).
Mechanism: Exact mechanism is unknown; may occur via inhibition of DNA methylation of CD4+ T-cells, leading to autoreactivity and subsequent excess autoantibody production (Ref). Another proposed mechanism is via IL-10 suppression at higher doses of hydralazine (Ref).
Onset: Delayed; onset reported after at least 3 months of therapy. However, this may vary based on dosing regimen (Ref). Duration of therapy in case reports varies from 1 to 24 months (Ref).
Risk factors:
• Females (Ref)
• White race (Ref)
• Slow hepatic acetylation (Ref)
• Doses ≥200 mg per day (Ref)
• Cumulative dose >100 g (Ref)
• Treatment for at least 3 months (Ref)
• Human leukocyte antigen DR4 genotype (Ref)
• Family history of autoimmune disease (Ref)
• History of thyroid disease (Ref)
• Null gene for C4 (Ref)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Acute myocardial infarction, angina pectoris, edema (Cohn 2011), flushing, hypotension, myocardial stimulation, palpitations, paradoxical response to antihypertensive, tachycardia (Cohn 2011; Kandler 2011; Weingarten 2018)
Dermatologic: Pruritus, skin rash (including eczema) (Thestrup-Pederson 1987), urticaria (Thestrup-Pederson 1987)
Gastrointestinal: Anorexia (Paykel 1982), constipation, diarrhea (Paykel 1982), nausea (Paykel 1982), paralytic ileus, vomiting (Paykel 1982)
Genitourinary: Difficulty in micturition
Hematologic & oncologic: Agranulocytosis (Andrès 2017), eosinophilia, leukopenia, lymphadenopathy, purpuric disease, splenomegaly
Hepatic: Hepatitis (Amjad 2018)
Nervous system: Chills, dizziness, headache (Cohn 2011; Paykel 1982), peripheral neuropathy (Raskin 1965; Tsujimoto 1980), psychotic reaction (including anxiety, depression, disorientation, euphoria, hypomania, nervousness) (Paykel 1982)
Neuromuscular & skeletal: Arthralgia, muscle cramps, tremor
Ophthalmic: Conjunctivitis, lacrimation
Respiratory: Dyspnea, nasal congestion
Miscellaneous: Fever (Paykel 1982)
Postmarketing:
Cardiovascular: Vasculitis (Pendergraft 2014; Suneja 2014; Zuckerman 2018)
Dermatologic: Toxic epidermal necrolysis (Chan 2014)
Hematologic & oncologic: Hemolytic anemia (Kandler 2011)
Hepatic: Hepatotoxicity (Harati 2016; Sharma 2018)
Nervous system: Fatigue (Paykel 1982), malaise (Paykel 1982)
Neuromuscular & skeletal: Lupus-like syndrome (common: ≥10% in doses ≥200 mg for ≥3 months [Iyer 2017]; multi-organ involvement [eg, pericarditis, hepatosplenomegaly], severe malaise/myalgias, acute joint pain and swelling, blood dyscrasias [eg, leukopenia, thrombocytopenia], positive serologies [eg, antinuclear antibodies, antihistone antibodies, elevated erythrocyte sedimentation rate] [Handler 2012], and lupus erythematous-like rash [Thestrup-Pederson 1987])
Renal: Glomerulonephritis (Bjorck 1985; Suneja 2014)
Hypersensitivity to hydralazine or any component of the formulation; coronary artery disease; mitral valve rheumatic heart disease
Canadian labeling: Additional contraindications (not in US labeling): Idiopathic systemic lupus erythematosus and related diseases; severe tachycardia and heart failure (HF) with high cardiac output (eg, in thyrotoxicosis); myocardial insufficiency due to mechanical obstruction (eg, aortic or mitral stenosis, constrictive pericarditis); isolated right ventricular HF due to pulmonary hypertension; acute dissecting aneurysm of the aorta; porphyria (injection only)
Disease-related concerns:
• Cardiovascular disease: Use is contraindicated in patients with coronary artery disease (CAD). Use with caution in patients with cerebral vascular accidents and suspected CAD; myocardial stimulation produced by hydralazine can cause anginal attacks and electrocardiogram (ECG) changes of myocardial ischemia; has been implicated in the production of myocardial infarction. According to the American Heart Association/American College of Cardiology/American Society of Hypertension 2015 scientific statement for the treatment of hypertension in patients with CAD, hydralazine (without a concomitant nitrate [eg, isosorbide dinitrate]) should be avoided for the treatment of hypertension in patients with heart failure (with reduced ejection fraction) of ischemic origin (AHA/ACC/ASH [Rosendorff 2015]).
• Mitral valvular disease: Use with caution in patients with mitral valvular disease; may increase pulmonary artery pressure in these patients. Use is contraindicated in patients with mitral valve rheumatic heart disease.
• Renal impairment: Use with caution in patients with advanced renal impairment; dosage adjustment recommended.
Dosage form specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).
• Tartrazine sensitivity: May contain tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is low, it is frequently seen in patients who are also hypersensitive to aspirin.
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
None known.
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification
Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination
Dapoxetine: May enhance the orthostatic hypotensive effect of HydrALAZINE. Risk C: Monitor therapy
Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy
Herbal Products with Blood Pressure Increasing Effects: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy
Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May diminish the antihypertensive effect of HydrALAZINE. Risk C: Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Food enhances bioavailability of hydralazine. Management: Administer without regard to food, but keep consistent.
Hydralazine crosses the placenta (Lamont 1986; Liedholm 1982).
Due to pregnancy-induced physiologic changes and maternal acetylator status (NAT2 genotype), some pharmacokinetic properties of oral hydralazine may be altered. Larger studies are needed to evaluate if or how these changes influence safety or efficacy during pregnancy (Han 2019).
Chronic maternal hypertension may increase the risk of birth defects, low birth weight, preterm delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to duration and severity of maternal hypertension. Untreated hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, myocardial infarction, preeclampsia, stroke, and delivery complications (ACOG 2019b).
Agents other than oral hydralazine are more commonly used to treat chronic hypertension in pregnancy (ACOG 2019b; ESC [Regitz-Zagrosek 2018]). Females with preexisting hypertension may continue their medication during pregnancy unless contraindications exist (ESC [Regitz-Zagrosek 2018]). Intravenous hydralazine is recommended for use in the management of acute onset, severe hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥110 mm Hg) with preeclampsia or eclampsia in pregnant and postpartum women (ACOG 2019a).
Hydralazine is present in breast milk.
The relative infant dose (RID) of hydralazine is 0.77% to 3% when calculated using the highest breast milk concentration located and compared to an oral infant therapeutic dose of 0.7 to 3 mg/kg/day
In general, breastfeeding is considered acceptable when an RID of a medication is <10% (Anderson 2016; Ito 2000).
The RID of hydralazine was calculated in one patient using a milk concentration of 0.0016 mg/mL (792 nmol/L), providing an estimated daily infant dose via breast milk of 0.023 mg/kg/day. This milk concentration was obtained following maternal administration oral hydralazine 50 mg 3 times a day. Hydralazine metabolites were also present in breast milk (Liedholm 1982). In a study of four breastfeeding women, breast milk concentrations of hydralazine were approximately one-half of maternal serum concentrations. Hydralazine was detected in the serum of their breastfeeding infants (Lamont 1986).
The manufacturer recommends that caution be used if administered to a breastfeeding woman. Hydralazine is considered compatible with breastfeeding; however, sufficient information is not available following long-term use (WHO 2002).
Blood pressure (monitor closely with IV use), standing and sitting/supine, heart rate, complete blood cell count (CBC), antinuclear antibody (ANA) titer
The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (ACC/AHA [Whelton 2018]):
Confirmed hypertension and known CVD or 10-year ASCVD risk ≥10%: Target blood pressure <130/80 mm Hg is recommended.
Confirmed hypertension without markers of increased ASCVD risk: Target blood pressure <130/80 mm Hg may be reasonable.
Direct vasodilation of arterioles (with little effect on veins) with decreased systemic resistance. Although exact mechanism unknown, arterial vasodilation may occur via inhibition of calcium release from the sarcoplasmic reticulum and inhibition of myosin phosphorylation in arterial smooth muscle cells (McComb 2016).
Onset of action: IV: 10 to 80 minutes
Duration: IM, IV: Up to 12 hours (Marik 2007); Note: Duration may vary depending on acetylator status of patient. Hypotension due to hydralazine may last longer even though the circulating half-life is much shorter (Marik 2007; O’Malley 1975).
Absorption: Oral: Rapidly absorbed
Protein binding: 87%
Metabolism: Hepatically acetylated; extensive first-pass effect (oral)
Bioavailability: ~22% to 69% depending on acetylator status (increased in slow acetylators and decreased in rapid acetylators) (Ludden1982); increased with food
Half-life elimination: 3 to 7 hours
Time to peak, plasma: Oral: 1 to 2 hours
Excretion: Urine (as metabolites)
Slow acetylators: Patients will generally have higher plasma levels of hydralazine and require lower doses to maintain control of BP.
Solution (hydrALAZINE HCl Injection)
20 mg/mL (per mL): $4.20 - $127.73
Tablets (hydrALAZINE HCl Oral)
10 mg (per each): $0.12 - $0.41
25 mg (per each): $0.07 - $0.51
50 mg (per each): $0.08 - $0.56
100 mg (per each): $0.09 - $1.01
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