Class: Direct Vasodilators
VA Class: CV490
CAS Number: 304-20-1
Brands: Hydra-Zide, BiDil
Introduction
Vasodilating agent.134 d e
Uses for Hydralazine Hydrochloride
Hypertension
Management of hypertension (alone or in combination with other classes of antihypertensive agents).134 d
Can be used as monotherapy for initial management of uncomplicated hypertension;126 however, thiazide diuretics are preferred by JNC 7.126
Do not use for the treatment of hypertension in patients with left ventricular hypertrophy.126
Hypertensive Crises
Parenteral drug of choice for management of pregnancy-associated hypertensive emergencies (e.g., preeclampsia, eclampsia) when delivery is imminent.124 126
Parenteral management of severe hypertension when the drug cannot be given orally or when BP must be lowered immediately;e other parenteral hypotensive agents (e.g., sodium nitroprusside) usually are preferred for these indications.b
Not recommended for the management of severe hypertension or hypertensive emergencies associated with cerebrovascular accidents or in patients with cerebral edema and encephalopathy.b
Although some manufacturers have not established pediatric dosage recommendations, some clinicians suggest the IV or IM use of hydralazine for rapid reduction of BP in pediatric patients 1–17 years of age† with hypertensive urgencies or emergencies.†133
CHF: Fixed-combination Therapy with Isosorbide Dinitrate in Self-identified Black Patients
In fixed combination with isosorbide dinitrate as adjunct to standard therapy for the treatment of CHF in self-identified black patients to improve survival, decrease rate of hospitalization for worsened heart failure, and improve patient-reported functional status.135 136 137
CHF: Other Therapies in the General Population
Hydralazine (in combination with cardiac glycosides and diuretics and/or with isosorbide dinitrate) has been used effectively for the treatment of CHF†113 b ; should be considered particularly in those intolerant of ACE inhibitors.113
There is little evidence to support the use of hydralazine alone in the treatment of CHF†.113
Hydralazine Hydrochloride Dosage and Administration
General
Hypertension
Fixed combination with a thiazide diuretic is not recommended for initial combination therapy; adjust initial and subsequent dosages by administering each drug separately.d
Adjust dosage carefully according to individual requirements and BP response at approximately monthly intervals or more aggressively in high-risk patients.109 126
Tolerance to antihypertensive effect develops during prolonged therapy, especially if a diuretic is not administered concurrently.b
Administer lowest effective dosage to minimize risk and occurrence of adverse effects.109 126
Hypertensive Crises
Monitor BP closely when parenteral hydralazine is used.e
Avoid excessive BP decreases in any hypertensive crisis since they may precipitate renal, cerebral, or coronary ischemia.107 109
Avoid abrupt discontinuance in patients with a marked reduction in BP.109 To minimize risk for sudden BP increase, reduce dosage gradually.b
Administration
Administer orally or by IM or IV injection.b Usually administer orally; may be administered IM or IV if patient unable to take drug orally or if a rapid decrease in BP is required.b
Oral Administration
Administer orally 2–4 times daily.134 b d
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Administer by rapid IV injection directly into the vein.e
Replace parenteral therapy with oral therapy as soon as possible.b
Dosage
Available as hydralazine hydrochloride; dosage expressed in terms of the salt.b
20–25 mg of IV hydralazine hydrochloride was approximately equal to 75–100 mg of oral hydralazine hydrochloride in one study.b
Pediatric Patients
Hypertension†
Oral
Initially, 0.75 mg/kg daily (or 25 mg/m2 daily) given in 4 divided doses;133 134 b initial dose should not exceed 25 mg.b
Dosages may be increased gradually (over 3–4 weeks) up to a maximum of 7.5 mg/kg daily (or 200 mg daily).133 134 b
IM or IV
Usual dosage: 1.7–3.5 mg/kg daily or 50–100 mg/m2 daily given in 4–6 divided doses; initial dose should not exceed 20 mg.b e
If administered with reserpine, hydralazine hydrochloride dosages may be reduced to 0.15 mg/kg or 4 mg/m2 every 12–24 hours.b
Hypertensive Urgencies or Emergencies†
Rapid Reduction of BP†
IV or IM
Children and adolescents 1–17 years of age: 0.2–0.6 mg/kg IV or IM per dose; administer every 4 hours when given by IV bolus injection.133
Hypertensive Crises†
IM or IV
For rapid reduction of blood pressure in patients 1–17 years of age with severe hypertension, some clinicians have suggested a dose of 0.2–0.6 mg/kg; drug should be administered every 4 hours when given by injection (“IV bolus”).133
Adults
Hypertension
Monotherapy
Oral
Initially, 10 mg 4 times daily for 2–4 days.134 Dosage then can be increased to 25 mg 4 times daily for the remainder of the week.134 If necessary, dosage can be increased for the second and subsequent weeks to 50 mg 4 times daily.134 Usual dosages of 12.5–50 mg twice daily recommended by JNC 7.126
Combination Therapy
Oral
If BP is not adequately controlled by monotherapy with hydalazine or hydrochlorothiazide, can switch to fixed-combination capsules containing hydralazine hydrochloride 25 mg and hydrochlorothiazide 25 mg; then hydralazine hydrochloride 50 mg and hydrochlorothiazide 50 mg, administered twice daily.d
Hypertensive Crises
Management of Hypertensive Emergencies
IM or IV
Usual dose: 20–40 mg.e Parenteral doses are repeated as necessary and may be increased within these ranges according to the BP response.b e
Initial goal of therapy is to reduce mean arterial BP by no more than 25% (within minutes to 1 hour), then, if stable, to 160/100 to 110 mm Hg within the next 2 to 6 hours.126
If this BP is well tolerated and the patient is clinically stable, implement further gradual reductions toward normal in the next 24–48 hours.131 In patients with aortic dissection, reduce SBP to less than 100 mm Hg if tolerated.131
Management of Pregnancy-associated Hypertensive Emergencies
Antihypertensives are administered before induction of labor for persistent DBP ≥105–110 mm Hg, aiming for levels of 95–105 mm Hg.131
In pregnant women, DBP >109 mm Hg are associated with an increased risk of cerebral hemorrhage.111
IV
Usual initial dose: 5–10 mg,101 103 105 108 109 111 followed by 5–10 mg (range: 5–20 mg) every 20–30 minutes as necessary to achieve an adequate BP reduction.101 102 103 104 105 108 109 111
CHF
Fixed-combination Therapy with Isosorbide Dinitrate in Self-identified Black Patients
Oral
Initially, hydralazine hydrochloride 37.5 mg and isosorbide dinitrate 20 mg (1 tablet of BiDil) 3 times daily.135 May titrate dosage to a maximum tolerated dosage not to exceed 2 tablets (a total of 75 mg of hydralazine hydrochloride and 40 mg of isosorbide dinitrate) 3 times daily.135 Rapid titration (over 3–5 days) may be possible; however, slower titration may be needed due to adverse effects.135 May decrease dosage to as little as one-half of the fixed-combination tablet 3 times daily in patients who experience intolerable effects, but attempt to titrate dosage up once adverse effects subside.135
Prescribing Limits
Pediatric Patients
Hypertension
Oral
Maximum 7.5 mg/kg daily (or 200 mg daily).133 134 b
Adults
Hypertension
Maintenance Therapy
Oral
Maximum 100 mg daily; addition of another antihypertensive agent is preferable to increasing dosage beyond 100 mg because of poor patient tolerance.132
CHF
Fixed-combination Therapy with Isosorbide Dinitrate in Self-identified Black Patients
Oral
Maximum 75 mg of hydralazine hydrochloride and 40 mg of isosorbide dinitrate (2 tablets of BiDil) 3 times daily.135
Special Populations
Renal Impairment
Lower dosage may be required in severe renal failure.b
Geriatric Patients
The manufacturer of the fixed combination of hydralazine hydrochloride and isosorbide dinitrate states that dosage should be selected with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.135
Cautions for Hydralazine Hydrochloride
Contraindications
CAD.134 e
Mitral valvular rheumatic heart disease.134 e
Hypersensitivity to hydralazine hydrochloride or any ingredient in the formulation.134 e
Warnings/Precautions
Warnings
Systemic Lupus Erythematosus (SLE)
May cause SLE (e.g., glomerulonephritis) or rheumatoid arthritis,134 d e particularly in patients receiving >200 mg daily dosage for prolonged periods, in slow acetylators of hydralazine, or in those with decreased renal function.b
If unexplained signs and symptoms (e.g., arthralgia, fever, chest pain, continued malaise) occur, perform appropriate laboratory studies (e.g., CBCs, ANA titer determinations).b
If test results confirm SLE, discontinue hydralazine unless benefit outweighs risk.b Signs and symptoms usually regress with hydralazine discontinuance, but residual effects may be detected after many years.134 b Long-term corticosteroid treatment may be necessary if symptoms do not regress.b
Sensitivity Reactions
Sulfite Sensitivity
Some formulations contain sulfites that may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.b
General Precautions
Cardiovascular Effects
Possible precipitation of angina attacks and/or MI; 134 b use with caution in patients with suspected coronary artery disease.134 d e
May increase pulmonary artery pressure in patients with mitral valvular disease.134 d e (See Contraindications.)
Possible orthostatic hypotension; use with caution in patients with cerebrovascular accidents,134 135 those who may be volume-depleted, those with preexisting hypotension, or those receiving other hypotensive agents.135 b
Drug Interaction
May paradoxically reduce pressor response to epinephrine.134 b
Peripheral Neuritis
Possible peripheral neuritis (e.g., paresthesia, numbness, tingling);134 d e may be caused by pyridoxine deficiency.b
If such symptoms occur, use concomitantly with pyridoxine.b
Hematologic Effects
Possible blood dyscrasias (e.g., decreased hemoglobin and erythrocytes, leukopenia, agranulocytosis, thrombocytopenia with or without purpura).134 d e
If such abnormalities occur, discontinue therapy.134 d e
Adequate Patient Monitoring
Perform CBCs and ANA titer determinations before initiation and then periodically thereafter during prolonged therapy (even in asymptomatic patients).134 b d e
Manufacturers state that a positive ANA titer requires that the implications of the test result be weighed against the benefits from therapy with the drug,134 d e whereas some experts state that an increase in ANA titer requires immediate discontinuance of the drug.b
Carefully monitor hemodynamic and clinical status in patients with AMI.135
Use of Fixed Combinations
When hydralazine is used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.d
When hydralazine is used in fixed combination with isosorbide dinitrate, consider the cautions, precautions, and contraindications associated with isosorbide dinitrate.135
Specific Populations
Pregnancy
Category C.134 d e
Lactation
Distributed into milk.b Use caution.134 d e
Pediatric Use
Safety and efficacy alone or in fixed combination with isosorbide dinitrate not established.134 135 e Use is based on clinical experience.134 e
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.135 (See Geriatric Patients under Dosage.)
Renal Impairment
Generally considered to be safe; manufacturers state to use with caution in severe renal impairment.b
Common Adverse Effects
Headache, palpitation, tachycardia.b
Interactions for Hydralazine Hydrochloride
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
β-Adrenergic blocking agents | Additive hypotensive effectb Concomitant use may minimize adverse cardiac effects (e.g., tachycardia, precipitation of angina) associated with hydralazineb | Usually used to therapeutic advantage; adjust dosages carefully and monitor for excessive BP reductionb |
Diazoxide | Possibly profound hypotensive episodesb | |
Diuretics | Additive hypotensive effectb Concomitant use may prevent tolerance to hydralazine and also prevent sodium retention and increased plasma volume that may occur after prolonged hydralazine therapyb | Usually used to therapeutic advantage; adjust dosage carefully and monitor for excessive BP reductionb |
Epinephrine | Decreased pressor response to epinephrine134 d e | |
Hypotensive agents | Additive hypotensive effectb | Usually used to therapeutic advantage; adjust dosage carefully and monitor for excessive BP reductionb |
MAO inhibitors | Synergistic effect, resulting in marked BP decreaseb | Use concomitantly with cautionb |
Phosphodiesterase (PDE) inhibitors, selective when using hydralazine in fixed combination with isosorbide dinitrate | Sildenafil and other selective PDE inhibitors (e.g., tadalafil, vardenafil) profoundly potentiate the vasodilatory effects of isosorbide dinitrate and potentially life-threatening hypotension and/or hemodynamic compromise can result135 | Because of the serious risk of concurrent use of isosorbide dinitrate and selective PDE inhibitors, such combined use is contraindicated135 |
Hydralazine Hydrochloride Pharmacokinetics
Absorption
Bioavailability
Absorption from GI tract is rapid;b 66% of an oral dose may be absorbed.135
Onset
Following oral administration, antihypertensive effect occurs in 20–30 minutes.b
Following IM administration, hypotensive effect occurs within 10–30 minutes.b
Following IV administration, hypotensive effect occurs within 5–20 minutes, is maximum in 10–80 minutes.b
Duration
Following oral administration, antihypertensive effect lasts 2–4 hours.b
Following IM administration, hypotensive effect lasts 2–6 hours.b
Following IV administration, hypotensive effect lasts 2–6 hours.b
Food
Food increases plasma hydralazine concentrations.134 The effect of food on the bioavailability of hydralazine when administered in fixed combination with isosorbide dinitrate is not known.135
Distribution
Extent
Widely distributed into body tissues in animals;b highest concentrations in kidneys, plasma, and liver; high affinity for arterial walls;b lower concentrations in the brain, lungs, muscle, heart, and fat.b
Readily crosses the placenta.b
Distributed into milk.b
Plasma Protein Binding
85–87%.b
Elimination
Metabolism
Metabolized extensively in the GI mucosa during absorption and in the liver by acetylation, hydroxylation, and conjugation with glucuronic acid.b
Acetylation rate is genetically determined; slow acetylators have higher plasma hydralazine concentrations than rapid acetylators at the same oral dose.b
Elimination Route
Excreted principally in urine as metabolites and in feces (10%).b
Half-life
Plasma half-life: approximately 2–4 hours.b
Special Populations
Not known whether hydralazine is dialyzable.b
Not known whether impaired renal or hepatic function has an effect on the pharmacokinetics of hydralazine.135
Hydralazine may be eliminated more slowly in geriatric patients.135
Stability
Storage
Oral
Capsules or Tablets
Tight, light-resistant containers at 15–30°C.134 b d
Tablets (Hydralazine Hydrochloride and Isosorbide Dinitrate)
Tight, light-resistant containers at 25°C (may be exposed to 15–30°C).135
Parenteral
Injection
15–30°;e avoid freezing.b
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Color change develops after dilution with most IV infusion solutions.b Color changes that occur over 8–12 hours generally do not indicate loss of potency when stored at ≤30°C.b
Solution CompatibilityHID
Compatible |
|---|
Dextran 6% in dextrose 5% |
Dextran 6% in sodium chloride 0.9% |
Dextrose–Ringer’s injection combinations |
Dextrose 5% in Ringer’s injection, lactated |
Dextrose 2½% in half-strength Ringer’s injection, lactated |
Dextrose–saline combinations |
Dextrose 2½ or 10% in water |
Invert sugar 5 and 10% in sodium chloride 0.9% |
Invert sugar 5 and 10% in water |
Ionosol products |
Ringer’s injection |
Ringer’s injection, lactated |
Sodium chloride 0.45 or 0.9% |
Sodium lactate (1/6) M |
Incompatible |
Dextrose 5% in water |
Dextrose 10% in Ringer’s injection, lactated |
Fructose 10% in sodium chloride 0.9% |
Fructose 10% in water |
Drug Compatibility
Compatible |
|---|
Dobutamine HCl |
Incompatible |
Aminophylline |
Ampicillin sodium |
Chlorothiazide sodium |
Edetate calcium disodium |
Ethacrynate sodium |
Hydrocortisone sodium succinate |
Methohexital sodium |
Nitroglycerin |
Pantoprazole sodium |
Phenobarbital sodium |
Verapamil HCl |
Compatible |
|---|
Heparin sodium |
Hydrocortisone sodium succinate |
Potassium chloride |
Verapamil HCl |
Vitamin B complex with C |
Incompatible |
Aminophylline |
Ampicillin sodium |
Diazoxide |
Furosemide |
Variable |
Nitroglycerin |
ActionsActions
Mechanism of action as an antihypertensive agent is presumed to be a result of a direct vasodilatory effect on vascular smooth muscle.134 d e
Advice to Patients
Importance of informing clincian about occurrence of SLE symptoms (e.g., joint or chest pain or fever).134 d e
Potential to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.134 d e
Importance of consulting clinician if headache continues with repeated dosing.135
Importance of informing patients receiving hydralazine in fixed combination with isosorbide dinitrate that inadequate fluid intake or excessive fluid loss due to diarrhea, vomiting, or perspiration may result in excessive hypotension, possibly leading to lightheadedness or syncope; if syncope occurs, discontinue treatment and notify clinician immediately.135
Importance of taking hydralazine regularly and continuously as prescribed.134 d e
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.134 d e
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.134 d e
Importance of informing patients of other important precautionary information.134 d e (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 10 mg* | Hydralazine Hydrochloride Tablets | Par, Pliva, Sandoz, Teva, Watson |
25 mg* | Hydralazine Hydrochloride Tablets | Par, Pliva, Sandoz, Teva, Watson | ||
50 mg* | Hydralazine Hydrochloride Tablets | Par, Pliva, Sandoz, Teva, Watson | ||
100 mg* | Hydralazine Hydrochloride Tablets | Par, Pliva | ||
Parenteral | Injection | 20 mg/mL* | Hydralazine Hydrochloride Injection | Abraxis, American Regent, Sicor |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 25 mg with Hydrochlorothiazide 25 mg* | Hydra-Zide | Par |
50 mg with Hydrochlorothiazide 50 mg* | Hydra-Zide | Par | ||
100 mg with Hydrochlorothiazide 50 mg* | Hydra-Zide | Par | ||
Tablets, film-coated | 37.5 mg with Isosorbide Dinitrate 20 mg | BiDil (scored) | NitroMed |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
HydrALAZINE HCl 25MG Tablets (PAR): 100/$27.99 or 200/$52.98
HydrALAZINE HCl 50MG Tablets (CAMBER PHARMACEUTICALS): 30/$19.98 or 60/$27.97
Hydralazine-HCTZ 25-25MG Capsules (PAR): 30/$22.69 or 90/$51.04
Hydralazine-HCTZ 50-50MG Capsules (PAR): 30/$33.99 or 90/$79.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
Only references cited for selected revisions after 1984 are available electronically.
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134. Par Pharmaceutical, Inc. Hydralazine hydrochloride tablets prescribing information. Spring Valley, NY; 2003 Jun.
135. NitroMed, Inc. BiDil (isosorbide dinitrate and hydralazine hydrochloride) tablets prescribing information. Lexington, MA; 2005 Jun 23.
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d. Par Pharmaceutical, Inc. Hydralazine hydrochloride and Hydrochlorothiazide capsules prescribing information. Spring Valley, NY; 2000 Jul.
e. American Regent. Hydralazine hydrochloride injection prescribing information. Shirley, NY; 2002 Jun.
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