HydrALAZINE (Lexi-Drugs)

Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

Pronunciation

(hye DRAL a zeen)

Brand Names: Canada

APO-HydrALAZINE; Apresoline; JAMP-HydrALAZINE; MINT-HydrALAZINE; PMS-HydrALAZINE [DSC]

Pharmacologic Category

AntihypertensiveVasodilator

Dosing: Adult

Heart failure with reduced ejection fraction (HFrEF) (off-label use): Note: As additional therapy for persistent NYHA class III or IV HFrEF despite optimal medical therapies or for patients who cannot tolerate an ACE inhibitor, ARB, or angiotensin II-neprilysin inhibitor (ARNI) (ACCF/AHA [Yancy 2013]; Colucci 2018).

Oral: Initial: 25 to 50 mg 3 or 4 times daily in combination with isosorbide dinitrate 3 or 4 times daily; titrate dose every 2 to 4 weeks; maximum dose: 300 mg/day in divided doses (ACCF/AHA [Yancy 2013]). Some experts initiate 25 mg 3 times daily in combination with isosorbide dinitrate 3 times daily; evaluate every 2 to 4 weeks and gradually titrate as tolerated to a target dose of 75 mg 3 times daily in combination with isosorbide dinitrate 3 times daily (Colucci 2018; Gottlieb 2018). Note: May also consider use of the fixed-dose combination of isosorbide dinitrate/hydralazine instead of separate components (ACCF/AHA [Yancy 2013]; ACC/AHA/HFSA [Yancy 2017]).

Hypertension (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 2017]).

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 2017]). 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 2017]).

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 2017]; Elliott 2019; 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 2017).

IM, IV: Initial: 5 or 10 mg; repeat with 5 to 10 mg doses every 20 minutes if blood pressure continues to exceed thresholds (ACOG 2017; 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 2017; August 2018).

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 2018; Lien 2012).

IV: 5 to 20 mg every 4 to 6 hours as needed (Broussard 2018; Lien 2012)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

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 of 25 to 50 mg every 8 hours:

GFR ≥10 mL/minute: Administer every 8 hours.

GFR <10 mL/minute: Administer every 8 to 16 hours.

Intermittent hemodialysis: Dose after dialysis.

Peritoneal dialysis: Administer every 8 to 16 hours.

Continuous renal replacement therapy: Administer every 8 hours.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; however, hydralazine undergoes extensive hepatic metabolism.

Dosing: Pediatric

Note: Individualize dose; titrate to patient response.

Heart failure, afterload reduction: Limited data available (Artman 1987, Friedman 1985, Park 2014): Note: May cause reflex tachycardia; use in combination with beta-blocker therapy has been suggested (Park, 2014).

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 dose: 10 mg/dose; may increase gradually over 3 to 4 weeks up to a maximum of 7.5 mg/kg/day in 2 to 4 divided doses not to exceed 200 mg/day (NHBPEP 2004; NHLBI 2012; Park 2014)

Hypertensive emergency/urgency: Infants, Children, and Adolescents: IM, IV: Initial: 0.1 to 0.2 mg/kg/dose every 4 to 6 hours; increase as required to suggested usual range: 0.2 to 0.6 mg/kg/dose every 4 to 6 hours as needed; maximum dose: 20 mg/dose (NHBPEP 2004; Park 2014; Thomas 2011); manufacturer labeling suggests a dose range of 1.7 to 3.5 mg/kg/day divided in 4 to 6 doses

Dosing: Renal Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, hydralazine undergoes extensive hepatic metabolism.

Use: Labeled Indications

Hypertension: Management of moderate to severe hypertension. Note: Not recommended for the initial treatment of hypertension (ACC/AHA [Whelton 2017])

Use: Off-Label: Adult

  Heart failure with reduced ejection fraction (HFrEF)Level of Evidence [A, G]

Data from a randomized, double-blind trial comparing enalapril and hydralazine plus isosorbide dinitrate in patients with chronic HFrEF support the use of hydralazine (in combination with isosorbide dinitrate) in patients with intolerance to ACE inhibitor therapy Ref. Data from a randomized, double-blind, placebo-controlled trial in black patients with NYHA class III or IV HFrEF on optimal guideline-directed medical therapy support the use of hydralazine (in combination with isosorbide dinitrate) for the management of this condition Ref.

Based on the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines for the management of heart failure, hydralazine (in combination with isosorbide dinitrate) is effective and recommended as additional therapy to optimal guideline-directed medical therapy for self-identified African-American patients with persistent NYHA class III or IV HFrEF or for patients who do not tolerate an ACE inhibitor or an ARB Ref. Some experts recommend hydralazine (in combination with isosorbide dinitrate) in addition to optimal guideline-directed medical therapy for black and nonblack patients with persistent NYHA class III or IV HFrEF, particularly for those with low output states or hypertension, or for patients who do not tolerate an ACE inhibitor, ARB, or angiotensin II-neprilysin inhibitor (ARNI) Ref.

  Hypertensive emergency in pregnancy or postpartum (including acute-onset hypertension in preeclampsia/eclampsia)Level of Evidence [G]

Based on the American College of Obstetricians and Gynecologists (ACOG) opinion on emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period, the use of hydralazine is effective and recommended as a treatment option in pregnant and postpartum patients who are experiencing acute-onset, severe hypertension with preeclampsia or eclampsia Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Heart Failure:

ACCF/AHA, “2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines,” June 2013

Canadian Cardiovascular Society, “2012 Heart Failure Management Guidelines Update: Focus on Acute and Chronic Heart Failure,” 2012

“HFSA 2010 Comprehensive Heart Failure Practice Guideline,” July 2010

Hypertension:

“2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults,” November 2017.

“ACCF/AHA Expert Consensus Document on Hypertension in the Elderly,” 2011

AHA/ACC/CDC, “AHA/ACC/CDC Science Advisory: An Effective Approach to High Blood Pressure Control” November 2013

ASH/ISH “Clinical Practice Guidelines for the Management of Hypertension in the Community: A Statement by the American Society of Hypertension and the International Society of Hypertension,” January 2014

Eighth Joint National Committee (JNC 8), “2014 Evidence-based Guideline for the Management of High Blood Pressure in Adults,” December 2013.

“National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents,” May 2005

Stroke:

AHA/ASA, “Guidelines for the Early Management of Patients with Acute Ischemic Stroke,” February 2013

Administration: IM

Administer undiluted as IM injection.

Administration: IV

Administer undiluted as slow IV push.

Administration: Injectable Detail

pH: 3.4 to 4.4

Administration: Oral

Administer without regard to meals. However, food enhances bioavailability; administer consistently with regard to meals.

Administration: Pediatric

Oral: Administer with food

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)

Storage/Stability

Tablets: Store at 15ºC to 30ºC (59ºF to 86ºF).

Injection: Store at 20ºC to 25ºC (68ºF to 77ºF); use immediately after vial is opened. Solution may discolor upon contact with metal; discard discolored solutions.

Preparation for Administration: Pediatric

Parenteral: IV: Manufacturer does not recommend dilution. If further dilution is desired hydralazine should be diluted in NS for IVPB administration due to decreased stability in D5W; hydralazine diluted in NS to a concentration of 0.2 mg/mL is reported as stable for at least 1 day at room temperature (Gupta 2005).

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

4 mg/mL Oral Suspension (ASHP standard concentration) (ASHP 2017)

A 4 mg/mL oral suspension may be made with tablets and a 1:1 mixture of Ora-Sweet SF and Ora-Plus. Crush four 100 mg tablets in a mortar and reduce to a fine powder. Add 15 mL of the vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 100 mL. Label “shake well”, “protect from light”, “store in a refrigerator.” Stable for 2 days when stored in amber plastic prescription bottles in the dark and refrigerated (Allen 1998).

Note: Stability reduced to 24 hours if Ora-Sweet is substituted for Ora-Sweet SF.

Allen LV Jr, Erickson MA 3rd. Stability of alprazolam, chloroquine phosphate, cisapride, enalapril maleate, and hydralazine hydrochloride in extemporaneously compounded oral liquids. Am J Health-Syst Pharm. 1998;55(18):1915-1920.[PubMed 9784772]

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, diarrhea, lack of appetite, vomiting, or nausea. Have patient report immediately to prescriber signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), change in amount of urine passed, urinary retention, severe dizziness, passing out, angina, tachycardia, abnormal heartbeat, chills, pharyngitis, burning or numbness feeling, severe loss of strength and energy, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
Contraindications

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 or constrictive pericarditis); isolated right-ventricular HF due to pulmonary hypertension; acute dissecting aneurysm of the aotrta

Warnings/Precautions

Concerns related to adverse effects:

• Drug-induced lupus-like syndrome: May cause a drug-induced lupus-like syndrome including glomerulonephritis, especially in patients receiving higher doses. If this syndrome occurs, discontinue therapy unless the benefit-to-risk requires continued therapy. Signs and symptoms usually regress after discontinuation of therapy, but residua have been detected many years later. Long-term treatment with steroids may be necessary.

• Hematologic effects: Blood dyscrasias (eg, reduction in hemoglobin and red blood cell count, leukopenia, agranulocytosis, purpura) may occur; discontinue therapy if these hematologic effects occur.

• Hypotension: Postural hypotension may occur.

• Peripheral neuritis: Hydralazine has been associated with peripheral neuritis (eg, paresthesia, numbness, and tingling), possibly due to an antipyridoxine effect. Pyridoxine therapy should be initiated with onset of such symptoms.

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage forms related issues:

• 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.

Geriatric Considerations

Due to the vasodilating effects, lower initial doses within the recommended dosage range should be used in elderly patients.

The AHA/ACC/ASH 2015 scientific statement on the treatment of hypertension in patients with CAD warns to use caution and avoid decreases in DBP <60 mm Hg especially in patients >60 years of age since reduced coronary perfusion may occur. When lowering SBP in older hypertensive patients with wide pulse pressures, very low DBP values (<60 mm Hg) may result. In patients with obstructive CAD, clinicians should lower blood pressure slowly and carefully monitor for any untoward signs or symptoms, especially those resulting from myocardial ischemia and worsening heart failure (AHA/ACC/ASH [Rosendorff 2015]).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Hydralazine crosses the placenta (Lamont 1986; Liedholm 1982).

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 2017).

Untreated chronic maternal hypertension is associated with adverse events in the fetus, infant, and mother. If treatment for chronic hypertension in pregnancy is needed, other oral agents are preferred as initial therapy (ACOG 2013; Magee 2014).

Breast-Feeding Considerations

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 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). Hydralazine can be detected in the serum of 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).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined.

Cardiovascular: Angina pectoris, circulatory shock, flushing, orthostatic hypotension, palpitations, paradoxical pressor response, peripheral edema, tachycardia

Central nervous system: Anxiety, chills, depression, disorientation, dizziness, headache, increased intracranial pressure (IV; in patient with preexisting increased intracranial pressure), peripheral neuritis, psychotic reaction

Dermatologic: Diaphoresis, pruritus, skin rash, urticaria

Gastrointestinal: Anorexia, constipation, diarrhea, nausea, paralytic ileus, vomiting

Genitourinary: Dysuria, impotence

Hematologic & oncologic: Agranulocytosis, decreased hemoglobin, decreased red blood cells, eosinophilia, hemolytic anemia, leukopenia

Neuromuscular & skeletal: Lupus-like syndrome (dose related; fever, arthralgia, splenomegaly, lymphadenopathy, asthenia, myalgia, malaise, pleuritic chest pain, edema, positive ANA, positive LE cells, maculopapular facial rash, positive direct Coombs’ test, pericarditis, pericardial tamponade), muscle cramps, rheumatoid arthritis, tremor, weakness

Ophthalmic: Conjunctivitis, lacrimation

Respiratory: Dyspnea, nasal congestion

Miscellaneous: Fever

<1%, postmarketing, and/or case reports: Hepatotoxicity (Sharma 2018), thrombocytopenia (IV)

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

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 amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. 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: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. 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

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbs (Hypotensive Properties): 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

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Food Interactions

Food enhances bioavailability of hydralazine. Management: Administer without regard to food, but keep consistent.

Monitoring Parameters

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 2017]):

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.

Advanced Practitioners Physical Assessment/Monitoring

Orthostatic precautions should be observed and patient monitored closely during and following infusion. Monitor for hypotension and fluid retention periodically during therapy.

Nursing Physical Assessment/Monitoring

Orthostatic precautions should be observed and patient monitored closely during and following infusion. Monitor for hypotension and fluid retention periodically during therapy.

Dosage Forms: US

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

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection, as hydrochloride:

Apresoline: 20 mg/mL (1ea, 1ml)

Tablet, Oral, as hydrochloride:

Generic: 10 mg, 25 mg, 50 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C02DB02
Generic Available (US)

Yes

Pricing: US

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

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Direct vasodilation of arterioles (with little effect on veins) with decreased systemic resistance

Pharmacodynamics/Kinetics

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: Increased with food

Half-life elimination: 3 to 7 hours

Time to peak, plasma: Oral: 1 to 2 hours

Excretion: Urine (as metabolites)

Pharmacodynamics/Kinetics: Additional Considerations

Slow acetylators: Patients will generally have higher plasma levels of hydralazine and require lower doses to maintain control of BP.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Apresoline; Hydralazine HCl; Hydralazine Hydrochloride

FDA Approval Date
January 15, 1953
References

American College of Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122-1131.[PubMed 24150027]

American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee opinion No. 692: emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;129(4):e90-e95.[PubMed 28333820]

American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi:10.1111/jgs.13702.[PubMed 26446832]

Apresoline (hydralazine) [product monograph]. Mississauga, Ontario, Canada; SteriMax Inc; May 2012.

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th ed. Philadelphia, PA: American College of Physicians; 2007.

August P. Management of hypertension in pregnant and postpartum women. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 21, 2018.

Begum MR, Quadir E, Begum A, Akhter S, Rahman K. Management of hypertensive emergencies of pregnancy by hydralazine bolus injection vs continuous drip–a comparative study. Medscape Womens Health. 2002;7(5):1.[PubMed 12466730]

Broussard D. Cardiovascular problems in the post-anesthesia care unit (PACU). Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 19, 2018.

Cohn JN, Johnson G, Ziesche S, et al. A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure. N Engl J Med.1991;325(5):303-310.[PubMed 2057035]

Colucci WS. Hydralazine plus nitrate therapy in patients with heart failure with reduced ejection fraction. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 19, 2018.

Elliott WJ. Drugs used for the treatment of hypertensive emergencies. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed January 29, 2019.

Gottlieb SS. Pharmacologic therapy of heart failure with reduced ejection fraction. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 19, 2018.

Hydralazine Hydrochloride tablets [prescribing information]. Spring Valley, NY; Par Pharmaceutical Companies Inc; November 2014.

Hydralazine Hydrochloride injection [prescribing information]. Lake Zurich, IL: Fresenius Kabi; June 2015.

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520.[PubMed 24352797]

Jauch EC, Saver JL, Adams HP Jr, et al, “Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association,” Stroke, 2013, 44(3):870-947.[PubMed 23370205]

Klaus JR, Knodel LC, Kavanagh RE. Administration guidelines for parenteral drug therapy. Part I: pediatric patients. J Pharm Technol. 1989;5(3):101-128.[PubMed 10318297]

Lamont RF, Elder MG. Transfer of hydralazine across the placenta and into breast milk. J Obstet Gynaecol. 1986;7:47-48.

Liedholm H, Wahlin-Boll E, Hanson A, et al, “Transplacental Passage and Breast Milk Concentrations of Hydralazine,” Eur J Clin Pharmacol, 1982, 21(5):417-9.[PubMed 7200428]

Lien SF, Bisognano JD. Perioperative hypertension: defining at-risk patients and their management. Curr Hypertens Rep. 2012;14(5):432-441.[PubMed 22864917]

Lindenfeld J, Albert NM, Boehmer JP, et al, “HFSA 2010 Comprehensive Heart Failure Practice Guideline,” J Card Fail, 2010, 16(6):e1-194.[PubMed 20610207]

Magee LA, Pels A, Helewa M, et al; Canadian Hypertensive Disorders of Pregnancy Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy: executive summary. J Obstet Gynaecol Can. 2014;36(5):416-441.[PubMed 24927294]

Marik PE, Varon J. Hypertensive crises: challenges and management. Chest. 2007;131(6):1949-1962.[PubMed 17565029]

National Heart, Lung, and Blood Institute. Expert panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. Clinical Practice Guidelines. 2012. National Institutes of Health. http://www.nhlbi.nih.gov/guidelines/cvd_ped/peds_guidelines_full.pdf. Accessed April 11, 2016.

National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004;114(2)(suppl 4th report):555-576.[PubMed 15286277]

O’Malley K, Segal JL, Israili ZH, et al. Duration of hydralazine action in hypertension. Clin Pharmacol Ther, 1975;18(5):581-586.[PubMed 1102235]

Park, MK. Park’s Pediatric Cardiology for Practitioners. 6th ed. Philadelphia, PA: Elsevier Health Sciences; 2014.

Rhoney D, Peacock WF. Intravenous therapy for hypertensive emergencies, part 1 [published correction appears in Am J Health Syst Pharm. 2009;66(19):168]. Am J Health Syst Pharm. 2009;66(15):1343-1352.[PubMed 19635770]

Rosendorff C, Lackland DT, Allison M, et al; American Heart Association, American College of Cardiology, and American Society of Hypertension. Treatment of hypertension in patients with coronary artery disease: A scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension. J Am Soc Hypertens. 2015;9(6):453-98. doi: 10.1016/j.jash.2015.03.002.[PubMed 25840695]

Sharma M, Foge M, Mascarenhas D. A suspected case of hydralazine-induced hepatotoxicity: a case report and review of literature. Am J Case Rep. 2018;19:800-803.[PubMed 29980661]

Taylor AL, Ziesche S, Yancy C, et al; African-American Heart Failure Trial Investigators. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure [published correction appears in N Engl J Med. 2005;352(12):1276]. N Engl J Med. 2004;351(20):2049-2057.[PubMed 15533851]

Thomas CA. Drug treatment of hypertensive crisis in children. Paediatr Drugs. 2011;13(5):281-290.[PubMed 21888442]

Too GT, Hill JB. Hypertensive crisis during pregnancy and postpartum period. Semin Perinatol. 2013;37(4):280-287.[PubMed 23916027]

Varon J, Marik PE. Perioperative hypertension management. Vasc Health Risk Manag. 2008;4(3):615-627.[PubMed 18827911]

Weber MA, Schiffrin EL, White WB, et al. Clinical Practice Guidelines for the Management of Hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hyperten (Greenwich). 2014;16(1):14-26.[PubMed 24341872]

Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines [published online November 13, 2017]. Hypertension. doi: 10.1161/HYP.0000000000000065.[PubMed 29133356]

World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/

Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128(16):e240-e319. http://circ.ahajournals.org/content/early/2013/06/03/CIR.0b013e31829e8776.citation. Accessed June 6, 2013.[PubMed 23741058]

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Brand Names: International

Ademan (TW); Alphapress (AU); Aprelazine (TW); Apresol (IN); Apresolin (NO, QA, SE); Apresolina (MX, PT, UY, VE); Apresoline (AU, BB, BF, BH, BJ, BM, BS, BZ, CI, CY, ET, GB, GH, GM, GN, GY, JM, KE, LR, MA, ML, MR, MU, MW, NE, NG, NL, NZ, PH, SA, SC, SD, SG, SL, SN, SR, TH, TN, TR, TT, TW, TZ, UG, ZM, ZW); Aprezin (TW); Apulon (TW); Ardiolazin (EG); Cesoline Y (TH); Cesoline-W (TH); Hidral (AR, UY); Hydrapres (AR, ES); Hylazine (PH); Hyperphen (ZA); Hyperphen-50 (ZW); Hyperzine (PH); Slow-Apresoline (AE, BB, BF, BJ, BM, BS, BZ, CI, ET, GH, GM, GN, GY, IL, IQ, IR, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, NL, OM, PR, SC, SD, SL, SN, SR, SY, TN, TT, TZ, UG, YE, ZM, ZW); Stable (TW)

Hydralazine (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(hye DRAL a zeen)

Brand Names: Canada

Apresoline

What is this drug used for?
  • It is used to treat high blood pressure.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to hydralazine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have rheumatic heart disease that affected a heart valve.
  • If you have heart disease, talk with your doctor.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • If you are taking this drug and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Talk with your doctor before you drink alcohol.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Not able to pass urine or change in how much urine is passed.
  • Very bad dizziness or passing out.
  • Chest pain or pressure.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Fever or chills.
  • Sore throat.
  • A burning, numbness, or tingling feeling that is not normal.
  • Feeling very tired or weak.
  • Any unexplained bruising or bleeding.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Diarrhea.
  • Not hungry.
  • Upset stomach or throwing up.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Tablet:
  • Take with or without food. Take with food if it causes an upset stomach.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Injection:
  • It is given as a shot into a muscle or vein.
What do I do if I miss a dose?
  • Tablet:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • Tablet:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Hydralazine (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(hye DRAL a zeen)

Brand Names: Canada

Apresoline

What is this drug used for?
  • It is used to treat high blood pressure.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child had rheumatic heart disease that affected a heart valve.
  • If your child has heart disease, talk with the doctor.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
  • Have your child’s blood pressure checked often. Talk with your child’s doctor.
  • Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • If your child is taking this drug and has high blood pressure, talk with the doctor before giving OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Not able to pass urine or change in how much urine is passed.
  • Very bad dizziness or passing out.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Fever or chills.
  • Sore throat.
  • A burning, numbness, or tingling feeling that is not normal.
  • Feeling very tired or weak.
  • Any unexplained bruising or bleeding.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Diarrhea.
  • Not hungry.
  • Upset stomach or throwing up.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Tablet:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Injection:
  • It is given as a shot into a muscle or vein.
What do I do if my child misses a dose?
  • Tablet:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • Tablet:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.