Minoxidil

Pronunciation

Class: Direct Vasodilators
VA Class: CV490
CAS Number: 38304-91-5

Warning(s)

  • Risk of developing potentially serious cardiac effects.110 b (See Cardiovascular Effects under Cautions.) Pericardial effusion, progressing to tamponade may occur and angina pectoris may be exacerbated.110 b Reserve for hypertensive patients who do not respond to maximum therapeutic doses of a diuretic and 2 other antihypertensive agents.110 b

  • In animal studies, minoxidil caused myocardial lesions and other adverse cardiac effects.110 b

  • Administer under close supervision, usually concomitantly with a β-adrenergic blocking agent and a diuretic, usually a loop diuretic, to prevent adverse effects.110 b

  • Hospitalize and monitor patients with malignant hypertension or those already receiving concomitant guanethidine therapy to prevent too rapid or severe orthostatic decreases in BP.110 b

Introduction

Vasodilating agent.b

Uses for Minoxidil

Hypertension

Management of severe symptomatic hypertension or hypertension associated with end-organ damage in patients with uncontrolled hypertension not manageable with maximal therapeutic dosages of a diuretic and 2 other antihypertensive agents.110 158 b

Not recommended for mild or moderate hypertension or severe hypertension controllable with other drugs.110 143 b

Often effective in management of hypertension resistant to other drugs.b

May be used in combination with other antihypertensive therapies (e.g., a diuretic and a β-adrenergic blocking agent, an ACE inhibitor, a calcium-channel blocking agent, and/or an angiotensin II receptor antagonist).110 158 b

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Do not use for the treatment of hypertension in patients with left ventricular hypertrophy.158 b

Androgenetic Alopecia

Used topically to stimulate regrowth of hair in patients with androgenetic alopecia106 107 108 109 116 117 118 119 122 123 124 128 129 130 131 132 133 134 135 137 b (male pattern alopecia, hereditary alopecia, common male baldness) or alopecia areata†.102 103 104 105 106 107 116 117 118 125 126 127 b Safety and efficacy of extemporaneously prepared formulations of topical minoxidil in promoting hair growth not fully evaluated and such preparations may vary in strength and efficacy.110 b FDA requests that physicians and pharmacists refrain from preparing extemporaneous topical formulations using the commercially available tablets.113

Minoxidil Dosage and Administration

General

  • A β-adrenergic blocking agent (equivalent to 80–160 mg of propranolol daily) must be given before initiation of minoxidil therapy and continued for duration of therapy, to minimize minoxidil-induced tachycardia and increased myocardial workload.110 b If a β-adrenergic blocking agent is contraindicated, methyldopa (250–750 mg twice daily) should be initiated at least 24 hours prior to minoxidil therapy; clonidine (0.1–0.2 mg twice daily) may be used as an alternative.110 b

  • A thiazide or loop diuretic must be used in patients dependent on renal function for maintenance of sodium and water balance.110 b

  • Once therapy initiated, adjust dosage carefully according to individual requirements and BP response at approximately monthly intervals or more aggressively in high-risk patients.145 158 b

Administration

Oral Administration

Administer orally once daily if patient’s supine DBP has been reduced by <30 mm Hg; administer twice daily (in equally divided doses) if patient’s supine DBP reduced >30 mm Hg.110 b

If rapid control needed, may give dose every 6 hours; monitor BP closely.110 b

Dosage

Pediatric Patients

Hypertension
Oral

Children <12 years of age: Initially, 0.2 mg/kg110 b (not to exceed 5 mg) once daily.b

Dosages may be increased at intervals of at least 3 days in increments of 50–100% until optimum BP response is achieved.110 b If rapid control needed, adjust dosage every 6 hours; monitor BP closely.110 b

Usual effective dosage is 0.25–1 mg/kg daily in 1 or 2 doses up to a maximum dosage of 50 mg daily.110 b

Children >12 years of age: Initially, 2.5–5 mg once daily.b Dosages may be increased at intervals of least 3 days to 10 mg, 20 mg, and then 40 mg daily in 1 or 2 divided doses until optimum BP response is achieved.110 b If rapid control needed, adjust dosage every 6 hours; monitor BP closely.110 b

Usual effective dosage is 10–40 mg daily in 1 or 2 doses up to maximum dosage of 100 mg daily.110 b

Some experts (JNC 7) recommend a usual dosage of 2.5–80 mg daily given in 1 or 2 divided doses daily.158

Severe Hypertension
Oral

Pediatric patients 1–17 years of age: For rapid reduction of blood pressure, 0.1–0.2 mg/kg may be used.163 b

Adults

Hypertension
Oral

Initially, 2.5–5 mg once daily.b Dosages may be increased at intervals of least 3 daysb to 10 mg, 20 mg, and then 40 mg daily in 1 or 2 divided doses until optimum BP response is achieved.110 b If rapid control needed, adjust dosage every 6 hours; monitor BP closely.110 b

Usual effective dosage is 10–40 mg daily in 1 or 2 doses up to maximum dosage of 100 mg daily.110 b

Some experts (JNC 7) recommend a usual dosage of 2.5–80 mg daily given in 1 or 2 divided doses.158 b

Prescribing Limits

Pediatric Patients

Hypertension
Oral

Children <12 years of age: maximum 50 mg daily.110 b

Children >12 years of age: maximum 100 mg daily.110 b

Adults

Hypertension
Oral

Maximum 100 mg daily.110 b

Special Populations

Renal Impairment

Lower dosage may be required in renal failure or dialysis (about (1/3) less than in patients who are not receiving dialysis).110 b

Removed during dialysis.b Some clinicians recommend administering minoxidil immediately after dialysis (if dialysis is at 9 a.m.); if dialysis is after 3 p.m., the daily dose is given at 7 a.m. (i.e., 8 hours before dialysis). b

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.110 b

Cautions for Minoxidil

Contraindications

  • Pheochromocytoma.110 b

  • Known hypersensitivity to minoxidil or any ingredient in the formulation.110 b

Warnings/Precautions

Warnings

Cardiovascular Effects

Sodium and water retention occur frequently; may result in edema, weight gain, CHF, pulmonary edema, and refractoriness to the antihypertensive effects of minoxidil.110 b Concomitant administration of a diuretic (usually a loop diuretic) generally required.110 b (See General under Dosage and Administration.) Ascites also reported.110 b

Tachycardia occurs commonly and angina pectoris may worsen or occur without previous angina; these effects may be minimized by concomitant administration of a β-adrenergic blocking agent.110 b (See General under Dosage and Administration.)

Pericarditis and pericardial effusion (occasionally with tamponade) reported mainly in patients with connective tissue disease, uremic syndrome, CHF, or marked fluid retention; idiopathic cases also reported.110 b Observe patients closely.110 b (See Boxed Warning.)

Rapid or excessive BP reductions in patients with severe BP elevation may precipitate syncope, cerebrovascular accidents, MI, and ischemia of special sense organs resulting in decrease or loss of vision or hearing;110 b hospitalize patients with malignant hypertension and those already receiving guanethidine (see Specific Drugs under Interactions) during initial minoxidil therapy and monitor closely to assure that BP is decreasing but not too rapidly.110 b

Use with caution in patients with recent MI (within previous month); decreased arterial BP may further limit myocardial blood flow.110 b

Sensitivity Reactions

Possible hypersensitivity (skin rash); may consider discontinuance depending on alternative therapies.110 b

General Precautions

Patient Monitoring

Monitor fluid and electrolyte balance and body weight.110 b Closely supervise patients with renal failure or those undergoing dialysis to prevent exacerbation of renal failure or precipitation of cardiac failure.110 b Observe patients for signs and symptoms of pericardial effusion.110 b

Repeat any abnormal laboratory test (e.g., urinalysis, renal function, ECG, chest radiograph, echocardiogram) occurring at initiation of therapy, initially at 1- to 3-month intervals and as stabilization occurs, at 6- to 12-month intervals.110

Specific Populations

Pregnancy

Category C.110

Lactation

Distributed into milk. 110 b Use not recommended by manufacturers.110

Pediatric Use

Clinical experience with minoxidil for management of hypertension in children, especially infants, is limited.110 b Careful titration of dosage required.110 b

Geriatric Use

Insufficient experience in patients ≥ 65 years of age to determine whether geriatric patients respond differently than younger adults.110 b

Select dosage with caution; because of greater frequency of hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in the elderly.110 b (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Hypertrichosis,110 salt and water retention,110 b pericardial effusion,110 b nausea, 110 b vomiting. 110

Interactions for Minoxidil

Specific Drugs

Drug

Interaction

Comments

Diuretics

Additive hypotensive effect.b Concomitant use may prevent sodium retention and increased plasma volume that may occur with minoxidil therapy110 b

Usually used to therapeutic advantage; adjust dosage carefully and monitor for excessive BP reduction110 b

Guanethidine

Possibly profound orthostatic hypotensive effects110 b

Withdraw guanethidine110 b 1–3 weeks prior to initiating minoxidil therapy.b If not possible, initiate minoxidil in hospital setting and monitor until orthostasis no longer present110 b

Hypotensive agents

Additive hypotensive effect.b Concomitant use may prevent sodium retention and increased plasma volume that may occur with minoxidil therapy110 b

Usually used to therapeutic advantage; adjust dosage carefully and monitor for excessive BP reduction110 b

Minoxidil Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; at least 90% of an oral dose is absorbed.110 Peak plasma concentrations of unchanged drug usually attained within 1 hour.110 b

Onset

Following oral administration, antihypertensive effect occurs within 30 minutes and is maximum in 2–8 hours.110 b

Duration

2–5 days.110 b

Distribution

Extent

Readily distributed into body tissues.b

Distributed into milk.110 b

Plasma Protein Binding

Does not bind to plasma proteins.110 b

Elimination

Metabolism

Approximately 90% of an oral dose is metabolized to less active metabolites than parent drug, principally by conjugation with glucuronic acid and by conversion to more polar metabolites.110 b

Elimination Route

Excreted principally in urine by glomerular filtration.110 b

Half-life

4.2 hours.110 b

Special Populations

Clearance is directly affected by GFR.110

Stability

Storage

Oral

Tablets

20–25°C.110 b

Actions

  • Reduces peripheral vascular resistance and BP through direct vasodilation of vascular smooth muscle.110 b

  • Reduces BP in both supine and standing patients; does not produce orthostatic hypotension.b

  • Increases heart rate, cardiac output, and stroke volume.110 b

  • Causes sodium and water retention and increased plasma volume.110 b

Advice to Patients

  • Importance of informing patients about continuance of all antihypertensive drugs and taking only as prescribed.110

  • Do not discontinue minoxidil unless instructed by a clinician.110

  • Importance of informing patients of symptoms of fluid overload and cardiac effects.110 Importance of reporting these symptoms to a clinician.110

  • Importance of providing patient a copy of manufacturer's patient information.110

  • Inform patients of the likelihood of hair growth, which may develop within 3 to 6 weeks after starting therapy and may be especially disturbing to children and women.110 Inform patients about this effect before initiating therapy.110

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.110

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.110

  • Importance of informing patients of other important precautionary information. (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

Minoxidil

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

2.5 mg*

Minoxidil Tablets

Mutual, Par, Watson

10 mg*

Minoxidil Tablets

Mutual, Par, Watson

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Minoxidil 10MG Tablets (PAR): 90/$53.99 or 180/$85.96

Minoxidil 2.5MG Tablets (PAR): 60/$19.99 or 180/$50.99

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 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.

100. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

101. Valdivieso A, Valdés G, Spiro TE et al. Minoxidil in breast milk. Ann Intern Med. 1985; 102:135. [IDIS 194820] [PubMed 3966734]

102. Weiss VC, West DP, Mueller CE. Topical minoxidil in alopecia areata. J Am Acad Dermatol. 1981; 5:224-6. [PubMed 7263970]

103. Fenton DA, Wilkinson JD. Topical minoxidil in the treatment of alopecia areata. BMJ. 1983; 287:1015-7. [IDIS 177632] [PubMed 6412929]

104. King CM, Harrop B, Dave VK. Topical minoxidil in the treatment of alopecia areata. BMJ. 1983; 287:1380. [IDIS 178404] [PubMed 6416428]

105. Weiss VC, West DP, Fu TS et al. Alopecia areata treated with topical minoxidil. Arch Dermatol. 1984; 120:457-63. [IDIS 185288] [PubMed 6703751]

106. Vanderveen EE, Ellis CN, Kang S et al. Topical minoxidil for hair regrowth. J Am Acad Dermatol. 1984; 11:416-21. [PubMed 6384289]

107. Novak E, Franz TJ, Headington JT et al. Topically applied minoxidil in baldness. Int J Dermatol. 1985; 24:82-7. [PubMed 3886571]

108. Vermorken AJM. Reversal of androgenic alopecia by minoxidil: lack of effect of simultaneously administered intermediate doses of cyproterone acetate. Acta Derm Venereol. 1983; 63:268-9. [PubMed 6192653]

109. De Villez RL. Topical minoxidil therapy in hereditary androgenetic alopecia. Arch Dermatol. 1985; 121:197-202. [IDIS 196318] [PubMed 3883902]

110. Par Pharmaceutical, Inc. Minoxidil tablets prescribing information. Spring Valley, NY; 2003 Apr.

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112. Franz TJ. Percutaneous absorption of minoxidil in man. Arch Dermatol. 1985; 121:203-6. [IDIS 196319] [PubMed 3977334]

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114. Kaler SG, Patrinos ME, Lambert GH et al. Hypertrichosis and congenital anomalies associated with maternal use of minoxidil. Pediatrics. 1987; 79:434-6. [IDIS 227024] [PubMed 3547299]

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