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Drug overview for MINOXIDIL (minoxidil):
Generic name: MINOXIDIL (mi-NOX-i-dil)
Drug class: Vasodilators
Therapeutic class: Cardiovascular Therapy Agents
Minoxidil is a vasodilating agent.
No enhanced Uses information available for this drug.
Generic name: MINOXIDIL (mi-NOX-i-dil)
Drug class: Vasodilators
Therapeutic class: Cardiovascular Therapy Agents
Minoxidil is a vasodilating agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
MINOXIDIL 10 MG TABLET
MINOXIDIL 2.5 MG TABLET
The following indications for MINOXIDIL (minoxidil) have been approved by the FDA:
Indications:
Hypertension
Professional Synonyms:
Elevated blood pressure
Essential hypertension
Hyperpiesia
Hyperpiesis
Hypertensive disorder
Systemic arterial hypertension
Indications:
Hypertension
Professional Synonyms:
Elevated blood pressure
Essential hypertension
Hyperpiesia
Hyperpiesis
Hypertensive disorder
Systemic arterial hypertension
The following dosing information is available for MINOXIDIL (minoxidil):
Dosage of minoxidil must be adjusted according to the patient's blood pressure response and tolerance.
The need for pretreatment with certain drugs (e.g., beta-blockers) and possible concomitant use of a diuretic should be considered in patients receiving minoxidil. (See Dosage and Administration: Administration.)
For the management of hypertension in patients older than 12 years of age, the recommended initial dosage of minoxidil is 5 mg once daily. Dosage may be gradually increased after at least 3-day intervals to 10 mg, 20 mg, and then to 40 mg daily in 1 or 2 doses until optimum blood pressure response is attained. The manufacturer states that the usual effective dosage of minoxidil in patients older than 12 years of age is 10-40 mg daily, and the maximum daily dosage is 100 mg.
Some experts state that the usual dosage range is 5-100 mg daily given as a single dose or in 2 or 3 divided doses. If rapid control of hypertension is required, dosage may be adjusted every 6 hours while monitoring blood pressure closely.
Clinical experience with minoxidil for the management of hypertension in children, particularly infants, is limited and dosage must be carefully titrated. In children younger than 12 years of age, the usual initial dosage of minoxidil is 0.2 mg/kg once daily.
If necessary, dosage is gradually increased at intervals of at least 3 days in increments of 50-100% until optimal blood pressure response is attained. If rapid control of hypertension is required, dosage may be adjusted every 6 hours while monitoring blood pressure closely. The usual effective dosage of minoxidil in children is 0.25-1
mg/kg daily, and the maximum dosage recommended by the manufacturers is 50 mg daily.
For rapid reduction of blood pressure in children and adolescents with severe hypertension and non-life-threatening symptoms+, some experts recommend an oral minoxidil dose of 0.1-0.2 mg/kg up to 10 mg per dose administered every 8-12 hours.
Although minoxidil has been used safely in usual doses for the management of hypertension in patients with renal failure, patients with renal failure or those receiving dialysis may require smaller doses of minoxidil (about one-third less than in patients who are not receiving dialysis). Since minoxidil is removed by dialysis, some clinicians recommend that on the day of dialysis the drug be administered 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).
The need for pretreatment with certain drugs (e.g., beta-blockers) and possible concomitant use of a diuretic should be considered in patients receiving minoxidil. (See Dosage and Administration: Administration.)
For the management of hypertension in patients older than 12 years of age, the recommended initial dosage of minoxidil is 5 mg once daily. Dosage may be gradually increased after at least 3-day intervals to 10 mg, 20 mg, and then to 40 mg daily in 1 or 2 doses until optimum blood pressure response is attained. The manufacturer states that the usual effective dosage of minoxidil in patients older than 12 years of age is 10-40 mg daily, and the maximum daily dosage is 100 mg.
Some experts state that the usual dosage range is 5-100 mg daily given as a single dose or in 2 or 3 divided doses. If rapid control of hypertension is required, dosage may be adjusted every 6 hours while monitoring blood pressure closely.
Clinical experience with minoxidil for the management of hypertension in children, particularly infants, is limited and dosage must be carefully titrated. In children younger than 12 years of age, the usual initial dosage of minoxidil is 0.2 mg/kg once daily.
If necessary, dosage is gradually increased at intervals of at least 3 days in increments of 50-100% until optimal blood pressure response is attained. If rapid control of hypertension is required, dosage may be adjusted every 6 hours while monitoring blood pressure closely. The usual effective dosage of minoxidil in children is 0.25-1
mg/kg daily, and the maximum dosage recommended by the manufacturers is 50 mg daily.
For rapid reduction of blood pressure in children and adolescents with severe hypertension and non-life-threatening symptoms+, some experts recommend an oral minoxidil dose of 0.1-0.2 mg/kg up to 10 mg per dose administered every 8-12 hours.
Although minoxidil has been used safely in usual doses for the management of hypertension in patients with renal failure, patients with renal failure or those receiving dialysis may require smaller doses of minoxidil (about one-third less than in patients who are not receiving dialysis). Since minoxidil is removed by dialysis, some clinicians recommend that on the day of dialysis the drug be administered 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).
Minoxidil is administered orally. Minoxidil may be administered once or twice daily, depending on the patient's blood pressure response. The manufacturers recommend that the drug be administered once daily in patients whose supine diastolic pressure has been reduced by less than 30 mm Hg and twice daily in equally divided doses in those whose supine diastolic pressure has been reduced by more than 30 mm Hg during minoxidil therapy.
A beta-adrenergic blocking agent (beta-blocker) (e.g., equivalent to 80-160 mg of propranolol daily) must be given before minoxidil therapy is begun and should be continued during minoxidil therapy to minimize minoxidil-induced tachycardia and increased myocardial workload. If a beta-blocker is contraindicated, another sympathetic nervous system suppressant such as methyldopa (250-750 mg twice daily) should be used and must be started at least 24 hours before minoxidil because of the delayed onset of methyldopa's action. Limited clinical experience indicates that clonidine (0.1-0.2 mg twice daily) may be used as an alternative to methyldopa.
Minoxidil also must be used in conjunction with a thiazide (e.g., hydrochlorothiazide 50 mg twice daily, chlorthalidone 50-100 mg once daily) or loop diuretic (e.g., furosemide 40 mg twice daily) when initiating minoxidil therapy in patients dependent on renal function for maintenance of sodium and water balance. If excessive sodium and water retention results in weight gain exceeding 2.3 kg during minoxidil therapy, diuretic therapy should be changed to a loop diuretic or, in patients already receiving a loop diuretic, the dosage should be increased.
A beta-adrenergic blocking agent (beta-blocker) (e.g., equivalent to 80-160 mg of propranolol daily) must be given before minoxidil therapy is begun and should be continued during minoxidil therapy to minimize minoxidil-induced tachycardia and increased myocardial workload. If a beta-blocker is contraindicated, another sympathetic nervous system suppressant such as methyldopa (250-750 mg twice daily) should be used and must be started at least 24 hours before minoxidil because of the delayed onset of methyldopa's action. Limited clinical experience indicates that clonidine (0.1-0.2 mg twice daily) may be used as an alternative to methyldopa.
Minoxidil also must be used in conjunction with a thiazide (e.g., hydrochlorothiazide 50 mg twice daily, chlorthalidone 50-100 mg once daily) or loop diuretic (e.g., furosemide 40 mg twice daily) when initiating minoxidil therapy in patients dependent on renal function for maintenance of sodium and water balance. If excessive sodium and water retention results in weight gain exceeding 2.3 kg during minoxidil therapy, diuretic therapy should be changed to a loop diuretic or, in patients already receiving a loop diuretic, the dosage should be increased.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MINOXIDIL 2.5 MG TABLET | Maintenance | Adults take 2 tablets (5 mg) by oral route once daily |
| MINOXIDIL 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MINOXIDIL 2.5 MG TABLET | Maintenance | Adults take 2 tablets (5 mg) by oral route once daily |
| MINOXIDIL 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
The following drug interaction information is available for MINOXIDIL (minoxidil):
There are 0 contraindications.
There are 0 severe interactions.
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Tizanidine/Selected Antihypertensives SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tizanidine is an alpha-2 agonist. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and tizanidine may result in hypotension.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. The risk of hypotension may be decreased by careful titration of tizanidine dosages and monitoring for hypotension prior to dose advancement. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Severe hypotension has been reported following the addition of tizanidine to existing lisinopril therapy.(2-4) |
TIZANIDINE HCL, ZANAFLEX |
| Apomorphine/Selected Antihypertensives and Vasodilators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Apomorphine causes dose-dependent decreases in blood pressure. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and apomorphine may result in orthostatic hypotension with or without dizziness, nausea, or syncope.(1) PREDISPOSING FACTORS: The risk of orthostatic hypotension may be increased during dose escalation of apomorphine and in patients with renal or hepatic impairment.(1) PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Healthy volunteers who took sublingual nitroglycerin (0.4 mg) concomitantly with apomorphine experienced a mean largest decrease in supine systolic blood pressure (SBP) of 9.7 mm Hg and in supine diastolic blood pressure (DBP) of 9.3 mm Hg, and a mean largest decrease in standing SBP and DBP of 14.3 mm Hg and 13.5 mm Hg, respectively. The maximum decrease in SBP and DBP was 65 mm Hg and 43 mm Hg, respectively. When apomorphine was taken alone, the mean largest decrease in supine SBP and DBP was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing SBP and DBP was 6.7 mm Hg and 8.4 mm Hg, respectively.(1) |
APOKYN, APOMORPHINE HCL, ONAPGO |
| NSAIDs; Salicylates/Minoxidil SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Oral minoxidil functions as a direct-acting peripheral vasodilator, lowering elevated systolic and diastolic blood pressure by reducing resistance in peripheral blood vessels. This triggers a compensatory increase in cardiac output and renin secretion and results in sodium and water retention. NSAIDs inhibit prostaglandin synthesis and also result in sodium and water retention.(1,2) CLINICAL EFFECTS: The risk of heart failure may increase with oral minoxidil and NSAIDs due to their combined effects on blood vessel dilation, fluid retention, and altered sodium balance. Minoxidil efficacy may be compromised.(1,2) PREDISPOSING FACTORS: Higher doses of oral minoxidil have been associated with serious adverse events, including hypotensive syncope, pericarditis, pericardial effusion, and myocardial infarction.(1-5) PATIENT MANAGEMENT: Closely monitor body weight, fluid and electrolyte balance, and blood pressure when using oral minoxidil and NSAIDs concurrently. Minoxidil tablets should be co-administered with an appropriate diuretic to prevent fluid retention and potential congestive heart failure. A high-ceiling (loop) diuretic is often necessary alongside vigilant monitoring of body weight. Without concurrent diuretic use, minoxidil may lead to the retention of salt and water within a few days.(1,2) DISCUSSION: While the manufacturer of minoxidil does not provide specific recommendations regarding NSAID co-administration, it emphasizes the necessity of combining minoxidil with a beta-blocker to prevent tachycardia and increased myocardial workload. Additionally, concurrent use with a diuretic is recommended to avert serious fluid accumulation and potential congestive heart failure. NSAID labeling warns about fluid retention, edema, an elevated risk of heart failure, and potential drug interactions with beta-blockers and diuretics which can result in a blunting of the antihypertensive and cardiovascular effects of these agents.(1-5) |
ACETYL SALICYLIC ACID, ANAPROX DS, ARTHROTEC 50, ARTHROTEC 75, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ASPIRIN, ASPIRIN-DIPYRIDAMOLE ER, BISMUTH SUBSALICYLATE, BROMFENAC SODIUM, BUTALBITAL-ASPIRIN-CAFFEINE, CALDOLOR, CARISOPRODOL-ASPIRIN, CARISOPRODOL-ASPIRIN-CODEINE, CELEBREX, CELECOXIB, CHOLINE MAGNESIUM TRISALICYLAT, COMBOGESIC, COMBOGESIC IV, CONSENSI, COXANTO, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, DIFLUNISAL, DISALCID, DOLOBID, DURLAZA, EC-NAPROSYN, ELYXYB, ETODOLAC, ETODOLAC ER, FELDENE, FENOPROFEN CALCIUM, FENOPRON, FLURBIPROFEN, HYDROCODONE-IBUPROFEN, IBU, IBUPAK, IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN-FAMOTIDINE, INDOCIN, INDOMETHACIN, INDOMETHACIN ER, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), KETOPROFEN, KETOPROFEN MICRONIZED, KETOROLAC TROMETHAMINE, LODINE, LOFENA, LURBIRO, MECLOFENAMATE SODIUM, MEFENAMIC ACID, MELOXICAM, NABUMETONE, NABUMETONE MICRONIZED, NALFON, NAPRELAN, NAPROSYN, NAPROTIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM CR, NAPROXEN SODIUM ER, NAPROXEN-ESOMEPRAZOLE MAG, NEOPROFEN, NORGESIC, NORGESIC FORTE, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, OXAPROZIN, PHENYL SALICYLATE, PHENYLBUTAZONE, PIROXICAM, RELAFEN DS, SALSALATE, SODIUM SALICYLATE, SULINDAC, SUMATRIPTAN SUCC-NAPROXEN SOD, SYMBRAVO, TOLECTIN 600, TOLMETIN SODIUM, TORONOVA II SUIK, TORONOVA SUIK, TRESNI, TREXIMET, VIMOVO, VIVLODEX, XIFYRM, YOSPRALA, ZIPSOR, ZORVOLEX |
The following contraindication information is available for MINOXIDIL (minoxidil):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pheochromocytoma |
There are 6 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| 30 day risk period post-myocardial infarction |
| Angina |
| Chronic heart failure |
| Pericardial effusion |
| Pericardial tamponade |
| Pericarditis |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Cerebrovascular disorder |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for MINOXIDIL (minoxidil):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 17 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Body fluid retention Cardiac arrhythmia Edema |
Angina Chest pain Pericarditis |
| Rare/Very Rare |
|---|
|
Abnormal ECG Allergic dermatitis Bullous dermatitis Leukopenia Pericardial effusion Pericardial tamponade Pruritus of skin Pulmonary hypertension Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis |
There are 5 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hirsutism |
None. |
| Rare/Very Rare |
|---|
|
Mastalgia Nausea Skin rash Vomiting |
The following precautions are available for MINOXIDIL (minoxidil):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Pronounced hypertrichosis and multiple congenital anomalies, including dysmorphic facial features (e.g., depressed nasal bridge, low-set ears, micrognathia), bilateral clinodactyly, omphalocele, undescended testes, midphallic constriction, unusual fat distribution, and ventriculoseptal defect, occurred in a neonate born to a woman who received minoxidil, captopril, furosemide, and propranolol throughout pregnancy. Hypertrichosis (which appeared as a general increase in bristly hair that was longest in the sacral area) occurred in another infant born to a woman who had received minoxidil as well as metoprolol and prazosin throughout pregnancy. Cyanotic heart disease resulting in death occurred in a neonate born to a woman receiving minoxidil, furosemide, hydralazine, methyldopa, and phenobarbital therapy during the pregnancy; an autopsy revealed transposition of the great vessels and pulmonic bicuspid valvular stenosis.
However, it is not known whether these effects resulted from minoxidil, concurrently administered drugs, the maternal condition, or other factors. There are no adequate and controlled studies to date using minoxidil in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. The effects of the drug on labor and delivery are not known.
Oral administration of minoxidil has been associated with evidence of increased fetal resorption in rabbits, but not rats, when administered at 5 times the maximum recommended oral human dosage. There has been no evidence of teratogenic effects in rats and rabbits. There was no evidence of teratogenic effects in rats receiving subcutaneous minoxidil dosages of 80 mg/kg daily (about 2000 times the maximal systemic human exposure achieved with daily administration of topical minoxidil); however, maternal toxicity was observed with this dosage. Evidence of developmental toxicity was observed in rats receiving subcutaneous dosages exceeding 80 mg/kg daily.
However, it is not known whether these effects resulted from minoxidil, concurrently administered drugs, the maternal condition, or other factors. There are no adequate and controlled studies to date using minoxidil in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. The effects of the drug on labor and delivery are not known.
Oral administration of minoxidil has been associated with evidence of increased fetal resorption in rabbits, but not rats, when administered at 5 times the maximum recommended oral human dosage. There has been no evidence of teratogenic effects in rats and rabbits. There was no evidence of teratogenic effects in rats receiving subcutaneous minoxidil dosages of 80 mg/kg daily (about 2000 times the maximal systemic human exposure achieved with daily administration of topical minoxidil); however, maternal toxicity was observed with this dosage. Evidence of developmental toxicity was observed in rats receiving subcutaneous dosages exceeding 80 mg/kg daily.
Minoxidil is distributed into milk. Because of the potential for adverse reactions from minoxidil in nursing infants, the drug should not be administered in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for MINOXIDIL (minoxidil):
WARNING: Minoxidil may cause serious heart problems or worsen chest pain (angina). This medication is only used when other treatments have not worked well or cannot be taken. Your doctor should direct you to also take other medications to reduce the side effects of minoxidil.
These medications include a "water pill" (diuretic) to prevent the body from holding on to too much water and salt and a heart medication (such as a beta blocker including propranolol) to prevent the heart from working too hard or beating too fast. Your doctor will follow you closely while you are taking this medication. Keep all regular medical and lab appointments.
WARNING: Minoxidil may cause serious heart problems or worsen chest pain (angina). This medication is only used when other treatments have not worked well or cannot be taken. Your doctor should direct you to also take other medications to reduce the side effects of minoxidil.
These medications include a "water pill" (diuretic) to prevent the body from holding on to too much water and salt and a heart medication (such as a beta blocker including propranolol) to prevent the heart from working too hard or beating too fast. Your doctor will follow you closely while you are taking this medication. Keep all regular medical and lab appointments.
The following icd codes are available for MINOXIDIL (minoxidil)'s list of indications:
| Hypertension | |
| I10 | Essential (primary) hypertension |
| I11 | Hypertensive heart disease |
| I11.0 | Hypertensive heart disease with heart failure |
| I11.9 | Hypertensive heart disease without heart failure |
| I12 | Hypertensive chronic kidney disease |
| I12.0 | Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease |
| I12.9 | Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease |
| I13 | Hypertensive heart and chronic kidney disease |
| I13.0 | Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease |
| I13.1 | Hypertensive heart and chronic kidney disease without heart failure |
| I13.10 | Hypertensive heart and chronic kidney disease without heart failure, with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease |
| I13.11 | Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease |
| I13.2 | Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease |
| I15.1 | Hypertension secondary to other renal disorders |
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