Minoxidil 10mg Tablets

Manufacturer PAR Active Ingredient Minoxidil (Systemic)(mi NOKS i dil) Pronunciation mi NOKS i dil
WARNING: This drug may cause very bad heart-related side effects. This includes chest pain that gets worse. This drug is only for use when blood pressure is not controlled by other drugs. Talk with the doctor.You will need to take certain other drugs with this drug to prevent side effects. If you have questions, talk with your doctor.Sometimes, this drug will need to be started in a hospital where you will be closely watched. Talk with your doctor. @ COMMON USES: It is used to treat high blood pressure.
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Drug Class
Antihypertensive
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Pharmacologic Class
Peripheral vasodilator; Potassium channel opener
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Pregnancy Category
Category C
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FDA Approved
Aug 1979
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Minoxidil is a medication used to treat very high blood pressure that hasn't responded to other medicines. It works by relaxing blood vessels, allowing blood to flow more easily. Because it can cause side effects like fluid retention and a fast heartbeat, it's usually taken with other medications (a water pill and a beta-blocker) to help manage these effects.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets, to prevent accidental ingestion.

Missing a Dose

If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually with a beta-blocker and a diuretic.
  • Do not stop taking abruptly without consulting your doctor.
  • Monitor your blood pressure and heart rate regularly at home if advised.
  • Weigh yourself daily and report any rapid weight gain or swelling to your doctor.
  • Report any new or worsening chest pain, shortness of breath, or dizziness.
  • Be aware of increased body hair growth (hypertrichosis), which is a common side effect.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 5 mg once daily. Titrate gradually. Usual maintenance: 10-40 mg/day, given as a single dose or in 2 divided doses. Max: 100 mg/day.
Dose Range: 5 - 100 mg

Condition-Specific Dosing:

severe_hypertension: Initial: 5 mg once daily. Increase to 10 mg, 20 mg, and then 40 mg/day in single or divided doses, with 3-day or longer intervals between dose adjustments. Max: 100 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial: 0.2 mg/kg once daily. Max: 1 mg/kg/day (up to 50 mg/day). Titrate gradually in 0.1-0.2 mg/kg increments at 3-day or longer intervals. Max: 50 mg/day.
Adolescent: Initial: 5 mg once daily. Titrate gradually. Usual maintenance: 10-40 mg/day, given as a single dose or in 2 divided doses. Max: 100 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor response.
Moderate: Consider starting with a lower dose (e.g., 2.5 mg/day) and titrate cautiously. Monitor for fluid retention and electrolyte imbalances.
Severe: Consider starting with a lower dose (e.g., 2.5 mg/day) and titrate cautiously. Monitor closely for fluid retention, electrolyte imbalances, and signs of pericardial effusion. May require more frequent dialysis.
Dialysis: Minoxidil and its metabolites are dialyzable. Administer dose after dialysis session. Monitor for exaggerated hypotensive response.

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor response.
Moderate: Use with caution. Consider starting with a lower dose and titrate slowly, as minoxidil is extensively metabolized by the liver.
Severe: Use with caution. Consider starting with a lower dose and titrate slowly. Monitor for increased adverse effects due to reduced metabolism.

Pharmacology

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Mechanism of Action

Minoxidil is a direct-acting peripheral vasodilator that reduces elevated systolic and diastolic blood pressure by decreasing peripheral vascular resistance. It acts by opening ATP-sensitive potassium channels in vascular smooth muscle cells, leading to hyperpolarization and relaxation of the smooth muscle, primarily in arterioles. This vasodilation leads to a reflex increase in heart rate, stroke volume, and cardiac output, and increased renin secretion, which can lead to fluid and salt retention.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: 1 hour
FoodEffect: Food does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 2.8 L/kg
ProteinBinding: 0%
CnssPenetration: Limited

Elimination:

HalfLife: 2.8 to 4.2 hours (plasma elimination half-life)
Clearance: Not available
ExcretionRoute: Renal (90% as metabolites, 10% as unchanged drug)
Unchanged: Approximately 10%
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Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: 2-3 hours
DurationOfAction: Up to 24 hours (despite short plasma half-life, due to persistent effect on vascular smooth muscle)

Safety & Warnings

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BLACK BOX WARNING

Minoxidil can cause serious adverse effects, including pericardial effusion, occasionally progressing to tamponade, and angina pectoris exacerbation. Patients should be hospitalized and closely monitored during initial titration. Minoxidil must be administered with a concomitant diuretic to prevent fluid retention and a beta-adrenergic blocking drug (or other sympathetic nervous system suppressant) to prevent reflex tachycardia.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
New or worsening chest, arm, or shoulder pain
Dizziness or fainting
Fast or abnormal heartbeat
Severe or persistent heartburn
Changes in hearing or eyesight

Additionally, this medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. If you notice any of these symptoms, inform your doctor.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Excessive hair growth
* Upset stomach or vomiting

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • New or worsening chest pain (angina)
  • Shortness of breath, especially when lying down
  • Swelling of the face, hands, ankles, or abdomen
  • Rapid weight gain (e.g., 5 pounds in a few days)
  • Dizziness or fainting spells
  • Persistent fast heartbeat or palpitations
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with pheochromocytoma, a type of adrenal gland tumor.
If you have recently experienced a heart attack.
If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.

Regular monitoring of your blood pressure and heart rate is crucial, as directed by your doctor. Before initiating this medication and during treatment, you will need to undergo heart checks, including an electrocardiogram (ECG). Discuss the details with your doctor.

Adhere to your doctor's recommendations for blood work and other laboratory tests. Weigh yourself daily and consult your doctor before using any over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

If you are pregnant or planning to become pregnant, inform your doctor. You will need to discuss the benefits and risks associated with using this medication during pregnancy to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Tachycardia (very fast heart rate)
  • Fluid retention
  • Shock

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including intravenous fluids to maintain blood pressure. Vasopressors may be used if hypotension is severe and unresponsive to fluids. Dialysis can remove minoxidil from the body.

Drug Interactions

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Major Interactions

  • Guanethidine (severe orthostatic hypotension)
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Moderate Interactions

  • Other antihypertensives (additive hypotensive effects)
  • Diuretics (may enhance hypotensive effect and fluid retention)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for reflex tachycardia.

Timing: Prior to initiation

Fluid and Electrolyte Status (e.g., weight, edema, serum electrolytes)

Rationale: Minoxidil can cause significant fluid retention and edema.

Timing: Prior to initiation

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, as drug is renally eliminated.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing cardiac conditions and monitor for pericardial effusion/angina.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Daily initially, then regularly (e.g., weekly) until stable, then periodically.

Target: <140/90 mmHg (or individualized target)

Action Threshold: Persistent hypotension or uncontrolled hypertension

Heart Rate (HR)

Frequency: Daily initially, then regularly (e.g., weekly) until stable, then periodically.

Target: <90 bpm (or individualized target)

Action Threshold: Persistent tachycardia (>90 bpm) despite beta-blocker

Weight and Signs of Fluid Retention (e.g., edema, dyspnea)

Frequency: Daily initially, then weekly, then periodically.

Target: Stable weight, no significant edema

Action Threshold: Rapid weight gain (>2-3 kg/week), new or worsening edema, dyspnea

Electrocardiogram (ECG) and Chest X-ray (CXR)

Frequency: Periodically, especially if symptoms of pericardial effusion develop.

Target: Normal ECG, no signs of effusion

Action Threshold: New or worsening ECG changes, signs of pericardial effusion (e.g., muffled heart sounds, paradoxical pulse)

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Symptom Monitoring

  • Chest pain (new or worsening angina)
  • Shortness of breath (dyspnea)
  • Swelling of ankles, feet, or hands (edema)
  • Rapid weight gain
  • Dizziness or lightheadedness
  • Palpitations
  • Increased body hair growth (hypertrichosis)

Special Patient Groups

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Pregnancy

Minoxidil is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, but human data are limited.
Second Trimester: Potential for fetal harm, but human data are limited.
Third Trimester: Potential for fetal harm, including hypertrichosis in the neonate. May cause fluid retention in the mother.
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Lactation

Minoxidil is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately Safe) - Potential for adverse effects in the infant, including hypotension and fluid retention. Monitor infant for signs of adverse effects.
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Pediatric Use

Use in children is generally reserved for severe hypertension refractory to other treatments. Dosing is weight-based and requires careful titration and monitoring due to the potential for serious adverse effects, including pericardial effusion and fluid retention. Concomitant beta-blocker and diuretic therapy are essential.

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Geriatric Use

No specific dose adjustment is generally required based on age alone, but elderly patients may be more sensitive to the hypotensive effects and fluid retention. Start with lower doses and titrate cautiously. Monitor closely for adverse effects and ensure adequate concomitant therapy (beta-blocker, diuretic).

Clinical Information

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Clinical Pearls

  • Minoxidil is a potent vasodilator and should almost always be used in combination with a beta-blocker (to prevent reflex tachycardia) and a loop diuretic (to prevent fluid retention and edema).
  • The most common and bothersome side effect is hypertrichosis (excessive hair growth), which occurs in almost all patients and is reversible upon discontinuation.
  • Patients should be closely monitored for signs of fluid retention, including daily weights and assessment for edema.
  • Pericardial effusion, sometimes leading to tamponade, is a serious but rare side effect. Patients should be educated on symptoms like chest pain, shortness of breath, and fatigue.
  • Initial titration should ideally be done in a hospital setting due to the potential for profound hypotension and other serious adverse effects.
  • Minoxidil is typically reserved for severe, refractory hypertension due to its side effect profile.
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Alternative Therapies

  • Hydralazine (another direct vasodilator, but less potent)
  • Nitroprusside (IV, for hypertensive emergencies)
  • Other classes of antihypertensives (e.g., ACE inhibitors, ARBs, calcium channel blockers, diuretics, beta-blockers) are typically tried first for hypertension.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.