Minoxidil 5% Soln For Men 60ml

Manufacturer H2 PHARMA Active Ingredient Minoxidil Topical Solution(mi NOKS i dil) Pronunciation mi NOKS i dil
It is used to help regrow hair in some people.
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Drug Class
Hair growth stimulant
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Pharmacologic Class
Potassium channel opener (topical)
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Pregnancy Category
C
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FDA Approved
Aug 1988
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Minoxidil topical solution is a medication applied directly to the scalp to help regrow hair and slow hair loss in men with hereditary hair loss (androgenetic alopecia). It works by revitalizing hair follicles and promoting thicker, fuller hair growth. It must be used consistently, usually twice a day, for several months to see results, and continued indefinitely to maintain hair growth.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.

Apply this medication only to your scalp, as instructed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If the medication accidentally gets in your eyes, rinse them with cool water immediately.
Wash your hands thoroughly before and after applying the medication to prevent any potential irritation or infection.

Storing and Disposing of This Medication

Store this medication at room temperature, away from extreme heat or cold.
* Keep all medications in a safe and secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.

Missed Dose Instructions

If you miss a dose, skip it and resume your regular application schedule. Do not apply a double dose or extra doses to make up for the missed one, as this may increase the risk of side effects.
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Lifestyle & Tips

  • Apply only to a dry scalp. Do not use on other parts of the body.
  • Wash hands thoroughly before and after applying the solution.
  • Do not use more than the recommended dose or more often than recommended, as this will not improve results and may increase side effects.
  • Allow the solution to dry completely (usually 2-4 hours) before going to bed, wearing hats, or washing hair to prevent transfer to other areas or absorption into pillows/clothing.
  • Avoid contact with eyes, nose, mouth, or broken skin. If contact occurs, rinse thoroughly with cool water.
  • Protect treated areas from sun exposure, as minoxidil can make the scalp more sensitive to sunlight.
  • Be patient; visible results typically take 2-4 months, and full results may take up to a year. Hair shedding may occur initially (first 2-6 weeks) as old hairs are replaced by new ones; this is usually temporary.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply 1 mL of 5% solution to the affected area of the scalp twice daily, with at least 12 hours between applications.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

androgeneticAlopecia: Apply 1 mL of 5% solution to the affected area of the scalp twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (safety and efficacy not established for individuals under 18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations for topical use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

The exact mechanism by which minoxidil stimulates hair growth is not fully understood. It is thought to work by: 1. Vasodilation: Increasing blood flow to the scalp, which may deliver more nutrients and oxygen to hair follicles. 2. Follicular Enlargement: Converting miniaturized hair follicles (common in androgenetic alopecia) into larger, healthier follicles. 3. Prolongation of Anagen Phase: Extending the growth phase (anagen) of the hair cycle and shortening the resting phase (telogen). 4. Stimulation of Hair Follicle Cells: Directly stimulating proliferation and differentiation of follicular epithelial cells.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 1.4% to 1.7% of the topically applied dose is absorbed systemically.
Tmax: Systemic Tmax is approximately 1 hour after topical application (for absorbed drug).
FoodEffect: Not applicable for topical solution.

Distribution:

Vd: Not well-defined for topical application due to low systemic absorption.
ProteinBinding: Not well-defined for topical application; systemically, minoxidil does not bind to plasma proteins.
CnssPenetration: Limited (due to low systemic absorption).

Elimination:

HalfLife: Systemic elimination half-life is approximately 4.2 hours (for absorbed drug).
Clearance: Not well-defined for topical application.
ExcretionRoute: Primarily renal excretion (90% of absorbed drug and its metabolites are excreted in urine within 4 days).
Unchanged: Not well-defined for topical application; systemically, a small percentage is excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Hair growth may be seen in 2 to 4 months of consistent twice-daily use.
PeakEffect: Maximum effect typically observed after 4 to 12 months of continuous use.
DurationOfAction: Requires continuous application; cessation of treatment leads to reversal of hair growth within 3 to 4 months.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:

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
Chest pain or pressure
Fast heartbeat
Dizziness or fainting
Sudden significant weight gain
Swelling in the arms or legs
Scalp irritation

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or persist:

Change in hair color
* Change in hair texture

Important Note

This list is not exhaustive, and you may experience other side effects not mentioned here. 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. Your doctor can provide medical advice and guidance on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Severe scalp irritation (redness, itching, burning, flaking)
  • Unwanted hair growth on other body parts (e.g., face, arms)
  • Dizziness, lightheadedness, or fainting
  • Rapid or irregular heartbeat (palpitations)
  • Chest pain
  • Swelling of hands or feet (edema)
  • Sudden, unexplained weight gain
  • Difficulty breathing
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you do not have a family history of hair loss.
If your hair loss is sudden, patchy, or of unknown cause.
If you are pregnant, plan to become pregnant, or are breastfeeding, as not all products are approved for use in these situations. If you are unsure about your product, consult your doctor.
If the patient is a child, as this medication is not intended for children.
If your hair loss is related to childbirth, as this medication is not recommended for this type of hair loss.

Additionally, this medication may interact with other medications or health conditions. Therefore, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to verify the safety of this medication in combination with your other medications and health conditions.
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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 applying this drug, avoid areas of the scalp that are red, swollen, infected, irritated, or painful, as this may exacerbate these conditions. Additionally, do not use other scalp medications or hair care products concurrently with this drug, as interactions may occur.

Please note that it may take several months to observe the full effects of this medication. Furthermore, individual results may vary, and this drug may not be effective for everyone. If you have concerns about its efficacy, consult your doctor.

If you experience unwanted facial hair growth while using this drug, contact your doctor to discuss this side effect.

To ensure safe use, keep in mind that this drug is flammable. Therefore, avoid using it near open flames or while smoking, as this may pose a fire hazard. In the event of accidental ingestion, this drug may cause harm. If swallowed, immediately contact a doctor or a poison control center for assistance.
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Overdose Information

Overdose Symptoms:

  • Hypotension (low blood pressure)
  • Tachycardia (rapid heartbeat)
  • Fluid retention (edema, weight gain)
  • Dizziness
  • Fainting

What to Do:

If accidental ingestion or excessive topical application occurs, immediately contact a poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive and symptomatic, focusing on maintaining blood pressure and fluid balance.

Drug Interactions

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Contraindicated Interactions

  • None known for topical minoxidil.
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Major Interactions

  • None known for topical minoxidil.
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Moderate Interactions

  • Guanethidine (may enhance orthostatic hypotensive effects, though rare with topical minoxidil due to minimal systemic absorption).
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Minor Interactions

  • Topical corticosteroids, retinoids, or petrolatum (may increase minoxidil absorption).

Monitoring

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Baseline Monitoring

Scalp assessment

Rationale: To evaluate the extent of hair loss and scalp health.

Timing: Prior to initiation of therapy.

Blood pressure and heart rate

Rationale: Although systemic absorption is minimal, caution is advised in patients with known cardiovascular disease. Baseline assessment is prudent.

Timing: Prior to initiation of therapy, especially in patients with pre-existing cardiovascular conditions.

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Routine Monitoring

Hair growth progress

Frequency: Monthly to quarterly

Target: Visible hair regrowth or reduction in hair loss.

Action Threshold: If no improvement after 4-6 months, consider discontinuation or alternative therapies.

Scalp irritation/adverse reactions

Frequency: Regularly (e.g., weekly/monthly)

Target: Absence of significant redness, itching, flaking, or burning.

Action Threshold: If severe or persistent irritation occurs, reduce frequency or discontinue use. If systemic effects (e.g., dizziness, rapid heartbeat, swelling) occur, discontinue immediately and seek medical attention.

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Symptom Monitoring

  • Scalp irritation (redness, itching, dryness, flaking)
  • Unwanted non-scalp hair growth (hypertrichosis)
  • Dizziness or lightheadedness
  • Rapid or irregular heartbeat (palpitations)
  • Chest pain
  • Swelling of hands or feet (edema)
  • Sudden, unexplained weight gain
  • Fainting

Special Patient Groups

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Pregnancy

Minoxidil topical solution is not indicated for use in women. Systemic absorption, though minimal, could potentially lead to adverse effects. Minoxidil is excreted in breast milk. Therefore, it is contraindicated in pregnant women.

Trimester-Specific Risks:

First Trimester: Not recommended due to potential for systemic absorption and lack of safety data.
Second Trimester: Not recommended.
Third Trimester: Not recommended.
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Lactation

Minoxidil is excreted in human milk following oral administration. Although systemic absorption from topical application is low, it is not recommended for use by breastfeeding women due to potential risk to the infant.

Infant Risk: Potential for systemic effects in the infant, though risk is low due to minimal maternal systemic absorption.
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Pediatric Use

Not recommended for individuals under 18 years of age. Safety and efficacy have not been established in this population.

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Geriatric Use

No specific dose adjustments are required for elderly patients. However, caution is advised in elderly patients with pre-existing cardiovascular conditions due to the theoretical risk of systemic effects, although minimal with topical use.

Clinical Information

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Clinical Pearls

  • Minoxidil topical solution is for external use only and should not be ingested.
  • Consistency is key: Missed doses can reduce efficacy. If a dose is missed, do not double the next dose.
  • Initial shedding: Some users may experience increased hair shedding during the first few weeks of treatment. This is usually temporary and indicates that the product is working by pushing out old hairs to make way for new ones.
  • Results vary: Not everyone responds to minoxidil. It is most effective for recent hair loss and in younger men.
  • Avoid contact with pets: Minoxidil is highly toxic to cats and can cause serious adverse effects or death if ingested or if a cat comes into contact with a recently treated scalp.
  • Do not use if scalp is irritated, inflamed, infected, or painful.
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Alternative Therapies

  • Finasteride (oral, prescription-only for men)
  • Low-level laser therapy (LLLT)
  • Platelet-rich plasma (PRP) injections
  • Hair transplantation
  • Dermarolling/microneedling
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Cost & Coverage

Average Cost: $15 - $50 per 60ml bottle (1 month supply)
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance for cosmetic use; may be covered by some plans if prescribed for a medical condition, but typically out-of-pocket.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.