Clotrimazole 1% Solution 10ml

Manufacturer MARLEX PHARMACEUTICALS Active Ingredient Clotrimazole Cream, Ointment, and Solution(kloe TRIM a zole) Pronunciation kloe TRIM a zole
It is used to treat fungal infections of the skin.
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Drug Class
Antifungal
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Pharmacologic Class
Imidazole Antifungal
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Pregnancy Category
B
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FDA Approved
Jan 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clotrimazole 1% solution is an antifungal medicine applied to the skin to treat common fungal infections like athlete's foot, jock itch, and ringworm. It works by stopping the growth of the fungus that causes these infections.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.

Applying the Medication

This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Wash your hands before and after applying the medication, unless your hand is the area being treated, in which case you should not wash your hand after application.

Before applying the medication, clean the affected area and dry it thoroughly. Then, apply a thin layer of the medication to the affected skin and gently rub it in. Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a secure location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Clean and dry the affected area thoroughly before applying the solution.
  • Wash hands before and after applying the medication.
  • Apply a thin layer to cover the entire affected area and a small portion of the surrounding healthy skin.
  • Do not bandage, cover, or wrap the treated area unless directed by your doctor.
  • Wear loose-fitting clothing and well-ventilated shoes (for foot infections).
  • Change socks and underwear daily.
  • Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
  • Complete the full course of treatment as prescribed, even if symptoms improve, to prevent the infection from returning.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer of 1% solution to the affected area and surrounding skin twice daily (morning and evening).

Condition-Specific Dosing:

tineaPedis: Apply twice daily for 4 weeks.
tineaCruris: Apply twice daily for 2 weeks.
tineaCorporis: Apply twice daily for 2 weeks.
cutaneousCandidiasis: Apply twice daily for 2 weeks.
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Pediatric Dosing

Neonatal: Not established (consult physician)
Infant: Not established (consult physician for children under 2 years)
Child: Apply a thin layer to the affected area twice daily for children 2 years and older. Duration depends on the infection type (e.g., 2-4 weeks).
Adolescent: Apply a thin layer to the affected area twice daily. Duration depends on the infection type (e.g., 2-4 weeks).
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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 negligible 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

Clotrimazole is an imidazole antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to structural and functional impairment of the fungal cytoplasmic membrane, resulting in leakage of cellular contents and ultimately cell death. It exhibits fungistatic and fungicidal activity depending on the concentration.
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Pharmacokinetics

Absorption:

Bioavailability: <0.5% (systemic after topical application)
Tmax: Not clinically relevant for topical application
FoodEffect: Not applicable for topical application

Distribution:

Vd: Not clinically relevant for topical application
ProteinBinding: Not clinically relevant for topical application
CnssPenetration: No

Elimination:

HalfLife: Not clinically relevant for topical application
Clearance: Not clinically relevant for topical application
ExcretionRoute: Primarily via feces and urine (if systemically absorbed)
Unchanged: Negligible
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Pharmacodynamics

OnsetOfAction: Symptomatic relief typically within a few days (e.g., 2-7 days)
PeakEffect: Full therapeutic effect and mycological cure typically achieved after 2-4 weeks of consistent use.
DurationOfAction: Effect persists as long as treatment continues and for a period after cessation, depending on the infection and adherence to treatment.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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
Irritation at the site where the medication was applied
Blisters or sores that ooze, drain, or crust over
Burning sensation
* Swelling at the site where the medication was applied

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor or seek medical help. It's essential to note that this is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects

If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of the rash or infection
  • Severe burning, itching, stinging, or redness at the application site
  • Development of blistering, oozing, or swelling
  • Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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 allergic reaction you experienced, including any symptoms that occurred.
If you have nail or scalp infections, as this medication is not effective in treating these types of infections.

Additionally, to ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

This information will help your doctor determine if it is safe for you to take this medication, and if so, what dosage is appropriate. Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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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.

If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.

Before taking this medication, notify your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical use.
  • Accidental ingestion may cause nausea, vomiting, abdominal pain, or dizziness.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Clinical assessment of fungal infection (e.g., type, extent, severity)

Rationale: To confirm diagnosis and establish baseline for treatment efficacy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Resolution of symptoms (e.g., itching, redness, scaling, burning)

Frequency: Daily/Weekly

Target: Progressive improvement

Action Threshold: Lack of improvement after 7 days or worsening of symptoms may indicate treatment failure, incorrect diagnosis, or adverse reaction.

Local adverse reactions (e.g., irritation, burning, stinging, erythema, peeling)

Frequency: Daily

Target: Absence or mild, transient reactions

Action Threshold: Severe or persistent reactions warrant discontinuation and medical evaluation.

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Symptom Monitoring

  • Reduction in itching
  • Decrease in redness
  • Resolution of scaling or flaking
  • Absence of burning or stinging sensation
  • Improvement in skin appearance

Special Patient Groups

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Pregnancy

Clotrimazole topical is generally considered safe for use during pregnancy (Pregnancy Category B). Minimal systemic absorption is expected.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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Lactation

Clotrimazole topical is considered compatible with breastfeeding (Lactation Risk L3). Minimal systemic absorption makes significant excretion into breast milk unlikely. Avoid applying to the breast area if breastfeeding.

Infant Risk: Low risk
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Pediatric Use

Safe and effective for children 2 years of age and older. For children under 2 years, consult a physician. Dosing is generally similar to adults for topical application.

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Geriatric Use

No specific dose adjustments or precautions are generally needed for geriatric patients. Safety and efficacy are similar to younger adults.

Clinical Information

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Clinical Pearls

  • Ensure the affected area is clean and completely dry before applying the solution to maximize efficacy.
  • Clotrimazole solution is particularly useful for hairy areas or intertriginous areas where creams may be less suitable.
  • Advise patients to continue treatment for the full prescribed duration, even if symptoms improve, to ensure complete eradication of the fungal infection and prevent recurrence.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes. If accidental contact occurs, rinse thoroughly with water.
  • Not effective for viral or bacterial infections. If the condition does not improve or worsens, re-evaluate the diagnosis.
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Alternative Therapies

  • Miconazole (topical)
  • Terbinafine (topical)
  • Econazole (topical)
  • Ketoconazole (topical)
  • Naftifine (topical)
  • Butenafine (topical)
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Cost & Coverage

Average Cost: $10 - $30 per 10ml solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 information about what was taken, the amount, and the time it occurred.