Clotrimazole 1% Solution 30ml

Manufacturer TARO 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
Category B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clotrimazole is an antifungal medicine used on the skin to treat infections like athlete's foot, jock itch, ringworm, and certain yeast infections. It works by stopping the growth of the fungus.
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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 precisely. 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 skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.

Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash your hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.

Unless directed by your doctor, do not cover the treated area with bandages or dressings.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.

Missing 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 dosing 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

  • Wash the affected area and dry thoroughly before applying the medication.
  • Apply a thin layer of the solution to the affected skin and the area immediately surrounding it.
  • Rub in gently until it disappears.
  • Wash hands immediately after applying the medication, unless your hands are the treated area.
  • Do not cover the treated area with bandages or dressings unless directed by your doctor.
  • Wear loose-fitting clothing and well-ventilated shoes (for foot infections).
  • Keep the affected area clean and dry.
  • Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

tineaPedis: Apply twice daily for 4 weeks
tineaCruris/Corporis: Apply twice daily for 2 weeks
cutaneousCandidiasis: Apply twice daily for 2-4 weeks
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Pediatric Dosing

Neonatal: Not established (consult pediatrician)
Infant: Apply twice daily (consult pediatrician)
Child: Apply twice daily (similar to adult dosing, consult pediatrician)
Adolescent: Apply twice daily (similar to adult dosing)
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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 (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

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 increased permeability and leakage of essential intracellular components, ultimately causing fungal cell death.
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Pharmacokinetics

Absorption:

Bioavailability: < 0.5% (systemic after topical application)
Tmax: Not clinically relevant due to minimal systemic absorption
FoodEffect: Not applicable for topical administration

Distribution:

Vd: Not clinically relevant due to minimal systemic absorption
ProteinBinding: Not clinically relevant due to minimal systemic absorption
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not clinically relevant due to minimal systemic absorption
Clearance: Not clinically relevant due to minimal systemic absorption
ExcretionRoute: Not clinically relevant due to minimal systemic absorption
Unchanged: Not clinically relevant due to minimal systemic absorption
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Pharmacodynamics

OnsetOfAction: Symptomatic relief may begin within a few days; mycological cure typically requires 2-4 weeks of treatment.
PeakEffect: Not well-defined for topical agents; clinical improvement observed over the course of treatment.
DurationOfAction: Duration of effect depends on continued application and resolution of infection.
Confidence: Medium

Safety & Warnings

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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 immediately or seek emergency 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 application site
Blisters or sores that ooze, drain, or crust over
Burning sensation
* Swelling at the application site

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with 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 can also provide guidance on managing side effects and answering any questions you may have.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of the rash or infection
  • Severe burning, stinging, or irritation at the application site
  • Blistering, peeling, or oozing of the skin
  • Signs of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble 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 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 safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are 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 confirm it is safe to do so.
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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 an event, immediately contact a doctor or a poison control center for assistance.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Ingestion of topical clotrimazole is unlikely to cause serious systemic effects due to poor absorption. However, gastrointestinal upset (nausea, vomiting, abdominal pain) may occur if large amounts are swallowed.

What to Do:

If swallowed, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive.

Drug Interactions

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Minor Interactions

  • Topical corticosteroids (may reduce antifungal efficacy if applied concurrently to the same area)
  • Other topical preparations (potential for local irritation)

Monitoring

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Baseline Monitoring

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

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

Timing: Prior to initiation of therapy

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Routine Monitoring

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

Frequency: Daily/Weekly

Target: Progressive improvement leading to complete resolution

Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks of treatment warrants re-evaluation.

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

Frequency: Daily

Target: Minimal to no irritation

Action Threshold: Severe or persistent irritation, blistering, or allergic reactions require discontinuation and medical evaluation.

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Symptom Monitoring

  • Itching
  • Redness
  • Scaling
  • Burning sensation
  • Stinging sensation
  • Peeling of skin
  • Blistering
  • Swelling
  • Hives
  • General irritation at application site

Special Patient Groups

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Pregnancy

Clotrimazole topical is generally considered safe for use during pregnancy (Pregnancy Category B). Systemic absorption is minimal, limiting fetal exposure.

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 L2). Minimal systemic absorption means negligible amounts are expected to be excreted in breast milk. Avoid applying to the breast area if breastfeeding.

Infant Risk: Low risk; unlikely to cause adverse effects in a breastfed infant.
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Pediatric Use

Topical clotrimazole can be used in pediatric patients, including infants, under medical supervision. Dosing is generally similar to adults, but duration may vary. Consult a pediatrician.

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Geriatric Use

No specific dose adjustments or precautions are necessary for geriatric patients. Efficacy and safety are similar to younger adults.

Clinical Information

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Clinical Pearls

  • For external use only. Do not use in the eyes, mouth, or vagina (unless specifically formulated for vaginal use).
  • Ensure the affected area is clean and dry before application to maximize efficacy.
  • Patients should be advised to complete the full prescribed course of treatment, even if symptoms improve, to prevent relapse.
  • If no improvement is seen after 2-4 weeks of treatment, the diagnosis should be re-evaluated.
  • Avoid occlusive dressings unless specifically instructed by a healthcare professional, as this may increase irritation.
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Alternative Therapies

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

Average Cost: $10 - $30 per 30ml solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered by most insurance plans)
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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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.