Klayesta Top Pwdr 100,000 60gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal, topical
Pharmacologic Class
Polyene antifungal
Pregnancy Category
Category C
FDA Approved
May 1954
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nystatin topical powder is an antifungal medicine used to treat skin infections caused by yeast, such as diaper rash or other skin folds where moisture can cause fungal growth. It works by stopping the growth of the fungus.
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. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
This medication is for external use only and should not be taken by mouth. Apply it directly to the affected skin area, avoiding the mouth, nose, and eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. Clean the affected area and dry it well before sprinkling the powder over the skin. If you are using this medication to treat athlete's foot, you can also sprinkle it in your shoes and socks.
Storage and Disposal
Store the medication at room temperature, away from heat, and keep the lid tightly closed. Do not freeze the medication.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
This medication is for external use only and should not be taken by mouth. Apply it directly to the affected skin area, avoiding the mouth, nose, and eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. Clean the affected area and dry it well before sprinkling the powder over the skin. If you are using this medication to treat athlete's foot, you can also sprinkle it in your shoes and socks.
Storage and Disposal
Store the medication at room temperature, away from heat, and keep the lid tightly closed. Do not freeze the medication.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Keep the affected area clean and dry.
- Avoid tight-fitting clothing that can trap moisture.
- Ensure good air circulation to the affected area.
- Complete the full course of treatment as prescribed, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas 2 to 3 times daily
Condition-Specific Dosing:
cutaneouscandidiasis:
Apply a thin layer to the affected skin areas 2 to 3 times daily until healing is complete.
Pediatric Dosing
Neonatal:
Apply to affected areas 2 to 3 times daily
Infant:
Apply to affected areas 2 to 3 times daily
Child:
Apply to affected areas 2 to 3 times daily
Adolescent:
Apply to affected areas 2 to 3 times daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Dialysis:
No adjustment needed (topical application, minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Pharmacology
Mechanism of Action
Nystatin is a polyene antifungal antibiotic that binds to sterols, primarily ergosterol, in the cell membrane of susceptible fungi. This binding creates pores in the fungal cell membrane, leading to leakage of intracellular components (e.g., potassium, amino acids) and ultimately cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (systemic from topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical application)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical improvement
PeakEffect:
Not precisely quantifiable for topical effect
DurationOfAction:
Maintained with continued application
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
Although 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 medical attention right away:
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
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.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although 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 medical attention right away:
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
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.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening of the rash or infection
- Severe burning, itching, or irritation at the application site
- Development of new skin reactions (e.g., hives, swelling)
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts might cause gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention. For topical overdose, simply wipe off excess and continue with prescribed dosing.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of affected skin area
Rationale: To establish baseline severity and extent of fungal infection.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., redness, itching, irritation)
Frequency: Daily by patient, periodically by clinician
Target: Complete resolution or significant improvement
Action Threshold: Lack of improvement or worsening symptoms after 7-14 days may indicate need for re-evaluation or alternative therapy.
Adverse skin reactions (e.g., burning, itching, irritation)
Frequency: Daily by patient
Target: Absence of severe reactions
Action Threshold: Discontinue if severe irritation or sensitization occurs.
Symptom Monitoring
- Redness
- Itching
- Burning sensation
- Irritation
- Rash
- Signs of worsening infection (e.g., increased pain, swelling, pus)
Special Patient Groups
Pregnancy
Nystatin topical is generally considered safe for use during pregnancy due to minimal systemic absorption. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Nystatin topical is considered compatible with breastfeeding. Systemic absorption is minimal, making infant exposure unlikely. Avoid applying to the nipple/areola area if breastfeeding, or wipe off before feeding.
Infant Risk:
Low risk (L3 - Moderately safe)
Pediatric Use
Nystatin topical powder is commonly used and considered safe for infants and children, including for diaper rash caused by Candida. Dosing is similar to adults (apply to affected areas 2-3 times daily).
Geriatric Use
No specific dose adjustments or precautions are generally necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not typically a concern for topical use.
Clinical Information
Clinical Pearls
- Nystatin topical powder is particularly useful for intertriginous areas (skin folds) where moisture can exacerbate fungal infections, as the powder formulation helps keep the area dry.
- Ensure the affected area is clean and dry before applying the powder.
- Continue treatment for the full prescribed duration, typically for at least 2 weeks, even if symptoms improve, to prevent relapse.
- Not effective for bacterial or viral infections.
- Minimal systemic absorption makes it a safe option for many patient populations, including pregnant/lactating women and pediatric patients.
Alternative Therapies
- Clotrimazole topical (cream, lotion, solution)
- Miconazole topical (cream, powder)
- Ketoconazole topical (cream, foam)
- Terbinafine topical (cream, gel, spray)
Cost & Coverage
Average Cost:
$15 - $50 per 60gm powder
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 the medication taken, the amount, and the time it happened.