Klayesta Top Pwdr 100,000 15gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Polyene Antifungal
Pregnancy Category
Category C
FDA Approved
Jan 1970
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 infections in skin folds. It works by stopping the growth of the yeast.
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 irritation. Wash your hands before and after applying the medication. Clean the affected area before use and make sure it is completely dry. Sprinkle the powder evenly over the affected 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 this medication at room temperature, away from heat sources, 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 scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
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 irritation. Wash your hands before and after applying the medication. Clean the affected area before use and make sure it is completely dry. Sprinkle the powder evenly over the affected 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 this medication at room temperature, away from heat sources, 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 scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Keep affected areas clean and dry.
- Avoid tight-fitting clothing that can trap moisture.
- For diaper rash, change diapers frequently and allow skin to air dry when possible.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply Nystatin topical powder to affected areas 2 to 3 times daily.
Condition-Specific Dosing:
cutaneousCandidiasis:
Apply to affected 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 (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
Mechanism of Action
Nystatin is a polyene antifungal antibiotic that binds to sterols (primarily ergosterol) in the fungal cell membrane, leading to a change in membrane permeability and leakage of intracellular components. This results in fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (<0.1%)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
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 (clinical improvement)
PeakEffect:
Not precisely defined for topical application, clinical improvement seen over days to weeks.
DurationOfAction:
Not precisely defined for topical application, depends on continued application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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
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, talk to 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 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
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, talk to 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:
- Increased redness or irritation at the application site
- Swelling
- Blistering
- Signs of allergic reaction (e.g., severe rash, hives, difficulty breathing - rare for topical)
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This will help prevent potential interactions or adverse effects.
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This will help prevent potential interactions or adverse effects.
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:
- Not expected with topical application due to minimal absorption. Ingestion of large amounts may cause gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
Call 1-800-222-1222 (Poison Control). For topical exposure, wash off with soap and water. For accidental ingestion, supportive care as needed.
Drug Interactions
Monitoring
Routine Monitoring
Clinical improvement of lesions (e.g., reduction in redness, itching, rash)
Frequency: Daily
Target: Resolution of symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 7-14 days of treatment, or development of irritation/allergic reaction.
Symptom Monitoring
- Resolution of rash
- Reduction in itching
- Decrease in redness
- Absence of irritation or allergic reaction
Special Patient Groups
Pregnancy
Nystatin topical is generally considered safe for use during pregnancy due to minimal systemic absorption. Consult with a healthcare provider.
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 safe for use during breastfeeding as it is not systemically absorbed by the mother and therefore not excreted in breast milk. Avoid applying to the nipple/areola area if breastfeeding, or wipe off before feeding.
Infant Risk:
Low risk
Pediatric Use
Safe and effective for use in pediatric patients, including neonates, for cutaneous candidiasis. Dosing is similar to adults.
Geriatric Use
No specific dose adjustments or precautions are necessary for geriatric patients. Safety and efficacy are similar to younger adults.
Clinical Information
Clinical Pearls
- Ensure the affected area is clean and dry before applying the powder.
- Continue treatment for at least 2 days after symptoms clear to prevent recurrence.
- Nystatin powder is particularly useful in moist, intertriginous areas (e.g., skin folds, groin, under breasts) where creams or ointments might exacerbate maceration.
- Not effective for bacterial or viral infections.
- If no improvement is seen after 14 days, re-evaluate diagnosis.
Alternative Therapies
- Clotrimazole topical (cream, lotion, solution)
- Miconazole topical (cream, powder)
- Ketoconazole topical (cream, foam)
- Terbinafine topical (cream, gel, spray)
Cost & Coverage
Average Cost:
Typically low cost per 15gm powder
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. 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 details about the medication taken, the amount, and the time it happened.