Nystatin Ointment 15gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Polyene Antifungal
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nystatin ointment is an antifungal medicine used to treat skin infections caused by yeast, such as diaper rash or other skin folds infections. 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 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.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature and avoid freezing. Keep the lid tightly closed and protect the medication from heat.
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 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.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature and avoid freezing. Keep the lid tightly closed and protect the medication from heat.
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
- Clean and dry the affected skin area thoroughly before applying the ointment.
- Apply a thin layer of ointment to cover the entire affected area.
- Wash hands before and after applying the medication.
- Do not cover the treated area with occlusive dressings unless directed by your doctor.
- Continue using the medication for the full prescribed time, even if symptoms improve, to prevent the infection from returning.
- Wear loose-fitting clothing and keep the affected area dry and exposed to air if possible.
Available Forms & Alternatives
Available Strengths:
- Nystatin Cream 15gm
- Nystatin Oral Susp 100000unit/ml
- Nystatin Oral Susp 100000u/ml 60ml
- Nystatin Cream 30gm
- Nystatin 500,000 Units Oral Tablets
- Nystatin Top Pwdr 100,000 15gm
- Nystatin 500,000 Units Oral Tablets
- Nystatin Top Pwdr 100,000 60gm
- Nystatin Top Pwdr 100,000 30gm
- Nystatin Cream 30gm
- Nystatin Cream 15gm
- Nystatin Ointment 15gm
- Nystatin Ointment 30gm
- Nystatin Oral Susp 100000unit/ml
- Nystatin Oral Susp 100000u/ml 60ml
- Nystatin Top Pwdr 100,000 15gm
- Nystatin Top Pwdr 100,000 30gm
- Nystatin Top Pwdr 100,000 60gm
- Nystatin Oral Susp 100000u/ml 60ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply liberally to affected areas 2 to 4 times daily.
Condition-Specific Dosing:
cutaneous_candidiasis:
Apply 2 to 4 times daily until healing is complete.
Pediatric Dosing
Neonatal:
Apply liberally to affected areas 2 to 4 times daily.
Infant:
Apply liberally to affected areas 2 to 4 times daily.
Child:
Apply liberally to affected areas 2 to 4 times daily.
Adolescent:
Apply liberally to affected areas 2 to 4 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. This binding creates pores or channels in the membrane, leading to increased permeability and leakage of intracellular components (e.g., potassium, amino acids), ultimately causing fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (systemic from topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (localized action)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (not absorbed systemically)
Clearance:
Not applicable (not absorbed systemically)
ExcretionRoute:
Not applicable (not absorbed systemically)
Unchanged:
Not applicable (not absorbed systemically)
Pharmacodynamics
OnsetOfAction:
Days to weeks (clinical improvement)
PeakEffect:
Not applicable (localized action)
DurationOfAction:
Dependent 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, itching, or irritation at the application site
- Development of new rash or hives
- Swelling or blistering of the skin
- No improvement in symptoms after 7-14 days of treatment
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 information will help your doctor and pharmacist 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 it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 information will help your doctor and pharmacist 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 it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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, you must discuss this with your doctor. This conversation will help you understand the benefits and risks of taking this drug, both for you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Topical overdose is highly unlikely due to minimal systemic absorption. Ingestion of large quantities may cause gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
For topical overdose, simply wipe off excess medication. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention if symptoms are severe or persistent. Treatment is generally supportive.
Drug Interactions
Monitoring
Routine Monitoring
Clinical improvement of skin lesions (e.g., reduction in redness, itching, rash)
Frequency: Daily observation by patient/caregiver
Target: Resolution of symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 7-14 days of treatment; signs of irritation or allergic reaction.
Symptom Monitoring
- Resolution of rash
- Decrease in itching
- Reduction in redness and inflammation
- Absence of new lesions
- Signs of local irritation (e.g., burning, itching, redness) at application site
Special Patient Groups
Pregnancy
Nystatin topical is generally considered safe for use during pregnancy (Pregnancy Category B) due to minimal systemic absorption. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk; minimal systemic absorption.
Second Trimester:
Low risk; minimal systemic absorption.
Third Trimester:
Low risk; minimal systemic absorption.
Lactation
Nystatin topical is considered safe for use during breastfeeding (Lactation Risk L1) as it is not absorbed systemically by the mother and therefore not excreted in breast milk. Avoid applying to the nipple/areola area if breastfeeding to prevent direct infant ingestion.
Infant Risk:
Low risk.
Pediatric Use
Nystatin ointment is commonly used and considered safe for infants and children, including for diaper rash caused by Candida. Dosing is similar to adults (apply 2-4 times daily).
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
- Nystatin ointment is particularly effective for intertriginous candidiasis (in skin folds) and diaper rash caused by Candida.
- It is fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida species.
- Unlike some other antifungals, nystatin is not effective against bacterial or viral infections.
- Patients should be advised to continue treatment for at least 2 days after symptoms have disappeared to prevent recurrence, or as directed by their physician.
- Ensure the skin is clean and dry before application for optimal efficacy.
Alternative Therapies
- Clotrimazole topical (cream, lotion, solution)
- Miconazole topical (cream, powder)
- Ketoconazole topical (cream, foam)
- Terbinafine topical (cream, gel, spray) - generally for dermatophytes, less for Candida
- Econazole topical (cream)
Cost & Coverage
Average Cost:
$10 - $30 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.