Nystatin Cream 30gm
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 cream 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 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 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. Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store the medication at room temperature, avoiding 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 resume 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 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. Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store the medication at room temperature, avoiding 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 resume 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 cream.
- Apply a thin layer of cream to cover the entire affected area.
- Wash hands before and after applying the cream.
- Avoid tight-fitting clothing or diapers that can trap moisture and worsen the infection.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
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 thinly to affected area 2-3 times daily.
Condition-Specific Dosing:
cutaneousCandidiasis:
Apply thinly to affected area 2-3 times daily until healing is complete.
Pediatric Dosing
Neonatal:
Apply thinly to affected area 2-3 times daily.
Infant:
Apply thinly to affected area 2-3 times daily.
Child:
Apply thinly to affected area 2-3 times daily.
Adolescent:
Apply thinly to affected area 2-3 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. 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:
<0.1% (minimal systemic absorption from intact skin)
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 (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:
Symptomatic relief typically within 2-3 days; mycological cure within 1-2 weeks.
PeakEffect:
Not applicable (topical effect)
DurationOfAction:
Dependent on application frequency (e.g., 8-12 hours per application).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
If you experience any of the following symptoms, call your doctor or seek medical help right away, as they may be signs of a severe and potentially life-threatening side effect:
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, call your doctor for advice.
Reporting Side Effects
This list of side effects is not exhaustive. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical help right away, as they may be signs of a severe and potentially life-threatening side effect:
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, call your doctor for advice.
Reporting Side Effects
This list of side effects is not exhaustive. If you have questions or concerns about side effects, consult 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 blisters
- Signs of an allergic reaction (e.g., severe rash, swelling, difficulty breathing - seek immediate medical attention)
- No improvement in symptoms after 7-14 days of use
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 assess potential interactions between this medication and other substances you are taking.
* 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 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 assess potential interactions between this medication and other substances you are taking.
* 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 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 potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts may cause gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
For accidental ingestion, contact a poison control center (1-800-222-1222) or seek medical attention. Treatment is generally supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Visual 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., itching, redness, irritation)
Frequency: Daily
Target: Progressive improvement
Action Threshold: Lack of improvement or worsening symptoms after 7-14 days may indicate treatment failure, incorrect diagnosis, or secondary infection.
Visual assessment of skin lesion
Frequency: Weekly or as needed
Target: Reduction in size, erythema, and presence of satellite lesions
Action Threshold: Persistent or spreading lesions.
Symptom Monitoring
- Persistent or worsening redness
- Increased itching or burning
- Development of new lesions or spread of existing rash
- Signs of secondary bacterial infection (e.g., pus, severe pain)
Special Patient Groups
Pregnancy
Nystatin is considered safe for use during pregnancy (Category B). Minimal systemic absorption is expected after topical application, making systemic exposure to the fetus unlikely.
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 is considered safe for use during lactation (L1). Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. If applied to the breast area, ensure the area is clean before nursing to prevent infant ingestion.
Infant Risk:
Low risk; unlikely to cause adverse effects in breastfed infants.
Pediatric Use
Nystatin cream is safe and effective for use in pediatric patients, including neonates, for the treatment of cutaneous candidiasis (e.g., diaper rash). Dosing is similar to adults: apply thinly to affected area 2-3 times daily.
Geriatric Use
No specific dose adjustments or precautions are necessary for geriatric patients. Efficacy and safety are similar to younger adults.
Clinical Information
Clinical Pearls
- Nystatin cream is effective only against fungal infections, not bacterial or viral.
- Ensure the affected area is clean and dry before each application to maximize efficacy.
- Advise patients to complete the full prescribed course of therapy, even if symptoms improve, to prevent relapse.
- If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis or consider alternative treatments.
- Avoid occlusive dressings unless specifically instructed by a healthcare professional, as this can increase moisture and potentially worsen fungal growth.
Alternative Therapies
- Clotrimazole cream
- Miconazole cream
- Ketoconazole cream
- Terbinafine cream
Cost & Coverage
Average Cost:
$15 - $35 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (most insurance plans)
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, including the amount taken and the time it happened, to ensure you receive the best possible care.