Nystatin Ointment 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 ointment is an antifungal medicine applied to the skin to treat yeast infections, such as diaper rash caused by yeast, or 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 store this medication, keep it at room temperature and do not freeze. Ensure the lid is tightly closed and protect the medication from heat.
Missed Dose Instructions
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 store this medication, keep it at room temperature and do not freeze. Ensure the lid is tightly closed and protect the medication from heat.
Missed Dose Instructions
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 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 ointment.
- Avoid tight-fitting clothing or diapers that may trap moisture.
- Continue using the medication for the full prescribed duration, 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 to affected areas 2 to 3 times daily
Condition-Specific Dosing:
cutaneous_candidiasis:
Apply a thin layer to the affected area 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 due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to 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. This results in the leakage of intracellular components (e.g., potassium, amino acids) and ultimately cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (systemic) from intact skin or mucous membranes.
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 (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Not applicable (minimal systemic absorption).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within a few days.
PeakEffect:
Varies with severity and type of infection; full therapeutic effect may take 1-2 weeks.
DurationOfAction:
Maintained as long as applied regularly.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, 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, or 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 may only have mild ones, it's essential to discuss any concerns with your doctor. If you have 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, 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 attention immediately, 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, or 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 may only have mild ones, it's essential to discuss any concerns with your doctor. If you have 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, 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:
- Worsening of the rash or infection
- Severe burning, itching, or irritation at the application site
- Signs of an allergic reaction (e.g., rash, hives, swelling of the face/lips/tongue, difficulty breathing)
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 assess 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. Never start, stop, or adjust the dosage 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 assess 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. Never start, stop, or adjust the dosage 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 unlikely 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 (e.g., 1-800-222-1222) or seek medical attention. Treatment is generally supportive.
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 signs and symptoms of infection (e.g., redness, itching, rash)
Frequency: Daily by patient, periodically by clinician.
Target: Progressive improvement leading to complete resolution.
Action Threshold: Lack of improvement or worsening symptoms after 7-14 days may indicate need for re-evaluation or alternative therapy.
Local skin irritation or allergic reaction
Frequency: Daily by patient.
Target: Absence of new or worsening irritation.
Action Threshold: Development of severe burning, itching, redness, or swelling may require discontinuation.
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Resolution of rash or lesions
- Absence of burning sensation
- Improvement in skin integrity
Special Patient Groups
Pregnancy
Nystatin ointment 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 ointment is considered compatible with breastfeeding due to negligible systemic absorption by the mother and minimal risk of exposure to the infant.
Infant Risk:
Low risk.
Pediatric Use
Nystatin ointment is safe and effective for use in pediatric patients, including neonates and infants, for cutaneous candidiasis (e.g., diaper rash). Dosing is similar to adults.
Geriatric Use
No specific dose adjustments or precautions are generally required for geriatric patients. Safety and efficacy are similar to younger adults.
Clinical Information
Clinical Pearls
- Ensure the affected skin area is clean and dry before applying the ointment to maximize efficacy.
- Nystatin ointment is for external use only and should not be used orally or intravaginally (unless specifically formulated for those routes).
- Advise patients that the ointment may stain clothing.
- If no improvement is seen after 14 days of treatment, the diagnosis should be re-evaluated.
Alternative Therapies
- Topical azole antifungals (e.g., clotrimazole, miconazole, ketoconazole)
- Topical allylamine antifungals (e.g., terbinafine)
Cost & Coverage
Average Cost:
Low price range per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2
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 have additional patient information leaflets, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.