Nystatin Cream 15gm

Manufacturer COSETTE Active Ingredient Nystatin Cream and Ointment(nye STAT in) Pronunciation nye STAT in
It is used to treat fungal infections of the skin.
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Drug Class
Antifungal
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Pharmacologic Class
Polyene antifungal
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Pregnancy Category
Category B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nystatin cream 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.
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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 it in your mouth, nose, or eyes, as it may cause burning.

Before applying, 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

Store this 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 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.
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Lifestyle & Tips

  • Keep the affected skin area clean and dry.
  • Wear loose-fitting clothing to allow air circulation.
  • Avoid scratching the infected area.
  • Complete the full course of treatment, even if symptoms improve.

Dosing & Administration

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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.
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Pediatric Dosing

Neonatal: Apply to affected areas 2 to 3 times daily (e.g., for diaper rash with candidiasis)
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
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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 adjustment needed (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

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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 allows for leakage of intracellular components (e.g., potassium, amino acids) and ultimately causes fungal cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible (systemic from topical application)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not applicable (topical)

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)
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically seen within a few days
PeakEffect: Within 1-2 weeks of consistent application
DurationOfAction: Maintained as long as applied, resolution of infection upon completion of therapy

Safety & Warnings

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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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, itching, or irritation at the application site
  • Development of new rash or hives
  • Swelling of the face, lips, or tongue (signs of allergic reaction)
  • No improvement in symptoms after 1-2 weeks of treatment
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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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 for both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is highly unlikely due to minimal absorption. Ingestion of large amounts may cause gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

For topical overdose, wipe off excess. For accidental ingestion, seek medical advice. Call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Routine Monitoring

Clinical signs and symptoms of infection (e.g., redness, itching, rash)

Frequency: Daily, during treatment

Target: Resolution or improvement of symptoms

Action Threshold: Worsening symptoms, no improvement after 1-2 weeks, or signs of allergic reaction

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Symptom Monitoring

  • Resolution of rash
  • Decrease in itching or burning
  • Reduction in redness or inflammation
  • Absence of satellite lesions

Special Patient Groups

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Pregnancy

Nystatin cream 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
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Nystatin cream is considered safe for use during breastfeeding as it is minimally absorbed systemically and unlikely to pass into breast milk in significant amounts. Avoid applying directly to the nipple area if breastfeeding.

Infant Risk: Low risk (L1)
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Pediatric Use

Safe and effective for use in pediatric patients, including neonates, for cutaneous candidiasis. Dosing is similar to adults.

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Geriatric Use

No specific dose adjustments or precautions are generally required for geriatric patients. Safety and efficacy are similar to younger adults.

Clinical Information

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Clinical Pearls

  • Often used for intertrigo (rash in skin folds) and diaper rash when a fungal component is suspected.
  • Ensure the skin is clean and dry before application for optimal efficacy.
  • Continue treatment for at least 2-3 days after symptoms resolve to prevent recurrence.
  • Not effective for bacterial or viral skin infections.
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Alternative Therapies

  • Clotrimazole cream
  • Miconazole cream
  • Ketoconazole cream
  • Econazole cream
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Cost & Coverage

Average Cost: $10 - $30 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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.