Nystatin Top Pwdr 100,000 60gm

Manufacturer LEADING PHARMA Active Ingredient Nystatin Topical Powder(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 C
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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 topical powder is an antifungal medication used to treat skin infections caused by yeast, such as diaper rash or other skin folds where moisture can lead to fungal growth. It works by stopping the growth of the fungus.
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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 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 application. 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.
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Lifestyle & Tips

  • Keep the affected area clean and dry.
  • Avoid tight-fitting clothing that can trap moisture.
  • Ensure good hygiene practices, especially in skin folds or diaper areas.
  • Complete the full course of treatment, even if symptoms improve, to prevent recurrence.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer of powder to the affected area 2 to 3 times daily, or as directed by a physician. Treatment should be continued for at least 2 days after symptoms have disappeared.

Condition-Specific Dosing:

cutaneousCandidiasis: Apply to affected area 2-3 times daily.
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Pediatric Dosing

Neonatal: Apply a thin layer of powder to the affected area 2 to 3 times daily.
Infant: Apply a thin layer of powder to the affected area 2 to 3 times daily.
Child: Apply a thin layer of powder to the affected area 2 to 3 times daily.
Adolescent: Apply a thin layer of powder to the affected area 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 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

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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 the leakage of intracellular components, ultimately causing cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible (from topical application)
Tmax: Not applicable systemically
FoodEffect: Not applicable

Distribution:

Vd: Not applicable systemically
ProteinBinding: Not applicable systemically
CnssPenetration: No

Elimination:

HalfLife: Not applicable systemically
Clearance: Not applicable systemically
ExcretionRoute: Not applicable systemically
Unchanged: Not applicable systemically
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically seen within a few days to a week.
PeakEffect: Full therapeutic effect may take 1-2 weeks of consistent application.
DurationOfAction: Continuous with regular application; effect persists as long as the drug is present at the site of infection.

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 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 or irritation at the application site
  • Worsening of the rash or infection
  • Development of new symptoms like severe burning, itching, or swelling
  • Signs of allergic reaction (e.g., rash, hives, difficulty breathing)
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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.
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 it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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, 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.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is highly 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 (Call 1-800-222-1222). For topical irritation, discontinue use and wash the area.

Drug Interactions

Monitoring

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Baseline Monitoring

Clinical assessment of affected area

Rationale: To establish baseline severity and extent of fungal infection.

Timing: Prior to initiation of therapy

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Routine Monitoring

Resolution of symptoms (e.g., itching, redness, rash)

Frequency: Daily to weekly

Target: Complete resolution

Action Threshold: Lack of improvement after 1-2 weeks or worsening symptoms

Skin integrity at application site

Frequency: Daily

Target: No signs of irritation, burning, or allergic reaction

Action Threshold: Development of severe irritation, burning, or signs of allergic reaction

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Symptom Monitoring

  • Resolution of rash
  • Decrease in itching
  • Reduction in redness
  • Absence of burning sensation
  • Absence of irritation or sensitization at the application site

Special Patient Groups

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Pregnancy

Nystatin topical is generally considered safe for use during pregnancy due to minimal systemic absorption. Use only if clearly needed.

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.
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Lactation

Nystatin topical is considered safe for use during breastfeeding as it is not absorbed systemically and therefore not excreted in breast milk. Avoid applying directly to the nipple/areola area if breastfeeding to prevent infant ingestion.

Infant Risk: Low risk
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Pediatric Use

Nystatin topical powder is commonly used and considered safe for infants and children, including for diaper rash caused by Candida. Dosing is similar to adults.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Nystatin topical powder is particularly useful in moist areas like skin folds, groin, and diaper areas where creams or ointments might exacerbate maceration.
  • Ensure the affected area is clean and dry before applying the powder for optimal efficacy.
  • Continue treatment for at least 2 days after symptoms resolve to prevent relapse.
  • Not effective for bacterial or viral infections; specifically targets Candida species.
  • Patients should be advised that improvement may not be immediate and consistent application is key.
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Alternative Therapies

  • Clotrimazole topical (cream, lotion, solution)
  • Miconazole topical (cream, powder)
  • Ketoconazole topical (cream, foam, gel)
  • Terbinafine topical (cream, gel, spray)
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Cost & Coverage

Average Cost: $30 - $60 per 60gm powder
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.