Nystatin Top Pwdr 100,000 30gm

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 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 topical powder is an antifungal medicine used to treat skin infections caused by yeast, such as diaper rash or jock itch. 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 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 burning.

Before applying the medication, wash your hands thoroughly. Clean the affected area and dry it well before sprinkling the powder over the 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 the medication at room temperature, away from heat, 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 resume your regular application schedule. Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Keep the affected area clean and dry.
  • Avoid tight-fitting clothing that can trap moisture.
  • For diaper rash, change diapers frequently and allow the skin to air dry when possible.
  • Complete the full course of treatment as prescribed, even if symptoms improve.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected area 2 to 3 times daily

Condition-Specific Dosing:

cutaneous_candidiasis: Apply a sufficient amount to cover the affected area 2 to 3 times daily until healing is complete.
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Pediatric Dosing

Neonatal: Apply to affected area 2 to 3 times daily
Infant: Apply to affected area 2 to 3 times daily
Child: Apply to affected area 2 to 3 times daily
Adolescent: Apply to 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 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, ultimately causing cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible systemic absorption from intact skin or mucous membranes.
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)
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Pharmacodynamics

OnsetOfAction: Within days (clinical improvement)
PeakEffect: Within 1-2 weeks (full resolution of symptoms)
DurationOfAction: Maintained with continued application

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 medical attention immediately:

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, swelling, or irritation at the application site
  • New rash or hives
  • Signs of allergic reaction (e.g., severe itching, difficulty breathing, swelling of face/throat) - seek immediate medical attention
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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 interact with other drugs or exacerbate certain health problems.

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

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

Carefully review your medication regimen and health status to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. 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, 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 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

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Routine Monitoring

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

Frequency: Daily

Target: Improvement or resolution of symptoms

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

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Considered safe for topical use during pregnancy due to negligible systemic absorption. Category B.

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Considered safe for use during breastfeeding. Minimal to no systemic absorption by the mother, therefore unlikely to be excreted in breast milk or cause infant exposure. L1 (safest).

Infant Risk: Very low risk to breastfed infant.
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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 necessary for geriatric patients. Safety and efficacy are similar to younger adults.

Clinical Information

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Clinical Pearls

  • Ensure the affected area is clean and dry before applying the powder.
  • Nystatin powder is particularly useful in intertriginous areas (skin folds) where moisture can accumulate.
  • Continue treatment for at least 2-3 days after symptoms resolve to prevent recurrence.
  • Not effective for bacterial or viral infections.
  • Avoid contact with eyes and mucous membranes (other than the intended application site).
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Alternative Therapies

  • Clotrimazole topical
  • Miconazole topical
  • Ketoconazole topical
  • Terbinafine topical (less effective for Candida)
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Cost & Coverage

Average Cost: $10 - $30 per 30gm powder
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 is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it happened, as this will help healthcare professionals provide the best possible care.