Nystatin Top Pwdr 100,000 15gm

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 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.
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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 applying the medication. 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 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.
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Lifestyle & Tips

  • Keep the affected area clean and dry.
  • Ensure good air circulation to the affected area.
  • Avoid tight-fitting clothing that can trap moisture.
  • Change diapers frequently if used for diaper rash.
  • Complete the full course of treatment, even if symptoms improve, to prevent recurrence.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected areas 2-3 times daily

Condition-Specific Dosing:

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

Neonatal: Apply to affected areas 2-3 times daily
Infant: Apply to affected areas 2-3 times daily
Child: Apply to affected areas 2-3 times daily
Adolescent: Apply to affected areas 2-3 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 increased permeability and leakage of intracellular components. This fungistatic and fungicidal action is specific for fungi and does not affect bacterial or human cells.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not applicable (localized action)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: No

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
DurationOfAction: Maintained with continued application

Safety & Warnings

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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 drug was administered

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 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.
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Seek Immediate Medical Attention If You Experience:

  • Increased irritation or redness at the application site
  • Worsening of the rash or infection
  • Development of new symptoms
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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 identify potential interactions between this medication and other substances.
* Any health problems you have, 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 other 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, notify your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby 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:

Call 1-800-222-1222 (Poison Control). For topical exposure, wash the area. For accidental ingestion, symptomatic and supportive care.

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

Frequency: Daily to weekly, as assessed by patient/caregiver

Target: Complete resolution

Action Threshold: Lack of improvement or worsening after 1-2 weeks of therapy may indicate resistant infection or incorrect diagnosis.

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Symptom Monitoring

  • Reduction in itching
  • Decrease in redness
  • Healing of skin lesions
  • Absence of new lesions

Special Patient Groups

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Pregnancy

Nystatin topical powder is generally considered safe for use during pregnancy due to minimal systemic absorption. Category C is assigned for oral forms, but topical risk is lower.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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Lactation

Nystatin topical powder is considered safe for use during lactation. It is poorly absorbed systemically, making transfer to breast milk unlikely. Avoid applying directly to the nipple/areola area if breastfeeding.

Infant Risk: Low risk
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Pediatric Use

Nystatin topical powder is commonly used and considered safe and effective for infants and children, including neonates, for the treatment of cutaneous candidiasis (e.g., diaper rash).

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Geriatric Use

No specific dose adjustments or precautions are generally required for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not typically a concern.

Clinical Information

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Clinical Pearls

  • Ensure the skin is clean and dry before applying the powder for optimal efficacy.
  • Nystatin powder is particularly useful in intertriginous areas (skin folds) where moisture is a problem, as it helps to keep the area dry.
  • Continue treatment for at least 2-3 days after symptoms disappear to prevent relapse.
  • If the infection does not improve after 1-2 weeks of treatment, re-evaluate the diagnosis or consider other antifungal agents.
  • Nystatin is effective only against fungi and will not treat bacterial or viral infections.
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Alternative Therapies

  • Clotrimazole topical
  • Miconazole topical
  • Ketoconazole topical
  • Terbinafine topical
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Cost & Coverage

Average Cost: Check current per 15gm powder
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.