Nystatin/triamcinolone Cream 60gm

Manufacturer TARO Active Ingredient Nystatin and Triamcinolone(nye STAT in & trye am SIN oh lone) Pronunciation nye STAT in & trye am SIN oh lone
It is used to treat fungal infections of the skin.
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Drug Class
Antifungal and Corticosteroid (Topical)
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Pharmacologic Class
Polyene Antifungal / Synthetic Glucocorticoid
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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?

This cream contains two medicines: Nystatin, which treats fungal infections like yeast, and Triamcinolone, a steroid that reduces redness, swelling, and itching. It's used to treat skin conditions where both a fungal infection and inflammation are present.
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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

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Avoid using bandages, dressings, or makeup on the treated area unless advised by your doctor.
If applying the medication to the groin area, use a small amount and avoid wearing tight clothing.

Storage and Disposal

Store the medication at room temperature, avoiding freezing.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so.
Consult your pharmacist for guidance on the best disposal method or to learn about potential drug take-back programs in your area.

Missed Dose Instructions

If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Wash and dry the affected area thoroughly before applying the cream.
  • Apply a thin layer of cream to cover the entire affected area.
  • Rub in gently until the cream disappears.
  • Do not cover the treated area with bandages or dressings unless directed by your doctor, as this can increase absorption of the steroid.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes.
  • Wash hands thoroughly after applying the cream.
  • Do not use for longer than prescribed, especially on the face, groin, or armpits, or in children.
  • Do not use for conditions other than those for which it was prescribed.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected area(s) two to three times daily.

Condition-Specific Dosing:

duration: Treatment should be continued for a few days after clinical cure, but generally not exceeding 2 weeks for corticosteroid component, or until resolution of fungal infection.
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Pediatric Dosing

Neonatal: Not established
Infant: Apply a thin film to the affected area(s) two to three times daily. Use with caution, especially on large surface areas or under occlusion, due to increased risk of systemic absorption.
Child: Apply a thin film to the affected area(s) two to three times daily. Use with caution, especially on large surface areas or under occlusion, due to increased risk of systemic absorption.
Adolescent: Apply a thin film to the affected area(s) two to three 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)
Confidence: Medium

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. Triamcinolone acetonide is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
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Pharmacokinetics

Absorption:

Bioavailability: Nystatin: Negligible systemic absorption from intact skin or mucous membranes. Triamcinolone: Variable, depends on vehicle, integrity of epidermal barrier, site of application, and use of occlusive dressings. Can be absorbed systemically.
Tmax: Not applicable for topical Nystatin. For Triamcinolone, systemic absorption is slow and variable.
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not applicable for topical Nystatin. For Triamcinolone, if absorbed systemically, distributes widely.
ProteinBinding: Nystatin: Not applicable. Triamcinolone: Approximately 60-80% bound to plasma proteins (if systemically absorbed).
CnssPenetration: Limited (for Triamcinolone, if systemically absorbed)

Elimination:

HalfLife: Nystatin: Not applicable. Triamcinolone: Systemic half-life is approximately 2-5 hours (if systemically absorbed).
Clearance: Nystatin: Not applicable. Triamcinolone: Primarily renal excretion of metabolites.
ExcretionRoute: Nystatin: Excreted unchanged in feces (if ingested). Triamcinolone: Renal (metabolites).
Unchanged: Nystatin: >95% (topical). Triamcinolone: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Nystatin: Antifungal effect develops over days. Triamcinolone: Anti-inflammatory/antipruritic effects can be seen within hours.
PeakEffect: Nystatin: Full antifungal effect over several days to weeks. Triamcinolone: Peak anti-inflammatory effect within days.
DurationOfAction: Variable, depends on frequency of application and severity of condition.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Changes in skin color
Skin irritation
Thinning of the skin

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Burning sensation
Itching
* Dry skin

This is not an exhaustive list of 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:

  • Worsening of the skin condition
  • Increased irritation, redness, or burning at the application site
  • Development of new skin problems like pimples, thinning skin, or stretch marks
  • Signs of a new infection (e.g., pus, fever)
  • Unusual weight gain, swelling in ankles/feet, or changes in vision (rare, signs of systemic absorption)
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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. 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. Before using any other medications or products on your skin, including soaps, consult with your doctor.

To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor.

Adhere to your doctor's instructions regarding the duration of treatment, and do not use this medication for longer than prescribed. If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.

When using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause acute life-threatening symptoms. Prolonged or extensive use of large amounts may lead to systemic corticosteroid effects such as Cushing's syndrome, hyperglycemia, and glucosuria.

What to Do:

Discontinue use. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice if significant ingestion or systemic symptoms occur.

Drug Interactions

Monitoring

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Baseline Monitoring

Clinical assessment of affected skin area

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical improvement of skin lesions (reduced redness, itching, scaling)

Frequency: Daily to weekly

Target: Resolution of symptoms

Action Threshold: Lack of improvement or worsening of symptoms after 7-14 days may indicate incorrect diagnosis, resistance, or need for alternative therapy.

Signs of local adverse reactions (e.g., irritation, burning, atrophy, striae, folliculitis)

Frequency: Daily to weekly

Target: Absence of adverse reactions

Action Threshold: Presence of significant adverse reactions warrants discontinuation or dose reduction.

Signs of systemic corticosteroid absorption (rare, but possible with extensive use, occlusion, or in children)

Frequency: Periodically, especially with prolonged or extensive use

Target: Absence of Cushing's syndrome symptoms, adrenal suppression

Action Threshold: Symptoms like weight gain, moon face, striae, or growth retardation in children require immediate medical evaluation.

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Symptom Monitoring

  • Worsening redness or inflammation
  • Increased itching or burning
  • Development of new skin lesions (e.g., pustules, blisters)
  • Signs of skin thinning or discoloration
  • Unusual fatigue or weakness (rare, systemic absorption)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in animals. Systemic absorption of topical corticosteroids can occur.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester: Risk generally considered lower than first trimester, but still use with caution.
Third Trimester: Risk of adrenal suppression in the neonate if used extensively or for prolonged periods near term.
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Lactation

L3 (Moderately Safe). It is not known whether topically administered corticosteroids are excreted in human milk. Systemic absorption is minimal. Caution should be exercised. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk of adverse effects due to minimal systemic absorption, but monitor for potential effects if extensive use.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension, growth retardation). Use the least amount compatible with an effective therapeutic regimen. Avoid prolonged use or use under occlusion.

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Geriatric Use

Generally safe for use in the elderly. However, elderly patients may have thinner skin, which could potentially increase systemic absorption or local adverse effects like skin atrophy. Monitor for skin integrity and adverse reactions.

Clinical Information

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Clinical Pearls

  • This combination cream is particularly useful for inflammatory fungal infections, such as candidiasis with significant erythema and pruritus.
  • Ensure the patient understands that this cream is for external use only and should not be used in the eyes or internally.
  • Advise patients not to use this cream for longer than prescribed, especially the triamcinolone component, to avoid skin atrophy or systemic side effects.
  • If the fungal infection persists or worsens after a reasonable course of treatment (e.g., 7-14 days), re-evaluate the diagnosis and consider alternative antifungal agents.
  • For diaper rash, use sparingly and avoid tight-fitting diapers or plastic pants, which can act as occlusive dressings.
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Alternative Therapies

  • Topical antifungals alone (e.g., Nystatin cream, Clotrimazole cream, Miconazole cream)
  • Topical corticosteroids alone (e.g., Triamcinolone cream, Hydrocortisone cream) if inflammation is primary concern without fungal infection
  • Oral antifungals (for severe or widespread fungal infections)
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Cost & Coverage

Average Cost: $30 - $100+ per 60gm tube
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 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.