Nystatin/triamcinolone Cream 15gm

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 Combination
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Pharmacologic Class
Polyene Antifungal; Synthetic Corticosteroid
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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 fights fungal infections like yeast, and Triamcinolone, which is a steroid that reduces redness, swelling, and itching. It's used to treat skin infections that are caused by yeast and also have inflammation.
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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.
Do not use bandages, dressings, or makeup on the treated area unless directed 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 and do not freeze it.
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 by your doctor or pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a drug take-back program in your area.

Missed Dose

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.
  • Do not use occlusive dressings (e.g., bandages, plastic wrap) over the treated area unless directed by your doctor, as this can increase absorption of the steroid.
  • Avoid contact with eyes, 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.
  • Wear loose-fitting clothing to allow air circulation to the affected area.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected area(s) twice daily (morning and evening).

Condition-Specific Dosing:

duration: Treatment should be continued for at least 2 weeks for candidiasis and for 2 weeks for intertrigo. Discontinue if no improvement after 2-4 weeks.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to increased systemic absorption risk)
Infant: Apply a thin film to the affected area(s) twice daily. Use with caution and for the shortest duration possible due to increased systemic absorption risk.
Child: Apply a thin film to the affected area(s) twice daily. Use with caution and for the shortest duration possible due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected area(s) twice daily (morning and evening).
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Dose Adjustments

Renal Impairment:

Mild: Not typically required for topical use
Moderate: Not typically required for topical use
Severe: Not typically required for topical use
Dialysis: Not typically required for topical use

Hepatic Impairment:

Mild: Not typically required for topical use
Moderate: Not typically required for topical use
Severe: Not typically required for topical use

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 induces 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: Minimal systemic absorption for both components when applied topically to intact skin. Absorption of triamcinolone can increase with inflammation, skin barrier disruption, prolonged use, large surface area application, or occlusive dressings.
Tmax: Not applicable for topical use (systemic levels are generally undetectable)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for topical use
ProteinBinding: Triamcinolone: Approximately 60-80% (systemic); Nystatin: Not significantly absorbed
CnssPenetration: Limited (systemic absorption is minimal)

Elimination:

HalfLife: Triamcinolone: Approximately 2-5 hours (systemic); Nystatin: Not significantly absorbed or eliminated systemically.
Clearance: Not applicable for topical use
ExcretionRoute: Triamcinolone: Primarily renal (metabolites); Nystatin: Primarily fecal (unabsorbed drug)
Unchanged: Not applicable for topical use
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Pharmacodynamics

OnsetOfAction: Within days for symptomatic relief (itching, redness); full antifungal effect may take 1-2 weeks.
PeakEffect: Within 1-2 weeks of consistent application.
DurationOfAction: Depends on continued application; effects diminish rapidly upon discontinuation.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Change in skin color
Skin irritation
Thinning of the skin

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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Burning
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 rash or infection
  • Development of new skin problems like thinning skin, stretch marks, or acne
  • Signs of a new infection (e.g., pus, fever)
  • Severe burning, itching, or irritation at the application site
  • Unusual fatigue, weight gain, or swelling (rare, but can indicate systemic steroid 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, any of 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) medications, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* 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. Never start, stop, or change the dose 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 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 may increase the amount of medication absorbed into the body.

When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. 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, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you, considering both your health and the health of your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with acute topical overdose.
  • Chronic excessive use, especially over large areas or under occlusion, can lead to systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression, hyperglycemia).

What to Do:

Discontinue use. Symptomatic and supportive treatment. For suspected systemic effects, consult a healthcare professional immediately. Call 1-800-222-1222 for poison control.

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 symptoms (e.g., reduction in redness, itching, rash)

Frequency: Daily by patient, weekly by clinician if needed

Target: Progressive reduction in symptoms

Action Threshold: Lack of improvement after 2-4 weeks, or worsening symptoms, requires re-evaluation.

Signs of local adverse reactions (e.g., skin atrophy, striae, folliculitis, secondary infection)

Frequency: At each follow-up visit or if patient reports new symptoms

Target: Absence of new or worsening skin changes

Action Threshold: Presence of significant adverse reactions warrants discontinuation or change in therapy.

Signs of systemic corticosteroid absorption (rare with appropriate topical use)

Frequency: If extensive use, prolonged use, or in pediatric patients

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

Action Threshold: Any suspicion of systemic effects requires immediate medical evaluation and discontinuation.

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Symptom Monitoring

  • Worsening redness
  • Increased itching or burning
  • Development of new lesions or pustules
  • Thinning of skin
  • Stretch marks (striae)
  • Increased hair growth at application site
  • Signs of secondary bacterial or viral infection

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid prolonged use, large areas, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high-dose systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester: Similar considerations as first trimester; minimal systemic absorption expected.
Third Trimester: Similar considerations; potential for low birth weight or adrenal suppression in neonate with extensive maternal use.
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Lactation

L3 (Moderately Safe). Nystatin is not significantly absorbed. Triamcinolone is minimally absorbed topically, but systemic corticosteroids can be excreted in breast milk. Use with caution, avoid applying to breast area to prevent infant ingestion.

Infant Risk: Low risk of adverse effects due to minimal systemic absorption, but monitor infant for potential effects if mother uses extensively.
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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 smallest amount for the shortest duration necessary. Not recommended for children under 2 years unless specifically directed by a physician.

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Geriatric Use

Generally safe. Elderly patients may have thinner skin, which could potentially increase absorption, but systemic effects are still rare with appropriate use. Monitor for skin atrophy.

Clinical Information

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Clinical Pearls

  • This combination cream is effective for fungal infections (especially Candida) that are accompanied by significant inflammation, itching, or redness.
  • It is crucial to limit the duration of use, especially in sensitive areas (face, groin, axillae) and in children, to minimize the risk of corticosteroid-induced skin atrophy or systemic effects.
  • If the fungal infection does not improve or worsens after 2-4 weeks, re-evaluate the diagnosis and treatment plan.
  • Advise patients not to use this cream for conditions other than those for which it was prescribed.
  • Ensure patients understand that this is for external use only and to avoid contact with eyes.
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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) for inflammatory dermatoses without fungal infection.
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Cost & Coverage

Average Cost: $15 - $40 per 15gm 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 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.