Nystatin/triamcinolone Cream 30gm

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.
đŸˇī¸
Drug Class
Antifungal / Corticosteroid Combination
đŸ§Ŧ
Pharmacologic Class
Polyene Antifungal / Synthetic Glucocorticoid
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

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 that have both inflammation and a fungal infection.
📋

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 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 local drug take-back programs.

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 to make up for a missed dose.
💡

Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer to the affected skin area, gently rubbing it in.
  • Do not cover the treated area with bandages or tight dressings unless your doctor tells you to, as this can increase absorption of the steroid.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes.
  • Do not use for longer than prescribed, especially on the face, groin, or in skin folds, or on children, due to the risk of steroid side effects.
  • Keep the treated area clean and dry.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Apply a thin film to affected areas 2 to 3 times daily.

Condition-Specific Dosing:

duration: Treatment should be continued for 2 weeks for candidiasis, or until clinical improvement is evident. Do not use for more than 2 weeks unless directed by a physician.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (use with extreme caution due to risk of systemic absorption of corticosteroid)
Infant: Apply a thin film to affected areas 2 to 3 times daily. Use with caution and for the shortest duration possible due to risk of systemic absorption and HPA axis suppression.
Child: Apply a thin film to affected areas 2 to 3 times daily. Use with caution and for the shortest duration possible due to risk of systemic absorption and HPA axis suppression.
Adolescent: Apply a thin film to affected areas 2 to 3 times daily.
âš•ī¸

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

đŸ”Ŧ

Mechanism of Action

Nystatin: A polyene antifungal antibiotic that binds to sterols (primarily ergosterol) in the fungal cell membrane, leading to a change in membrane permeability and leakage of intracellular components. Triamcinolone Acetonide: 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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Nystatin: Negligible systemic absorption from intact skin or mucous membranes. Triamcinolone: Variable systemic absorption from intact skin, dependent on vehicle, skin integrity, duration of exposure, and use of occlusive dressings. Absorption is increased in areas of skin folds, thin skin, or damaged skin.
Tmax: Not applicable for topical Nystatin; Triamcinolone topical Tmax not well-defined due to variable absorption.
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Triamcinolone: Approximately 60-80% (systemic); Nystatin: Not applicable (minimal systemic absorption)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Nystatin: Not applicable (not absorbed). Triamcinolone: Systemic half-life is approximately 2-5 hours, but biological half-life is longer.
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Nystatin: Unabsorbed drug is excreted in feces. Triamcinolone: Metabolites primarily excreted in urine.
Unchanged: Nystatin: >95% (unabsorbed). Triamcinolone: Minimal unchanged drug excreted.
âąī¸

Pharmacodynamics

OnsetOfAction: Within days for symptomatic relief (anti-inflammatory effect); full antifungal effect may take longer.
PeakEffect: Within 1-2 weeks for full therapeutic effect.
DurationOfAction: Effects persist as long as applied; residual anti-inflammatory effect may last hours after application.

Safety & Warnings

âš ī¸

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 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
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 fainting
+ 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 unusual symptoms, contact your doctor for guidance:

Burning
Itching
* Dry skin

This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • If the skin condition worsens or does not improve after 7-14 days.
  • If you develop new skin irritation, burning, or itching.
  • Signs of skin thinning, easy bruising, or stretch marks.
  • Signs of systemic steroid absorption, such as unusual weight gain, swelling in the face, or increased thirst/urination (rare with proper topical use).
📋

Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergy, be sure to describe the symptoms you experienced.

This medication may interact with other medications or health conditions. To ensure your safety, it is crucial to:
- Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about your health problems
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not:
- Start taking a new medication
- Stop taking a medication
- Change the dose of any medication
without first consulting your doctor.
âš ī¸

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. Do not use this medication for a longer period than prescribed by your doctor.

If you are treating an area that will be covered by a diaper, 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, caution is advised, as the risk of certain side effects may be higher. In some cases, this medication can affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Unlikely with topical application.
  • Extensive or prolonged use, especially under occlusion or on large surface areas, could lead to systemic corticosteroid effects (e.g., Cushing's syndrome, hyperglycemia, adrenal suppression).

What to Do:

Discontinue use and seek medical attention. Call 1-800-222-1222 for poison control.

Drug Interactions

Monitoring

đŸ”Ŧ

Baseline Monitoring

Skin condition and extent of infection

Rationale: To assess severity and guide treatment duration.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Clinical response (reduction in inflammation, pruritus, and fungal lesions)

Frequency: Daily to weekly

Target: Improvement of symptoms

Action Threshold: Lack of improvement or worsening symptoms after 7-14 days may indicate resistant infection or incorrect diagnosis.

Local adverse effects (e.g., skin atrophy, striae, telangiectasias, burning, itching, irritation)

Frequency: Weekly or as symptoms arise

Target: Absence of new or worsening adverse effects

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

Signs of systemic corticosteroid absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)

Frequency: Periodically, especially with extensive use, prolonged use, or in pediatric patients

Target: Absence of systemic effects

Action Threshold: Any signs of systemic absorption require immediate medical evaluation and discontinuation.

đŸ‘ī¸

Symptom Monitoring

  • Worsening of rash or infection
  • Increased redness, swelling, or pus
  • Severe burning, itching, or irritation at application site
  • Thinning of skin, easy bruising, or stretch marks (striae)
  • Unusual fatigue or weakness
  • Weight gain, moon face, or buffalo hump (signs of Cushing's syndrome)
  • Increased thirst or urination (signs of hyperglycemia)

Special Patient Groups

🤰

Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high systemic exposure to corticosteroids, though unlikely with topical use.
Second Trimester: Similar considerations as first trimester; minimal risk with appropriate topical use.
Third Trimester: Minimal risk with appropriate topical use; theoretical risk of adrenal suppression in the neonate if significant maternal systemic absorption occurs.
🤱

Lactation

L3. Nystatin is not absorbed. Triamcinolone is minimally absorbed topically. Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate topical use. Monitor infant for any unusual effects.
đŸ‘ļ

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, growth retardation). Use the smallest effective amount for the shortest duration possible. Avoid occlusive dressings.

👴

Geriatric Use

No specific dosage adjustments needed. Elderly patients may have thinner skin, which could increase susceptibility to local adverse effects like skin atrophy.

Clinical Information

💎

Clinical Pearls

  • This combination cream is effective for inflammatory dermatoses complicated by candidal infections.
  • Ensure the diagnosis includes a fungal component; prolonged use of corticosteroids alone can worsen fungal infections.
  • Advise patients not to use this cream for conditions other than those for which it was prescribed.
  • Educate patients on the signs of skin atrophy (thinning, bruising, stretch marks) and systemic corticosteroid effects, especially with prolonged or extensive use.
  • Not for ophthalmic use.
🔄

Alternative Therapies

  • Topical antifungals (e.g., Nystatin cream, Clotrimazole cream, Miconazole cream)
  • Topical corticosteroids (e.g., Triamcinolone cream, Hydrocortisone cream)
  • Oral antifungals (for severe or widespread infections)
💰

Cost & Coverage

Average Cost: $20 - $60 per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
📚

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 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.