Nystatin/triamcinolone Oint 30gm

Manufacturer PADAGIS 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 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 ointment contains two medicines: Nystatin, which treats fungal infections like yeast, and Triamcinolone, which is a steroid that helps reduce redness, swelling, and itching. It's used to treat skin conditions that have both inflammation and a fungal infection.
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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 directed 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 instructed to do so 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.
Consult your pharmacist for guidance on the best way to dispose of medications. You may also have access to drug take-back programs 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 ointment.
  • Apply a thin layer of ointment to the affected skin and rub in gently.
  • 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 ointment.
  • Continue using for the full prescribed duration, even if symptoms improve, to ensure the fungal infection is fully cleared.
  • 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 affected areas 2 to 3 times daily

Condition-Specific Dosing:

tinea_pedis: Apply to affected areas 2-3 times daily
candidiasis: Apply to affected areas 2-3 times daily
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Pediatric Dosing

Neonatal: Not established
Infant: Apply a thin film to affected areas 2 to 3 times daily; use with caution due to potential for systemic absorption of corticosteroid
Child: Apply a thin film to affected areas 2 to 3 times daily; use with caution due to potential for systemic absorption of corticosteroid
Adolescent: Apply a thin film to affected areas 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: Binds to sterols (primarily ergosterol) in the fungal cell membrane, leading to increased permeability and leakage of intracellular components. Triamcinolone: 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.
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Pharmacokinetics

Absorption:

Bioavailability: Nystatin: Negligible systemic absorption from intact skin or mucous membranes. Triamcinolone: Variable systemic absorption depending on the vehicle, integrity of the epidermal barrier, duration of exposure, and use of occlusive dressings. Absorption is increased in areas with thin skin (e.g., face, groin) or damaged skin.
Tmax: Not applicable for topical Nystatin; variable for topical Triamcinolone (systemic absorption is minimal but can occur)
FoodEffect: Not applicable (topical)

Distribution:

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

Elimination:

HalfLife: Nystatin: Not applicable (not absorbed); Triamcinolone: Approximately 2-5 hours (if systemically absorbed)
Clearance: Not applicable for Nystatin; Triamcinolone: Primarily renal excretion of metabolites (if systemically absorbed)
ExcretionRoute: Nystatin: Feces (unabsorbed); Triamcinolone: Urine (metabolites)
Unchanged: Nystatin: >95% (feces); Triamcinolone: Minimal (urine)
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Pharmacodynamics

OnsetOfAction: Within days for symptomatic relief (Triamcinolone); several days to weeks for complete fungal eradication (Nystatin)
PeakEffect: Variable, depends on severity and duration of treatment
DurationOfAction: Depends on frequency of application and underlying condition

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 or seek immediate medical attention:

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, excessive 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. 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 persist, contact your doctor for guidance:

Burning sensation
Itching
* Dry skin

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 redness, swelling, or irritation at the application site
  • Signs of a new skin infection (e.g., pus, fever)
  • Skin thinning, easy bruising, or stretch marks (striae) with prolonged use
  • Blurred vision or other visual disturbances (rare, with significant 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 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. Before using any other medications or skin products, such as soaps, consult with your doctor to ensure safe use.

To minimize potential risks, 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 any concerns with your doctor.

Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period. 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, making regular growth checks necessary. Consult with your doctor to discuss this potential risk.

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

Overdose Symptoms:

  • For topical overdose, systemic effects are rare but may include Cushing's syndrome (moon face, buffalo hump, central obesity), hyperglycemia, glucosuria, and adrenal suppression, especially with prolonged use over large surface areas or under occlusion.
  • Local symptoms may include severe irritation, burning, or itching.

What to Do:

Discontinue use. If systemic effects are suspected, seek medical attention. Symptomatic and supportive treatment. Call 1-800-222-1222 for poison control.

Drug Interactions

Monitoring

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Routine Monitoring

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

Frequency: Regularly during treatment

Target: Improvement of symptoms and resolution of lesions

Action Threshold: Lack of improvement or worsening of symptoms after 7-14 days; signs of local irritation or infection

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

Frequency: Regularly during treatment

Target: Absence of adverse effects

Action Threshold: Presence of significant local adverse effects; discontinue or reduce frequency

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Symptom Monitoring

  • Redness
  • Swelling
  • Itching
  • Burning
  • Pain
  • Pus or discharge
  • Skin thinning or discoloration
  • New skin lesions

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical absorption of triamcinolone can occur, and corticosteroids have been shown to be teratogenic in animals. Nystatin topical absorption is negligible.

Trimester-Specific Risks:

First Trimester: Potential risk of teratogenicity with systemic corticosteroids; topical absorption is generally low but caution advised.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: No specific risks identified beyond general corticosteroid concerns; potential for low birth weight with prolonged, high-dose systemic exposure.
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Lactation

Use with caution. It is not known whether topically administered corticosteroids are excreted in human milk. Systemic absorption is generally low. Nystatin is not absorbed. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use; monitor for potential systemic effects in infant if significant maternal absorption occurs (unlikely).
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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 potent corticosteroid for the shortest duration possible. Avoid occlusive dressings. Not recommended for infants under 2 years unless specifically directed by a physician.

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Geriatric Use

No specific dosage adjustments are typically needed. Elderly patients may have thinner skin, which could potentially increase systemic absorption, but this is generally not clinically significant with appropriate use. Monitor for skin atrophy.

Clinical Information

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Clinical Pearls

  • This combination ointment is effective for inflammatory dermatoses complicated by candidal infections.
  • Do not use for viral or bacterial skin infections.
  • Prolonged use, especially on the face, groin, or axillae, or under occlusion, can lead to local side effects like skin atrophy, striae, telangiectasias, and acneiform eruptions.
  • If no improvement is seen after 7-14 days, re-evaluate the diagnosis and treatment plan.
  • Educate patients on proper application technique and the importance of not exceeding the prescribed duration or frequency to minimize steroid-related side effects.
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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)
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Cost & Coverage

Average Cost: $20 - $60 per 30gm 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.