Nystatin/triamcinolone Oint 60gm

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
Topical Antifungal / Topical Corticosteroid
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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 ointment contains two medicines: Nystatin, which treats fungal infections, and Triamcinolone, which is a steroid that reduces 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 make sure it is dry.
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 way to dispose of medications, 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.
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Lifestyle & Tips

  • Wash hands before and after applying the ointment.
  • Apply a thin layer to the affected skin area as directed by your doctor.
  • Do not cover the treated area with bandages or dressings unless specifically told to by your doctor, as this can increase absorption.
  • Avoid getting the ointment in your eyes, nose, mouth, or vagina.
  • Do not use for longer than prescribed, especially on the face, groin, or armpits, or in children.
  • Report any worsening of the condition or new skin irritation to your doctor.

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:

dermatoses: Apply a thin film to affected areas 2 to 3 times daily.
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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 affected areas 2 to 3 times daily (use with caution, limit duration and amount)
Child: Apply a thin film to affected areas 2 to 3 times daily (use with caution, limit duration and amount)
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 (topical)
Moderate: No adjustment needed (topical)
Severe: No adjustment needed (topical)
Dialysis: No specific considerations (topical)

Hepatic Impairment:

Mild: No adjustment needed (topical)
Moderate: No adjustment needed (topical)
Severe: No adjustment needed (topical)

Pharmacology

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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, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (topical)
Tmax: Not applicable (topical)
FoodEffect: Not applicable (topical)

Distribution:

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

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: Days to weeks for full therapeutic effect
PeakEffect: Not precisely defined for topical
DurationOfAction: Varies with condition and frequency of application

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, 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 advice:

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:

  • Increased redness, itching, or irritation at the application site
  • Signs of a new infection (e.g., pus, fever)
  • Skin thinning, easy bruising, or stretch marks (with prolonged use)
  • Blurred vision or other eye problems (rare, if absorbed systemically)
  • Unexplained weight gain or swelling (rare, if absorbed systemically)
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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 identify potential interactions between this medication and other substances.
* 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 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 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 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, planning to become pregnant, or 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:

  • Topical overdose is unlikely to cause acute systemic symptoms due to minimal absorption.
  • Prolonged or excessive use, especially over large surface areas or under occlusion, can lead to systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression, hyperglycemia).

What to Do:

Discontinue use and consult a healthcare professional. For accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention. Management is supportive.

Drug Interactions

Monitoring

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, and fungal infection signs)

Frequency: Regularly during treatment

Target: Improvement of symptoms

Action Threshold: Lack of improvement or worsening of symptoms after 1-2 weeks, or signs of adverse effects

Local skin reactions (atrophy, striae, burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection)

Frequency: Regularly during treatment

Target: Absence of severe reactions

Action Threshold: Presence of severe or persistent reactions, requiring discontinuation or dose adjustment

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

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings

Target: Absence of systemic effects

Action Threshold: Any signs of systemic absorption, requiring medical evaluation

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation
  • Pus or signs of secondary bacterial infection
  • Thinning of skin
  • Stretch marks
  • Unusual hair growth
  • Acne-like breakouts
  • Changes in skin color
  • Fatigue
  • Weight gain (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. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption is minimal with topical use, but caution is advised.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects with systemic corticosteroids; topical absorption is minimal but caution is advised.
Second Trimester: Minimal risk with topical use, but monitor for systemic effects.
Third Trimester: Minimal risk with topical use, but monitor for systemic effects.
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Lactation

Caution is advised. It is not known whether topically administered corticosteroids are excreted in human milk. Systemic absorption is minimal, but consider the risk-benefit. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk due to minimal systemic absorption, but monitor for potential effects if applied to large areas or for prolonged periods.
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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) than adult patients. Use the smallest amount for the shortest duration possible. Avoid occlusive dressings. Not recommended for neonates.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • This combination ointment is effective for inflammatory dermatoses complicated by candidal infections.
  • Limit the duration of treatment, especially in children and on sensitive areas like the face, groin, and axillae, to minimize the risk of corticosteroid-induced skin atrophy or systemic effects.
  • Advise patients not to use occlusive dressings unless specifically instructed by a physician, as this significantly increases corticosteroid absorption.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan.
  • Educate patients on proper application technique: apply a thin film, rub in gently, and wash hands after application.
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Alternative Therapies

  • Topical antifungals (e.g., Nystatin cream, Clotrimazole cream)
  • Topical corticosteroids (e.g., Triamcinolone cream, Hydrocortisone cream)
  • Oral antifungals (for severe or widespread infections)
  • Other anti-inflammatory agents
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Cost & Coverage

Average Cost: $20 - $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's 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 be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.