Nystatin/triamcinolone Oint 15gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal/Corticosteroid Combination
Pharmacologic Class
Polyene Antifungal / Topical Corticosteroid
Pregnancy Category
Category C
FDA Approved
Jun 1974
DEA Schedule
Not Controlled
Overview
What is this medicine?
This ointment contains two medicines: Nystatin, which treats fungal infections like athlete's foot or jock itch, and Triamcinolone, a steroid that helps reduce redness, swelling, and itching caused by skin irritation. It's used to treat skin conditions where both a fungal infection and inflammation are present.
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 advised 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.
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 advised 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.
Lifestyle & Tips
- Wash and dry the affected area thoroughly before applying the ointment.
- Apply a thin layer of ointment to the affected skin area, gently rubbing it in.
- Do not use more than directed or for longer than prescribed, especially on the face, groin, or in skin folds, as this can increase the risk of side effects.
- Avoid getting the ointment in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
- Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption of the steroid.
- Wash your hands thoroughly after applying the ointment.
- Continue using the medication for the full prescribed duration, even if symptoms improve, to ensure the fungal infection is completely cleared.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected area 2 to 3 times daily.
Condition-Specific Dosing:
duration:
Continue for a few days after symptoms subside, typically not exceeding 2 weeks for corticosteroid component, or until fungal infection is resolved.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased systemic absorption and HPA axis suppression risk)
Infant:
Apply a thin film to the affected area 2 to 3 times daily. Use with caution and for shortest duration possible due to increased systemic absorption and HPA axis suppression risk.
Child:
Apply a thin film to the affected area 2 to 3 times daily. Use with caution and for shortest duration possible due to increased systemic absorption and HPA axis suppression risk.
Adolescent:
Apply a thin film to the affected area 2 to 3 times daily.
Dose Adjustments
Renal Impairment:
Mild:
Not typically adjusted for topical use.
Moderate:
Not typically adjusted for topical use.
Severe:
Not typically adjusted for topical use.
Dialysis:
Not typically adjusted for topical use.
Hepatic Impairment:
Mild:
Not typically adjusted for topical use.
Moderate:
Not typically adjusted for topical use.
Severe:
Not typically adjusted for topical use.
Pharmacology
Mechanism of Action
Nystatin is 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 is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Pharmacokinetics
Absorption:
Bioavailability:
Nystatin: Negligible systemic absorption from intact skin. Triamcinolone: Variable systemic absorption depending on skin integrity, site of application, and use of occlusive dressings. Can be significant.
Tmax:
Not available (topical application)
FoodEffect:
Not applicable (topical application)
Distribution:
Vd:
Not available (topical application)
ProteinBinding:
Triamcinolone: Approximately 60-80% (if absorbed systemically). Nystatin: Not applicable.
CnssPenetration:
Limited (Triamcinolone if significant systemic absorption)
Elimination:
HalfLife:
Not available (topical application for Nystatin); Triamcinolone: Approximately 2-5 hours (systemic)
Clearance:
Not available (topical application)
ExcretionRoute:
Nystatin: Excreted unchanged in feces. Triamcinolone: Primarily renal excretion of metabolites.
Unchanged:
Nystatin: >95% (feces); Triamcinolone: <5% (urine)
Pharmacodynamics
OnsetOfAction:
Within days for symptomatic relief (Triamcinolone); within days to weeks for fungal eradication (Nystatin)
PeakEffect:
Not precisely defined for topical agents
DurationOfAction:
Varies with application frequency and severity of condition
Safety & Warnings
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 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 have mild 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.
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 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 have mild 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.
Seek Immediate Medical Attention If You Experience:
- Worsening of the skin condition or no improvement after 7-14 days.
- Increased redness, itching, burning, or irritation at the application site.
- Development of new skin problems like thinning skin, stretch marks, or acne-like breakouts.
- Signs of a new infection (e.g., pus, fever).
- Unusual fatigue, weight gain, or swelling in the face (rare, but can indicate systemic absorption of the steroid).
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
Please describe the allergy and the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting 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
Please describe the allergy and the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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 use; do not exceed the recommended treatment 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 the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks; consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as it is crucial to weigh the benefits and risks of using this medication to both you and your baby.
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 use; do not exceed the recommended treatment 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 the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks; consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as it is crucial to weigh the benefits and risks of using this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- With excessive or prolonged use, especially over large areas or under occlusive dressings, systemic effects of triamcinolone may occur, including: Cushing's syndrome (moon face, buffalo hump, central obesity), hyperglycemia, glucosuria, HPA axis suppression (fatigue, weakness, nausea, vomiting, low blood pressure).
What to Do:
Discontinue use and consult a healthcare professional. Symptomatic and supportive treatment. For severe systemic effects, medical emergency. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Hypersensitivity to Nystatin, Triamcinolone, or any component of the formulation.
Monitoring
Baseline Monitoring
Clinical assessment of affected skin area
Rationale: To establish baseline severity of fungal infection and inflammation.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical improvement of symptoms (e.g., reduced redness, itching, scaling)
Frequency: Daily to weekly
Target: Progressive reduction in symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 7-14 days may indicate resistant infection or incorrect diagnosis; discontinue if no improvement.
Local adverse reactions (e.g., irritation, burning, skin atrophy, striae, folliculitis)
Frequency: Daily to weekly
Target: Absence of adverse reactions
Action Threshold: Presence of significant or worsening adverse reactions; consider discontinuation or alternative therapy.
Signs of systemic corticosteroid absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis 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 effects; discontinue and consult endocrinologist.
Symptom Monitoring
- Worsening redness
- Increased itching or burning
- Development of new rash or lesions
- Signs of secondary bacterial infection (pus, fever)
- Skin thinning or discoloration
- Unusual fatigue or weakness (rare, signs of systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nystatin is poorly absorbed. Topical corticosteroids, especially when used extensively or for prolonged periods, can be absorbed systemically and have been shown to be teratogenic in animal studies.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with systemic absorption of triamcinolone, though risk from topical use is low.
Second Trimester:
Similar considerations as first trimester.
Third Trimester:
Potential for HPA axis suppression in the neonate if used extensively near term.
Lactation
Use with caution. It is not known whether Nystatin or Triamcinolone are excreted in human milk after topical application. Systemic absorption of triamcinolone is possible. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited topical use; potential for HPA axis suppression or growth retardation if significant systemic absorption occurs in the infant via breast milk or direct contact.
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity, including HPA axis suppression and Cushing's syndrome. Use the smallest effective amount for the shortest possible duration. Avoid use on large surface areas or with occlusive dressings. Monitor for growth retardation.
Geriatric Use
Generally safe for use in the elderly. However, geriatric patients may have thinner skin, which could potentially increase systemic absorption of the corticosteroid. Monitor for skin atrophy and other local side effects.
Clinical Information
Clinical Pearls
- This combination ointment is particularly useful for inflammatory dermatoses complicated by candidal infections.
- Advise patients to apply a very thin layer; a little goes a long way.
- Educate patients on the importance of not using this product for longer than prescribed, especially due to the corticosteroid component which can cause skin thinning (atrophy) with prolonged use.
- If the condition does not improve within 7-14 days, or worsens, re-evaluate the diagnosis and treatment plan.
- Avoid using on the face, groin, or axillae unless specifically directed by a physician, as these areas are more prone to corticosteroid side effects.
Alternative Therapies
- Topical antifungals alone (e.g., Nystatin cream, Clotrimazole cream, Miconazole cream)
- Topical corticosteroids alone (e.g., Triamcinolone cream, Hydrocortisone cream)
- Oral antifungals (for severe or widespread infections)
- Other anti-inflammatory agents
Cost & Coverage
Average Cost:
$15 - $50 per 15gm 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 this 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.