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Nystatin and Triamcinolone (Topical)


VA CLASSIFICATION
Primary: DE250{11}

Commonly used brand name(s): Dermacomb; Myco II; Myco-Triacet II; Mycobiotic II; Mycogen II; Mycolog II; Mykacet; Mykacet II; Mytrex; Tristatin II.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Antifungal-corticosteroid (topical)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Candidiasis, cutaneous (treatment)—Nystatin and triamcinolone combination is indicated as a secondary agent {10} in the topical treatment of cutaneous candidiasis, [accompanied by inflammation{10}] , caused by Candida albicans (Monilia albicans) and other Candida species. {16} {25}

—The use of nystatin and triamcinolone combination has been shown to provide greater benefit than nystatin alone during the first few days of treatment [or for as long as inflammation persists. After this time, USP medical experts recommend the use of plain nystatin or other topical antifungal agents. Also, nystatin and triamcinolone combination is recommended only for short-term (less than 2 weeks) treatment of inflammatory candidiasis confined to limited areas of the skin{10}] .

—Not all species or strains of a particular organism may be susceptible to nystatin.

Unaccepted
Nystatin and triamcinolone combination is not recommended in the treatment of mucocutaneous candidiasis. {10} In addition, nystatin is not effective against bacteria, protozoa, trichomonads, or viruses. {25}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    434.50 {22}

Mechanism of action/Effect:

Nystatin—Binds to sterols in the fungal cell membrane, resulting in the cell membrane's inability to function as a selective barrier, thus allowing loss of essential cellular constituents. {01} {02} {03} {04} {05} {16} {25}

Triamcinolone—Mechanism of its dermatological action is unclear; however, corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin), and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be ultimately responsible for the anti-inflammatory effects of topically applied corticosteroids. {01} {02} {03} {04} {05}

Absorption:

Nystatin—Not absorbed following topical application to intact skin or mucous membranes. {01} {02} {03} {04} {05} {25}

Triamcinolone—May be absorbed systemically from normal intact skin; inflammation and/or other dermatologic pathology increases percutaneous absorption of topically applied corticosteroids, while occlusive dressings significantly increase percutaneous absorption; other factors that augment absorption include the vehicle, overall integrity of the epidermal barrier, corticosteroid potency, use over an extensive surface area, and prolonged use; children may absorb proportionately larger amounts of topically applied corticosteroids and are thus more susceptible to systemic toxicity. {01} {02} {03} {04} {05}

Protein binding:

Triamcinolone (absorbed)—Bound to plasma proteins in varying degrees. {01} {02} {03} {04} {05} {16}

Biotransformation:

Triamcinolone (unabsorbed)—Mostly in skin; fluorinated compounds are more slowly metabolized in skin and thus tend to be systemically absorbed to a greater extent.

Triamcinolone (absorbed)—Primarily hepatic, mostly to inactive metabolites; metabolized in a manner similar to that of systemically absorbed corticosteroids. {01} {02} {03} {04} {05} {25}

Elimination:
    Renal; absorbed triamcinolone excreted via the kidneys, mainly as inactive metabolites. {01} {02} {03} {04} {05}
    Biliary; some topically applied corticosteroids and their metabolites also excreted in bile. {01} {02} {03} {04} {05} {16}


Precautions to Consider

Carcinogenicity/Mutagenicity

Long-term animal studies have not been done to evaluate carcinogenic or mutagenic potential. {01} {02} {03} {04} {05} {16} {25}

Pregnancy/Reproduction
Fertility—
Long-term studies in animals have not been done to evaluate possible impairment of fertility in males or females. {01} {02} {03} {04} {05} {16} {25}

Pregnancy—
Teratogenicity studies with nystatin and triamcinolone combination have not been done in humans.

Studies in animals have shown that corticosteroids are generally teratogenic when administered systemically at relatively low doses. In addition, the more potent corticosteroids have been shown to be teratogenic following dermal application in animals. Therefore, topical corticosteroid-containing preparations should not be used on extensive surface areas, in large amounts, or for prolonged periods of time in pregnant patients.

FDA Pregnancy Category C. {01} {02} {03} {04} {05} {25}

Breast-feeding

It is not known whether topically applied nystatin or triamcinolone is distributed into human breast milk. {16} {25} Problems in humans have not been documented. However, risk-benefit must be considered since topically applied corticosteroids may be systemically absorbed. Systemic corticosteroids are distributed into breast milk and may cause unwanted effects, such as growth suppression, in the infant. {01} {02} {03} {04} {05}

Pediatrics

Children may absorb proportionately larger amounts of topically applied corticosteroids than mature patients. Children may thus be more susceptible to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome because of larger surface-area to body-weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Therefore, topical administration of corticosteroids in children should be limited to the least amount that is effective. Chronic corticosteroid therapy may interfere with the growth and development of children. {01} {02} {03} {04} {05} {16} {25}

As a general rule, pediatric therapy continuing for longer than 2 weeks and consisting of doses in excess of one daily application of triamcinolone 0.1% (an intermediate-potency corticosteroid) should be carefully evaluated by the physician. This is especially important if medication is applied to more than 5 to 10% of the body surface or if an occlusive dressing is used. A tight-fitting diaper or one covered with plastic pants may constitute an occlusive dressing. {25}


Geriatrics


Appropriate studies on the relationship of age to the effects of topical nystatin and triamcinolone combination have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.


Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Adrenal function as assessed by corticotropin (ACTH) stimulation or measurement of plasma cortisol and
Hypothalamic-pituitary-adrenal (HPA) axis function    (may be decreased if significant absorption of triamcinolone occurs, especially in children {16} {25})


Blood glucose concentrations and
Urine glucose concentrations    (may be increased because of intrinsic hyperglycemic activity of triamcinolone {25})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Sensitivity to nystatin or corticosteroids
For triamcinolone acetonide:
» Herpes simplex
» Tubercular infections of the skin
» Vaccinia, eczema vaccinatum, varicella, or other viral infections of the skin


Side/Adverse Effects

Note: Some, although not all, {10} formulations of the cream dosage form contain ethylenediamine, a potent sensitizer. Other sensitizers may also be present.
Side/adverse effects may be more pronounced with the use of an occlusive dressing; also, they may be more severe with fluorinated corticosteroids.
Since topically applied corticosteroids may be absorbed systemically, systemic effects may occur with prolonged use. The risk of adrenal suppression increases with the potency of the corticosteroids, the size of the area of application, and the duration of therapy. However, serious side/adverse effects with dermatological use are unlikely. {01} {02} {03} {04} {05}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare {10} {16}
    
Hypersensitivity (blistering, burning, dryness, itching, peeling, or other sign of irritation not present before therapy){01}{02}{03}{04}{05}{25}

With prolonged use
    
Acne or oily skin
    
increased hair growth, especially on the face
    
increased loss of hair, especially on the scalp{01}{02}{03}{04}{05}{25}
    
reddish purple lines on arms, face, legs, trunk, or groin
    
skin atrophy (thinning of skin with easy bruising)





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Nystatin and Triamcinolone (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to nystatin or corticosteroids

Pregnancy—Topical corticosteroids may be systemically absorbed; potent corticosteroids have been shown to be teratogenic in animals following topical application





Breast-feeding—Systemic corticosteroids are distributed into breast-milk and may cause growth suppression in the infant; topical corticosteroids may be systemically absorbed





Use in children—Children may absorb a proportionately larger amount of topical corticosteroid than adults, making them more susceptible to HPA axis suppression and Cushing's syndrome

Other medical problems, especially Herpes simplex; tubercular infections of the skin; vaccinia, eczema vaccinatum, varicella, or other viral infections of the skin

Proper use of this medication
» Not for ophthalmic use {16} {25}

» Checking with physician before using medication on other skin problems

Applying a thin layer of medication to affected area and rubbing in gently and thoroughly

» Not applying occlusive dressing over this medication unless directed to do so by physician; wearing loose-fitting clothing when using on inguinal area; avoiding tight-fitting diapers and plastic pants on diaper area of children {16} {25}

» Compliance with full course of therapy; not using more often or longer than directed by physician; excessive use on thin skin areas may result in skin atrophy and stretch marks

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

Precautions while using this medication
» Using hygienic measures to cure infection or prevent reinfection; keeping affected area as cool and dry as possible {10}

Checking with physician if no improvement within 2 or 3 weeks {10}

» May be more likely to cause systemic toxicity in children; chronic use may interfere with growth and development also; having children closely monitored by their physician

» Diabetics: May rarely {10} cause hyperglycemia and glucosuria; checking with physician before changing diet or dosage of antidiabetic medication


Side/adverse effects
Side effects more likely to occur in children

Signs of potential side effects, especially hypersensitivity; acne or oily skin; increased hair growth especially on the face; increased loss of hair, especially on the scalp; reddish purple lines on arms, face, legs, trunk, or groins; skin atrophy


General Dosing Information
Therapeutic efficacy of the corticosteroid depends on drug release from the vehicle, solubilization of the drug at the skin surface, and its subsequent percutaneous absorption through the outer barrier layer of the epidermis (stratum corneum) so that it can reach the site of action in the living epidermis and/or the dermis.

Factors influencing product selection include skin hydration, site, severity, age, whether the lesion is moist or dry, and the method of application.

This medication contains an intermediate-potency corticosteroid that is fluorinated and has a substituted 17-hydroxyl group.

Fluorinated corticosteroids containing substituted 17-hydroxyl groups are resistant to local metabolism in the skin. Repeated application results in a cumulative depot effect in the skin, which may lead to a prolonged duration of action, increased side effects, and increased risk of systemic absorption.

When this medication is used in the treatment of candidiasis, occlusive dressings should be avoided since they provide conditions that favor growth of yeast and release of its irritating endotoxin. {25} An oleaginous ointment, a thin film of polyethylene, bandage, tight-fitting diaper, plastic pants, or tape may constitute an occlusive dressing.

Nystatin and triamcinolone acetonide combination should be discontinued if symptoms persist after 25 days of therapy. {01} {02} {03} {04} {05} {25}


Topical Dosage Forms

NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM USP

Usual adult and adolescent dose
Antifungal
Topical, to the skin, two times a day, morning and evening. {01} {02} {03} {04} {05} {16}


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


100,000 Units of nystatin and 1 mg of triamcinolone acetonide per gram [Dermacomb] [Myco II] [Mycobiotic II] [Mycogen II] [Mycolog II] [Myco-Triacet II] [Mykacet II] [Mytrex] [Tristatin II][Generic]{12}{13}{14}{15}{16}{17}{19}{20}{21}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.
   • Do not use in or around the eyes.


NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT USP

Usual adult and adolescent dose
Antifungal
Topical, to the skin, two or three times a day. {01} {02} {03} {04} {05} {25}


Usual pediatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


100,000 Units of nystatin and 1 mg of triamcinolone acetonide per gram [Myco II] [Mycobiotic II] [Mycogen II] [Mycolog II] [Myco-Triacet II] [Mykacet] [Mytrex] [Tristatin II][Generic]{12}{13}{14}{15}{16}{17}{18}{20}{21}{25}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.
   • Do not use in or around the eyes.

Additional information:
Petrolatum-base ointments may be more occlusive and may cause increased absorption.



Revised: 08/15/1994



References
  1. Mycolog-II package insert (Squibb—US), Rev 5/85, Rec 9/85.
  1. Myco-Triacet II package insert (Lemmon—US), Rec 6/85, Rec 3/86.
  1. Nystatin and Triamcinolone package insert (Clay-Park—US), Rev 9/85, Rec 11/85.
  1. Mytrex F package insert (Savage—US), Rev 5/85, Rec 4/86.
  1. Mykacet package insert (NMC—US), Rev 2/86, Rec 5/86.
  1. Hold
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  1. Panel comments, 7/86.
  1. VA Medication Classification System, USP DI 1989: 2472.
  1. Nystatin/Triamcinolone (various). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 520.
  1. Myco II (Bioline). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 490.
  1. Mycobiotic II(Moore). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 490.
  1. Mycogen II (Goldline). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 490.
  1. Mycolog II package insert (Squibb—US), Rev 4/87, Rec 3/89.
  1. Myco-Triacet II (Gen-King). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 491.
  1. Mykacet (Major). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 492.
  1. Mykacet II (Tex Drug Reps). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 492.
  1. Mytrex (Savage). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 493.
  1. Tristatin II(Rugby). In: Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 706.
  1. Fleeger CA, editor. USAN 1989. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1988: 396, 567.
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  1. Nystatin and Triamcinolone Acetonide ointment package insert (Bausch and Lomb—US), Rev 9/91, Rec 8/93.
  1. Mycolog II cream package insert (Squibb—US), Rev /88, Rec 7/93.
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