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  • CLASSES

    Combinations of Corticosteroids with Antibacterials
    Combinations of Corticosteroids with Antibacterials and Antifungals
    Combinations of Corticosteroids with Antifungals

    DEA CLASS

    Rx

    DESCRIPTION

    Nystatin and triamcinolone are used together topically for short-term (< 2 weeks) treatment of candidal skin infections. Nystatin is an antifungal agent and triamcinolone is a corticosteroid used for its antiinflammatory, vasoconstrictive, and antipruritic properties. Compared to nystatin or triamcinolone alone, the combination has been shown to provide faster and more pronounced clearing of erythema and pruritus, especially in the first few days of treatment.

    COMMON BRAND NAMES

    Myco-Triacet-II, Mycogen-II, Mycolog II, Mytrex, N.T.A.

    HOW SUPPLIED

    Mycogen-II/Mycolog II/Mytrex/Nystatin, Triamcinolone/Nystatin, Triamcinolone Acetonide Topical Ointment: 100000-0.1%, 100000-1mg
    Mycogen-II/Myco-Triacet-II/Mytrex/N.T.A./Nystatin, Triamcinolone/Nystatin, Triamcinolone Acetonide Topical Cream: 100000-0.1%

    DOSAGE & INDICATIONS

    For the short-term (i.e., less than 2 weeks) treatment of inflammatory cutaneous candidiasis caused by Candida albicans and other Candida sp..
    Topical dosage (cream or ointment)
    Adults, Adolescents, Children, and Infants >= 2 months

    Apply sparingly as a thin film to the affected skin twice daily, morning and evening.

    MAXIMUM DOSAGE

    Adults

    No maximum dosage information is available.

    Elderly

    No maximum dosage information is available.

    Adolescents

    No maximum dosage information is available.

    Children

    No maximum dosage information is available.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment is needed.

    Renal Impairment

    No dosage adjustment is needed.

    ADMINISTRATION

    Topical Administration

    For topical dermatologic use only. Not for ophthalmic, oral, or intravaginal use.
    Wash hands before and after application. Use gloves if required by universal precautions. Apply sparingly in a thin film and rub gently into affected area(s) of clean, dry skin. Restrict application to the affected areas and try to avoid normal surrounding skin.
    Patients who fail to respond to topical treatment after 1—4 weeks should be re-evaluated.
    Topical preparations containing steroids generally should not be used with occlusive dressings. Instruct patients not to bandage, cover, or wrap area in any way that may be occlusive, unless directed by prescriber.

    Cream/Ointment/Lotion Formulations

    The amount of cream needed to cover a certain skin area can be calculated. A 1 g application of cream covers 100 cm2 of skin. The entire skin surface of the average size adult will be covered by 30 g of topical cream.

    STORAGE

    Generic:
    - Protect from freezing
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Mycogen-II:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Mycolog II:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Myco-Triacet-II:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Mytrex:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    N.T.A.:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Cushing's syndrome, hypothalamic-pituitary-adrenal (HPA) suppression, occlusive dressing

    Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which increase systemic absorption include application of high-potency corticosteroids, use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted, and the use of an occlusive dressing. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids. Nystatin; triamcinolone topical preparations should not be used with occlusive dressings.

    Children, infants

    Nystatin; triamcinolone has been used in infants as young as 2 months of age. Children and infants may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, and therefore are more susceptible to developing systemic toxicity. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Chronic corticosteroid therapy in children may also interfere with growth and development.

    Pregnancy

    There are no adequate and well-controlled studies regarding use of nystatin; triamcinolone topical formulations during human pregnancy, and it is unknown if the drug causes fetal harm or affect reproductive capacity. Some potent topical corticosteroids have been shown to be teratogenic in laboratory animals; therefore, the drug should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Administer during pregnancy only if the benefit to the mother justifies the potential risk to the infant.

    Breast-feeding

    Although corticosteroids are known to be excreted in breast milk, data regarding use of nystatin; triamcinolone during breast-feeding are limited. Recommendations from the American Academy of Pediatrics (AAP) on the use of triamcinolone in lactating women are not available; however, the AAP considers other corticosteroids, such as prednisone and prednisolone, to be usually compatible with breast-feeding. The manufacturer advises caution if administering the drug to breast-feeding women. To limit a nursing infants potential exposure, instruct women not to apply on the breast immediately prior to nursing. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    Peripheral vascular disease, skin abrasion

    Topical nystatin; triamcinolone should be used with extreme caution in patients with peripheral vascular disease or other conditions causing poor circulation due to the risk of skin ulceration. Because corticosteroids can inhibit wound healing, nystatin; triamcinolone should not be used in areas of skin abrasion.

    Geriatric, skin atrophy

    Topical corticosteroid preparations including nystatin; triamcinolone, may exacerbate preexisting skin atrophy. Geriatric patients, due to the concomitant thinning of the skin that occurs with aging, may be at increased risk for this effect. It is recommended that topical corticosteroids be used with caution and under close monitoring in patients with skin atrophy. The use of lower potency topical corticosteroids may be necessary in some patients.

    Ocular exposure

    Avoid ocular exposure of nystatin; triamcinolone, If ocular exposure occurs, rinse eye thoroughly with water.

    Benzyl alcohol hypersensitivity

    Some topical preparations of nystatin; triamcinolone contain benzyl alcohol as a preservative and should not be used in patients with benzyl alcohol hypersensitivity.

    Corticosteroid hypersensitivity

    Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to triamcinolone should not receive any form of or product containing triamcinolone. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.

    ADVERSE REACTIONS

    Severe

    skin atrophy / Delayed / 1.0-10.0
    increased intracranial pressure / Early / Incidence not known

    Moderate

    contact dermatitis / Delayed / 1.0-10.0
    glycosuria / Early / Incidence not known
    hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
    hyperglycemia / Delayed / Incidence not known
    Cushing's syndrome / Delayed / Incidence not known
    superinfection / Delayed / Incidence not known

    Mild

    miliaria / Delayed / 1.0-10.0
    skin irritation / Early / 1.0-10.0
    xerosis / Delayed / 1.0-10.0
    striae / Delayed / 1.0-10.0
    folliculitis / Delayed / 1.0-10.0
    skin hypopigmentation / Delayed / 1.0-10.0
    hypertrichosis / Delayed / 1.0-10.0
    pruritus / Rapid / 1.0-10.0
    acneiform rash / Delayed / 1.0-1.0
    infection / Delayed / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Nystatin; Triamcinolone products.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no adequate and well-controlled studies regarding use of nystatin; triamcinolone topical formulations during human pregnancy, and it is unknown if the drug causes fetal harm or affect reproductive capacity. Some potent topical corticosteroids have been shown to be teratogenic in laboratory animals; therefore, the drug should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Administer during pregnancy only if the benefit to the mother justifies the potential risk to the infant.

    Although corticosteroids are known to be excreted in breast milk, data regarding use of nystatin; triamcinolone during breast-feeding are limited. Recommendations from the American Academy of Pediatrics (AAP) on the use of triamcinolone in lactating women are not available; however, the AAP considers other corticosteroids, such as prednisone and prednisolone, to be usually compatible with breast-feeding. The manufacturer advises caution if administering the drug to breast-feeding women. To limit a nursing infants potential exposure, instruct women not to apply on the breast immediately prior to nursing. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action:•Nystatin: Nystatin binds to sterols in fungal cell membranes. As a result of this binding, membrane integrity of fungal cells is impaired, causing the loss of intracellular potassium and other cellular contents. Nystatin is ineffective against bacteria because they do not contain sterols in their cell membranes. Nystatin is also ineffective against protozoa, trichomonads, and viruses.•Triamcinolone: At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.

    PHARMACOKINETICS

    Nystatin; triamcinolone is applied topically to the skin.
     
    Nystatin: Nystatin is not systemically absorbed from intact skin or mucous membranes.
    Triamcinolone: Any triamcinolone that reaches the systemic circulation is metabolized by the liver to inactive metabolites. These inactive metabolites, as well as a small portion of unchanged drug, are excreted in the urine

    Topical Route

    Triamcinolone: Bioavailability of triamcinolone following topical application is dependent on the condition of the skin at the application site. Absorption is increased in areas of skin damage, inflammation, or occlusion, or where the stratum corneum is thin such as the eyelids, genitalia, and face. Prolonged use can also lead to systemic absorption. Topically administered triamcinolone is metabolized in the skin.