Mycogen-II

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

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.

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.

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

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

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

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

Rx

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.

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

No dosage adjustment is needed.

No dosage adjustment is needed.

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

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%

No maximum dosage information is available.

No maximum dosage information is available.

No maximum dosage information is available.

No maximum dosage information is available.

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.

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

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.

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.