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Nuliza 1%Nuliza 1% cream is indicated for the topical treatment of interdigital tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.Theropeutic ClassMiscellaneous topical agentsPharmacologyNuliza 1% is an antifungal that belongs to the azole class. Although the exact mechanism of action against dermatophytes is unknown, Nuliza 1% appears to inhibitergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme?s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol.Dosage & Administration of Nuliza 1%For topical use only. Nuliza 1% Cream, 1% is not for ophthalmic, oral, or intravaginal use. When treating interdigital tinea pedis, a thin layer of Nuliza 1% Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two (2) weeks. When treating tinea cruris or tinea corporis, Nuliza 1% Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one (1) week. Dosage of Nuliza 1%Adult & Geriatric: Interdigital tinea pedis: Nuliza 1% cream should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two weeks. Tinea cruris and Tinea corporis: Nuliza 1% cream should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one week. Pediatric: Safety and effectiveness have not been established.Interaction of Nuliza 1%The potential of Nuliza 1% to inhibit cytochrome P-450 (CYP) enzymes 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated in vitro. Based on in vitro assessment, Nuliza 1% at therapeutic doses, particularly when applied to patients with moderate to severe tinea cruris, may inhibit the activity of CYP2C19 and CYP3A4.However, no in vivo drug interaction trials have been conducted to evaluate the effect of Nuliza 1% on other drugs that are substrates of CYP2C19 and CYP3A4. Nuliza 1% is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in vitro assessment. The induction potential of Nuliza 1% on CYP enzymes has not been evaluated.ContraindicationsNuliza 1% cream is contraindicated in patients with a history of hypersensitivity to Nuliza 1%.Side Effects of Nuliza 1%Contact dermatitis and cellulitis may occur. Application site reactions were observed in iess than 1% of subjects in clinical trial.Pregnancy & LactationPregnancy Category C. There are no adequate and well-controlled studies of Nuliza 1% Cream, 1% in pregnant women. Nuliza 1% Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nursing Mothers: It is not known whether Nuliza 1% is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nuliza 1% Cream, 1% is administered to women who are breastfeeding.Precautions & WarningsIf there is any unusual allergic reaction with the use of Nuliza 1%, then treatment should be discontinued and appropriate therapy should be instituted. Nuliza 1% is recommended for topical use only. It is not intended for ophthalmic, oral or intravaginal use.Storage ConditionsDo not store above 30?C. Keep away from light and out of the reach of children.Use In Special PopulationsPediatric Use: The safety and effectiveness of Nuliza 1% Cream, 1% in pediatric patients have not been established. The number of pediatric patients ? 12 years of age were too small to adequately assess safety and efficacy.Geriatric Use: Of the total number of subjects in clinical studies of Nuliza 1% Cream, 1%, 8 percent were 65 and over, while 1.4 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.Drug ClassesMiscellaneous topical agentsMode Of ActionNuliza 1% is a topical antifungal agent. It is a broad-spectrum antifungal agent that belongs to the azole group. It acts against fungus by inhibiting the enzyme lanosterol demethylase and blocks ergosterol synthesis which is an important constituent of fungal cell membrane. Thus it exerts strong fungicidal activity both in-vitro and in-vivo against dermatophytes, Candida albicans, Malassezia spp, Trichophyton and Epidermophyton spp.PregnancyThere are no adequate and well-controlled studies of Nuliza 1% cream in pregnant women. Nuliza 1% cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Nuliza 1% is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nuliza 1% cream is applied to women who are breastfeeding.