LIDEX*(fluocinonide) 0.05% Cream and Ointment
TOPSYN(ftaocinMide)
Cryo Corner Wisdom of Subsequent Biopsies
0.05% Gel Summary of prescribing information Description LIDEX cream 0.05%, LIDEX ointment 0.05% and TOPSYN gel 0.05% contain the active compound fluocinonide. Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide, has the chemical formula 6a, 9a, -difluoro-11/2,16af 17a, 21-tetrahydroxypregna-l,4-diene-3, 20-dione, cyclic 1 6 ,17-acetal with acetone 21-acetate. LIDEX cream contains fluocinonide in FAPG® cream, a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 6000, propylene glycol, 1, 2, 6-hexanetriol and citric acid. This white cream vehicle is greaseless, non-staining, anhydrous and com pletely water miscible.The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. LIDEX ointment contains fluocinonide in a specially formulated ointment base consisting of Amerchol CAB (mixture of sterols and higher alcohols), white petrolatum, propylene carbonate and propylene glycol. It provides the occlusive and emollient effects desirable in an ointment. In this formulation the active ingredient is totally in solution. TOPSYN gel contains fluocinonide in a specially formulated gel base consisting of propylene glycol, propyl gallate, disodium edetate, and Carbopol 940 (carboxypolymethylene) with NaOH and/or HCL added to adjust the pH. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water m isdble. In this formulation, the active ingredient is totally in solution.
Indications LIDEX cream and ointment and TOPSYN gel are intended for the relief of inflammatory manifestations of corticosteroid responsive dermatoses.
Contraindications Topical steroids are contraindicated in vaccinia and varicella. Topical steroids are contraindicated in those patients witn a history of hypersensitivity to any of the components of the preparation.
Precautions If irritation develops, the cream, ointment or gel should be discontinued and appropriate therapy instituted. In the presence of an infection the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid cream, ointment or gel should be discontinued until the infection has been adequately controlled. If extensive areas are treated, the possibility exists of increased systemic absorption and suitable precautions should be taken. Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use in pregnant females has not absolutely been estabhshed.Therefore, they should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time. LIDEX® (fluocinonide) cream and ointment and TOPSYN® (fluocinonide) gel are not for opthalmic use.
Adverse reactions The following local adverse reactions have been reported with topical corticosteroids: burning folliculitis itching acneform eruptions irritation hypopigmentation dryness striae secondary infection skin atrophy
Dosage and adm inistration A small amount should be gently massaged into the affected area three or four times daily, as needed.
How supplied LIDEX 0.05% Cream—15 g 30 g and 60 g tubes. LIDEX 0.05% Ointment—15 g 30 g and 60 g tubes. TOPSYN Gel 0.05% 15 g and 60 g tubes.
5
Y N TEX
SYNTEX LABORATORIES, INC. PALO ALTO, CALIFORNIA 94304
R IC H A R D F. E L T O N , M .D . Cryo Corner is a new feature we have instituted that will present original observations and clinical applications o f cryosurgical techniques o f interest to the dermatologist. We welcome submis sion o f such material fo r possible publication. A 11correspondence should be addressed to Dr. S. Zacarian, 50 Maple Street, Springfield, Ma. 01103.
N o l e s i o n suspected o f being m align an t should ever be treated w ithout an adequ ate biopsy taken either at the time o f treatm en t in nearly sure cases or well before treatm ent in uncertain cases. In cases o f large m alignant lesions or in certain histologic types o f m alignancies, such as sclerosing basal-cell epitheliom as, there is a need for a subsequent biopsy to assess the adequacy o f treatm ent. In the m atter o f cryosurgery, after the freezing o f large lesions, healing takes place in a few weeks, usually ending in a clean, hypo pig m ented scar. In our recent experience, we have h a d a n u m b e r o f recurrences o f m alignancy in such cases not only at m argins o f treated m alignancies w here they m ay be expected, b u t also u n d e r norm al-ap p earin g scars, m uch in the m an n er o f w hat m ay occur u n d e r skin grafts. This has been especially true in cases o f large, deep, p e n e trating m alignant neoplasm s and sclerosing basal-cell epitheliom as situated in places w here one is unable to freeze the tissue throug h and thro ugh like the cheeks, chin and neck. In contrast, the ears, eyelids an d nose can be easily frozen through and through. Clinically, there m ay be no signs on the surface o f the healed skin to m ake one suspect recurrence. This p h e n o m e n o n has been a disturbing finding o f late and m ay well prove to be one o f the m ore serious pitfalls in the treatm ent o f large skin cancers with cryosurgery. H ence, the need for a subsequent biopsy as a routine is obvious. E ither by scalpel or punch, deep specim ens should be taken from both the m argins o f treated areas an d from the centers. Biopsy is best done ab o u t three to six m onths after healing is-complete. A fter that, given negative findings, one should be guided by w hat one sees as suspicious in follow-up exam inations at six-m onth intervals. Even w ith a com bined technique o f electrodesiccation and curettage followed by cryosurgery, one should be highly suspicious o f the possibility o f recurrences. Cryosurgery m ay be repeated for a recurrence w ith fair expectation o f success, b u t in m any cases it is best to refer patients for treatm en t by histologically controlled m icroscopic excision. Dr. Elton is Assistant Clinical Professor, D epartm ent o f D erm atol ogy, W ayne State University, Detroit, Michigan.
TOPSYN(ftaocinMide)
Cryo Corner Wisdom of Subsequent Biopsies
0.05% Gel Summary of prescribing information Description LIDEX cream 0.05%, LIDEX ointment 0.05% and TOPSYN gel 0.05% contain the active compound fluocinonide. Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide, has the chemical formula 6a, 9a, -difluoro-11/2,16af 17a, 21-tetrahydroxypregna-l,4-diene-3, 20-dione, cyclic 1 6 ,17-acetal with acetone 21-acetate. LIDEX cream contains fluocinonide in FAPG® cream, a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 6000, propylene glycol, 1, 2, 6-hexanetriol and citric acid. This white cream vehicle is greaseless, non-staining, anhydrous and com pletely water miscible.The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. LIDEX ointment contains fluocinonide in a specially formulated ointment base consisting of Amerchol CAB (mixture of sterols and higher alcohols), white petrolatum, propylene carbonate and propylene glycol. It provides the occlusive and emollient effects desirable in an ointment. In this formulation the active ingredient is totally in solution. TOPSYN gel contains fluocinonide in a specially formulated gel base consisting of propylene glycol, propyl gallate, disodium edetate, and Carbopol 940 (carboxypolymethylene) with NaOH and/or HCL added to adjust the pH. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water m isdble. In this formulation, the active ingredient is totally in solution.
Indications LIDEX cream and ointment and TOPSYN gel are intended for the relief of inflammatory manifestations of corticosteroid responsive dermatoses.
Contraindications Topical steroids are contraindicated in vaccinia and varicella. Topical steroids are contraindicated in those patients witn a history of hypersensitivity to any of the components of the preparation.
Precautions If irritation develops, the cream, ointment or gel should be discontinued and appropriate therapy instituted. In the presence of an infection the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid cream, ointment or gel should be discontinued until the infection has been adequately controlled. If extensive areas are treated, the possibility exists of increased systemic absorption and suitable precautions should be taken. Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use in pregnant females has not absolutely been estabhshed.Therefore, they should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time. LIDEX® (fluocinonide) cream and ointment and TOPSYN® (fluocinonide) gel are not for opthalmic use.
Adverse reactions The following local adverse reactions have been reported with topical corticosteroids: burning folliculitis itching acneform eruptions irritation hypopigmentation dryness striae secondary infection skin atrophy
Dosage and adm inistration A small amount should be gently massaged into the affected area three or four times daily, as needed.
How supplied LIDEX 0.05% Cream—15 g 30 g and 60 g tubes. LIDEX 0.05% Ointment—15 g 30 g and 60 g tubes. TOPSYN Gel 0.05% 15 g and 60 g tubes.
5
Y N TEX
SYNTEX LABORATORIES, INC. PALO ALTO, CALIFORNIA 94304
R IC H A R D F. E L T O N , M .D . Cryo Corner is a new feature we have instituted that will present original observations and clinical applications o f cryosurgical techniques o f interest to the dermatologist. We welcome submis sion o f such material fo r possible publication. A 11correspondence should be addressed to Dr. S. Zacarian, 50 Maple Street, Springfield, Ma. 01103.
N o l e s i o n suspected o f being m align an t should ever be treated w ithout an adequ ate biopsy taken either at the time o f treatm en t in nearly sure cases or well before treatm ent in uncertain cases. In cases o f large m alignant lesions or in certain histologic types o f m alignancies, such as sclerosing basal-cell epitheliom as, there is a need for a subsequent biopsy to assess the adequacy o f treatm ent. In the m atter o f cryosurgery, after the freezing o f large lesions, healing takes place in a few weeks, usually ending in a clean, hypo pig m ented scar. In our recent experience, we have h a d a n u m b e r o f recurrences o f m alignancy in such cases not only at m argins o f treated m alignancies w here they m ay be expected, b u t also u n d e r norm al-ap p earin g scars, m uch in the m an n er o f w hat m ay occur u n d e r skin grafts. This has been especially true in cases o f large, deep, p e n e trating m alignant neoplasm s and sclerosing basal-cell epitheliom as situated in places w here one is unable to freeze the tissue throug h and thro ugh like the cheeks, chin and neck. In contrast, the ears, eyelids an d nose can be easily frozen through and through. Clinically, there m ay be no signs on the surface o f the healed skin to m ake one suspect recurrence. This p h e n o m e n o n has been a disturbing finding o f late and m ay well prove to be one o f the m ore serious pitfalls in the treatm ent o f large skin cancers with cryosurgery. H ence, the need for a subsequent biopsy as a routine is obvious. E ither by scalpel or punch, deep specim ens should be taken from both the m argins o f treated areas an d from the centers. Biopsy is best done ab o u t three to six m onths after healing is-complete. A fter that, given negative findings, one should be guided by w hat one sees as suspicious in follow-up exam inations at six-m onth intervals. Even w ith a com bined technique o f electrodesiccation and curettage followed by cryosurgery, one should be highly suspicious o f the possibility o f recurrences. Cryosurgery m ay be repeated for a recurrence w ith fair expectation o f success, b u t in m any cases it is best to refer patients for treatm en t by histologically controlled m icroscopic excision. Dr. Elton is Assistant Clinical Professor, D epartm ent o f D erm atol ogy, W ayne State University, Detroit, Michigan.
