United States - English - NLM (National Library of Medicine)

bryant ranch prepack - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide topical oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions section).

United States - English - NLM (National Library of Medicine)

galderma laboratories, l.p. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m), hydroquinone (unii: xv74c1n1ae) (hydroquinone - unii:xv74c1n1ae), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - fluocinolone acetonide 0.1 mg in 1 g - tri-luma cream is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. tri-luma cream is not indicated for the maintenance treatment of melasma. after achieving control with tri-luma cream, some patients may be managed with other treatments instead of triple therapy with tri-luma cream. melasma usually recurs upon discontinuation of tri-luma cream. the safety and efficacy of tri-luma cream in patients of fitzpatrick skin types v and vi have not been studied. excessive bleaching resulting in undesirable cosmetic effect in patients with darker skin cannot be excluded. the safety and efficacy of tri-luma cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied. because pregnant and lactating women were excluded from, and women of childbearing potential had to use birth control measures in the clinical trials, the safety and efficacy of tri-luma cream in pregnant women and nursing mothers have not been established [see use in specific populations (8.1, 8.3)]. tri-luma cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women. tri-luma cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. tri-luma cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. in clinical trials involving tri-luma cream in the treatment of facial melasma, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. however, 13 women became pregnant during treatment with tri-luma cream. most of the pregnancy outcomes are unknown. three women gave birth to apparently healthy babies. one pregnancy was terminated prematurely, and another ended in miscarriage. in general, use of drugs should be reduced to a minimum in pregnancy. if a patient has been inadvertently exposed to tri-luma cream in pregnancy, she should be counseled on the risk of teratogenesis due to this exposure. the risk of teratogenesis due to topical exposure to tri-luma cream may be considered low. however, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy. tretinoin is considered to be highly teratogenic upon systemic administration. animal reproductive studies are not available with topical hydroquinone. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. • in a dermal application study using tri-luma cream in pregnant rabbits, there was an increase in the number of in utero deaths and a decrease in fetal weights in litters from dams treated topically with the drug product. • in a dermal application study in pregnant rats treated with tri-luma cream during organogenesis there was evidence of teratogenicity of the type expected with tretinoin. these morphological alterations included cleft palate, protruding tongue, open eyes, umbilical hernia, and retinal folding or dysplasia. • in a dermal application study on the gestational and postnatal effects of a 10-fold dilution of tri-luma cream in rats, an increase in the number of stillborn pups, lower pup body weights, and delay in preputial separation were observed. an increase in overall activity was seen in some treated litters at postnatal day 22 and in all treated litters at five weeks, a pattern consistent with effects previously noted in animals exposed in utero with retinoic acids. no adequate study of the late gestational and postnatal effects of the full-strength tri-luma cream has been performed. • it is difficult to interpret these animal studies on teratogenicity with tri-luma cream, because the availability of the dermal applications in these studies could not be assured, and comparison with clinical dosing is not possible. corticosteroids, when systemically administered, appear in human milk. it is not known whether topical application of tri-luma cream could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide, hydroquinone, or tretinoin in human milk. because many drugs are secreted in human milk, caution should be exercised when tri-luma cream is administered to a nursing woman. care should be taken to avoid contact between the infant being nursed and tri-luma cream. safety and effectiveness of tri-luma cream in pediatric patients have not been established. clinical studies of tri-luma cream did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

United States - English - NLM (National Library of Medicine)

medimetriks pharmaceuticals, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.1 mg in 1 ml - synalar® solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

United States - English - NLM (National Library of Medicine)

royal pharmaceuticals - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 1 ml - dermotic® oil is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions).

United States - English - NLM (National Library of Medicine)

bausch & lomb incorporated - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.59 mg - retisert ® is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. surgical placement of retisert is contraindicated in active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye. no adequate animal reproduction studies have been conducted with fluocinolone acetonide. corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. fluocinolone acetonide when administered subcutaneously at a dose of 0.13 mg/kg/day (approximately 10,000 times the daily clinical dose of retisert), during days 6 to 18 of pregnancy in the rabbit, induced abortion at the end of the third and at the beginning of the fourth gestational week. when administered subcutaneously to rats and rabbits during gestation at a maternal toxic dose of 50 mcg/kg/day (approximately 4,000 times the clinical dose of retisert), fluocinolone acetonide caused abortions and malformations in a few surviving fetuses. there are no adequate and well-controlled studies in pregnant women. retisert should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. caution should be exercised when retisert is implanted in a nursing woman. safety and effectiveness in pediatric patients below the age of 12 years have not been established. no overall differences in safety and effectiveness have been observed between elderly and younger patients.

United States - English - NLM (National Library of Medicine)

medimetriks pharmaceuticals, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.25 mg in 1 g - synalar® cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

reig jofre uk ltd - clioquinol; fluocinolone acetonide - cutaneous cream - 30mg/1gram ; 250microgram/1gram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

reig jofre uk ltd - neomycin sulfate; fluocinolone acetonide - cutaneous cream - 5mg/1gram ; 250microgram/1gram

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

arpimed llc - fluocinolone acetonide - ointment for external use - 0,25mg/g

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

arpimed llc - fluocinolone acetonide - ointment for external use - 0,25mg/g