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)

pella pharmaceutical co. ltd - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r), fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m), hydroquinone (unii: xv74c1n1ae) (hydroquinone - unii:xv74c1n1ae) - triderma is indicated for the short-term intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. triderma is contraindicated in individuals with a history of hypersensitivity, allergy, or intolerance to this product or any of its components.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - fluocinolone acetonide; hydroquinone; tretinoin -

Singapore - English - HSA (Health Sciences Authority)

galderma singapore private limited - fluocinolone acetonide; hydroquinone; tretinoin - cream - 0.1 mg/g - fluocinolone acetonide 0.1 mg/g; hydroquinone 40 mg/g; tretinoin 0.5 mg/g

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

sincerus florida, llc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m), minoxidil (unii: 5965120sh1) (minoxidil - unii:5965120sh1), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) -

Kenya - English - Pharmacy and Poisons Board

la pristine bioceuticals pvt. ltd. a-23, sector 9, noida up-201 301 - hydroquinone, tretinoin & fluocinolone acetonide… - cream - hydroquinone usp 4.000% w/w tretinoin usp … - gamolenic acid combinations

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

physicians total care, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 118.28 ml - fluocinolone acetonide 0.01% topical oil is indicated for the topical treatment of atopic dermatitis in adult patients. fluocinolone acetonide 0.01% topical oil is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. safety and effectiveness in pediatric patients younger than 3 months of age have not been established. apply the least amount of fluocinolone acetonide 0.01% topical oil needed to cover the affected areas. as with other corticosteroids, fluocinolone acetonide 0.01% topical oil should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. fluocinolone acetonide 0.01% topical oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. fluocinolone acetonide 0.01% topical oil should not be used on the face, axillae, or groin unless directed by the physician.  application to intertriginous areas should be avoided due

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

rising pharmaceuticals, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 1 ml - fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. safety and effectiveness in pediatric patients younger than 3 months of age have not been established. apply the least amount of fluocinolone acetonide topical oil, 0.01% needed to cover the affected areas. as with other corticosteroids, fluocinolone acetonide topical oil, 0.01% should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. application to intertriginous areas should be avo

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

taro pharmaceuticals u.s.a., inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 118.28 ml - fluocinolone acetonide topical oil is indicated for the topical treatment of atopic dermatitis in adult patients. fluocinolone acetonide topical oil is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. safety and effectiveness in pediatric patients younger than 3 months of age have not been established. apply the least amount of fluocinolone acetonide topical oil needed to cover the affected areas. as with other corticosteroids, fluocinolone acetonide topical oil should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. fluocinolone acetonide topical oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. fluocinolone acetonide topical oil should not be used on the face, axillae, or groin unless directed by the physician. application to intertriginous areas should be avoided due to the increased risk of local adver

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

amneal pharmaceuticals llc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 118.28 ml - fluocinolone acetonide 0.01% topical oil is a low to medium potency corticosteroid indicated: in adult patients for the treatment of psoriasis of the scalp (scalp oil). fluocinolone acetonide 0.01% topical 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 section).