TRI-LUMA- fluocinolone acetonide, hydroquinone, and tretinoin cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M), HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Dostupno od:

Galderma Laboratories, L.P.

INN (International ime):

FLUOCINOLONE ACETONIDE

Sastav:

FLUOCINOLONE ACETONIDE 0.1 mg in 1 g

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

TRI-LUMA Cream is light yellow in color, and supplied in 30 g aluminum tubes, NDC 0299-5950-30. Storage:   Keep tightly closed. Store in a refrigerator, 2° - 8°C (36° - 46°F). Protect from freezing.

Status autorizacije:

New Drug Application

Svojstava lijeka

TRI-LUMA- FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN CREAM
GALDERMA LABORATORIES, L.P.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRI-LUMA CREAM SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRI-LUMA CREAM.
TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, TRETINOIN) CREAM,
0.01%/4%/0.05% FOR
TOPICAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
Apply a thin film to the affected area once daily, at least 30 minutes
before bedtime. (2)
During the day, use a sunscreen of SPF 30, and wear protective
clothing. Avoid sunlight exposure. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 0.01%/4%/0.05%. Each gram of TRI-LUMA Cream contains 0.1 mg of
fluocinolone acetonide, 40
mg of hydroquinone, and 0.5 mg of tretinoin. (3)
CONTRAINDICATIONS
TRI-LUMA Cream is contraindicated in individuals with a history of
hypersensitivity to this product or any
of its components. (4)
WARNINGS AND PRECAUTIONS
TRI-LUMA Cream contains sodium metabisulfite, a sulfite that may cause
allergic-type reactions
including anaphylactic symptoms and life-threatening asthmatic
episodes in susceptible people. If
anaphylaxis, asthma or other clinically significant hypersensitivity
reaction occurs, institute appropriate
therapy and discontinue TRI-LUMA. (5.1)
TRI-LUMA Cream contains hydroquinone, which may produce exogenous
ochronosis, a gradual blue-
black darkening of the skin, the occurrence of which should prompt
discontinuation of therapy. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 5%) are erythema,
desquamation, burning, dryness,
pruritus, and acne. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS