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REFISSA
Overview
What is REFISSA?
What does REFISSA look like?
What are the available doses of REFISSA?
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What should I talk to my health care provider before I take REFISSA?
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How should I use REFISSA?
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What interacts with REFISSA?
This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.
What are the warnings of REFISSA?
There are no adequate and well-controlled studies of fluconazole in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg. A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If this drug is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus (see ).
Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Refissa. Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Refissa. Patients with sunburn should be advised not to use Refissa until fully recovered. Patients who may have considerable sun exposure, e.g., due to their occupation and those patients with inherent sensitivity to sunlight, should exercise particular caution when using Refissa and assure that the precautions outlined in the Patient Package Insert are observed.
Tretinoin should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily, or discontinue use altogether.
Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with caution in patients with this condition.
Application of larger amounts of medication than recommended will not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.
- Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic long-term use are not known. There is evidence of atypical changes in melanocytes and keratinocytes, and of increased dermal elastosis in some patients treated with Tretinoin Cream, USP (Emollient) 0.05% for longer than 48 weeks. The significance of these findings is unknown.
- Safety and effectiveness of Refissa in individuals with moderately or heavily pigmented skin have not been established.
- Refissa should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
What are the precautions of REFISSA?
General
Refissa [Tretinoin Cream, USP (Emollient) 0.05%] should only be used as an adjunct to a comprehensive skin care and sun avoidance program. (See section.)
If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use of Refissa should be discontinued.
Weather extremes, such as wind or cold, may be more irritating to patients using Refissa.
Information for Patients
See Patient Package Insert.
Drug Interactions
Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with Refissa [Tretinoin Cream, USP (Emollient) 0.05%] because they may increase irritation with Refissa.
Refissa should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a lifetime dermal study in CD-1 mice at 100 and 200 times the average recommended human topical clinical dose, a few skin tumors in the female mice and liver tumors in male mice were observed. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when tretinoin was administered topically at a dose 5 times the average recommended human topical clinical dose. For purposes of comparisons of the animal exposure to the human exposure, the “recommended human topical clinical dose” is defined as 500 mg of Refissa applied daily to a 50 kg person.
In a chronic, two-year bioassay of Vitamin A acid in mice performed by Tsubura and Yamamoto, generalized amyloid deposition was reported in all groups in the basal layer of the Vitamin A treated skin. In CD-1 mice, a similar study reported hyalinization of the treated skin sites and the incidence of this finding was 0/50, 3/50, and 2/50 in male mice and 1/50, 0/50, 4/50 and 2/50 in female mice from the vehicle control, 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg groups, respectively.
Studies in hairless albino mice suggest that tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. In other studies, when lightly pigmented hairless mice treated with tretinoin were exposed to carcinogenic doses of UVB light, the incidence and rate of development of skin tumors were either reduced or no effect was seen. Due to significantly different experimental conditions, no strict comparison of these disparate data is possible at this time. Although the significance of these studies in humans is not clear, patients should minimize exposure to sun.
The mutagenic potential of tretinoin was evaluated in the Ames assay and in the mouse micronucleus assay, both of which were negative.
Dermal Segment l and III studies with Tretinoin Cream, USP (Emollient) 0.05% have not been performed in any species. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (>400 times the average human topical clinical dose).
Pregnancy
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Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Refissa is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in patients less than 18 years of age have not been established.
Geriatric Use
Safety and effectiveness in individuals older than 50 years of age have not been established.
What are the side effects of REFISSA?
(See and sections.)
In double-blind, vehicle-controlled studies involving 179 patients who applied Tretinoin Cream, USP (Emollient) 0.05% to their faces, adverse reactions associated with the use of Tretinoin Cream, USP (Emollient) 0.05% were limited primarily to the skin. During these trials, 4% of patients had to discontinue use of Tretinoin Cream, USP (Emollient) 0.05% because of adverse reactions. These discontinuations were due to skin irritation or related cutaneous adverse reactions.
Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy with Tretinoin Cream, USP (Emollient) 0.05%. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. In most patients the dryness, peeling, and redness recurred after an initial (24 week) decline.
What should I look out for while using REFISSA?
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What might happen if I take too much REFISSA?
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How should I store and handle REFISSA?
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Clinical Information
Chemical Structure
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Non-Clinical Toxicology
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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