Linked Life Data

Finacea (Gel)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1531

Statements in which the resource exists as a subject.
PredicateObject
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Finacea (Gel)
dailymed-instance:dosage
A thin layer of FINACEA Gel, 15%, should be gently massaged into the affected areas on the face twice daily, in the morning and evening. Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.
dailymed-instance:descripti...
FINACEA (azelaic acid) Gel, 15%, contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid, with the molecular formula CHO, a molecular weight of 188.22, and the structural formula: Azelaic acid is a white, odorless crystalline solid that is poorly soluble in water at 20��C (0.24%), but freely soluble in boiling water and in ethanol. Each gram of FINACEA Gel, 15%, contains 0.15 gm azelaic acid (15% w/w) as the active ingredient in an aqueous gel base containing benzoic acid (as a preservative), disodium-EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.
dailymed-instance:clinicalP...
The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.<br/>Pharmacokinetics:: The percutaneous absorption of azelaic acid after topical application of FINACEA Gel, 15%, could not be reliably determined. Mean plasma azelaic acid concentrations in rosacea patients treated with FINACEA Gel, 15%, twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL. These values are within the maximum concentration range of 24.0 to 90.5 ng/mL observed in rosacea patients treated with vehicle only. This indicates that FINACEA Gel, 15%, does not increase plasma azelaic acid concentration beyond the range derived from nutrition and endogenous metabolism. In vitro and human data suggest negligible cutaneous metabolism ofH-azelaic acid 20% cream after topical application. Azelaic acid is mainly excreted unchanged in the urine, but undergoes some��-oxidation to shorter chain dicarboxylic acids.
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dailymed-instance:contraind...
FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.
dailymed-instance:supply
FINACEA' Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 10922-825-02 Storage Store at 25��C (77��F); excursions permitted between 15-30��C (59-86��F) [See USP Controlled Room Temperature]. Distributed under license; U.S. Patent No 4,713,394 ��2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870
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dailymed-instance:precautio...
General:: Contact with the eyes should be avoided. If sensitivity or severe irritation develops with the use of FINACEA Gel, 15%, treatment should be discontinued and appropriate therapy instituted.<br/>Information For Patients: Patients using FINACEA Gel, 15%, should receive the following information and instructions:<br/>Drug interactions:: There have been no formal studies of the interaction of FINACEA Gel, 15%, with other drugs.<br/>Carcinogenesis, mutagenesis, impairment of fertility:: Long-term animal studies have not been performed to evaluate the carcinogenic potential of FINACEA Gel, 15%. Azelaic acid was not mutagenic or clastogenic in a battery of in vitro (Ames assay, HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration assay in human lymphocytes) and in vivo (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests. Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area) did not affect fertility or reproductive performance in male or female rats.<br/>Pregnancy::<br/>Teratogenic effects:<br/>Nursing mothers:: Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid concentration of 25��g/mL, the milk/ plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose of azelaic acid cream, 20%, is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when FINACEA Gel, 15%, is administered to a nursing mother.<br/>Pediatric use:: Safety and effectiveness of FINACEA Gel, 15%, in pediatric patients have not been established.<br/>Geriatric use:: Clinical studies of FINACEA Gel, 15%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
dailymed-instance:overdosag...
FINACEA Gel, 15%, is intended for cutaneous use only. If pronounced local irritation occurs, patients should be directed to discontinue use and appropriate therapy should be instituted (See PRECAUTIONS).
dailymed-instance:genericMe...
azelaic acid
dailymed-instance:fullName
Finacea (Gel)
dailymed-instance:adverseRe...
Overall, treatment related adverse events, including burning, stinging/ tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1% (9/127) for the active comparator gel at 15 weeks. In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored in 788 patients who used twice daily FINACEA Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks FINACEA Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical studies, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies. In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis. Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye (see PRECAUTIONS).
dailymed-instance:warning
FINACEA Gel, 15%, is for dermatologic use only, and not for ophthalmic, oral or intravaginal use. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation.
dailymed-instance:indicatio...
FINACEA Gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing.
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dailymed-instance:name
Finacea