PIMPLES DON'T ALWAYS MEAN ACNE. You could have rosacea. Do you flush easily when you eat spicy foods or drink alcohol? Or does your face stay red for a long time, like a sunburn? Or have you noticed any broken blood vessels (spider veins) on your face? If so, maybe those pimples are really rosacea. Rosacea needs a doctor's care. Although over-the-counter medications may help breakouts temporarily, some can make things worse. And left untreated, rosacea often progresses — more broken blood vessels appear and noses can swell with excess tissue growth. So please, don't wait — talk to a dermatologist today. During clinical trials, at the recommended dosage, some patients experienced side effects such as watery eyes (when gel was applied too close), temporary redness, mild dryness, burning, and/or skin irritation. None of the side effects exceeded an incidence of 2% of patients. Ask a dermatologist about.. MetroBel (metronidazole topical gel) Topical Gel, 0.75% PRESCRIPTION-ONLY THERAPY FOR ROSACEA For a FREE helpful booklet, please call (toll-free): 1-800-432-4893 Please see this page for important product information. Brief Summary MetroGel. For more information or a free brochure about robctcea, write to: GALPERMA Laboratories, Inc. I P.O. Box331329 ' Fort Worth, TX 76163 FOR TOPICAL USE ONLY < NOT TOR OPHTHALMIC USE) CLINICAL PHARMACOLOGY The mechanisms by which METROGEL acts In reducing Inflammatory lesions of rosacea are unknown, but may Include an anti-bacterial and/or anti- inflammatory effect. INDICATIONS AND USAGE METROGEL Is Indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. CONTRAINDICATIONS METROGEL Is contraindlcated in individuals with a history of hypersensitivity to metronidazole, parabens, or other Ingredients of the formulation. PRECAUTIONS Because of the minimal absorption of metronidazole and consequently Its Insignificant plasma concentration after topical administration, the adverse experiences reported with the oral form of the drug have not been reported with METROGEL General METROGEL has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently, discontinue use temporarily, or discontinue use until further instructions. Metronidazole is a nitrolmldazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. Drug Interactions Drug interactions are less likely with topical administration but should be kept In mind when METROGEL Is prescribed for patients who are receiving anticoagulant treatment. Oral metronidazola has been reported to potentials the anticoagulant effect of coumarln and warfarin resulting in prolongation of prolhrombln lime. Carclnogerwds: Tumorigenldty In Rodent* Metronidazole has shown evidence of carcinogenic activity in a number of studies Involving chronic, oral administration in mice and rats but not In studies Involving hamsters. These studies have not been conducted with 0.75% meUonldazole gel, which would result in significantly lower systemic blood levels than oral formulations. Mutaganfctty Studlw Although metronidazole has shown mutagenlc activity In a number of in vitro bacterial assay systems, studies In mammals (in vivo) have failed to demonstrate a potential for genetic damage. Pregnancy: Pregnancy Category B There has been no experience to dale with the use ol METROGEL in pregnant patients. Metronidazola crosses the placental barrier and enters the fetal circulation rapidly. No letotoxlcity was observed after oral metronidazole In rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Even though METROGEL blood levels are significantly lower than those achieved after oral metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking Into account the importance of the drug to the mother. Pedlatric Use Safety and effectiveness In children have not been established. ADVERSE REACTIONS Adverse conditions reported Include watery (tearing) eyes it the gel is applied too closely to this area, transient redness, and mild dryness, burning, and skin irritation. None of the side effects exceeded an incidence of 2% of patients. OVERDOSAGE There Is no human experience with over- dosage of METROGEL. The acute oral toxicity of the METROGEL formulation was determined to be greater than 5 g/kg (the highest dose given) In albino rats. DOSAQE and ADMINISTRATION Apply and rub In a thin film ol METROGEL twice dally, morning and evening, to entire affected areas after washing. Significant therapeutic results should be noticed within three weeks. Clinical studies have demonstrated continuing Improvement through nine weeks ol therapy. Areas to be treated should be cleansed before application of METROGEL Patients may use cosmetics after application ol METROGEL HOW SUPPLIED METROGEL topical gel (0.75% metronida- zole) is supplied In a 1 oz. (28.4 g) aluminum tube — NOC 02993835-28 and a 45 g aluminum tube — NDC 0289-3835-45. Caution. Federal law prohibits dispensing without a prescription. Consult package insert lor full disclosure. Package insert revised B/95. Marketed by: GALDERMA Laboratories, Inc. v/iit P.O. Box 331329 '""' Fort Worth, TX 76163 USA Manufactured by: DPT Laboratories, Inc. San Antonio, Texas 76215 USA GALDERMA is a registered trademark Revised: July 1996 1<J9(> Gaklerma Laboratories, Inc.
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