Metrolotion Information
Metrolotion (Metronidazole) Description
Metrolotion (Metronidazole) (metronidazole lotion) Topical Lotion contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH.
Metronidazole is an imidazole and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1-imidazole-1-ethanol. The molecular formula is CHNO and molecular weight is 171.16. Metronidazole is represented by the following structural formula:
Metrolotion (Metronidazole) Clinical Pharmacology
The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
Metrolotion (Metronidazole) Indications And Usage
Metrolotion (Metronidazole) Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Metrolotion (Metronidazole) Clinical Studies
A controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which Metrolotion (Metronidazole) Topical Lotion was compared with its vehicle. Applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine. Patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. Metrolotion (Metronidazole) Topical Lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigators’ global assessment of improvement. The results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigators’ global assessment of improvement at week 12 are presented in the following table:
Metrolotion (Metronidazole) Contraindications
Metrolotion (Metronidazole) Topical Lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.
Metrolotion (Metronidazole) Precautions
Ultraviolet radiation-induced carcinogenesis was enhanced in albino mice by intraperitoneal infection of metronidazole at a dosage of 45 mg/m/day, 5 days per week for 10 weeks, as indicated by a decreased latency period to the development of skin neoplasms. It is unclear how this level of exposure compares to the clinical situation with respect to the concentration of the drug or metabolics in the skin. This study did not determine if metronidazole must be present during exposure to ultraviolet radiation in order to enhance tumor formation; metronidazole may promote tumor formation in cells that have previously been initiated by ultraviolet radiation.
Metronidazole exhibited mutagenic activity in several bacterial and mammalian assay systems. Intraperitoneal administration of metronidazole to mice resulted in a dosage-dependent increase in the incidence of chromosomal aberrations in peripheral lymphocytes was reported in patients with Crohn`s disease who were treated with metronidazole for 1 to 24 months at a dosage of 200 to 1200 mg/day. However, similar results were not observed in another study, in which humans were treated for 8 months.
In rats, oral metronidazole at a dosage of approximately 1800 mg/m/day (approximately 200 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of body surface area)) induced inhibition of spermatogenesis and severe testicular degeneration.
Metrolotion (Metronidazole) Adverse Reactions
In a controlled clinical trial, safety data from 141 patients who used Metrolotion (Metronidazole) Topical Lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, Metrolotion (Metronidazole) Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, Metrolotion (Metronidazole) Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, Metrolotion (Metronidazole) Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), Metrolotion (Metronidazole) Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, Metrolotion (Metronidazole) Topical Lotion 4 (6%), lotion vehicle 0; dry skin, Metrolotion (Metronidazole) Topical Lotion 0, lotion vehicle 1 (l%); and worsening of rosacea, Metrolotion (Metronidazole) Topical Lotion 1 (1%), lotion vehicle 7 (10%).
The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea.
Metrolotion (Metronidazole) Dosage And Administration
Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes.
Patients may use cosmetics after waiting for the Metrolotion (Metronidazole) Topical Lotion to dry (not less than 5 minutes).
Metrolotion (Metronidazole) How Supplied
Metrolotion (Metronidazole) (metronidazole lotion) Topical Lotion, 0.75% is supplied in the following size:
2 fl. oz. (59 mL) plastic bottle - 0299-3838-02
Protect from freezing.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAManufactured by:DPT Laboratories, Ltd.San Antonio, Texas 78215 USAGALDERMA is a registered trademark. Revised: July 2004
Metrolotion (Metronidazole) Package Label
Metrolotion (Metronidazole) (metronidazole lotion)
2 FL OZ(59 mL)
For Topical Use Only.
Not for Ophthalmic Use.
Store at controlled room temperature 68º to 77ºF (20º – 25ºC).
Protect from freezing.
See lot no. and expiration date on bottom of bottle.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAGALDERMA is a registered trademark.Manufactured by:DPT Laboratories, Ltd.San Antonio, Texas 78215 USA
326250-1209
