Metronidazole Topical Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol.
Metronidazole IP 2 %
Gel
For Derma Care
Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
Topical metronidazole 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
or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with
evidence of, or history of blood dyscrasia.
Information for patients:
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
Use this medication on the skin only. Wash and dry your hands before and after applying this medication. Wash and dry the area to be treated. Wait 15 minutes, then apply a thin layer of medication as directed by your doctor, usually once or twice daily. Wait 5 minutes before applying cosmetics. Avoid using this medication around the eye area, unless directed by your doctor. Watery eyes or tearing of the eyes may occur if this medication is applied too close to the eyes. Avoid getting this medication in your eyes. If this occurs, rinse your eyes with large amounts of cool water. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.