Application Nr Approved Date Route Status External Links
ANDA077197 2006-05-24 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Metronidazole Topical Lotion Is Indicated For Topical Application In The Treatment Of Inflammatory Papules And Pustules Of Rosacea. Clinical Studies A Controlled Clinical Study Was Conducted In 144 Patients With Moderate To Severe Rosacea, In Which 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. Metronidazole Topical Lotion Was Significantly More Effective Than Its Vehicle In Mean Percent Reduction Of Inflammatory Lesions Associated With Rosacea And In The Investigator's 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: Efficacy Outcomes At Week 12 Mean Percent Reduction In Inflammatory Lesion Counts From Baseline Metronidazole Topical Lotion N=65 Vehicle Lotion N=60 55% 20% Investigators' Global Assessment Of Improvement (percent Change From Baseline) Worse No Change Minimal Improvement Definite Improvement Marked Improvement Clear Metronidazole Topical Lotion N=65 5% 12% 11% 32% 32% 8% Vehicle Lotion N=60 15% 27% 23% 15% 20% 0% The Scale Is Based On The Following Definitions: Worse: Exacerbation Of Either Erythema Or Quantitative Assessment Of Papules And/or Pustules. No Change: Condition Remains The Same. Minimal Improvement: Slight Improvement In The Quantitative Assessment Of Papules And/or Pustules, And/or Slight Improvement In Erythema. Definite Improvement: More Pronounced Improvement In The Quantitative Assessment Of Papules And/or Pustules, And/or More Pronounced Improvement In Erythema. Marked Improvement: Obvious Improvement In The Quantitative Assessment Of Papules And/or Pustules, And/or Obvious Improvement In Erythema. Clear: No Papules Or Pustules And Minimal Residual Or No Erythema.

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) Unresolved
2. Cyclomethicone CYCLOMETHICONE Molecular
3. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
5. Light Mineral Oil LIGHT MINERAL OIL Unresolved
6. Peg-100 Stearate PEG-100 STEARATE Unresolved
7. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
8. Potassium Sorbate POTASSIUM SORBATE Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
9. Water WATER Molecular
10. Steareth-21 STEARETH-21 Unresolved
11. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metronidazole METRONIDAZOLE ZINC113442

Comments