Metronidazole Lotion
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
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. |
History
There is currently no drug history available for this drug.
Other Information
Metronidazole Topical Lotion, 0.75% 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-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:
Sources
Metronidazole Lotion Manufacturers
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Physicians Total Care, Inc.
![Metronidazole Lotion [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Metronidazole Lotion | Physicians Total Care, Inc.
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 metronidazole topical lotion to dry (not less than 5 minutes).
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E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Metronidazole Lotion | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
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 metronidazole topical lotion to dry (not less than 5 minutes).
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Actavis Mid Atlantic Llc,
Metronidazole Lotion | Actavis Mid Atlantic Llc,
Apply a thin layer to the 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 Metronidazole Topical Lotion to dry (not less than 5 minutes).
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Prasco Laboratories
Metronidazole Lotion | Prasco Laboratories
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 Metronidazole Topical Lotion to dry (not less than 5 minutes).
![Metronidazole Lotion [E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5368755a-dd37-4e34-843f-ece6bac8ef6a&name=metronidazole-lot-02.jpg)
![Metronidazole Lotion [Actavis Mid Atlantic Llc,]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c860c7ef-c1e1-488b-8236-c87d8421820b&name=Metronidazole-Ltn-75-02-Bck.jpg)
![Metronidazole Lotion [Prasco Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fce3e59e-8e08-47f1-947f-5a6d141ba1b2&name=p51801-0-prasco-2-oz-frnt-usa.jpg)
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