Dosing & Uses
Dosage Forms & Strengths
topical gel
- 1% (MetroGel)
topical cream
- 0.75% (MetroCream)
- 1% (Noritate)
topical lotion
- 0.75% (MetroLotion)
Rosacea
Indicated for the topical treatment of inflammatory lesions of rosacea
1%: Apply topically qDay to affected area(s)
0.75%: Apply topically BID to affected area(s)
Administration
Cleanse treated areas prior to application
Apply thin film and rub into skin
Cosmetics may be applied ≥5 minutes after application
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (2)
- disulfiram
disulfiram increases toxicity of metronidazole topical by decreasing metabolism. Minor/Significance Unknown. Enhanced CNS & cardiac toxicity with oral metronidazole and disulfiram; less likely to occur with topical administration because of low absorption.
- ethanol
metronidazole topical will increase the level or effect of ethanol by decreasing metabolism. Minor/Significance Unknown. Disulfiram-like reaction with oral metronidazole and alcohol; less likely to occur with vaginal administration because of low absorption
Adverse Effects
>10%
Skin dryness (25.4%)
Skin scaling (24.6%)
Pruritus (15.8%)
Cutaneous stinging/burning (10.3%)
Frequency Not Defined
Application site reaction
Aggravated condition
Paresthesia
Acne
Dry skin
Tearing of eyes
Postmarketing Reports
Peripheral neuropathy
Allergic reactions
Skin and eye irritation
Rash
Headache
Nausea
Constipation
Contact dermatitis
Warnings
Contraindications
Hypersensitivity
Cautions
For external use only
Avoid contact with eyes; tearing may occur
Nitroimidazole; use caution with evidence or history of blood dyscrasia
Discontinue use if dermatitis occurs
Administer with caution in patients with CNS diseases due to risk of numbess or paresthesia of an extremity
Pregnancy & Lactation
Pregnancy
Available data not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes
Animal data
- No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice; available data do not allow calculation of relevant comparisons between systemic exposures of metronidazole observed in animal studies to systemic exposures that would be expected in humans after topical use of this drug
Lactation
Not known whether metronidazole is present in human milk after topical administration; published literature reports presence of the drug in human milk after oral administration
There are reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole
There are no data on effects of this drug on milk production; because of potential for serious adverse reactions, advise patients that breastfeeding is not recommended during therapy
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Mechanism by which metronidazole acts in the treatment of rosacea is unknown, but appears to include an anti-inflammatory effect
Inhibits nucleic acid synthesis by disrupting DNA
Pharmacokinetics
Peak Plasma Time: 6-10 hr
Peak Plasma Concentration: 32 ng/mL (<1% of PO dose)
AUC: 595 ng•hr/mL (<1% of single PO dose)
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Formulary
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