metronidazole topical (MetroCream, MetroGel, MetroLotion, Noritate)
Classes: Antibacterials, Topical
Dosing and uses of MetroGel, Noritate (metronidazole topical)
Adult dosage forms and 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
Pediatric dosage forms and strengths
Safety and efficacy not established
MetroGel, Noritate (metronidazole topical) adverse (side) 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 and lactation
Pregnancy category: B
Lactation: Unknown if excreted in human milk; caution advised
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 of MetroGel, Noritate (metronidazole topical)
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)
