metronidazole topical (MetroCream, MetroGel, MetroLotion, Noritate)

Dosing and uses of MetroGel, Noritate (metronidazole topical)

• Adult
• Pediatric

 

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)