MetroCream
RxNorm 211666· METRONIDAZOLE· TOPICAL
Nitroimidazole Antimicrobial [EPC] · Galderma Laboratories, L.P.
Indications and usage
INDICATIONS AND USAGE: METROCREAM ® (metronidazole topical cream) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage and administration
DOSAGE AND ADMINISTRATION: Apply and rub in a thin layer of METROCREAM ® (metronidazole topical cream) Topical Cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of METROCREAM ® (metronidazole topical cream) Topical Cream.
Contraindications
CONTRAINDICATIONS: METROCREAM ® (metronidazole topical cream) Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.
Adverse events
Most frequently reported events (FDA FAERS). Report frequency does not imply causation.
- drug ineffective5,596
- nausea4,880
- diarrhoea4,251
- off label use4,209
- vomiting3,409
- pyrexia3,312
- pain3,196
- drug hypersensitivity3,176
- abdominal pain3,061
- headache3,044
- fatigue2,981
- dyspnoea2,328
- dizziness2,305
- condition aggravated2,172
- malaise2,076
- rash2,060
Adverse reactions (label)
ADVERSE REACTIONS: In controlled clinical trials, the total incidence of adverse reactions associated with the use of METROCREAM ® Topical Cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
View more: Full FDA label on DailyMed →Label effective 20180626