MetroGel - Consumer Medicine Information
|Condition:||Erythema Mulitforme, Erythema (Skin Rash), Rosacea|
|Class:||Topical anti-rosacea agents|
|Form:||Cream, gel, liniment or balm, lotion, ointment, etc|
|Ingredients:||Betadex, edetate disodium, hydroxyethyl cellulose 250 HHX, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben, purified water|
About This Medication
What the Medication is Used For
METROGEL, METROCREAM, and METROLOTION are used to treat rosacea (roh-ZAY-she -ah). Patients with dry or sensitive skin may prefer using the cream or lotion formulation. This medication should not be used for any other reason than that which it is prescribed.
What It Does
METROGEL, METROCREAM, and METROLOTION is effective in reducing the inflammatory lesions of rosacea. It works by reducing inflammation and/or by killing bacteria.
When It Should not be Used
METROGEL, METROCREAM, and METROLOTION should not be used in individuals with a history of hypersensitivity to metronidazole or other ingredients of the formulations. See, “What the important nonmedicinal ingredients are”.
What the Medicinal Ingredient Is
METROGEL, METROCREAM, and METROLOTION contain metronidazole.
What the Important Nonmedicinal Ingredients Are
Non-medicinal ingredients: MetroGel 1% - betadex, edetate disodium, hydroxyethyl cellulose 250 HHX, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben, and purified water. MetroGel 0.75% - carbopol 940, edetate disodium, methylparaben, propylene glycol, propylparaben, sodium hydroxide and purified water. MetroCream - benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid and/or sodium hydroxide, sorbitol solution and purified water. MetroLotion - benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, polyethylene glycol 100 stearate, polyethylene glycol 400, potassium sorbate, sodium hydroxide and/or lactic acid, stearyl alcohol, steareth-21 and purified water.
What Dosage Forms It Comes in
METROGEL 1% is supplied in a 55 g high-density polyethylene (HDPE) bottle with a polypropylene (PP) pump. METROGEL 0.75% is supplied in 60 g aluminum tubes.
METROCREAM (metronidazole topical cream 0.75%) is supplied in 60 g aluminum tubes.
METROLOTION (metronidazole topical lotion 0.75%) is supplied in 120 mL oval plastic bottles.
Warnings and Precautions
BEFORE you use METROGEL, METROCREAM, and METROLOTION talk to your doctor or pharmacist if:
- You have any allergies to this drug or its ingredients.
- You have a history of blood disease or your blood is not normal in some way.
- You are pregnant or nursing.
- You plan to be in the sun. Avoid excessive exposure to sunlight, including sunlamps and tanning beds.
- Irritation occurs during treatment, discuss with your doctor. Your doctor may advise that you discontinue the medication, discontinue the medication temporarily, or take the medication less frequently.
Interactions With This Medication
Drugs that may interact with METROGEL, METROCREAM, and METROLOTION include: coumarin, warfarin, other imidazole preparations such as clotrimazole and tioconazole, and possibly alcohol.
Proper Use of This Medication
Usual Adult Dose
Cleanse and dry affected area before applying medication.
METROGEL 1%: Apply and rub in a thin film once daily to the affected area.
METROGEL 0.75%, METROCREAM and METROLOTION: Apply and rub in a thin film twice daily, morning and evening to affected areas.
After applying metronidazole gel, cream or lotion, and the medication has dried, cosmetics can be applied.
Results should be expected in about three weeks with continuing improvement through nine weeks of treatment.
This medicine is for external use only. Do not use this medicine in or near the eyes. If this medicine does get into your eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.
Topically applied metronidazole can be absorbed in sufficient amount to produce systemic effects. Massive ingestion may produce vomiting and slight disorientation. If you or anyone else suspects an overdose, promptly call your doctor or pharmacist.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Side Effects and What to Do About Them
Like all prescription medicines, METROGEL, METROCREAM AND METROLOTION can have side effects. Some common side effects related to metronidazole were skin redness, burning/stinging, hypersensitivity, skin irritation, dry skin, itching, rosacea worsening. Uncommon side effects were watery eyes, eye irritation, rash, skin peeling, skin tightness, facial swelling, hives, contact dermatitis, skin inflammation, skin pain.
This is not a complete list of side effects. For any unexpected effects while taking METROGEL, METROCREAM, and METROLOTION, contact yourdoctor or pharmacist.
How to Store It
METROGEL 1%: Store at room temperature (15º to 30ºC).
METROGEL 0.75%, METROCREAM, and METROLOTION: Store at 15º to 30ºC. Protect METROLOTION from freezing.
Keep out of reach of children.
Reporting Suspected Side Effects
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax: 866-678-6789
By email: firstname.lastname@example.org
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Marketed Health Products Directorate Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Galderma Canada Inc., at:
105 Commerce Valley Drive West, Suite 300 Thornhill, ON L3T 7W3 1-800-467-2081