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Details for: METROGEL

Company: GALDERMA CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02092832METROGEL 0.75%METRONIDAZOLE0.75 %GELTOPICAL
02297809METROGEL 1%METRONIDAZOLE1 %GELTOPICAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

METROGEL is 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.

METROGEL contains an antibacterial ingredient called metronidazole, and it should be used exactly as directed by your healthcare professional. Misuse or overuse of METROGEL could lead to the growth of bacteria that will not be killed by metronidazole. This means that METROGEL or other medicines that contain metronidazole may not work for you in the future. Do not share your medicine.

What it does

METROGEL 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 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 contain metronidazole.

What the non-medicinal 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.

What dosage form 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.

Warnings and precautions

BEFORE you use METROGEL 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 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% : Apply and rub in a thin film twice daily, morning and evening to affected areas.

After applying metronidazole gel 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.

Overdose

For management of a suspected drug overdose, contact your regional Poison Control Centre

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. Do not exceed the recommended dose and duration of treatment.

Missed Dose

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 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 contact your doctor or pharmacist.

How to store

METROGEL 1%: Store at room temperature (15º to 30ºC).

METROGEL 0.75%: Store at 15º to 30ºC.

Keep out of sight and reach of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.galderma.ca
or by contacting the sponsor, Galderma Canada Inc., at:
Questions or concerns: 1-800-467-2081

This leaflet was prepared by Galderma Canada Inc.

Last revised: February 22, 2018

Date modified: