Details for: METROGEL
Company: GALDERMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02092832 | METROGEL 0.75% | METRONIDAZOLE | 0.75 % | GEL | TOPICAL |
| 02297809 | METROGEL 1% | METRONIDAZOLE | 1 % | GEL | TOPICAL |
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
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:
- Visiting the Web page on Adverse Reaction Reporting (www.hc-sc.gc.ca/dhpmps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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