Metronidazole (topical)

What is Metronidazole (topical)?

• Metronidazole (topical) (MetroCream; MetroGel; MetroLotion; Noritate Cream) is a member of the imidazole class of anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent.

Metronidazole

Metronidazole 3d structure

Metronidazole

What are the uses of this medicine?

• Metronidazole (topical) (MetroCream; MetroGel; MetroLotion; Noritate Cream) is used for topical application in the treatment of inflammatory papules and pustules of rosacea.

How does this medicine work?

• The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven).

Is this medicine FDA approved?

• Metronidazole was approved for use in the United States in 1963 and currently several million prescriptions are filled yearly.

How should this medicine be used?

Recommended dosage:

• Apply and rub in a thin layer of metronidazole topical cream twice daily, morning and evening, to entire affected areas after washing.

Administration:

• Metronidazole comes as a cream, lotion, or gel to be applied to your skin.
• Metronidazole is usually is applied once or twice a day.
• Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application.
• Do not use metronidazole topical in your eyes, mouth, or vagina.
• Be careful not to get metronidazole gel, cream, or lotion in your eyes or mouth.
• If you do get metronidazole in your eyes, wash with plenty of water and contact your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a cream, lotion, or gel

This medicine is available in fallowing brand namesː

• MetroCream; MetroGel; MetroLotion; Noritate Cream

What side effects can this medication cause?

The most common side effects of this medicine may include:

• Skin discomfort (burning and stinging)
• erythema
• skin irritation
• pruritus
• worsening of rosacea

Additional side effects may include:

• dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

What special precautions should I follow?

• Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.
• Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.
• This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
• Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
• After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
• Tell your doctor if you have or have ever had a central nervous system condition (diseases of the spinal cord or brain) or a blood disease.
• Apply the cream, lotion, or gel as soon as you remember, but do not apply a double dose to make up for a missed dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy category B.
• There are no adequate and well-controlled studies with the use of metronidazole topical cream in pregnant women.
• Metronidazole crosses the placental barrier and enters the fetal circulation rapidly.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• metronidazole

Inactive ingredients:

• sorbitol
• glycerin
• isopropyl palmitate
• benzyl alcohol
• LACTIC ACID, UNSPECIFIED FORM
• sodium hydroxide
• water

Who manufactures and distributes this medicine?

• E. FOUGERA & CO.
• A division of Fougera Pharmaceuticals Inc.
• MELVILLE, NEW YORK

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C
• (59°F to 86°F).

• Dailymed label info on Metronidazole (topical)
• FDA Metronidazole (topical)