MetroGel 75

DRUG DESCRIPTION

METROGEL® Topical Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propyl-paraben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:

MetroGel ® (metronidazole) Structural Formula Illustration

What are the possible side effects of metronidazole vaginal (MetroGel-Vaginal, Vandazole)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Rare but serious side effects may include:

  • seizure (convulsions); or
  • numbness, burning, pain, or tingly feeling in your hands or feet.

Less serious side effects may include:

  • mild burning or stinging when the medication is applied;
  • pelvic pain or cramps;
  • loss...

Read All Potential Side Effects and See Pictures of MetroGel 75 »

What are the precautions when taking metronidazole topical gel (MetroGel 75)?

Before using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (such as tinidazole); or to other ingredients in this product; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (blood dyscrasias).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Discuss the risks and benefits with your doctor before...

Read All Potential Precautions of MetroGel 75 »


MetroGel 75 Consumer (continued)

SIDE EFFECTS: Stinging, burning, skin irritation, dryness, redness, metallic taste, nausea, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you have this unlikely but serious side effect: tingling or numbness of the hands and feet.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (such as tinidazole); or to other ingredients in this product; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (blood dyscrasias).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.


MetroGel 75 Patient Information Including Side Effects

Brand Names: MetroGel-Vaginal, Vandazole

Generic Name: metronidazole vaginal (Pronunciation: MET roe NYE da zole)

  • What is metronidazole vaginal (MetroGel 75)?
  • What are the possible side effects of metronidazole vaginal (MetroGel 75)?
  • What is the most important information I should know about metronidazole vaginal (MetroGel 75)?
  • What should I discuss with my doctor before using metronidazole vaginal (MetroGel 75)?
  • How should I use metronidazole vaginal (MetroGel 75)?
  • What happens if I miss a dose (MetroGel 75)?
  • What happens if I overdose (MetroGel 75)?
  • What should I avoid while using metronidazole vaginal (MetroGel 75)?
  • What other drugs will affect metronidazole vaginal (MetroGel 75)?
  • Where can I get more information?

What is metronidazole vaginal (MetroGel 75)?

Metronidazole is an antibiotic that fights bacteria in the body.

Metronidazole vaginal is used to treat vaginal infections caused by bacteria.

Metronidazole vaginal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of metronidazole vaginal (MetroGel 75)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Rare but serious side effects may include:

  • seizure (convulsions); or
  • numbness, burning, pain, or tingly feeling in your hands or feet.

Less serious side effects may include:

  • mild burning or stinging when the medication is applied;
  • pelvic pain or cramps;
  • loss of appetite, constipation, upset stomach, vomiting;
  • dizziness, sleep problems (insomnia);
  • runny nose;
  • urinating more than usual;
  • acne, increased sweating; or
  • breast discharge or enlargement.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about metronidazole vaginal (MetroGel 75)?

Do not use metronidazole vaginal if you have ever had an allergic reaction to it.

Before using metronidazole vaginal, tell your doctor if you have liver disease, a seizure disorder, problems with circulation (such as Raynaud's syndrome), or if you have taken disulfiram (Antabuse) within the past 14 days.

Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.

Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.

Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.

If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat.

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