MetroGel Vaginal

DRUG DESCRIPTION

METROGEL-VAGINAL (metronidazole) is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure:

 METROGEL-VAGINAL (metronidazole) Structural Formula Illustration

METROGEL-VAGINAL (metronidazole) is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 934P, edetate disodium, methyl paraben, propyl paraben, propylene glycol, and sodium hydroxide.

Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole.

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 Vaginal

What are the precautions when taking metronidazole (MetroGel Vaginal)?

Before using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (e.g., tinidazole); or if you have any other allergies. This product may contain inactive ingredients (such as paraben preservatives), 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: seizures, liver disease, certain blood disorders (blood dyscrasias), nervous system disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication should be used only if...

Read All Potential Precautions of MetroGel Vaginal


MetroGel Vaginal Consumer (continued)

SIDE EFFECTS: Dizziness, headache, nausea, diarrhea, unusual taste in the mouth, stomach cramps, or vaginal itching/burning/discharge 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 any of these unlikely but serious side effects occur: fainting, painful urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: tingling or numbness of the hands and feet, seizures, signs of another infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., depression).

Use of this medication for prolonged or repeated periods may result in a new vaginal yeast infection (vaginal fungal infection). Contact your doctor if you notice a change in vaginal discharge or other new symptoms.

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 (e.g., tinidazole); or if you have any other allergies. This product may contain inactive ingredients (such as paraben preservatives), 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: seizures, liver disease, certain blood disorders (blood dyscrasias), nervous system disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication should be used only if clearly needed during pregnancy. Oral antibiotics have been used to treat vaginal infections during pregnancy, especially high-risk pregnancies (e.g., risk of early childbirth). Consult your doctor for more details and to discuss the risks and benefits.

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


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

What is metronidazole vaginal (MetroGel Vaginal)?

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 Vaginal)?

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 Vaginal)?

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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