Nuvessa (for use in the vagina) is an antibiotic that is used to treat vaginal infections caused by bacteria.

Do not use metronidazole to treat any condition that has not been checked by your doctor.

Nuvessa may also be used for purposes not listed in this medication guide.

You should not use metronidazole if you have taken disulfiram (Antabuse) within the past 2 weeks.

Do not drink alcohol or consume foods or medicines that contain propylene glycol while you are using metronidazole and for at least 3 days after you stop using it.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Use this medicine at bedtime.

Nuvessa is often given as a single dose. However, you might need to use the medicine for 5 nights in a row. Follow your doctor's dosing instructions very carefully.

Do not take Nuvessa by mouth. It is for use only in the vagina.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Gently wash your vaginal area before applying the medicine. Wash your hands before and after handling the medicine tube or vaginal applicator.

Insert the medicine directly into your vagina using the applicator provided. Each disposable applicator is for one use only.

You may need to use a sanitary napkin during treatment, but do not use a tampon. Do not use a douche or other vaginal product while using Nuvessa.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication.

Call your doctor if your symptoms do not improve, or if they get worse.

Do not share this medicine with another person, even if they have the same symptoms you have.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Nuvessa.

Nuvessa will not treat a vaginal yeast infection. You may even develop a new vaginal yeast infection, which may need to be treated with antifungal medication. Tell your doctor if you have symptoms such as itching or discharge during or after treatment with this medicine.

Store at room temperature away from moisture or heat. Do not refrigerate or freeze.

You should not use Nuvessa if you are allergic to metronidazole, secnidazole, or tinidazole, or if:

• you are allergic to parabens or polyethylene glycol;

• you recently drank alcohol; or

• you took disulfiram (Antabuse) within the past 14 days.

Tell your doctor if you have ever had:

• nerve problems;

• a seizure; or

• peripheral vascular disease such as Raynaud's syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breastfeed within 48 hours after using metronidazole. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Nuvessa is not approved for use in children younger than 12 years old, or in girls who have not begun having menstrual periods.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

An overdose of Nuvessa is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

While you are using Nuvessa and for 3 days after your last dose: Avoid drinking alcohol or consuming foods or other products that contain alcohol or propylene glycol. Drinking alcohol may cause unpleasant effects such as headaches, nausea, vomiting, stomach cramps, and warmth or tingling under your skin.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Getting this medicine in your eyes can cause burning or irritation. If contact does occur, rinse with water and call your doctor.

Avoid using other vaginal medications unless your doctor tells you to. Avoid having sex until your vaginal infection has been completely treated.

Get emergency medical help if you have signs of an allergic reaction (hives, itching, warmth or tingling; fever, joint pain; dry mouth, dry vagina; stuffy nose, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Rare but serious side effects may include:

• seizure (convulsions); or

• numbness, burning, pain, or tingly feeling in your hands or feet.

Call your doctor at once if you have new or worsening vaginal symptoms.

Common side effects of Nuvessa may include:

• vaginal itching or discharge;

• menstrual pain, heavy bleeding;

• breast pain;

• headache;

• rash, itching;

• stomach pain, nausea, diarrhea; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• lithium; or

• a blood thinner (warfarin, Coumadin, Jantoven).

This list is not complete. Other drugs may affect Nuvessa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.