Metrogel-Vaginal (Vaginal)

Metronidazole vaginal is used to treat women with vaginal infections (for example, bacterial vaginosis).

Metronidazole is part of a group of medicines called antibiotics. It works by killing bacteria or stopping them from growing. However, this medicine will not work for vaginal fungus or yeast infections.

This medicine is available only with your doctor's prescription.

It is important for your doctor to check your progress after you finish using this medicine to ensure that the infection is completely gone.

If your symptoms do not get better within a few days after starting this medicine, or if they worsen, contact your doctor.

You should not use this medicine if you are taking or have taken disulfiram (Antabuse®) in the last 2 weeks. Disulfiram is used for people with drinking problems. Taking these 2 medicines close together can cause serious unwanted effects.

Drinking alcohol while using this medicine may lead to stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Alcohol-containing medicines (like elixirs, cough syrups, or tonics) can also cause issues. The risk of these problems may last for at least a day after you stop using metronidazole. You should not drink alcohol (like ethanol or propylene glycol) or take other alcohol-containing medicines while on this medicine and for at least 24 hours after treatment.

Contact your doctor immediately if you experience dizziness, muscle control or coordination issues, shakiness or an unsteady walk, slurred speech, or trouble speaking. These may be signs of a serious brain condition called encephalopathy.

Call your doctor right away if you feel confused, drowsy, have a fever, feel generally unwell, have a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be signs of a serious condition called aseptic meningitis.

Check with your doctor immediately if you have burning, numbness, tingling, or painful sensations in your arms, hands, legs, or feet. These could indicate a condition called peripheral neuropathy.

This medicine may cause some people to feel dizzy or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these side effects are very bothersome, consult your doctor.

Vaginal medicines usually leak out during treatment. To prevent the medicine from staining your clothes, wear a mini-pad or sanitary napkin. Do not use tampons as they may absorb the medicine.

To help completely clear your infection and prevent it from returning, good health habits are also necessary.

• Wear cotton underwear (or underwear or pantyhose with cotton crotches) instead of synthetic ones (like nylon or rayon).
• Wear freshly washed underwear every day.

Do not have sexual intercourse while using this medicine. Having sexual intercourse may lessen the effectiveness of the medicine. This can prevent the medicine from working properly. Also, the oils in the cream and vaginal tablets (but not the vaginal gel) can damage latex contraceptives (like cervical caps, condoms, or diaphragms), leading to leaks, wear, or ineffective protection.

Avoid using douches or other vaginal products unless your doctor advises you to.

Many vaginal infections (like trichomoniasis) can be transmitted through sexual intercourse. You can pass the infection to your partner, and they could give it back to you. Your partner may also need treatment for some infections. Until you are sure the infection is completely cleared after treatment with this medicine, your partner should use a condom during sexual intercourse. If you have questions about this, speak with your doctor.

Before undergoing any medical tests, inform the doctor in charge that you are using this medicine. The results of some tests may be influenced by this medicine.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it may provide. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare provider about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how Vandazole® affects children. However, there are no known problems that would limit its use in teenagers. This medicine can be used for bacterial vaginosis in teenage females, but it should not be used before menstruation starts.

Appropriate studies have not been done on how Nuvessa™ affects children younger than 12 years. Its safety and effectiveness are not established.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of metronidazole vaginal gel.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits against the possible risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together. In other cases, two different medicines may be used at the same time, even if an interaction might happen. In these situations, your doctor may change the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are chosen for their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or adjust some of the other medicines you take.

• Amprenavir
• Bepridil
• Cisapride
• Disulfiram
• Dronabinol
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Adagrasib
• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Bupropion
• Buserelin
• Busulfan
• Capecitabine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Cimetidine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxifluridine
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluorouracil
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lithium
• Lofexidine
• Lumefantrine
• Macimorelin
• Mebendazole
• Mefloquine
• Methadone
• Methotrimeprazine
• Mifepristone
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine Hydrochloride
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Pimavanserin
• Pipamperone
• Piperaquine
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tegafur
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Warfarin
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Cholestyramine
• Cyclosporine
• Milk Thistle

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as food, or with specific foods, due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected for their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, modify some of the other medicines you take, or provide you with specific instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to inform your doctor about any other medical conditions, especially:

• Aseptic meningitis, history of or
• Encephalopathy (brain disorder), history of or
• Leukopenia (low white blood cells), history of or
• Optic neuropathy (eye disease with vision changes), history of or
• Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or
• Seizures or epilepsy, history of—Use with caution. May worsen these conditions.

• Severe liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Itching in the vagina
• Pain during sexual intercourse
• Thick, white vaginal discharge with no odor or with a mild odor

Less common

• Burning on urination or needing to urinate more often
• Burning or irritation of the penis of the sexual partner
• Feeling of vaginal pressure
• Itching, pain, stinging, or redness of the genital area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Cramps
• Diarrhea
• Dizziness or lightheadedness
• Dryness of the mouth
• Feeling of a furry tongue
• Headache
• Heavy bleeding
• Loss of appetite
• Metallic taste or other change in taste sensation
• Mild skin dryness and burning
• Nausea
• Skin irritation
• Temporary skin redness
• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Metrogel-Vaginal
• Vandazole

In Canada

• Flagyl
• Neo-Metric
• Nidagel

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Antibacterial

Chemical Class: Nitroimidazole

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is to be used only in the vagina. Use it at bedtime, unless your doctor tells you otherwise.

Do not get it into your eyes, nose, mouth, or skin. If this medicine does get into your eyes, wash them out right away with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Wash your hands with soap and water before and after using this medicine.

Nuvessa™ is available inside a prefilled applicator. The applicator is open at one end where you will insert the plunger and has a pink cap on the other end where the medicine will come out.

Vandazole® is in a tube. You will use an applicator to put the gel into your vagina. The applicator has a plastic tube called a barrel that is open at one end and has a plunger (another piece of plastic that can move inside the barrel) at the other end.

To use the medicine:

• To fill the applicator: For cream or gel dosage forms: Nuvessa™: With the pink cap still on, push the tip of the plunger into the open end of the prefilled applicator. Pull the cap off before you insert the applicator into your vagina. Vandazole®: Break the metal seal at the opening of the tube by using the point on the top of the cap. Screw the applicator onto the tube. Squeeze the medicine into the applicator slowly until it is full. Remove the applicator from the tube. Replace the cap on the tube. For vaginal tablet dosage form: Place the vaginal tablet into the applicator. Wet the vaginal tablet with water for a few seconds.
• To insert vaginal metronidazole using the applicator:For all dosage forms: Relax while lying on your back with your knees bent (or in any position that you feel comfortable). Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable. Slowly press the plunger until it stops. Withdraw the applicator. The medicine will be left behind in the vagina. Remove the applicator from your vagina. Use each applicator only once, and then throw it away.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For bacterial vaginal infections: For vaginal dosage form (cream): Adults—One applicatorful (500 milligrams [mg]), inserted into the vagina. Use the medicine 1 or 2 times a day for 10 or 20 days. Children—Use and dose must be determined by your doctor. For vaginal dosage form (gel): Nuvessa™: Adults and children 12 years of age and older—One applicatorful (5 grams [g]) inserted into the vagina once (at bedtime). Each applicatorful of Nuvessa™ contains 65 mg of metronidazole. Children younger than 12 years of age—Use and dose must be determined by your doctor. Vandazole®: Adults—One applicatorful (5 grams [g]) inserted into the vagina once a day (at bedtime) for 5 days. Each applicatorful of Vandazole® contains 37.5 mg of metronidazole. Children—Use and dose must be determined by your doctor. For vaginal dosage form (tablets): Adults—One 500 milligram (mg) tablet, inserted high into the vagina. Use the medicine once a day in the evening for 10 or 20 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.