Metrogel-Vaginal

Generic name: Metronidazole

Usage of Metrogel-Vaginal

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

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing the bacteria or preventing their growth. However, this medicine will not work for vaginal fungus or yeast infections.

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

Metrogel-Vaginal side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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 need 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 about ways 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.

    Before taking Metrogel-Vaginal

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies on the relationship of age to the effects of Vandazole® have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for bacterial vaginosis in teenage females but should not be used before the start of menstruation.

    Appropriate studies have not been performed on the relationship of age to the effects of Nuvessa™ in children younger than 12 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole vaginal gel in the elderly.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance 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 change 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 may be required 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 cause an increased risk of certain side effects, but using both drugs may be the best treatment 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 used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance 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, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

    • Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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 make these conditions worse.
  • Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

    • How to use Metrogel-Vaginal

    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.

    Warnings

    It is important that your doctor check your progress after you finish using this medicine to make sure that the infection is cleared up.

    If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.

    You should not use this medicine if you are taking or have taken disulfiram (Antabuse®) within the last 2 weeks. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

    Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Alcohol-containing medicines (eg, elixirs, cough syrups, tonics) may also cause problems. The chance of these problems occurring may continue for at least a day after you stop using metronidazole. You should not drink alcoholic beverages (eg, ethanol or propylene glycol) or take other alcohol-containing medicines while you are using this medicine and for at least 24 hours after treatment.

    Check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

    Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

    Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

    This medicine may cause some people to become dizzy or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.

    Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a mini-pad or sanitary napkin. Do not use tampons since they may soak up the medicine.

    To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

  • Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (eg, nylon or rayon) panties.
  • Wear only freshly washed panties daily.

    • Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may keep the medicine from working properly. Also, oils in the cream and vaginal tablets (but not the vaginal gel) may damage latex (rubber) contraceptive devices (eg, cervical caps, condoms, or diaphragms), causing them to leak, wear out sooner, or not work properly.

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

    Many vaginal infections (eg, trichomoniasis) are spread by having sexual intercourse. You can give the infection to your sexual partner, and the infection could be given back to you. Your partner may also need to be treated for some infections. Until you are sure that the infection is completely cleared up after your treatment with this medicine, your partner should wear a condom during sexual intercourse. If you have any questions about this, check with your doctor.

    Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

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

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