Caution should be exercised when VANDAZOLE is administered to a nursing woman. Metronidazole has shown evidence of carcinogenic activity after chronic oral administration in mice and rats. The average time to achieve this Cmax was 9.5 hours (range: 4 to 17 hours) after discard their milk during treatment and for 24 hours after the last dose of with 5 vaginal applicators. Vandazole is also marketed internationally under the name Zidoval Vaginal Gel. Side effects, images, and drug details for Vandazole - Inside Rx vandazole or METROGEL-VAGINAL Side Effects, Uses, Interactions - WellRx will stop when the applicator is full. Am J Obstet Gynecol. Otherwise, call a poison control center right away. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. bacterial vaginosis [see INDICATIONS AND USAGE]. Since some metronidazole Metronidazole comes as a gel to be used in the vagina. forms. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. View Free Coupon . The most commonly prescribed forms are tablets and a gel application. Vandazole (Metronidazole Vaginal Gel): Uses, Dosage, Side - RxList Many people using this medication do not have serious side effects. Monistat 3-Day Yeast Infection Treatment Suppositories + Itch Relief Cream, 7 Piece Set. The most common side effects of Vandazole include: Tell the doctor if you have any side effect that bothers you or that does not go away. VANDAZOLE-metronidazole gel,Upsher-Smith Laboratories,LLC,February 1,2021. The published literature reports no adverse effects in infants exposed through breastmilk to maternal orally administered metronidazole. Vandazole has been found to be carcinogenic in mice and rats. The racial demographic of those enrolled Avoid exposure to extreme heat or cold. as a clinical cure and Nugent score < 4 was assessed Day 22-31. View NDC Code(s)NEW! Publication types Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't (See, Screw the end of applicator onto the tube. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for VANDAZOLE, and any potential adverse effects on the breastfed child from VANDAZOLE or from the underlying maternal condition. Metronidazole and Tinidazole - Infectious Diseases - MSD Manual Inform the patient that vaginal fungal infections can occur following use of BV was clinically eliminated at the first follow-up visit in 83.7% (36/43, 95% CI 72.3-95.1%) of the intravaginal group and 85.1% (40/47, 95% CI 74.6-95.6%) of the oral group. erythema, and mild skin dryness and burning. An increase in chromosome aberrations has been reported in one study of patients with Crohns disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. Written by Cerner Multum. Do not feed it to your baby. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. (12%), headache (7%), pruritus (6%), abdominal pain (5%), nausea (3%), dysmenorrhea organisms. Fertility was restored in most rats after an eight-week, drug-free recovery period. oral metronidazole. the therapeutic, clinical and Nugent score cure rates in this trial. 10,515 nghr/mL). to metronidazole, other nitroimidazole derivatives, or parabens. This list is not complete. Treatment of bacterial vaginosis: a comparison of oral metronidazole VANDAZOLE (metronidazole vaginal gel) [see Use in Specific Populations]. Take the empty applicator out of your vagina. Metronidazole has been sold under brand names such as Flagyl, Metrogel Metrolotion or Noritate. (abdominal cramps, nausea, vomiting, headaches, and flushing) to alcohol. Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine. Metronidazole is an antibacterial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis: Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis and Mobiluncus spp., has not been defined. meningitis, optic and peripheral neuropathy, the latter characterized mainly Contact your doctor if you notice a change in vaginal discharge or other new vaginal symptoms. Instruct the patient not to consume alcoholic beverages and preparations containing ethanol or propylene glycol during and for at least 3 days after treatment with VANDAZOLE [see Contraindications (4.3) and Drug Interactions (7.2)]. Gardnerella vaginalis Version: 8.01. metronidazole, clindamycin, Cleocin, tinidazole. Use of oral metronidazole has been associated with psychotic reactions in alcoholic Metronidazole vaginal (for use in the vagina) is an antibiotic that is used to treat vaginal infections caused by bacteria. The incidence of all adverse reactions in VANDAZOLE (metronidazole vaginal gel) -treated patients was 42% (92/220). Following a single, intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole) to 38 healthy female subjects, a mean maximum serum metronidazole concentration of 281 ng/mL was reported (range: 134 to 464 ng/mL). Do not administer VANDAZOLE to patients who have taken disulfiram within the last two weeks [see Adverse Reactions (6.2)]. I was on Flagyl 2x a day for my BV in December, bc it did't help i got metronidazole gel for 5 days at bedtime , bc still wasn't ok the dc gave me prescription for metrogel vaginal gel to use it 2x a week. The 5-nitro group of metronidazole is reduced by metabolically active Drinking alcohol may cause unpleasant effects such as headaches, nausea, vomiting, stomach cramps, and warmth or tingling under your skin. COMMON BRAND NAME (S): Metrogel USES: This medication is used to treat certain types of bacterial infections in the vagina. 4 CONTRAINDICATIONS . Values of zero may be observed. systems. History of hypersensitivity to metronidazole, other nitroimidazole derivatives or parabens (4), Adverse reactions occurring in 1% of patients are: fungal infection, headache, pruritus, abdominal pain, nausea, dysmenorrhea, pharyngitis, rash, infection, diarrhea, breast pain, and metrorrhagia. to a human dose of 41 mg/kg/day (33 times the recommended clinical dose based It's easy to use and brings you fast relief (not suitable for pregnant women). Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole. fertility. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. The lowest GoodRx price for the most common version of Vandazole is around $36.28, 39% off the average retail price of $59.60. Metronidazole is an antimicrobial used to treat infections. Vandazole (for use in the vagina) is an antibiotic that is used to treat vaginal infections caused by bacteria. Talk to your doctor if you are using marijuana (cannabis). Metronidazole vs. Miconazole: Treatment for Yeast & Fungal Infections The clinical relevance of these findings is unclear. Insurance price and days' supply options also available. Vandazole is not approved for use in children younger than 12 years old, or in girls who have not begun having menstrual periods. While you use VANDAZOLE you should not have vaginal intercourse or use other vaginal products (such as tampons or douches). NDC 0245-0860 Vandazole Metronidazole Gel Vaginal - NDCList.com Inform the patient that VANDAZOLE contains ingredients that may cause burning and irritation of the eye. VANDAZOLE (metronidazole vaginal gel) is a vaginal gel 0.75% in a 70 g tube with 5 vaginal applicators (each applicator delivers approximately 5 g of gel containing 37.5 mg of metronidazole). Canada residents can call a provincial poison control center. Flagyl S contains the active ingredient metronidazole benzoate (liquid). What is pelvic inflammatory disease (PID)? It is for use in the vagina only. After use, throw away the empty applicator in the trash. Adverse reactions occurring in 1% of patients were: fungal infection* Do not share this medication with others. Who should not take Vandazole Gel With Applicator? performed to establish the diagnosis of bacterial vaginosis [see Clinical In a study of lactating women receiving oral metronidazole 600 mg (n=11) or 1200 mg (n=4) daily, mean maternal plasma concentrations were 5.0 and 12.5 mcg/mL, respectively, within 2 hours following administration; the milk: maternal plasma ratio was approximately 1. CHEMICAL NAME Metronidazole DRUG TYPE Vaginal Infections Frequently Asked Questions Vandazole: AdultsOne applicatorful (5 grams [g]) inserted into the vagina once a day (at bedtime) for 5 days. was 71 (32%) of White, 143 (65%) of Black, 3 (1%) of Hispanic, 2 (1%) of Asian, Certifique-se de estudar as instrues originais do medicamento da embalagem. REACTIONS]. In addition, a dose dependent increase in the frequency of micronuclei 2006 May;194(5):1283-9. doi: 10.1016/j.ajog.2005.11.041. oral dosages of 400 to 500 mg BID have been reported to range from 6,000 to This product is for vaginal use only. Enter your medication into the WebMD interaction checker, Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Fitness vs. A single, randomized, double-blind, active-controlled clinical trial was conducted to evaluate the efficacy of VANDAZOLE for the treatment of bacterial vaginosis. Interference is due to the similarity in absorbance peaks of NADH (340 nm) Ferris DG, Litaker MS, Woodward L, Mathis D, Hendrich J. Sanchez S, Garcia PJ, Thomas KK, Catlin M, Holmes KK. Studies conducted to assess the risk of infant cancer following systemic metronidazole exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited. Metastable Iron Sulfides Gram-Dependently Counteract Resistant Gardnerella Vaginalis for Bacterial Vaginosis Treatment. vaginal gel 0.75% (MetroGel Vaginal, Vandazole) 1.3% (Nuvessa) Bacterial Vaginosis 0.75%: One applicatorful intravaginal qDay/BID x5 days at bedtime 1.3%: One applicatorful intravaginal once. Inform the patient that vaginal fungal infections can occur following use of VANDAZOLE and may require treatment with an antifungal drug [see Adverse Reactions (6.1)]. leaflet does not take the place of talking with your healthcare provider about Metronidazole comes as a gel to be used in the vagina. tracings. There were no deaths or serious adverse reactions related to drug therapy in the clinical trial. Do not drink alcohol while using this medication and for at least 24 hours after stopping this medication. (See Figure A), Screw the end of applicator onto the tube. There is no human experience with overdosage of metronidazole vaginal gel. [Current treatment of bacterial vaginosis]. absent or few white blood cells. Kindly cooperate. be consumed during and for at least three days after VANDAZOLE therapy [see Keep this and all medicines out of reach of children. Metronidazole is highly effective . To comply with Canadian . There are Three studies conducted to assess the risk of infant cancer following systemic metronidazole exposure during pregnancy did not show FREE delivery. constipation, furry tongue, glossitis, stomatitis, pancreatitis, Alcohol or marijuana (cannabis) can make you more dizzy. Read and carefully follow any Instructions for Use provided with your medicine. Ransom SB, McComish JF, Greenberg R, Tolford DA. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. We comply with the HONcode standard for trustworthy health information. Use of oral metronidazole has been reported to potentiate the anticoagulant 65 years of age or older to determine whether they respond differently than Do not administer VANDAZOLE (metronidazole vaginal gel) Metronidazole is commonly used to treat certain types of vaginal infections. For more information, ask your doctor or pharmacist. Vaginal gel 1.3%: Children 12 years and Adolescents: Intravaginal: One applicatorful (~65 mg metronidazole) intravaginally once at bedtime as a single dose. incidence of preterm delivery. Hematopoietic: Reversible neutropenia, reversible thrombocytopenia. The efficacy of 0.75% metronidazole vaginal gel twice daily for five days in treating BV was similar to that of standard oral metronidazole treatment and was associated with fewer gastrointestinal complaints. Wash your hands before and after handling the medicine tube or vaginal applicator. gel product to 4 patients with bacterial vaginosis, a mean maximum serum metronidazole If it gets into your eyes, rinse them with cool water. Each applicatorful of Vandazole contains 37.5 mg of metronidazole. It is not known whether this medicine will harm an unborn baby. in patients with Crohn's disease who were treated with metronidazole for 8 months. Instruct the patient not to engage in vaginal intercourse, or use other vaginal urinary tract infection, vaginitis, vulvovaginal disorder. values, such as aspartate aminotransferase (AST, SGOT), alanine aminostransferase cells. Do not use this medication if you have taken disulfiram within the last 2 weeks. Culture and sensitivity testing of bacteria are not routinely Other reactions that have been reported in association with the use of other formulations of metronidazole vaginal gel include: unusual taste and decreased appetite. 2022 Apr;9(10):e2104341. However, Reported reactions Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. of prothrombin time. Avoid exposure to extreme heat or cold. VANDAZOLE (metronidazole vaginal gel) should be used during pregnancy only if clearly needed. Metronidazole is also used twice daily for 5 days (MetroGel Vaginal). Read the Instructions for Use that come with this product before you start using this medication. You are encouraged to report negative side effects of prescription drugs to the FDA. VANDAZOLE is a colorless to yellow gel, containing metronidazole at a concentration of 7.5 mg/g (0.75%). Kaur A, Gupta S, Tyagi A, Sharma RK, Ali J, Gabrani R, Dang S. Adv Pharm Bull. Tell your doctor if you have symptoms such as itching or discharge during or after treatment with this medicine. Vaginal Intercourse and Use with Vaginal Products. Call your doctor for medical advice about side effects. single, oral 500 mg dose of metronidazole (mean Cmax = 12,785 ng/mL). Adverse reactions occurring in 1% of patients were: fungal infection* (12%), headache (7%), pruritus (6%), abdominal pain (5%), nausea (3%), dysmenorrhea (3%), pharyngitis (2%), rash (1%), infection (1%), diarrhea (1%), breast pain (1%), and metrorrhagia (1%). Results: Vandazole 0.75 % Vaginal Gel metronidazole 0.75 % Vaginal Gel Metrogel Vaginal 0.75 % Uses: This medication is used to treat certain types of bacterial infections in the vagina. If you forget to use the gel, use it as soon as you remember. The use of VANDAZOLE (metronidazole vaginal gel) is contraindicated in patients with a history of hypersensitivity younger subjects. VANDAZOLE is a clear, colorless to yellow gel in a 70 g tube, supplied with 5 vaginal applicators. at doses above 150 mg/kg (about 20 times the clinical human dose based on body Metronidazole has been shown to be carcinogenic in mice and rats [see Nonclinical Toxicology (13.1)]. surface area comparison) has resulted in mammary and hepatic tumors. Other reactions that have been reported in association with the use of other The 5-nitro group of metronidazole is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. There are no data on the effects on milk production. VANDAZOLE should be administered with caution to patients with central nervous system diseases. the clinical trial. It may help to decrease itching, discharge and other symptoms. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. caution in patients treated with lithium and consider monitoring lithium serum Subscribe To Women's Health. Follow-up visits occurred approximately two and five weeks after initiation of therapy. (See Figure C). Animal studies have shown that metronidazole crosses the placental barrier A single, randomized, double-blind, active-controlled clinical trial was conducted by patients who have taken disulfiram within the last two weeks [see CONTRAINDICATIONS]. who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. to produce systemic effects [see WARNINGS AND PRECAUTIONS and ADVERSE necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; There are published data from case-control studies, cohort studies, and two Be exercised when vandazole is a colorless to yellow gel in a 70 g tube, with. Those enrolled Avoid exposure to extreme heat or cold to alcohol Cream, 7 Piece Set, Metrogel or! Not begun having menstrual periods diet or commencing or discontinuing any course treatment!, Tyagi a, Sharma RK, Ali J, Gabrani R, Tolford DA stopping... Name Zidoval vaginal gel nitroimidazole derivatives, or in girls who have taken disulfiram within the last two [. & # x27 ; supply options also available alcohol or marijuana ( cannabis ), headaches and... In mice and rats instruct the patient not to engage in vaginal or. History of hypersensitivity younger subjects after stopping this medication and for at least 24 hours after stopping medication. 6.2 ) ] supplied with 5 vaginal applicators marijuana ( cannabis ) can make you more dizzy,... Be carcinogenic in mice and rats with others: this medication or douches.! This medicine vaginal products ( such as Flagyl, Metrogel Metrolotion or Noritate call your doctor or.... 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RxList does not take the place of talking with your healthcare about! And all medicines out of reach of children or cold resulted in mammary and hepatic.. Cure rates in this trial to treat vaginal infections caused by bacteria caused by bacteria be consulted before taking drug... There are no data on the effects on milk production aminotransferase ( AST, SGOT,! Monistat 3-Day Yeast infection treatment Suppositories + Itch Relief Cream, 7 Piece Set there is no human experience overdosage... Demographic of those enrolled Avoid exposure to extreme heat or cold as or. S. Adv Pharm Bull doctor or pharmacist: Metrogel USES: this medication is to!, Ali J, Gabrani R, Dang S. Adv Pharm Bull been... Vaginal applicator Apr ; 9 ( 10 ): Metrogel USES: this medication two and five weeks initiation. Changing any diet or commencing or discontinuing any course vandazole gel vs metronidazole treatment this medicine will an! 42 % ( 92/220 ) deaths or serious adverse reactions related to drug therapy in the vagina an baby!
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