vandazole
Pharmaranks rates Vandazole 2.8/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Vandazole (Metronidazole) is a nitroimidazole antimicrobial used to treat Abscess, Amebiasis, Bacteroides Infections, Bacterial Endocarditis.
Metronidazole · by Teva
Available as a generic: Metronidazole
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Metronidazole
- Drug class
- Nitroimidazole Antimicrobial
- Form
- Topical
- Strength
- Metronidazole 0.75%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- abscess, amebiasis, bacteroides infections
- Manufacturer
- Teva
- Half-life
- about 8 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.10 per gm — not your price
- FDA application
- NDA021806
What is Vandazole?
From the FDA label:VANDAZOLE (metronidazole gel, USP), 0.75% is the vaginal dosage form of the nitroimidazole antimicrobial metronidazole at a concentration of 0.75%. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. C 6 H 9 N 3 O 3 M.W. 171.16 VANDAZOLE is a colorless to yellow gel, containing metronidazole, USP at a concentration of 7.5 mg/g (0.75%). The gel also contains edetate disodium, hypromellose, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide (to adjust pH). Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole, USP. Structural formula for metronidazole
How to use
The recommended dose is one applicator full of VANDAZOLE, (approximately 5 grams of gel containing approximately 37.5 mg of metronidazole) administered intravaginally once a day for 5 days. For once a day dosing, VANDAZOLE should be administered at bedtime [see Patient Counseling Information ( 17.4 )] . Not for ophthalmic, dermal, or oral use. One applicator full of VANDAZOLE administered intravaginally once a day for 5 days. ( 2 ) Not for ophthalmic, dermal, or oral use. ( 2 )
Side effects
Adverse reactions occurring in ≥ 1% of patients are: fungal infection, headache, pruritus, abdominal pain, nausea, dysmenorrhea, pharyngitis, rash, infection, diarrhea, breast pain, and metrorrhagia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to VANDAZOLE compared to another formulation of vaginal metronidazole in 220 women in a single trial. The population was non-pregnant females (age range 18 to 72 years, the mean was 33 years +/- 11 years) with bacterial vaginosis. The racial demographic of those enrolled was 71 (32%) of White, 143 (65%) of Black, 3 (1%) of Hispanic, 2 (1%) of Asian, and 1 (0%) of other. Patients administered an applicator full of VANDAZOLE intravaginally once daily at bedtime for 5 days. There were no deaths or serious adverse reactions related to drug therapy in the clinical trial. VANDAZOLE was discontinued in 5 patients (2.3%) due to adverse reactions. The incidence of all adverse reactions in VANDAZOLE-treated…
Warnings
Important safety information
Central and Peripheral Nervous System Effects: Convulsive seizures and peripheral neuropathy have been reported in patients treated with oral or intravenous metronidazole; discontinue if abnormal neurologic signs develop. ( 5.1 ) Carcinogenicity in Animals: Metronidazole has been shown to be carcinogenic in mice and rats. ( 5.2 , 13.1 ) Interference with laboratory tests: Metronidazole may interfere with certain serum chemistry laboratory values ( 5.3 ) 5.1 Central and Peripheral Nervous System Effects Use of oral or intravenous metronidazole is associated with convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity [see Adverse Reactions ( 6.2 )] . VANDAZOLE should be administered with caution to patients with central nervous system diseases. Discontinue VANDAZOLE promptly if a patient develops abnormal neurologic signs. 5.2 Carcinogenicity in Animals Metronidazole has been shown to be carcinogenic in mice and rats [see Nonclinical Toxicology ( 13.1 )] . Unnecessary use of metronidazole should be avoided. Use of VANDAZOLE should be reserved for the treatment of bacterial vaginosis [see Indications and Usage ( 1 )] . 5.3 Interference with Laboratory Tests Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide-adenine dinucleotides (NAD + NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7. Consider postponing chemistry laboratory tests until treatment with VANDAZOLE is completed.
Who should not take Vandazole
History of hypersensitivity to metronidazole, other nitroimidazole derivatives or parabens ( 4 ) Disulfiram: Psychotic reactions have been reported with disulfiram and oral metronidazole; do not administer concurrently with or within the last 2 weeks of disulfiram ( 4.2 , 7.1 ). Alcohol: Disulfiram-like reactions to alcohol have been reported with oral metronidazole; do not consume alcohol during and for at least three days following treatment ( 4.3 , 7.2 ) 4.1 Hypersensitivity The use of VANDAZOLE is contraindicated in patients with a history of hypersensitivity to metronidazole, other nitroimidazole derivatives, or parabens. Reported reactions include urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains [see Adverse Reactions ( 6.2 )] . 4.2 Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer VANDAZOLE to patients who have taken disulfiram within the last two weeks [see Adverse Reactions ( 6.2 )] . 4.3 Interaction with Alcohol Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing [see Adverse Reactions ( 6.2 )] . Discontinue alcohol consumption during and for at least three days after therapy with VANDAZOLE.
Overdose — what happens if you take too much
There is no human experience with overdosage of metronidazole vaginal gel. Vaginally applied metronidazole gel, 0.75% could be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6.2 )] .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
The intravaginal administration of a single 5 gram dose of VANDAZOLE results in relatively lower mean systemic exposure to metronidazole that is approximately 2% to 5% of that achieved following a 500 mg oral dose of metronidazole [see Clinical Pharmacology ( 12.3 )] . The following drug interactions were reported for oral metronidazole. Warfarin and other coumarin anticoagulants: Prolonged anticoagulant effects reported with oral metronidazole; monitor INR and prothrombin time. ( 7.3 ) Lithium: Elevated lithium concentrations reported with oral metronidazole; monitor serum concentrations of lithium. ( 7.4 ) 7.1 Disulfiram Use of oral metronidazole has been associated with psychotic reactions in alcoholic patients who are using disulfiram concurrently. VANDAZOLE should not be used by patients who have taken disulfiram within the last two weeks [see Contraindications ( 4.2 )] . 7.2 Alcoholic Beverages Use of oral metronidazole has been associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) to alcohol. Alcoholic beverages and preparations containing ethanol or propylene glycol should not be consumed during and for at least three days after VANDAZOLE therapy [see Contraindications ( 4.3 )] . 7.3 Coumarin and Other Oral Anticoagulants Use of oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when VANDAZOLE is prescribed for patients on this type of anticoagulant therapy. In patients on oral anticoagulants, consider monitoring prothrombin time, international normalized ratio (INR), and other coagulation parameters while on VANDAZOLE. 7.4 Lithium Short-term use of oral metronidazole has been associated with elevation of serum lithium concentrations and, in a few cases signs of lithium toxicity, in patients stabilized on relatively high doses of lithium. Use VANDAZOLE with caution in patients treated with lithium and consider monitoring lithium serum concentrations while on VANDAZOLE. 7.5 Cimetidine Use of oral metronidazole with cimetidine may prolong the half-life and decrease plasma clearance of metronidazole. No dose adjustment of VANDAZOLE is necessary.
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
Alcohol
Watch out for: beer, wine, spirits, and other products containing alcohol.
Combining alcohol with this antibiotic can cause a disulfiram-like reaction — flushing, nausea, vomiting, headache, and a fast heartbeat.
What to do: Avoid alcohol while taking it and for a few days after your last dose, as your prescriber or the label directs. Alcohol can hide in some liquid medicines and mouthwashes.
Source: Metronidazole — MedlinePlus (U.S. National Library of Medicine)
How long does Metronidazole stay in your body?
The elimination half-life of metronidazole is about 8 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the average for healthy adults with normal kidney and liver function; the half-life is much longer in newborns (roughly 22 to 109 hours, longer the more premature the baby). Metronidazole has an active metabolite (hydroxy-metronidazole) whose levels build up in older adults (40-80% higher) and in severe kidney disease, though the label does not give a separate half-life for it.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: FLAGYL (metronidazole) label, DailyMed.
Drug class
How this class works, per Metronidazole - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- abscess
- amebiasis
- bacteroides infections
- bacterial endocarditis
- pseudomembranous enterocolitis
- giardiasis
See how Vandazole ranks — best-rated nitroimidazole antimicrobial for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Vandazole treat?
- Vandazole (Metronidazole) may be used to treat abscess, amebiasis, bacteroides infections, bacterial endocarditis, pseudomembranous enterocolitis, giardiasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Vandazole work?
- Vandazole is a nitroimidazole antimicrobial. Nitroimidazole antibiotics (such as metronidazole) are activated inside oxygen-free bacteria and parasites, where they turn into reactive forms that break and destabilize the microbe's DNA. This kills the germ while largely sparing the body's own cells.
- How is Vandazole rated?
- pharmaranks gives Vandazole a composite score of 2.8 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Vandazole cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.10 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Vandazole?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Vandazole. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Vandazole?
- Vandazole is marketed by Teva. You can see Teva's full profile, rating, and other products on pharmaranks.
- Is Vandazole a brand-name or generic drug?
- Vandazole is a brand-name product with the active ingredient Metronidazole. Lower-cost generic equivalents containing Metronidazole are available — ask your pharmacist.
- Is Vandazole available over the counter?
- No. Vandazole is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Vandazole come in?
- Vandazole is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Vandazole?
- Vandazole is classified as nitroimidazole antimicrobial, per the FDA's Established Pharmacologic Class.
- Is Vandazole FDA-registered?
- Vandazole is on record with the U.S. FDA under application number NDA021806. You can verify this on its official FDA label.
- Has Vandazole been recalled by the FDA?
- Vandazole has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Vandazole safe?
- There's no single safe-or-not verdict. pharmaranks gives Vandazole a recall-safety score of 56/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Vandazole?
- Vandazole's side effects are taken directly from its FDA label. From the label: Adverse reactions occurring in ≥ 1% of patients are: fungal infection, headache, pruritus, abdominal pain, nausea, dysmenorrhea, pharyngitis, rash, infection, diarrhea, breast pain, and metrorrhagia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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vandazole
56/100