Vandazole 7.5 mg/g

Metronidazole · GEL · Upsher-smith Laboratories, LLC

No Recall HistoryCurrently in Shortage

Plain English

Vandazole is a gel containing metronidazole at 7.5 mg/g, taken vaginal. Manufactured by Upsher-smith Laboratories, LLC.

Key Facts

Brand Name: Vandazole
Generic Name: Metronidazole
NDC Code (Product): 0245-0860
Manufacturer: Upsher-smith Laboratories, LLC
Strength: 7.5 mg/g
Dosage Form: GEL
Route: VAGINAL
Marketing Status
Application #: NDA021806
Drug Class: Nitroimidazole Antimicrobial [EPC]
Marketing Start: 10/04/2005

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective4,461 reports

nausea3,372 reports

off label use3,216 reports

diarrhoea2,649 reports

vomiting2,254 reports

pyrexia2,242 reports

headache2,174 reports

pain2,080 reports

abdominal pain2,045 reports

fatigue1,891 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE VANDAZOLE ® is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in post-menarchal females. VANDAZOLE is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in post-menarchal females. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 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 )

Contraindications

4 CONTRAINDICATIONS 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.…

Drug Interactions

7 DRUG 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 …

Adverse Reactions

6 ADVERSE REACTIONS 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…

Frequently Asked Questions

What is Vandazole used for?

Vandazole contains Metronidazole. It is a gel taken vaginal. Consult your doctor for specific uses.

Is Vandazole a controlled substance?

Vandazole is not classified as a controlled substance by the DEA.

What is the generic name for Vandazole?

The generic name for Vandazole is Metronidazole. There are 12 other brand versions of Metronidazole.

What is the NDC code for Vandazole 7.5 mg/g?

The NDC (National Drug Code) for Vandazole 7.5 mg/g is 0245-0860, listed by Upsher-smith Laboratories, LLC.

Product NDC

0245-0860

Package NDC

0245-0860-70

Other Metronidazole Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)