metronidazole vaginal 7.5 mg/g

metronidazole · GEL · Saptalis Pharmaceuticals LLC

1 Recall on RecordCurrently in Shortage

Plain English

metronidazole vaginal is a gel containing metronidazole at 7.5 mg/g, taken vaginal. Manufactured by Saptalis Pharmaceuticals LLC.

Key Facts

Brand Name: metronidazole vaginal
Generic Name: metronidazole
NDC Code (Product): 71656-067
Manufacturer: Saptalis Pharmaceuticals LLC
Strength: 7.5 mg/g
Dosage Form: GEL
Route: VAGINAL
Marketing Status
Application #: ANDA216750
Drug Class: Nitroimidazole Antimicrobial [EPC]
Marketing Start: 03/03/2025

Recall History

1 Recall on Record

Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective4,455 reports

nausea3,374 reports

off label use3,213 reports

diarrhoea2,652 reports

vomiting2,254 reports

pyrexia2,243 reports

headache2,175 reports

pain2,078 reports

abdominal pain2,044 reports

fatigue1,895 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. 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. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis , Chlamydia trachomatis , N. gonorrhoeae , Candida albicans , and Herpes simplex virus should be ruled out.

Dosage & Administration

DOSAGE AND ADMINISTRATION The recommended dose is one applicator full of metronidazole vaginal gel (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once-a-day dosing, metronidazole vaginal gel should be administered at bedtime.

Warnings

WARNINGS Convulsive Seizures and Peripheral Neuropathy Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole vaginal gel therapy. Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases. Psychotic Reactions Psychotic reactions have been reported in alcoholic patients who were using oral metronidazole and disulfiram concurrently. Metronidazole vaginal gel should not be administered to patients who have taken disulfiram within the last 2 weeks.

Contraindications

CONTRAINDICATIONS Metronidazole vaginal gel is contraindicated in patients with a prior history of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.

Drug Interactions

Drug Interactions 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 metronidazole vaginal gel is prescribed for patients on this type of anticoagulant therapy. In patients stabilized on relatively high doses of lithium, short-term oral metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity. Use of cimetidine with oral metronidazole may prolong the half-life and decrease plasma clearance of metronidazole.

Adverse Reactions

ADVERSE REACTIONS Clinical Trials There were no deaths or serious adverse events related to drug therapy in clinical trials involving 800 non-pregnant women who received metronidazole vaginal gel. In a randomized, single-blind clinical trial of 505 non-pregnant women who received metronidazole vaginal gel once or twice a day, 2 patients (one from each regimen) discontinued therapy early due to drug-related adverse events. One patient discontinued drug because of moderate abdominal cramping and loose stools, while the other patient discontinued drug because of mild vaginal burning. These symptoms resolved after discontinuation of drug. Medical events judged to be related, probably related, or possibly related to administration of metronidazole vaginal gel once or twice a day were reported for 195/505 (39%) patients. The incidence of individual adverse reactions were not significantly different between the two regimens. Unless percentages are otherwise stipulated, the incidence of individual adverse reactions listed below was less than 1%: Reproductive: Vaginal discharge (12%), Symptomatic Candida cervicitis/vaginitis (10%), Vulva/vaginal irritative symptoms (9%), Pelvic discomfort (…

Frequently Asked Questions

What is metronidazole vaginal used for?

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

Is metronidazole vaginal a controlled substance?

metronidazole vaginal is not classified as a controlled substance by the DEA.

What is the generic name for metronidazole vaginal?

The generic name for metronidazole vaginal is metronidazole. There are 12 other brand versions of metronidazole.

What is the NDC code for metronidazole vaginal 7.5 mg/g?

The NDC (National Drug Code) for metronidazole vaginal 7.5 mg/g is 71656-067, listed by Saptalis Pharmaceuticals LLC.

Product NDC

71656-067

Package NDC

71656-067-70

Other Metronidazole Brands

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

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