Rx Item-Metronidazole 0.75% Gel 70Gm By Sandoz Pharma

VANDAZOLE- metronidazole gel
Upsher-Smith Laboratories, Inc.

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 non-pregnant women.

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.

3 DOSAGE FORMS AND STRENGTHS

VANDAZOLE 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
DESCRIPTION

VANDAZOLE (metronidazole vaginal gel, 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.
Mechanism of Action
Metronidazole is an antibacterial drug
Microbiology
Mechanism of Action

The intracellular targets of action of metronidazole on anaerobes are largely unknown. 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. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of metronidazole on anaerobic organisms.

Activity In Vitro

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:
PATIENT COUNSELING INFORMATION

17.1 Interaction with Alcohol
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)].

17.2 Drug Interactions
Instruct the patient not to use VANDAZOLE if disulfiram had been used within the last two weeks [see Contraindications (4.2) ], and to inform their healthcare provider if they are taking oral anticoagulants, or lithium [see Drug Interactions (7.3, 7.4)].

17.3 Vaginal Intercourse and Use with Vaginal Products
Instruct the patient not to engage in vaginal intercourse, or use other vaginal products (such as tampons or douches) during treatment with VANDAZOLE.

17.4 Fungal Vaginal Infections
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) ].

17.5 Human Milk Feeding
Advise women that they may consider discontinuing milk feeding or pump and discard their milk during treatment and for 24 hours after the last dose of VANDAZOLE [see Use in Specific Populations (8.3) ].

17.6 Accidental Exposure to the Eye
Inform the patient that VANDAZOLE contains ingredients that may cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water and consult a healthcare provider.

17.7 Vaginal Irritation
Inform the patient to discontinue use and consult a healthcare provider if vaginal irritation occurs with use of VANDAZOLE.

17.8 Administration of Drug
Instruct the patient that VANDAZOLE (metronidazole vaginal gel, 0.75%) is supplied with 5 vaginal applicators. For once daily dosing, one applicator should be used per dose. See DIRECTIONS FOR USE for complete instructions on how to use the product and the vaginal applicator.

RX ITEM-Metronidazole 0.75% Gel 70Gm By
NDC 00781-7077-87 UPC/GTIN No.3-07817-07787-5 Mfg.Part No.707787

Metronidazole 0.75% Gel 70Gm By Sandoz P
BRAND: METRONIDAZOLE NDC: 00781-7077-87,781707787 UPC: 3-07817-07787-5,307817077875

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