Miconazole Nitrate

Prescription

Nombres comerciales: Miconazole Nitrate

Forma Farmacéutica

Other

Vía de Administración

VAGINAL

Fabricante

Actavis Pharma, Inc.

About This Medication

DESCRIPTION Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, USP 1-[2,4-Dichloro-β-[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. The molecular formula is C 18 H 14 Cl 4 N 2 O•HNO 3 ; the molecular weight is 479.14 and the structural formula may be represented as follows: 009711be-figure-01

Principios Activos

Ingrediente	Concentración
Miconazole Nitrate	-

Indicaciones y Uso

INDICATIONS AND USAGE Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.

Dosificación y Administración

DOSAGE AND ADMINISTRATION Miconazole Nitrate Vaginal Suppositories USP, 200 mg: One suppository (miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures to rule out other pathogens.

Side Effects Overview

ADVERSE REACTIONS During clinical studies with Miconazole Nitrate Vaginal Suppositories USP, 200 mg, 301 patients were treated. The incidence of vulvovaginal burning, itching or irritation was 2%. Complaints of cramping (2%) and headaches (1 . 3%) were also reported. Other complaints (hives, skin rash) occurred with less than a 0 . 5% incidence. The therapy-related dropout rate was 0 . 3%. To report SUSPECTED ADVERSE EVENTS, contact Teva Pharmaceuticals USA, Inc., at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Contraindicaciones

CONTRAINDICATIONS Patients known to be hypersensitive to this drug.

Frequently Asked Questions

INDICATIONS AND USAGE Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.

DOSAGE AND ADMINISTRATION Miconazole Nitrate Vaginal Suppositories USP, 200 mg: One suppository (miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures to rule out other pathogens.

CONTRAINDICATIONS Patients known to be hypersensitive to this drug.

Miconazole Nitrate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Miconazole Nitrate drug label (National Library of Medicine)
• openFDA — Miconazole Nitrate label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 992765 (NLM Normalized Drug Names)
• NDC Directory — Miconazole Nitrate (FDA National Drug Code)

Aviso Médico

La información en esta página tiene fines exclusivamente educativos y no debe utilizarse como sustituto del consejo médico profesional, diagnóstico o tratamiento.

Siempre consulte a su médico u otro proveedor de salud calificado ante cualquier pregunta que pueda tener sobre una condición médica o medicamento.

Fuentes de datos: DailyMed (NLM), openFDA, MFDS