Miconazole Nitrate

Prescription

Handelsnamen: Miconazole Nitrate

Darreichungsform

Other

Applikationsweg

VAGINAL

Hersteller

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

Wirkstoffe

Wirkstoff	Stärke
Miconazole Nitrate	-

Indikationen und Anwendung

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.

Dosierung und Verabreichung

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.

Kontraindikationen

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.

Similar Other Products

Cadmium Sulfate, Graphite, Phosphoric …

Romidepsin

Passiflora Incarnata, Ignatia Amara, …

Procaine, Tetracaine, Prilocaine

Iron, Folic Acid, Vitamin/Mineral …

Strontium Salicylate, Methenamine, Colchicum …

Browse all Other products →

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)

Medizinischer Haftungsausschluss

Die Informationen auf dieser Seite dienen ausschließlich zu Bildungszwecken und sollten nicht als Ersatz für professionellen ärztlichen Rat, Diagnose oder Behandlung verwendet werden.

Wenden Sie sich bei Fragen zu einem medizinischen Zustand oder einem Arzneimittel stets an Ihren Arzt oder einen anderen qualifizierten Angehörigen der Gesundheitsberufe.

Datenquellen: DailyMed (NLM), openFDA, MFDS