VAGISTAT-3 miconazole nitrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Miconazole nitrate (200 mg in each suppository), Miconazole nitrate 2% (external cream)

Available from:

Novartis Consumer Health, Inc.

Prescription type:

OTC DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VAGISTAT-3- MICONAZOLE NITRATE
NOVARTIS CONSUMER HEALTH, INC.
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DRUG FACTS
ACTIVE INGREDIENTS
Miconazole nitrate (200 mg in each suppository)
Miconazole nitrate 2% (external cream)
PURPOS E
Vaginal antifungal
US ES
treats vaginal yeast infections
relieves external itching and irritation due to a vaginal yeast
infection
WARNINGS
FOR VAGINAL USE ONLY
DO NOT USE IF YOU HAVE NEVER HAD A VAGINAL YEAST INFECTION DIAGNOSED
BY A DOCTOR
ASK A DOCTOR BEFORE USE IF YOU HAVE
VAGINAL ITCHING AND DISCOMFORT FOR THE FIRST TIME
LOWER ABDOMINAL, BACK OR SHOULDER PAIN, FEVER, CHILLS, NAUSEA,
VOMITING, OR FOUL-SMELLING
VAGINAL DISCHARGE. YOU MAY HAVE A MORE SERIOUS CONDITION.
vaginal yeast infections often (such as once a month or 3 in 6
months). You could be pregnant or
have a serious underlying medical cause for your symptoms, including
diabetes or a weakened
immune system.
been exposed to the human immunodeficiency virus (HIV) that causes
AIDS
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking a prescription blood thinning medicine, such as warfarin,
because bleeding or bruising may occur
WHEN USING THIS PRODUCT
do not use tampons, douches, spermicides or other vaginal products.
Condoms and diaphragms may
be damaged and fail to prevent pregnancy or sexually transmitted
diseases (STDs).
do not have vaginal intercourse
mild increase in vaginal burning, itching or irritation may occur
STOP USE AND ASK A DOCTOR IF
SYMPTOMS DO NOT GET BETTER IN 3 DAYS
SYMPTOMS LAST MORE THAN 7 DAYS
YOU GET A RASH OR HIVES, ABDOMINAL PAIN, FEVER, CHILLS, NAUSEA,
VOMITING, OR FOUL-SMELLING
VAGINAL DISCHARGE
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
before using this product, read the enclosed consumer information
leaflet for complete instructions
and information
adults and children 12 years of age and over:
1. ● SUPPOSITORIES: insert 1 suppository into the vagina at bedtime
for 3 nights in a