MICONAZOLE 7- miconazole nitrate suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)

Available from:

Strategic Sourcing Services LLC

INN (International Name):

MICONAZOLE NITRATE

Composition:

MICONAZOLE NITRATE 100 mg

Administration route:

VAGINAL

Prescription type:

OTC DRUG

Therapeutic indications:

Vaginal antifungal - treats vaginal yeast infections

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MICONAZOLE 7- MICONAZOLE NITRATE SUPPOSITORY
STRATEGIC SOURCING SERVICES LLC
----------
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH VAGINAL SUPPOSITORY)_
Miconazole nitrate, USP 100 mg
_PURPOSE_
Vaginal antifungal
_USE_
treats vaginal yeast infections
_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
VAGINAL YEAST INFECTIONS OFTEN (SUCH AS ONCE A MONTH OR 3 IN 6
MONTHS).
YOU MAY HAVE A MORE SERIOUS CONDITION. YOU COULD BE PREGNANT OR HAVE A
MEDICAL CONDITION, SUCH AS DIABETES OR A WEAKENED IMMUNE SYSTEM.
lower abdominal, back, or shoulder pain, fever, chills, nausea,
vomiting, or foul-
smelling vaginal discharge
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
do not use condoms or diaphragms. They may be damaged by this product
and not
prevent pregnancy or sexually transmitted diseases (STDs).
do not have vaginal intercourse (sex)
mild increase in vaginal burning, itching or irritation may occur
STOP USE AND ASK A DOCTOR IF
SIDE EFFECTS OCCUR.
SYMPTOMS DO NOT GET BETTER AFTER 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
(1-800-222-1222)
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: insert 1 suppository
into the vagina at
bedtime for 7 nights in a row. Wash appli