MERCILON- desogestrel, ethinyl estradiol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

OASIS TRADING

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral contraception 1 tab daily for 21 days; repeat.

Authorization status:

unapproved drug other

Summary of Product characteristics

MERCILON- DESOGESTREL, ETHINYL ESTRADIOL TABLET
OASIS TRADING
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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Desogestrel, Ethinyl Estradiol
Oral contraception
Keep out of reach of children
1 tab daily for 21 days; repeat.
Warnings/Precautions:
Smokers over 35yrs of age: not recommended. Uncontrolled hypertension.
Hypertriglyceridemia.
Discontinue if jaundice, visual disturbances, migraine or other severe
headaches occur. Do regular
complete physical exams. May need barrier contraception with Sunday
starts or postpartum use (see
literature). Nursing mothers: not recommended
Contraindications
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or
coronary artery disease. Breast
or other estrogen-dependent neoplasms. Undiagnosed abnormal genital
bleeding. Cholestatic jaundice
of pregnancy or jaundice with prior OC use. Hepatic adenoma or
carcinoma. Pregnancy (Cat.X).
Interactions
Antagonized by hepatic enzyme inducing drugs (eg, rifampin,
griseofulvin, St. John's wort), possibly
others. May affect measurement of sex hormone-binding globulin levels
Adverse Reactions:
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea,
transient delay of ovulation after
discontinuation, edema, chloasma, mastodynia, headache, intolerance to
contact lenses. Increased risk of
gallbladder disease, thromboembolic disorders.
Stearic acid, corn starch, polyethylene glycol 6000
For oral use only
MERCILON
desogestrel, ethinyl estradiol tablet
OASIS TRADING
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:726 8 9 -0 0 20
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DESO GESTREL (UNII: 8 1K9 V7M3A3) (DESOGESTREL - UNII:8 1K9 V7M3A3)
DESOGESTREL
0 .15 mg
ETHINYL ESTRADIO L (UNII: 423D2T571U) (ETHINYL ESTRADIOL -
UNII:423D2T571U)
ETHINYL ESTRADIOL
0 .0 2 mg
INACTIVE INGREDIENTS
INGREDIENT