DROSPIRENONE AND ETHINYL ESTRADIOL- drospirenone and ethinyl estradiol kit

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)

זמין מ:

LUPIN LIMITED

INN (שם בינלאומי):

ETHINYL ESTRADIOL

הרכב:

ETHINYL ESTRADIOL 0.03 mg

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Drospirenone and ethinyl estradiol tablets USP are indicated for use by women to prevent pregnancy. Do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following:      •      Renal impairment      •      Adrenal insufficiency       •      high risk of arterial or venous thrombotic diseases. Examples include women who are known to:               ○        Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1) ]               ○        Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS (5.1) ]               ○        Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS (5.1) ]               ○        Have coronary artery disease [see WARNINGS AND PRECAUTIONS (5.1) ]               ○        Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS (5.1) ]            

leaflet_short:

Drospirenone and ethinyl estradiol tablets USP, 3 mg and 0.03 mg are available in 28 tablets wallet (NDC 68180-902-11). Three such wallets are packed in a carton (NDC 68180-902-13). Each wallet contains 28 film-coated tablets in the following order: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DROSPIRENONE AND ETHINYL ESTRADIOL - DROSPIRENONE AND ETHINYL
ESTRADIOL
LUPIN LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS
USP.
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP, 3 MG/0.03 MG, FOR ORAL
USE
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE DROSPIRENONE AND
ETHINYL ESTRADIOL TABLETS. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Warnings and Precautions, Hyperkalemia (5.2) 5/2015
INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets USP are an
estrogen/progestin COC indicated for use by women to prevent
pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
DOSAGE FORMS AND STRENGTHS
Drospirenone and ethinyl estradiol tablets consists of 28 film-coated,
biconvex tablets in the following order (3):
21 yellow tablets, each containing 3 mg drospirenone (DRSP) and 0.03
mg ethinyl estradiol (EE),
7 inert white to off-white tablets
CONTRAINDICATIONS
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
WARNINGS AND PRECAUTIONS
Vascular risks : Stop drospirenone and ethinyl estradiol tablets if a
thrombotic event occurs. Stop at least 4 weeks
before and through 2 weeks after major surgery. Start no earlier than
4 weeks after delivery, in women who are not
breastfeeding. (5.1) COCs containing DRSP may be