SYEDA- drospirenone and ethinyl estradiol

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Sandoz Inc

INN (Alþjóðlegt nafn):

DROSPIRENONE

Samsetning:

DROSPIRENONE 3 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

SyedaTM (drospirenone and ethinyl estradiol tablets) are indicated for use by women to prevent pregnancy. Do not prescribe SyedaTM to women who are known to have the following: - Renal Impairment - Adrenal insufficiency - A 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 thorombosis 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 fibrilation) [see WARNINGS AND PRECAUTIONS (5.1)] Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS (5.1)] Have uncontrolled hypertension [see WARNINGS

Vörulýsing:

SyedaTM tablets (drospirenone and ethinyl estradiol tablets, USP) are (active tablets), round, yellow colored, film coated tablets, SZ and U3 are debossed on opposite sides of the tablet. Inert/Placebo, are round, white film coated tablets, SZ and J1 are debossed on opposite sides of the tablet. NDC 0781-5658-15, one box containing 3 individual unit cartons Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

SYEDA- DROSPIRENONE AND ETHINYL ESTRADIOL
SANDOZ INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYEDA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SYEDA
.
SYEDA (DROSPIRENONE AND ETHINYL ESTRADIOL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions, Hyperkalemia (5.5) 08/2017
INDICATIONS AND USAGE
Sye da
(drospirenone and ethinyl estradiol tablets, USP) is an
estrogen/progestin COC indicated for use by women to
prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Sye da
(drospirenone and ethinyl estradiol tablets) consists of 28
film-coated, tablets in the following order (3):
•
•
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)
Co-administration with Hepatits C drug combinations containing
ombitasvir, paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
•
•
TM
TM
TM
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)
TM
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)
TM
21 yellow active tablets, each containing 3 mg drospirenone (DRSP) and
0.03 mg ethinyl estradiol (EE),
7 inert white tablets
Vascular risks: Stop drospirenone and ethinyl estradiol 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 de