SYEDA- drospirenone and ethinyl estradiol kit

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Xiromed, LLC.

INN (Algemene Internationale Benaming):

DROSPIRENONE

Samenstelling:

DROSPIRENONE 3 mg

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Syeda (drospirenone and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Syeda is contraindicated in females who are known to have or develop the following conditions: - 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 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 fibrilation) [see WARNINGS AND PRECAUTIONS (5.1)] Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS (5.1)] Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS (5.6)] Have diabetes melli

Product samenvatting:

Syeda (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 70700-115-85, Carton containing three blister cards. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

SYEDA- DROSPIRENONE AND ETHINYL ESTRADIOL
XIROMED, LLC.
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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.
• WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE DROSPIRENONE AND
ETHINYL
ESTRADIOL). (4)
• CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR
EVENTS FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 4/2022
INDICATIONS AND USAGE
Syeda (drospirenone and ethinyl estradiol tablets) is 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
Syeda consists of 28 film-coated, 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 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)
Co-administration with Hepatitis C drug combinations containing
ombitasvir, paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
• 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 delivery, in
women who are not breastfeeding. (5.1) COCs containing DRSP may be
associated with a higher risk of
venous thromboembolism (VT