SEASONIQUE- levonorgestrel / ethinyl estradiol and ethinyl estradiol kit

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Tillgänglig från:

Teva Women's Health LLC

INN (International namn):

LEVONORGESTREL

Sammansättning:

LEVONORGESTREL 0.15 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

SEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy. SEASONIQUE is contraindicated in females who are known to have or develop the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]. Have current or history of deep vein thrombosis or pulmonary embolism [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)]. Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]. Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions ( 5.3 )].

Produktsammanfattning:

How Supplied SEASONIQUE tablets (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers (NDC 51285-087-87), each containing a 13-week supply of tablets: 84 light blue-green tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. The light blue-green tablets are round, film-coated, biconvex, unscored tablets debossed with stylized b on one side and 555 on the other side. The yellow tablets are round, biconvex, film-coated, unscored tablets debossed with stylized b on one side and 556 on the other side. Box of 2 Extended-Cycle Tablet Dispensers              NDC 51285-087-87 Storage and Handling Store at 20°C to 25°C (68°F to 77° F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].

Bemyndigande status:

New Drug Application

Produktens egenskaper

SEASONIQUE- LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
TEVA WOMEN'S HEALTH LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEASONIQUE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEASONIQUE.
SEASONIQUE (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS; ETHINYL
ESTRADIOL TABLETS) FOR
ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEASONIQUE IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE. CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE.
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 01/2023
Warnings and Precautions, Malignant Neoplasms (5.11) 04/2022
INDICATIONS AND USAGE
SEASONIQUE is a combination of levonorgestrel, a progestin, and
ethinyl estradiol, an estrogen, indicated
for use by females of reproductive potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day for 91 days
in the order directed on the blister
pack. (2)
DOSAGE FORMS AND STRENGTHS
SEASONIQUE consists of 84 light blue-green tablets containing 0.15 mg
levonorgestrel and 0.03 mg
ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl
estradiol. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Liver tumors or liver disease, acute viral hepatitis or decompensated
cirrhosis (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir.(4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop if a thrombotic or thromboembolic 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. Consider cardiovascular risk factors before in