SEASONIQUE- levonorgestrel / ethinyl estradiol and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.15 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Seasonique® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Do not prescribe Seasonique to women who are known to have the following: - 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 fibrillation) [see Warnings and Precautions (5.1)] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] Have uncontrolled hypertension [see Warnings and Precautions (5.4)] . Have diabetes with vascular

Product summary:

Seasonique tablets (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers (NDC 54868-6276-0), 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 1 Extended-Cycle Tablet Dispensers      NDC 54868-6276-0 Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

SEASONIQUE - LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
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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/ETHINYL ESTRADIOL TABLETS AND 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_.
WOMEN WHO ARE OVER 35 YEARS OLD AND SMOKE SHOULD NOT USE SEASONIQUE.
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE.
INDICATIONS AND USAGE
Seasonique 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 for 91 days.
(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 genital 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 Seasonique if a thrombotic event occurs. Stop
Seasonique at least 4 weeks before and through 2
weeks after major surgery. Start Seasonique no earlier than 4 weeks
after delivery, in women who are not
breastfeeding. (5.1)
Liver disease: Discontinue Seasonique if jaundice occurs. (5.3)
High blood pressure: Do not prescribe Seasonique for women with
uncontrolled hypertension or hypertension with
vascular disease. (5.4)
Carbohydrate and lipid metabolic effects: Monitor prediabetic and
diabetic women taking Seasonique. Consider an
alternate contraceptive method for women with uncontrolled
dyslipidemias. (5.6)
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