LOSEASONIQUE- 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:

Teva Women's Health LLC

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LOSEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy. LOSEASONIQUE 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 (5.5)]

Product summary:

How Supplied LOSEASONIQUE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in an Extended-Cycle Tablet Dispenser that contains 84 orange tablets and 7 yellow tablets. Each round orange tablet (debossed stylized b on one side and 28 on the other side) contains 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol. Each round yellow tablet (debossed stylized b on one side and 556 on the other side) contains 0.01 mg ethinyl estradiol. Box of 2 Extended-Cycle Tablet Dispensers      NDC 51285-092-87 Storage and Handling Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature]. The tablets should not be removed from the protective blister packaging and outer plastic dispenser to avoid damage to the product. The plastic dispenser should be kept in the foil pouch until dispensed to the patient.

Authorization status:

New Drug Application

Summary of Product characteristics

LOSEASONIQUE- 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
LOSEASONIQUE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOSEASONIQUE.
LOSEASONIQUE (LEVONORGESTREL AND 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._
LOSEASONIQUE IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE.
(4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 01/2023
Warnings and Precautions, Malignant Neoplasms (5.11) 04/2022
INDICATIONS AND USAGE
LOSEASONIQUE 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
LOSEASONIQUE consists of 84 orange tablets containing 0.1 mg
levonorgestrel and 0.02 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 fact