QUASENSE- levonorgestrel and ethinyl estradiol

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Actavis Pharma, Inc.

INN (International Nazwa):

LEVONORGESTREL

Skład:

LEVONORGESTREL 0.15 mg

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

QUASENSE® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Do not prescribe QUASENSE to women who are known to have the following conditions: - 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see Warnings

Podsumowanie produktu:

QUASENSE (levonorgestrel and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: 91-Day Regimen 84 white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 peach inert tablets. The active white tablets are round, flat faced, beveled edge, unscored tablets with debossed WATSON on one side and 966 on the other side. The inert tablets are peach, round, flat faced, beveled edge, unscored tablet debossed with WATSON on one side and P1 on the other side. Box of 3 Extended-Cycle Tablet Dispensers                         NDC 52544-966-91

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

QUASENSE- LEVONORGESTREL AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUASENSE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR QUASENSE.
QUASENSE (LEVONORGESTREL 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.
QUASENSE 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 (4) 08/2017
Warnings and Precautions (5.3) 08/2017
INDICATIONS AND USAGE
QUASENSE 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.
(2.1)
Take tablets in the order directed on the Extended-Cycle Tablet
Dispenser. (2.2)
DOSAGE FORMS AND STRENGTHS
QUASENSE consists of 84 round, white tablets containing 0.15 mg of
levonorgestrel and 0.03 mg of ethinyl estradiol, and 7
round, peach inert tablets. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
Thrombotic disorders and other vascular problems: Stop QUASENSE 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)
Liver disease: Discontinue QUASENSE if jaundice occurs. (5.2)
High blood pressure: If used in women with well-controlled
hypertension, monitor blood pressure and stop Q