VYLIBRA- norgestimate and ethinyl estradiol kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Disponível em:

RPK Pharmaceuticals, Inc.

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

VyLibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . VyLibra 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 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 and Precautions (5.4)] Have diabet

Resumo do produto:

VyLibra  ( norgestimate and ethinyl estradiol tablets USP 0.250 mg/0.035 mg) are available in a blister pack. Each blister pack (28 tablets) contains in the following order: The blister packs are available in the following packages: Carton of 1 Blister Pack                                                         NDC 50102-235-11 Carton of 3 Blister Packs packaged in mono cartons             NDC 50102-235-13

Status de autorização:

Abbreviated New Drug Application

Características técnicas

VYLIBRA- NORGESTIMATE AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VYLIBRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VYLIBRA.
VYLIBRA (NORGESTIMATE AND ETHINYL ESTRADIOL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
VYLIBRA IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVES (COC) USE. (4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.11) 11/2021
INDICATIONS AND USAGE
VyLibra is estrogen/progestin COCs, indicated for use by women to
prevent pregnancy. (1.1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.2)
Take tablets in the order directed on the blister pack. (2.2)
Do not skip or delay tablet intake. (2.2)
DOSAGE FORMS AND STRENGTHS
VyLibra consists of 28 round, biconvex tablets in the following order
(3):
21 dark blue, coated tablets each containing 0.250 mg norgestimate and
0.035 mg ethinyl estradiol
7 green, uncoated tablets (inert)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Current diagnosis of, or history of, breast cancer, which may be
hormone-sensitive (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Other Vascular Problems: Stop VyLibra 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 VyLibra if jaundice occurs. (5.2)
High blood pressure: If used in women with well-c