TRI-VYLIBRA LO- 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:

Afaxys Pharma, LLC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) 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

Resumo do produto:

Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets USP) 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 50102-231-11 Carton of 3 Blister Packs packaged in mono cartons                          NDC 50102-231-13 Keep out of the reach of children. 

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TRI-VYLIBRA LO- NORGESTIMATE AND ETHINYL ESTRADIOL
AFAXYS PHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRI-VYLIBRA LO SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRI-VYLIBRA LO.
TRI-VYLIBRA LO (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._
TRI-VYLIBRA LO 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
Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is an
estrogen/progestin COC, 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
Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets USP)
consists of 21 round, biconvex, coated
tablets and 7 round, mottled, biconvex, uncoated tablets in the
following order (3):
7 white to off white tablets each containing 0.180 mg norgestimate and
0.025 mg ethinyl estradiol
7 pale blue to bluish white tablets each containing 0.215 mg
norgestimate and 0.025 mg ethinyl
estradiol
7 blue to light blue tablets each containing 0.250 mg norgestimate and
0.025 mg ethinyl estradiol
7 green 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)
WAR