TRI-LINYAH- 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:

Northstar Rx LLC

DCI (Denominação Comum Internacional):

NORGESTIMATE

Composição:

NORGESTIMATE 0.18 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Tri-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Tri-Linyah is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Linyah should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)] . Tri-Linyah 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 cor

Resumo do produto:

Tri-Linyah Tablets are available in a compact blister card (NDC 16714-363-01). Each blister card (28 tablets) contains in the following order: Tri-Linyah is available in the following packaging configurations: Carton of 1 blister card     NDC 16714-363-02 Carton of 3 blister cards   NDC 16714-363-03 Carton of 6 blister cards   NDC 16714-363-04

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TRI-LINYAH- NORGESTIMATE AND ETHINYL ESTRADIOL
NORTHSTAR RX LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRI-LINYAH SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRI-LINYAH.
TRI-LINYAH (NORGESTIMATE/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-LINYAH 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)
04/2022
INDICATIONS AND USAGE
Tri-Linyah is an estrogen/progestin COC, indicated for use by women to
prevent pregnancy. (1.1)
Tri-Linyah is also indicated for the treatment of moderate acne
vulgaris in females at least 15 years of
age, who have no known contraindications to oral contraceptive therapy
and have achieved menarche.
Tri-Linyah should be used for the treatment of acne only if the
patient desires an oral contraceptive for
birth control. (1.2)
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-Linyah consists of 28 round, biconvex, coated tablets in the
following order (3):
7 green tablets each containing 0.180 mg norgestimate and 0.035 mg
ethinyl estradiol
7 light blue tablets each containing 0.215 mg norgestimate and 0.035
mg ethinyl estradiol
7 blue tablets each containing 0.250 mg norgestimate and 0.035 mg
ethinyl estradiol
7 white 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)
Breast cancer (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir