TRI-ESTARYLLA- 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:

Xiromed, LLC.

DCI (Denominação Comum Internacional):

NORGESTIMATE

Composição:

NORGESTIMATE 0.180 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Tri-Estarylla (norgestimate and ethinyl estradiol) Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)] . Tri-Estarylla 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-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see CLINICAL STUDIES (14)]. Tri-Estarylla 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 hyper coagulopathies [see WARNINGS AND PRECAUTIONS (5.1)] Have cerebrovascular

Resumo do produto:

Tri-Estarylla (norgestimate and ethinyl estradiol tablets, USP) is available in blisters containing 28 tablets as follows: Each blister card contains 21 active tablets and 7 inactive tablets. 7 white (active) tablets are round, debossed with SZ on one side and T2 on the other side and contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 light blue (active) tablets are round, debossed with SZ on one side and T3 on the other side and contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 blue (active) tablets are round, debossed with SZ on one side and T4 on the other side and contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 green (inert) tablets are round, debossed with SZ on one side and J1 on the other side. NDC 70700-121-85, Carton containing three blister cards.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TRI-ESTARYLLA- NORGESTIMATE AND ETHINYL ESTRADIOL
XIROMED, LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRI-ESTARYLLA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRI-ESTARYLLA.
TRI-ESTARYLLA (NORGESTIMATE AND ETHINYL ESTRADIOL, USP) TABLETS,
FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Contraindications. Pregnancy (4)
06/2023
INDICATIONS AND USAGE
Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a
combinations of norgestimate, a progestin, and
ethinyl estradiol, and estrogen, indicated for use by females of
reproductive potential to prevent
pregnancy. (1.1)
Tri-Estarylla 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-Estarylla 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. (2.1)
Take tablets in the order directed on the blister pack. (2.1)
Do not skip or delay tablet intake. (2.1)
DOSAGE FORMS AND STRENGTHS
Tri-Estarylla (norgestimate and ethinyl estradiol) tablets, USP
consists of 28 round, biconvex, coated
tablets in the following order (3):
7 white 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 dark 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)
Breast cancer (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/parit