TRI-LO- ESTARYLLA- norgestimate and ethinyl estradiol

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Sandoz Inc

INN (International Adı):

NORGESTIMATE

Kompozisyon:

NORGESTIMATE 0.18 mg

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Tri-Lo-EstaryllaTM (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)]. Do not prescribe norgestimate and ethinyl estradiol to women who are known to have the following conditions: There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion. Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is we

Ürün özeti:

Tri-Lo-EstaryllaTM (norgestimate and ethinyl estradiol tablets, USP) are available in a blister card: Each blister card (28 tablets) contains in the following order:

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

TRI-LO- ESTARYLLA- NORGESTIMATE AND ETHINYL ESTRADIOL
SANDOZ INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRI-LO-ESTARYLLA SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR TRI-LO-ESTARYLLA
.
T RI-LO -ESTARYLLA (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._
•
•
RECENT MAJOR CHANGES
RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.3) 08/2017
INDICATIONS AND USAGE
T ri-Lo-Estarylla
(norgestimate and ethinyl estradiol tablets) is an estrogen/progestin
COC, indicated for use by women
to prevent pregnancy. (1.1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
T ri-Lo-Estarylla
consists of 28 round, coated tablets in the following order (3):
•
•
•
•
CONTRAINDICATIONS
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
TM
TM
TM
NORGESTIMATE AND ETHINYL ESTRADIOL 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)
Contraindications (4) 08/2017
Warnings and Precautions (5.3) 08/2017
TM
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)
TM
7 white tablets each containing 0.18 mg norgestimate and 0.025 mg
ethinyl estradiol.
7 light blue tablets each containing 0.215 mg norgestimate and 0.025
mg ethinyl estradiol.
7 blue tablets each containing 0.25 mg norgestimate and 0.025 mg
ethinyl estradiol.
7 green tablets (inert).
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 combina