TRI-LO-MILI- norgestimate and ethinyl estradiol kit

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Proficient Rx LP

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Tri-Lo-Mili (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Tri-Lo-Mili (norgestimate and ethinyl estradiol tablets) is contraindicated in females who are known to have or develop 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 o

產品總結:

Tri-Lo-Mili (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 71205-746-28  

授权状态:

Abbreviated New Drug Application

产品特点

TRI-LO-MILI- NORGESTIMATE AND ETHINYL ESTRADIOL
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRI-LO-MILI® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRI-LO-MILI.
TRI-LO-MILI (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._
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RECENT MAJOR CHANGES
Warnings and Precautions (5.11) 11/2021
INDICATIONS AND USAGE
Tri-Lo-Mili (norgestimate and ethinyl estradiol tablets) is an
estrogen/progestin COC, indicated for use by
women to prevent pregnancy. (1.1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tri-Lo-Mili (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):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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TRI-LO-MILI 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)
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)
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)
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 con