Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Proficient Rx LP
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
TRI-LO-MILI- NORGESTIMATE AND ETHINYL ESTRADIOL PROFICIENT RX LP ---------- 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._ • • 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 • • • 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): • • • • CONTRAINDICATIONS • • • • • WARNINGS AND PRECAUTIONS • • • • 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 Прочетете целия документ