TRI-LO-MILI- norgestimate and ethinyl estradiol kit

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Aurobindo Pharma Limited

INN (Διεθνής Όνομα):

NORGESTIMATE

Σύνθεση:

NORGESTIMATE 0.180 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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: - 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 coronary artery disease [see Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)

Περίληψη προϊόντος:

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 65862-778-28 Carton of 3 Blister Packs packaged in mono cartons             NDC 65862-778-85 Carton of 6 Blister Packs packaged in mono cartons             NDC 65862-778-86 Carton of 1 Pouch                                                                     NDC 65862-778-87 Carton of 3 Pouches                                                                  NDC 65862-778-88 Carton of 6 Pouches                                                                  NDC 65862-778-92   Keep out of the reach of children. 

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TRI-LO-MILI- NORGESTIMATE AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED
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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._
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)
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
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-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):
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)
CONTRAINDICATIONS
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 containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRE