TRI-LO-SPRINTEC- norgestimate and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.18 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Tri-Lo-Sprintec 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 )] Have uncontrolled hypertension [

Product summary:

Tri-Lo-Sprintec® 28 (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of three blister cards (NDC: 0093-2140-62). Each of the 7 gray tablets contains 0.18 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 451 on the other side; Each of the 7 light blue tablets contains 0.215 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 452 on the other side; Each of the 7 blue tablets contains 0.25 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 453 on the other side. The 7 placebo tablets are white, round, biconvex, unscored, placebo tablets, debossed with stylized b on one side and 208 on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRI-LO-SPRINTEC- NORGESTIMATE AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRI-LO-SPRINTEC SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRI-LO-SPRINTEC.
TRI-LO-SPRINTEC (NORGESTIMATE/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-SPRINTEC 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-Sprintec
(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-Sprintec (norgestimate and ethinyl estradiol tablets USP) is
available in a blister card. Each blister
card contains 28 tablets in the following order (3):
7 gray tablets containing 0.18 mg norgestimate and 0.025 mg ethinyl
estradiol
7 light blue tablets containing 0.215 mg norgestimate and 0.025 mg
ethinyl estradiol
7 blue tablets containing 0.25 mg norgestimate and 0.025 mg ethinyl
estradiol
7 white 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)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Other Vascular Problems: Stop
Tri-Lo-Spr