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:

Proficient Rx LP

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)] . Do not prescribe Tri-Lo-Sprintec 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 well-established; howev

Product summary:

Tri-Lo-Sprintec® 28 (norgestimate and ethinyl estradiol tablets USP) is packaged in pouches of one blister card (NDC: 71205-287-28). 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
PROFICIENT RX LP
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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._
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RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.3) 08/2017
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
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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):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
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)
®
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 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)
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