TRI-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:

Preferred Pharmaceuticals Inc.

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.18 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Tri-Sprintec (norgestimate and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)] . Do not prescribe Tri-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

Product summary:

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) 0.18 mg/0.035 mg are gray, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 985 on the other side; 0.215 mg/0.035 mg are light blue, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 986 on the other side; 0.25 mg/0.035 mg are blue, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 987 on the other side; placebo tablets are white, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 143 on the other side. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of six blister cards. Each card contains 28 tablets as follows: Each gray tablet contains 0.18 mg of the progestational compound, norgestimate, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP. Each blue tablet contains 0.25 mg of the progestational compound, norgestimate, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP, and the 7 white placebo tablets contain inert ingredients. NDC: 68788-

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRI-SPRINTEC- NORGESTIMATE AND ETHINYL ESTRADIOL
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRI-SPRINTEC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRI-SPRINTEC.
TRI-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-Sprintec
(norgestimate and ethinyl estradiol tablets) is an estrogen/progestin
COC, indicated for use
by women to prevent pregnancy. (1.1)
Tri-Sprintec
(norgestimate and ethinyl estradiol tablets) is also indicated for the
treatment of moderate
acne vulgaris in females at least 15 years of age, who have no known
contraindications to oral
contraceptive therapy and have achieved menarche.
Tri-Sprintec
(norgestimate and ethinyl estradiol tablets) should be used for the
treatment of acne only if
the patient desires an oral contraceptive for birth control. (1.2)
DOSAGE AND ADMINISTRATION
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•
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DOSAGE FORMS AND STRENGTHS
Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) consists
of 28 round, flat-faced, beveled-
edge, unscored tablets in the following order (3):
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•
•
•
CONTRAINDICATIONS
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•
•
•
•
•
WARNINGS AND PRECAUTIONS
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•
®
TRI-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 each containing 0.18 mg norgestimate /0.035 mg ethinyl
estradiol
7 light blue tablets each containing 0.215 mg norgestimate /0.035 mg
ethinyl estradiol
7