TRI-SPRINTEC- norgestimate and ethinyl estradiol kit

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Teva Pharmaceuticals USA, Inc.

INN (Међународно име):

NORGESTIMATE

Састав:

NORGESTIMATE 0.18 mg

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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)] . Tri-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

Резиме производа:

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of six blister cards (NDC: 0555-9018-58). Each blister card contains 28 tablets in the following order:

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

TRI-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-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._
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)
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 06/2023
INDICATIONS AND USAGE
Tri-Sprintec
(norgestimate and ethinyl estradiol tablets) is a combination of
norgestimate, a progestin,
and ethinyl estradiol, an estrogen, indicated for use by females of
reproductive potential to prevent
pregnancy. (1.1)
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. (1.2)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.1)
Take tablets in the order directed on the blister pack. (2.1)
Do not skip or delay tablet intake. (2.1)
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):
7 gray tablets each containing 0.18 mg norgestimate and 0.035 mg
ethinyl estradiol
7 light blue tablets each containing 0.215 mg norgestimate and 0.035
mg ethinyl estradiol
7 blue tablets each containing 0.25 mg norgestimate and 0.035