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:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.18 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norgestimate and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. Do not prescribe norgestimate and ethinyl estradiol tablets 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

Product summary:

Norgestimate and Ethinyl Estradiol Tablets USP are available as blister card pill dispensers (NDC 68462-719-84). Each blister card contains 28 tablets in the following order: NDC 68462-719-29 1 carton containing 3 blister cards of 28 tablets

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL ESTRADIOL
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND ETHINYL
ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR NORGESTIMATE AND
ETHINYL ESTRADIOL TABLETS.
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._
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RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.3) 08/2017
INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets are 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
Norgestimate and Ethinyl Estradiol Tablets consist of 28 round,
biconvex, coated tablets in the following order (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Norgestimate and ethinyl estradiol tablets are 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 white to off-white tablets each containing 0.18 mg norgestimate, USP
and 0.025 mg ethinyl estradiol, USP
7 light blue tablets each containing 0.215 mg norgestimate, USP and
0.025 mg ethinyl estradiol, USP
7 blue tablets each containing 0.25 mg norgestimate, USP and 0.025 mg
ethinyl estradiol, USP
7 green to dark green 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