NORGESTIMATE AND ETHINYL ESTRADIOL - norgestimate and ethinyl estradiol

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:

Lupin Pharmaceuticals, Inc.

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.18 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norgestimate and ethinyl estradiol tablets USP are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)]. Norgestimate and ethinyl estradiol tablets USP 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. Norgestimate and ethinyl estradiol tablets USP 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 norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions:     •    A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:           o  Smoke, if over age 35 [see BOXED WARNING AND WARNINGS AND PRECAUTIONS (5.1)]           o   Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS (5.1)]           o   Hav

Product summary:

Norgestimate and ethinyl estradiol tablets USP are available in a wallet pack (NDC 68180-838-11) containing 28 tablets packed in a pouch (NDC 68180-838-11). Such three pouches are packaged in a carton (NDC 68180-838-13). Each wallet (28 tablets) contains in the following order:     •    7 white, round, film coated tablets, debossed with "E25" on one side and "LU" on the other side of the tablet contains 0.18 mg norgestimate and 0.035 mg ethinyl estradiol     •    7 light blue, round, film coated tablets, debossed with "E26" on one side and "LU" on the other side of the tablet contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol     •    7 blue round, film coated tablets, debossed with on "E27" one side and "LU" on the other side of the tablet contains 0.25 mg norgestimate and 0.035 mg ethinyl estradiol     •    7 green, round, biconvex, film coated tablets (non-hormonal placebo) debossed with 'LU' on one side and "E24" on the other side contains inert ingredients Keep out of reach of children.     •    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP controlled room temperature].     •    Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORGESTIMATE AND ETHINYL ESTRADIOL - NORGESTIMATE AND ETHINYL
ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND ETHINYL
ESTRADIOL TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR NORGESTIMATE AND
ETHINYL ESTRADIOL TABLETS USP.
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• NORGESTIMATE AND ETHINYL ESTRADIOL TABLET 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 (4) 8/2017
Warnings and Precautions (5.3) 8/2017
INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets USP are estrogen/progestin
COCs, indicated for use by women to prevent
pregnancy. (1.1)
Norgestimate and ethinyl estradiol tablets USP 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.
Norgestimate and ethinyl estradiol tablets USP 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. (2.2)
• Take tablets in the order directed on the wallet. (2.2)
• Do not skip or delay tablet intake. (2.2)
DOSAGE FORMS AND STRENGTHS
Norgestimate and ethinyl estradiol tablets consist of 28 round,
biconvex, coated tablets in the following order (3):
• 7 white 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