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:

AvKARE

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)]. Estarylla™ 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 or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS (5.1)] - Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS (5.1)] - Have coronary artery disease [see WARNINGS AND PRECAUTIONS (5.1)] - Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS (5.1)] - Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS (5.4) ] - Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS (5.6) ] - Have headaches with focal neurological symptoms or migraine headaches with aura [see WARNINGS AND PRECAUTIONS (5.7) ] Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS (5.7) ] - Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS (5.7) ] - Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS (5.2)] - Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS (5.8) ] - Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS (5.9) and USE IN SPECIFIC POPULATIONS (8.1)] - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see WARNINGS AND PRECAUTIONS (5.11) ] - Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS AND PRECAUTIONS (5.3)] 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; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. Safety and efficacy of norgestimate and ethinyl estradiol have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated. Norgestimate and ethinyl estradiol has not been studied in postmenopausal women and is not indicated in this population. The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. [See CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.2). ] The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in women with renal impairment.

Product summary:

Norgestimate and Ethinyl Estradiol Tablets, USP are available in a blister card: Each blister card (28 tablets) contains in the following order: NDC 42291-565-28, one box containing 1 individual unit carton. NDC 42291-565-84, one box containing 3 individual unit cartons.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL
ESTRADIOL
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, USP
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.
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NORGESTIMATE AND ETHINYL ESTRADIOL 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) 11/2021
Warnings and Precautions ( 5.11) 11/2021
INDICATIONS AND USAGE
Norgestimate and Ethinyl Estradiol Tablets, USP is an
estrogen/progestin COC, indicated for use by women
to prevent pregnancy. ( 1.1)
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 blister pack. ( 2.2)
Do not skip or delay tablet intake. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Norgestimate and Ethinyl Estradiol Tablets, USP consists of 28 round,
coated tablets in the following order
( 3):
7 white tablets each containing 0.18 mg norgestimate and 0.025 mg
ethinyl estradiol.
7 light blue tablets each containing 0.215 mg norgestimate and 0.025
mg ethinyl estradiol.
7 blue tablets each containing 0.25 mg norgestimate and 0.025 mg
ethinyl estradiol.
7 green tablets (inert).
CONTRAINDICATIONS
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, with
or without dasabuvir ( 4)
WARNINGS AND PRECAUTIONS
THROMBOEMBOLI