Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY)
Lupin Pharmaceuticals, Inc.
PRESCRIPTION DRUG
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 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)] - 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)] - 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 tablets 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 tablets have not been studied in postmenopausal women and are not indicated in this population. The pharmacokinetics of norgestimate and ethinyl estradiol tablets 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 tablets has not been studied in women with renal impairment.
Norgestimate and ethinyl estradiol tablets USP are available in a blister pack (NDC 68180-840-71) containing 28 tablets packed in a pouch (NDC 68180-840-71). Such three pouches are packaged in a carton (NDC 68180-840-73). Each blister (28 tablets) contains in the following order: Keep out of reach of children.
Abbreviated New Drug Application
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 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._ 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 Warnings and Precautions (5.11) 12/2021 INDICATIONS AND USAGE Norgestimate and ethinyl estradiol tablets USP are estrogen/progestin COCs, 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. (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): 21 blue tablets each containing 0.25 mg norgestimate and 0.035 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) Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4) WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Problems : Stop norgestimate and ethinyl estradiol tablets if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after m Aqra d-dokument sħiħ