United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg and norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg 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: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy

Canada - English - Health Canada

glenmark pharmaceuticals canada inc. - ethinyl estradiol; norgestimate; norgestimate; ethinyl estradiol; norgestimate; ethinyl estradiol - tablet - 0.035mg; 0.18mg; 0.215mg; 0.035mg; 0.25mg; 0.035mg - ethinyl estradiol 0.035mg; norgestimate 0.18mg; norgestimate 0.215mg; ethinyl estradiol 0.035mg; norgestimate 0.25mg; ethinyl estradiol 0.035mg - contraceptives

Canada - English - Health Canada

glenmark pharmaceuticals canada inc. - ethinyl estradiol; norgestimate; norgestimate; ethinyl estradiol; norgestimate; ethinyl estradiol - tablet - 0.035mg; 0.18mg; 0.215mg; 0.035mg; 0.25mg; 0.035mg - ethinyl estradiol 0.035mg; norgestimate 0.18mg; norgestimate 0.215mg; ethinyl estradiol 0.035mg; norgestimate 0.25mg; ethinyl estradiol 0.035mg - contraceptives

United Kingdom - English - myHealthbox

janssen-cilag ltd - norgestimate, ethinylestradiol - film-coated tablet - 35/ 250 micrograms - hormonal contraceptives for systemic use; progestogens and estrogens, fixed combinations - contraception and the recognised indications for such estrogen/progestogen combinations

United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - ethinyl estradiol 0.035 mg - norgestimate and ethinyl estradiol tablets usp 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: - 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 warni

United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - 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.

Canada - English - Health Canada

patriot a division of janssen inc - norgestimate; ethinyl estradiol - tablet - 0.250mg; 0.035mg - norgestimate 0.250mg; ethinyl estradiol 0.035mg - contraceptives

Canada - English - Health Canada

patriot a division of janssen inc - norgestimate; ethinyl estradiol - tablet - 0.250mg; 0.035mg - norgestimate 0.250mg; ethinyl estradiol 0.035mg - contraceptives

Canada - English - Health Canada

novopharm limited - norgestimate; ethinyl estradiol - tablet - 0.25mg; 0.035mg - norgestimate 0.25mg; ethinyl estradiol 0.035mg - contraceptives

Canada - English - Health Canada

novopharm limited - norgestimate; ethinyl estradiol - tablet - 0.25mg; 0.035mg - norgestimate 0.25mg; ethinyl estradiol 0.035mg - contraceptives