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

glenmark pharmaceuticals inc., usa - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.18 mg - 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)]. norgestimate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy, therefore, norgestimate and ethinyl

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

mylan pharmaceuticals inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive age to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets should be discontinued during 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 chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. risk summary contraceptive hormones and/or metabolites are present in human milk. chcs

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

glenmark pharmaceuticals inc., usa - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets should be discontinued during 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 cocs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. risk summary contraceptive hormones and/or metabolites are present in human milk. cocs can reduce milk production in breastfeeding females. this reduction can occur at any

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

rpk 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)]. norgestimate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: there is little or no increased risk of birth defects in women who inadvertently use cocs during

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lupin healthcare (uk) ltd - levonorgestrel - oral tablet - 1.5mg

Australia - English - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - levonorgestrel, quantity: 1.5 mg - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; lactose monohydrate; povidone; colloidal anhydrous silica - emergency contraception within 72 hours of unprotected intercourse.

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

mylan pharmaceuticals inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - norgestimate 0.18 mg

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

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

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

mylan 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 and 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 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 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. 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

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

lupin pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - 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)]. norgestimate and ethinyl estradiol tablets are 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:           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   have inherited or acquired hyper coagulopathies [see warnings and precautions (5.1)]           o   have cerebrovascular disease [see warnings and precautions (5.1)]           o   have coronary artery disease [see warnings and precautions (5.1)]           o   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)]           o   have uncontrolled hypertension [see warnings and precautions (5.4)]           o   have diabetes mellitus with vascular disease [see warnings and precautions (5.6)]           o   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)]     •    current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.10)]     •    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)] risk summary there is no use for contraception in pregnancy, therefore, norgestimate and ethinyl estradiol tablets usp should be discontinued during  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 chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. risk summary contraceptive hormones and/or metabolites are present in human milk. chcs can reduce milk production in breastfeeding females. this reduction can occur at any time but is less likely to occur once breastfeeding is well-established. when possible, advise the nursing female to use other forms of contraception until she discontinues breast-feeding. the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for norgestimate and ethinyl estradiol tablets usp and any potential adverse effects on the breast-fed child from norgestimate and ethinyl estradiol tablets usp or from the underlying maternal condition. 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. there was no significant difference between norgestimate and ethinyl estradiol tablets and placebo in mean change in total lumbar spine (l1 to l4) and total hip bone mineral density between baseline and cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the intent to treat (itt) population. 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.