LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Доступна з:

Lupin Pharmaceuticals, Inc.

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel 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 females who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] . Have current or history of deep vein thrombosis or pulmonary embolism [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 inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]. Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.4)] . Have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see Warnings and Precautions (5.7)] . - Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] . - Have current or history of deep vein thrombosis or pulmonary embolism [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 inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]. - Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.4)] . - Have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see Warnings and Precautions (5.7)] . - Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see Warnings and Precautions (5.8) ]. - Current diagnosis of, or history of breast cancer, which may be hormone sensitive [see Warnings and Precautions (5.11)].           Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].           Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9) ].           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, 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 time but is less likely to occur once breastfeeding is well- established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [see Dosage and Administration (2.1)]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for levonorgestrel and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets or the underlying maternal condition. Safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated. Levonorgestrel and ethinyl estradiol tablet has not been studied in postmenopausal women and is not indicated in this population. The pharmacokinetics of levonorgestrel and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. However, COCs may be poorly metabolized in patients with hepatic impairment. Levonorgestrel and ethinyl estradiol tablets is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see Contraindications (4) and Warnings and Precautions (5.2)] .

Огляд продуктів:

How Supplied Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg are available in Extended-Cycle Wallet of 91 tablets each containing a 13-week supply of tablets which is packed in a pouch (NDC 68180-843-11). Such three pouches are packed in a carton (NDC 68180-843-13). Each wallet (91 tablets) contains in the following order:

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL
ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVONORGESTREL AND
ETHINYL ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS.
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS ARE CONTRAINDICATED IN
WOMEN OVER 35
YEARS OLD WHO SMOKE. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (5.1)
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 01/2023
Warning and Precautions, Malignant Neoplasms (5.11) 04/2022
INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablet is a combination of
levonorgestrel, a progestin, and ethinyl
estradiol an estrogen indicated for use by females of reproductive
potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day for 91 days.
(2.1)
Take tablets in the order directed on the Extended-Cycle Wallet. (2.2)
DOSAGE FORMS AND STRENGTHS
Levonorgestrel and ethinyl estradiol tablets USP consists of 84 pink,
round, biconvex, film-coated tablets,
each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl
estradiol, and 7 white to off white, round,
biconvex, inert tablets. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease, acute viral hepatitis or decompensated
cirrhosis (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop if a thrombotic or thromboembolic e