DAYSEE- levonorgestrel and ethinyl estradiol kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Lupin Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

ETHINYL ESTRADIOL

Composição:

ETHINYL ESTRADIOL 0.03 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Daysee™ is indicated for use by females of reproductive potential to prevent pregnancy. Daysee 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 Warnings 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 (5.3)]. - Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with 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 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 (5.4)]. Risk Summary There is no use for contraception in pregnancy; therefore, Daysee 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 woman 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 Daysee and any potential adverse effects on the breastfed child from Daysee or the underlying maternal condition. Safety and efficacy of Daysee have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of Daysee before menarche is not indicated. Daysee has not been studied in postmenopausal women and is not indicated in this population. No studies have been conducted to evaluate the effect of hepatic disease on the disposition of Daysee. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Daysee is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see Contraindications (4) and Warnings and Precautions (5.2 )].

Resumo do produto:

How Supplied Daysee [levonorgestrel and ethinyl estradiol tablets USP (0.15 mg/0.03 mg) and ethinyl estradiol tablets USP (0.01 mg)] are available in Extended-Cycle Wallets each containing a 13-week supply of tablets: 84 light blue tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 mustard tablets, each containing 0.01 mg of ethinyl estradiol. The light blue tablets are round, biconvex, film-coated tablets, debossed with "LU" on one side and "V21" on the other side. The mustard tablets are round, biconvex, film-coated tablets debossed with "LU" on one side and "V22" on the other side. They are supplied as follows: Daysee [levonorgestrel and ethinyl estradiol tablets USP (0.15 mg/0.03 mg) and ethinyl estradiol tablets USP (0.01 mg)] is available in an extended cycle wallet of 91 tablets which is packed in a pouch (NDC 68180-846-11). Such two pouches are packed in a carton (NDC 68180-846-13). Storage and Handling Store at 20° C to 25° C (68° F to 77° F); excursions permitted to 15°C to 30° C (59°F to 86° F) [See USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DAYSEE - LEVONORGESTREL AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DAYSEE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DAYSEE.
DAYSEE™ [LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP (0.15
MG/0.03 MG) AND
ETHINYL ESTRADIOL TABLETS USP (0.01 MG)] FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: CIGARETTE SMOKING AND SERIOUS
CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning.
Daysee is contraindicated in women over 35 years old who smoke.
Cigarette smoking increases the risk of serious cardiovascular events
from combination oral
contraceptive (COC) use.
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 01/2023
Warnings and Precautions, Malignant Neoplasms (5.11) 04/2022
INDICATIONS AND USAGE
Daysee is a combination of levonorgestrel, a progestin, and ethinyl
estradiol, an estrogen, indicated for
use by females of reproductive to potential prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day for 91 days
in the order directed on the blister
pack. (2) (2)
DOSAGE FORMS AND STRENGTHS
Daysee consists of 84 light blue tablets containing 0.15 mg
levonorgestrel and 0.03 mg ethinyl estradiol,
and 7 mustard tablets containing 0.01 mg ethinyl estradiol. (3) (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Liver tumors or liver disease, acute viral hepatitis or decompensated
cirrhosis (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 event occurs.
Stop at least 4 weeks before and
through 2 weeks after major surgery. Start no earlier than 4 weeks
after delivery, in women who are not
breastfeeding. Consider cardiovascular risk factors befor