LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Lupin Pharmaceuticals, Inc.

INN（国際名）:

ETHINYL ESTRADIOL

構図:

ETHINYL ESTRADIOL 0.02 mg

処方タイプ:

PRESCRIPTION DRUG

適応症:

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets 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:    ο   Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] ο   Have current or history of deep vein thrombosis or pulmonary embolism. [see Warnings and Precautions (5.1) ]   ο   Have cerebrovascular disease [see Warnings and Precautions (5.1) ]  ο   Have coronary artery disease [see Warnings and Precautions (5.1) ]  ο   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) ]  ο   Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] ο   Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.5) ] ο   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) ] ο   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) ]. - Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] - 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, 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 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 ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or the underlying maternal condition. Safety and efficacy of levonorgestrel and Ethinyl estradiol tablets and ethinyl estradiol tablets 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 this product before menarche is not indicated.  Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in postmenopausal women and is not indicated in this population. The pharmacokinetics of levonorgestrel and ethinyl estradiol tablets 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 and ethinyl estradiol tablets is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [See Contraindications (4) and Warnings and Precautions (5.2) ]. LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS How do I take Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets? - Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. - Many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider. - Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. - If you have trouble remembering to take levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control. Before you start taking Levonorgestrel and Ethinyl Estradiol tablets and Ethinyl Estradiol tablets - Decide what time of day you want to take your pill. It is important to take it at about the same time every day. - Look at your Extended-Cycle Wallet. Your wallet consists of blister strips that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 orange pills and 7 mustard pills. Blister strip 1 and 2 each contain 28 orange pills (4 rows of 7 pills). Blister strip 3 contains 35 pills consisting of 28 orange pills (4 rows of 7 pills) and 7 mustard pills (1 row of 7 pills). 3.  Also find: - Where on the first strip in the pack to start taking pills (upper left corner at the start arrow) and - In what order to take the pills (follow the weeks and arrow). 4.  Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills. When to Start Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets - Take the first orange pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first orange pill that same day. - Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first orange pill until the next Sunday (first 7 days). If you are switching from another birth control method: If you have been using a different hormonal method of birth control (such as a different pill, the "patch," or the "vaginal ring"), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for 7 days. If you have recently given birth and have not yet had a period , use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets for 7 days. How to Take Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets - Take one pill at the same time every day until you have taken the last pill in the wallet. Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often. - Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea). - Do not skip pills even if you do not have sex very often. - When you finish a wallet After taking the last mustard pill, start taking the first orange pill from a new Extended-Cycle Wallet the very next day (this should be on a Sunday) regardless of when your period started. - After taking the last mustard pill, start taking the first orange pill from a new Extended-Cycle Wallet the very next day (this should be on a Sunday) regardless of when your period started. - If you miss your scheduled period when you are taking the mustard pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. WHAT TO DO IF YOU MISS PILLS If you MISS 1 orange pill: - Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. - You do not need to use a back-up birth control method if you have sex. If you MISS 2 orange pills in a row: - Take 2 pills on the day you remember, and 2 pills the next day. - Then take 1 pill a day until you finish the pack. - You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms or spermicide) as a back up for the 7 days after you restart your pills. If you MISS 3 OR MORE orange pills in a row: - Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under "Thursday" and do not take the missed pills. You may experience bleeding during the week following the missed pills. - You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. - You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the mustard pills, call your healthcare provider because you may be pregnant. If you MISS ANY of the 7 mustard pills: - Throw away the missed pills. - Keep taking the scheduled pills until the pack is finished. - You do not need a back-up method of birth control. Finally, if you are still not sure what to do about the pills you have missed - Use a back-up method anytime you have sex. - Keep taking one pill each day until you contact your healthcare provider. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Revised: September 2023                                                                              ID#: 274539

製品概要:

How Supplied Levonorgestrel and Ethinyl Estradiol Tablets, USP (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets, USP (0.01 mg) are available in Extended-Cycle Wallets, that contains 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol and 7 mustard tablets each containing 0.01 mg of ethinyl estradiol. Orange tablets are round biconvex, film-coated tablets, debossed with "LU" on one side and "T41" on the other side. 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: Levonorgestrel and Ethinyl Estradiol Tablets, USP (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets, USP (0.01 mg) are available in an extended cycle wallet of 91 tablets which is packed in a pouch (NDC 68180-848-11). Such two pouches are packed in a carton (NDC 68180-848-13). Storage and Handling Store at 25° C (77° F); excursions permitted to 15°to 30° C (59°to 86° F) [see USP Controlled Room Temperature] The tablets should not be removed from the protective blister packaging to avoid damage to the product. The wallet card should be kept in the pouch until dispensed to the patient.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

LEVONORGESTREL AND ETHINYL ESTRADIOL 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 AND ETHINYL ESTRADIOL TABLETS SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR LEVONORGESTREL AND ETHINYL ESTRADIOL
TABLETS AND
ETHINYL ESTRADIOL TABLETS.
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS 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 TABLET 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 CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 01/2023
Warnings and Precautions, Malignant Neoplasms (5.11) 04/2022
INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol
tablets are 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
in the order directed on the blister
pack. (2)
DOSAGE FORMS AND STRENGTHS
Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl
estradiol tablets, USP consist of 84 orange
tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl
estradiol, and 7 mustard tablets containing
0.01 mg ethinyl estradiol. (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
o