LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive potential 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: 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. 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 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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. No studies have been conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see Contraindications (4) and Warnings and Precautions (5.2)]. Levonorgestrel and Ethinyl Estradiol Tablets USP, (0.15 mg/0.03 mg) and Ethinyl Estradiol Tablets USP, (0.01 mg) How do I take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets? Before you start taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 When to start Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets How to Take Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets What to do if you miss pills If you MISS 1 white to off-white pill: If you MISS 2 white to off-white pills in a row: If you MISS 3 OR MORE white to off-white pills in a row: If you MISS ANY of the 7 light peach pills: Finally, if you are still not sure what to do about the pills you have missed This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Ahmedabad- 382 213, India Code No.: GUJ-DRUGS/G/28/1297 75102015 Revised: 2/2024 FC:OT:7285:R10

Product summary:

How Supplied Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP are available in an Extended-Cycle Tablet Blister Pack, each pouch contains 91 tablets. Each Extended-Cycle Tablet Blister Pack contains a 13-week supply of tablets: 84 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 light peach tablets each containing 0.01 mg of ethinyl estradiol. The white to off-white tablets are round, biconvex tablets debossed with 202 on one side and plain on the other side. The light peach tablets are round, biconvex tablets debossed with 222 on one side and plain on the other side. NDC 0378-7285-90 Carton containing 2 Extended-Cycle Tablet Blister Packs Storage and Handling Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL-
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS INC.
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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._
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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 and ethinyl estradiol
tablets consist of 84 white to off-white
tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl
estradiol, and 7 light peach tablets
containing 0.01 mg ethinyl estradiol. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL
TABLETS ARE
CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE.
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE.
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, wi