LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol · KIT · Mylan Pharmaceuticals Inc.
This is an oral contraceptive kit containing levonorgestrel and ethinyl estradiol used to prevent pregnancy. It works by combining a progestin and estrogen to stop ovulation and thicken cervical mucus as a barrier to sperm.
Key Facts
- Brand Name
- LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Generic Name
- Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol
- NDC Code (Product)
0378-7284- Manufacturer
- Mylan Pharmaceuticals Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA200493
- Marketing Start
- 11/07/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive age to prevent pregnancy.
Dosage & Administration
2 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 ) 2.1 How to Start and Take Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets Begin levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first white to off-white tablet that day. For each 91-day course, take in the following order: 1. Start the first white to off-white tablet on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Then take one white to off-white tablet once daily for a total of 42 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) for the first 7 days of treatment. 2. One light peach tablet once daily for 21 consecutive days. 3. One bluish green tablet once daily for 21 days. 4. One yellow tablet once daily for 7 days. Bleeding should occur during yellow tablet use. Begin the next and all subsequent 91-day courses of levonorgestrel and ethinyl estradiol tablets and e…
Contraindications
4 CONTRAINDICATIONS • A high risk of arterial or venous thrombotic diseases ( 4 ) • Undiagnosed abnormal uterine bleeding ( 4 ) • Breast cancer ( 4 ) • Liver tumors or liver disease ( 4 ) • Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Levonorgestrel and ethinyl estradiol tablets 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 current or history of deep vein thrombosis or pulmonary embolism [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 inherited or acquired hypercoagulopathies [see Warnings and Precau…
Drug Interactions
7 DRUG INTERACTIONS Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. ( 7.1 ) The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances D…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥2%) in clinical trials for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain and migraines. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Vascular events [see Warnings and Precautions ( 5.1 )] • Liver disease [see Warnings and Precautions ( 5.2 )] 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below are from a 12-month, US, open-label study, which enrolled women aged 18-40,…
Frequently Asked Questions
What is LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL used for?
This is an oral contraceptive kit containing levonorgestrel and ethinyl estradiol used to prevent pregnancy. It works by combining a progestin and estrogen to stop ovulation and thicken cervical mucus as a barrier to sperm.
Is LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL a controlled substance?
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL is not classified as a controlled substance by the DEA.
What is the generic name for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL?
The generic name for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL is Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol. There are 7 other brand versions of Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol.
What is the NDC code for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ?
The NDC (National Drug Code) for LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL is 0378-7284, listed by Mylan Pharmaceuticals Inc..