Ayuna
Levonorgestrel and Ethinyl Estradiol · KIT · Aurobindo Pharma Limited
Ayuna is a kit containing levonorgestrel and ethinyl estradiol. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- Ayuna
- Generic Name
- Levonorgestrel and Ethinyl Estradiol
- NDC Code (Product)
65862-848- Manufacturer
- Aurobindo Pharma Limited
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA206866
- Marketing Start
- 09/23/2016
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
INDICATIONS AND USAGE Ayuna is indicated for use by females of reproductive potential to prevent pregnancy.
Dosage & Administration
DOSAGE AND ADMINISTRATION 1. How to Start and Take Ayuna Ayuna is dispensed in a blister pack containing 28 tablets (see HOW SUPPLIED ). Ayuna may be started using either a Day 1 start or a Sunday start (see Table 3). For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Table 3: Instructions for Administration of Ayuna Starting Ayuna in females with no current use of hormonal contraception Day 1 start Take first tablet without regard to meals on the first day of menses Take subsequent tablets once daily at the same time each day Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Sunday start Take first tablet without regard to meals on the first Sunday after the onset of menstrual period Take subsequent tablets once daily at the same time each day Use additional nonhormonal contraception for the first seven days of product use Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Switching from another contraceptive method A COC T…
Warnings
WARNINGS 1. Thromboembolic Disorders and Other Vascular Conditions Stop levonorgestrel and ethinyl estradiol tablets if an arterial or venous thrombotic/thromboembolic event occurs. Stop levonorgestrel and ethinyl estradiol tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately. Discontinue levonorgestrel and ethinyl estradiol tablets during prolonged immobilization. If feasible, stop levonorgestrel and ethinyl estradiol tablets at least four weeks before and through two weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism. Start levonorgestrel and ethinyl estradiol tablets no earlier than four weeks after delivery in females who are not breast-feeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week. Before starting levonorgestrel and ethinyl estradiol tablets evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hype…
Contraindications
CONTRAINDICATIONS Ayuna is contraindicated in females who are known to have the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1) ]. Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1) ] . Have cerebrovascular disease [see WARNINGS (1) ] . Have coronary artery disease [see WARNINGS (1) ] . Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1) ] . Have inherited or acquired hypercoagulopathies [see WARNINGS (1) ] . Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3) ] . Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see WARNINGS (7) ] . Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see WARNINGS (8) ]. Current diagnosis of, or history of, breast cancer, which may be …
Drug Interactions
4. Drug Interactions 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. 4.1 Effects of Other Drugs on Combined Oral Contraceptives Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs: Table 1 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets. Table 1: Significant Drug Interactions Involving Substances That Affect COCs Metabolic Enzyme Inducers Clinical effect Concomitant use of COCs with metabolic enzyme inducers m…
Adverse Reactions
ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular adverse events [see BOXED WARNING and WARNINGS (1) ] Vascular events [see WARNINGS (1) ] Liver disease [see WARNINGS (2) ] Hypertension [see WARNINGS (3) ] Gallbladder disease [see WARNINGS (6) ] Carbohydrate and lipid effects [see WARNINGS (7) ] Headache [see WARNINGS (8) ] Carcinoma of the cervix [see WARNINGS (11) ] Adverse reactions reported by COC users and described elsewhere in the labeling are: Bleeding irregularities and amenorrhea [see WARNINGS (9) ] Mood changes, including depression [see WARNINGS (10) ] Melasma/chloasma which may persist [see WARNINGS (14) ] Edema/fluid retention [see PRECAUTIONS (2) ] Diminution in lactation when given immediately postpartum [see PRECAUTIONS (7) ] Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC user…
Frequently Asked Questions
What is Ayuna used for?
Ayuna contains Levonorgestrel and Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is Ayuna a controlled substance?
Ayuna is not classified as a controlled substance by the DEA.
What is the generic name for Ayuna?
The generic name for Ayuna is Levonorgestrel and Ethinyl Estradiol. There are 12 other brand versions of Levonorgestrel and Ethinyl Estradiol.
What is the NDC code for Ayuna ?
The NDC (National Drug Code) for Ayuna is 65862-848, listed by Aurobindo Pharma Limited.