JAIMIESS
levonorgestrel / ethinyl estradiol and ethinyl estradiol · KIT · Xiromed, LLC.
JAIMIESS is a kit containing levonorgestrel / ethinyl estradiol and ethinyl estradiol. Manufactured by Xiromed, LLC..
Key Facts
- Brand Name
- JAIMIESS
- Generic Name
- levonorgestrel / ethinyl estradiol and ethinyl estradiol
- NDC Code (Product)
70700-123- Manufacturer
- Xiromed, LLC.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA203770
- Marketing Start
- 01/01/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Jaimiess is indicated for use by females of reproductive potential to prevent pregnancy. Jaimiess is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
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 Jaimiess Begin Jaimiess on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first peach tablet that day. For each 91-day course, take in the following order: Start the first peach tablet on the first Sunday after onset of menstruation. Then take one peach tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) until a peach tablet has been taken daily for 7 consecutive days. Then take one yellow tablet for 7 consecutive days. Bleeding should occur during the 7 days that the yellow tablets are taken. Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of Jaimiess, following the same schedule: 84 days taking a peach tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method…
Contraindications
4 CONTRAINDICATIONS Jaimiess 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 females who are known to: Smoke, if over age 35 [see Boxed Warning 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 …
Drug Interactions
7 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 Jaimiess. Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of Jaimiess or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets, and ethinyl estradiol tablets. ( 7.1 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs: Table 4 includes substances th…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [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 )] The most common adverse reactions (≥5%) in clinical trials for Jaimiess are irregular and/or heavy uterine bleeding, weight gain, and acne. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC at 1-844-XIROMED (1-844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 clinical trial that evaluated the safety and efficacy of levonorgestrel and ethinyl estradiol tablets, and ethinyl estradiol was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18-40, of whom 1,006 took at least one dose of levonorgestrel and ethi…
Frequently Asked Questions
What is JAIMIESS used for?
JAIMIESS contains levonorgestrel / ethinyl estradiol and ethinyl estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is JAIMIESS a controlled substance?
JAIMIESS is not classified as a controlled substance by the DEA.
What is the generic name for JAIMIESS?
The generic name for JAIMIESS is levonorgestrel / ethinyl estradiol and ethinyl estradiol. There are 1 other brand versions of levonorgestrel / ethinyl estradiol and ethinyl estradiol.
What is the NDC code for JAIMIESS ?
The NDC (National Drug Code) for JAIMIESS is 70700-123, listed by Xiromed, LLC..