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JAIMIESS
Overview
What is JAIMIESS?
Jaimiess is an extended-cycle oral contraceptive consisting of 84 peach tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol.
The structural formulas for the active components are:
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.
Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.
Each peach tablet contains the following inactive ingredients
Each yellow tablet contains the following inactive ingredients
What does JAIMIESS look like?
What are the available doses of JAIMIESS?
Jaimiess consists of 84 Peach tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol.
What should I talk to my health care provider before I take JAIMIESS?
How should I use JAIMIESS?
Jaimiess is indicated for use by women to prevent pregnancy.
Take one tablet by mouth at the same time every day. The dosage of Jaimiess are one peach tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Jaimiess must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking Jaimiess on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first peach tablet is taken that day. One peach tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a peach tablet has been taken daily for 7 consecutive days. A scheduled period 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, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a light blue-green tablet daily for 7 consecutive days.
If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.
For patient instructions regarding missed pills, see .
For postpartum women who are not breastfeeding, start Jaimiess no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Jaimiess postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a peach tablet for 7 consecutive days.
What interacts with JAIMIESS?
Sorry No Records found
What are the warnings of JAIMIESS?
Sorry No Records found
What are the precautions of JAIMIESS?
Sorry No Records found
What are the side effects of JAIMIESS?
Sorry No records found
What should I look out for while using JAIMIESS?
Do not prescribe levonorgestrel/ethinyl estradiol and ethinyl estradiol to women who are known to have the following:
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of
age,
and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
CONTRAINDICATIONS (
).]
4
What might happen if I take too much JAIMIESS?
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
How should I store and handle JAIMIESS?
Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Isibloom Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are round, orange, film-coated, debossed with SZ on one side and D2 on the other side. The 7 inert tablets are round, green, film-coated, debossed with SZ on one side and J1 on the other.NDC 70700-113-84, one box containing 1 individual carton NDC 70700-113-85, one box containing 3 individual cartonsSTORAGE:Isibloom Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are round, orange, film-coated, debossed with SZ on one side and D2 on the other side. The 7 inert tablets are round, green, film-coated, debossed with SZ on one side and J1 on the other.NDC 70700-113-84, one box containing 1 individual carton NDC 70700-113-85, one box containing 3 individual cartonsSTORAGE:Isibloom Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are round, orange, film-coated, debossed with SZ on one side and D2 on the other side. The 7 inert tablets are round, green, film-coated, debossed with SZ on one side and J1 on the other.NDC 70700-113-84, one box containing 1 individual carton NDC 70700-113-85, one box containing 3 individual cartonsSTORAGE:Isibloom Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are round, orange, film-coated, debossed with SZ on one side and D2 on the other side. The 7 inert tablets are round, green, film-coated, debossed with SZ on one side and J1 on the other.NDC 70700-113-84, one box containing 1 individual carton NDC 70700-113-85, one box containing 3 individual cartonsSTORAGE:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Non-Clinical Toxicology
Do not prescribe levonorgestrel/ethinyl estradiol and ethinyl estradiol to women who are known to have the following:Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of
age,
and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
CONTRAINDICATIONS (
).]
4
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.
Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors
Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir]) /HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).
Do not co-administer desogestrel and ethinyl estradiol with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings,
Colesevelam, a bile acid sequestrant, given together with a combination oral hormonal contraceptive, has been shown to significantly decrease the AUC of EE. A drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.
Effects of Combined Hormonal Contraceptives on Other Drugs
COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increases with use of COCs.
Stop Jaimiess if an arterial or deep venous thrombotic event occurs. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The excess risk is highest during the first year of use of a COC. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
Use of Jaimiess provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year).
If feasible, stop Jaimiess at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start Jaimiess no earlier than 4 to 6 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), and hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.
Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Stop Jaimiess if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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