Take one tablet by mouth at the same time every day. The dosage of Jaimiess tablets is one white tablet containing Levonorgestrel (Jaimiess) and Ethinyl estradiol (Jaimiess) daily for 84 consecutive days, followed by one light blue Ethinyl estradiol (Jaimiess) tablet for 7 days. To achieve maximum contraceptive effectiveness, Jaimiess tablets must be taken exactly as directed and at intervals not exceeding 24 hours.

Instruct the patient to begin taking Jaimiess tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first white tablet is taken that day. One white tablet should be taken daily for 84 consecutive days, followed by one light blue tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a white tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the light blue 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 tablets, following the same schedule: 84 days taking a white tablet followed by 7 days taking a blue 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 white 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 FDA-Approved Patient Labeling.

For postpartum women who are not breastfeeding, start Jaimiess tablets no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Jaimiess tablets 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 white tablet for 7 consecutive days.

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Birth Control

What other drugs will affect Jaimiess?

Some drugs may decrease the effectiveness of Jaimiess, which may result in pregnancy. Before taking Jaimiess, talk to your doctor if you are taking any of the following medicines:

a penicillin antibiotic such as amoxicillin (Amoxil, Trimox, Augmentin, others), penicillin (Veetids, Pen Vee K, Bicillin, Permapen, others), ampicillin (Principen, Omnipen, Totacillin, others), bacampicillin (Spectrobid), carbenicillin (Geocillin), cloxacillin (Cloxapen, Tegopen), dicloxacillin (Dynapen, Dycill, others), nafcillin (Unipen, others), or oxacillin (Bactocill, others);
a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Doxy, Vibramycin, Vibra-Tabs, others), minocycline (Minocin), or tetracycline (Sumycin, Achromycin, Robitet, Panmycin, others);
a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);
a seizure or pain medicine such as phenytoin (Dilantin), primidone (Mysoline), ethosuximide (Zarontin), carbamazepine (Tegretol), and others; or
rifampin (Rifadin).

You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with Jaimiess. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Jaimiess interactions

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Interactions between Ethinyl estradiol (Jaimiess) and other substances may lead to decreased or increased serum Ethinyl estradiol (Jaimiess) concentrations, respectively.

Decreased Ethinyl estradiol (Jaimiess) serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the COC.

During concomitant use of Ethinyl estradiol (Jaimiess)-containing products and substances that may lead to decreased Ethinyl estradiol (Jaimiess) serum concentrations, it is recommended that a nonhormonal back-up method of birth control (eg, condoms and spermicide) be used in addition to the regular intake of Jaimiess. In the case of prolonged use of such substances, COCs should not be considered the primary contraceptive.

After discontinuation of substances that may lead to decreased Ethinyl estradiol (Jaimiess) serum concentrations, use of a nonhormonal back-up method is recommended for at least 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have lead to induction of hepatic microsomal enzymes, resulting in decreased Ethinyl estradiol (Jaimiess) serum concentrations. It may sometimes take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use and rate of elimination of the inducing substance.

Substances That May Decrease Serum Ethinyl estradiol (Jaimiess) Concentrations: Any substance that reduces gastrointestinal tract transit time and, therefore, Ethinyl estradiol (Jaimiess) absorption.

Substances that induce hepatic microsomal enzymes eg, rifampicin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil. Hypericum perforatum, also known as St. John's wort and ritonavir (possibly by induction of hepatic microsomal enzymes). Certain antibiotics (eg, ampicillin and other penicillins, tetracyclines), by a decrease of enterohepatic circulation of estrogens.

Substances That May Increase Serum Ethinyl estradiol (Jaimiess) Concentrations: Atorvastatin. Competitive inhibitors for sulfation in the gastrointestinal wall eg, as ascorbic acid (vitamin C) and paracetamol (acetaminophen). Substances that inhibit cytochrome P450 3A4 isoenzymes eg, indinavir, fluconazole and troleandomycin.

Troleandomycin may increase the risk of intrahepatic cholestasis during co-administration with COCs.

Ethinyl estradiol (Jaimiess) may interfere with the metabolism of other drugs by inhibiting hepatic microsomal enzymes, or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, plasma and tissue concentrations may either be increased (eg, cyclosporine, theophylline, corticosteroids) or decreased (eg, lamotrigine).

In patients treated with flunarizine, use of oral contraceptives has been reported to increase the risk of galactorrhea.

The prescribing information of concomitant medications should be consulted to identify potential interactions.

Although ritonavir is an inhibitor of cytochrome P450 3A4, treatment with ritonavir has been shown to decrease Ethinyl estradiol (Jaimiess) serum concentrations.

Effects on Laboratory Parameters: The use of COCs may cause certain physiologic changes which may be reflected in the results of certain laboratory tests, including biochemical parameters of liver function (including a decrease in bilirubin and alkaline phosphatase, thyroid function (increased total T3 and T4 due to increased TBG, decreased free T3 resin uptake), adrenal function [increased plasma cortisol and cortisol binding globulin, decreased dehydroepiandrosterone sulfate (DHEAS)] and renal function (increased plasma creatinine and creatinine clearance); plasma levels of (carrier) proteins eg, corticosteroid-binding globulin and lipid/lipoprotein fractions; parameters of carbohydrate metabolism; parameters of coagulation and fibrinolysis; decreased serum folate levels.

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References

DailyMed. "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DailyMed. "ESTRADIOL; LEVONORGESTREL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
FDA/SPL Indexing Data. "5W7SIA7YZW: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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