What is Jolessa?
See also: Mirena
Jolessa is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). Jolessa also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Jolessa is used as contraception to prevent pregnancy. There are many brands and forms of this medicine available. Not all brands are listed on this leaflet.
Jolessa may also be used for purposes not listed in this medication guide.
Jolessa indications
Jolessa® (Levonorgestrel (Jolessa), Ethinyl estradiol (Jolessa)) tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18-35 years of age during 809 completed 91-day cycles of Jolessa® (Levonorgestrel (Jolessa), Ethinyl estradiol (Jolessa)) during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) Pregnancy rate of 1.98 per 100 women-years of use.
Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE 2: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year: United States.
| % of Women Experiencing an Unintended Pregnancy within the First Year of Use | % of Women Continuing Useat One Year However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced or the baby reaches six months of age. |
How should I use Jolessa?
Use Jolessa as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Jolessa. Talk to your pharmacist if you have questions about this information.
- Take Jolessa by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Do not remove the tablet from the blister packaging until you are ready to take Jolessa.
- Begin taking Jolessa on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking Jolessa on that day.
- If you are switching from another form of hormonal birth control to Jolessa, be sure you know when you should start taking Jolessa. Talk with your doctor if you have any questions about how to switch from another form of hormonal birth control to Jolessa.
- Try to take Jolessa at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
- For Jolessa to be effective it must be taken every day. Do not skip doses, even if you are spotting, bleeding, or nauseous. Do not skip pills even if you do not have sex very often.
- If you miss 1 dose of Jolessa, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup method of birth control if you only miss 1 pill. If you miss more than 1 dose of Jolessa, read the extra patient information leaflet that comes with Jolessa or contact your doctor for instructions. You must use a backup method of birth control if you miss more than 1 dose of Jolessa. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) until you talk with your doctor.
Ask your health care provider any questions you may have about how to use Jolessa.
Uses of Jolessa in details
Use: Labeled Indications
Contraception: Prevention of pregnancy.
Emergency contraception: Postcoital emergency contraception.
Limitations of use: Ethinyl estradiol (Jolessa) in combination with Levonorgestrel (Jolessa) is effective and recommended as an alternative method for the management of emergency contraception when other methods are not available. The use of other methods is preferred due to increased side effects and decreased efficacy observed with this combination (AAP 2012; ACOG 2015)
Off Label Uses
Abnormal uterine bleeding
Based on the American College of Obstetricians and Gynecologists committee opinion on the management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women, Ethinyl estradiol (Jolessa) and Levonorgestrel (Jolessa) (among other oral contraceptive combinations) is effective and recommended for the management of abnormal uterine bleeding.
Jolessa description
Each tablet contains Levonorgestrel (Jolessa) 150μg and Ethinyl estradiol (Jolessa) 30 μg.
Ethinyl estradiol (Jolessa) is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol.
Levonorgestrel (Jolessa) is (-)-13-ethyl-17-hydroxy-18,19-dinor-17α-pregna-4-en-20-yn-3-one.
Ethinyl estradiol (Jolessa) is a white to creamy white, odorless, crystalline powder. It is insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils and aqueous solutions of alkali hydroxides.
Levonorgestrel (Jolessa) is a white, crystalline powder that is very slightly soluble in water, slightly soluble in alcohol and acetone and soluble in chloroform.
Jolessa dosage
Jolessa Dosage
Generic name: Ethinyl estradiol (Jolessa) 0.01mg; Ethinyl estradiol (Jolessa) 0.03mg, Levonorgestrel (Jolessa) 0.15mg
Dosage form: tablets
See also:
- Jolessa Lo tablets
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Take one tablet by mouth at the same time every day. The dosage of Jolessa tablets is one white tablet containing Levonorgestrel (Jolessa) and Ethinyl estradiol (Jolessa) daily for 84 consecutive days, followed by one light blue Ethinyl estradiol (Jolessa) tablet for 7 days. To achieve maximum contraceptive effectiveness, Jolessa tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking Jolessa 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 Jolessa 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 Jolessa tablets no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Jolessa 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.
More about Jolessa (Ethinyl estradiol (Jolessa) / Levonorgestrel (Jolessa))
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- En Espanol
- 7 Reviews - Add your own review/rating
Consumer resources
- Jolessa extended-cycle
- Other brands: Aviane, Lutera, Seasonique, Jolessa, More (29) »
Professional resources
- Jolessa (FDA)
Other formulations
- Jolessa Lo
Related treatment guides
- Birth Control
Jolessa interactions
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What other drugs will affect Jolessa?
Interactions between Ethinyl estradiol (Jolessa) and other substances may lead to decreased or increased serum Ethinyl estradiol (Jolessa) concentrations, respectively.
Decreased Ethinyl estradiol (Jolessa) 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 (Jolessa)-containing products and substances that may lead to decreased Ethinyl estradiol (Jolessa) 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 Jolessa. 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 (Jolessa) 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 (Jolessa) 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 (Jolessa) Concentrations: Any substance that reduces gastrointestinal tract transit time and, therefore, Ethinyl estradiol (Jolessa) 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 (Jolessa) 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 (Jolessa) 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 (Jolessa) 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.
Jolessa side effects
See also:
What are the possible side effects of Jolessa?
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and stroke
- Vascular events
- Liver disease
Adverse reactions commonly reported by COC users are:
- Irregular uterine bleeding
- Nausea
- Breast tenderness
- Headache
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 clinical practice.
The clinical trial that evaluated the safety and efficacy of Jolessa was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of Jolessa (345.14 woman-years of exposure).
Adverse Reactions Leading to Study Discontinuation: 14.9% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation in the Jolessa group were menorrhagia (5.7%), mood swings (1.9%), weight/appetite increase (1.5%), and acne (1.3%).
Common Adverse Reactions (≥ 2% of women): headache (20.6%), menorrhagia (11.6%), nausea (7.5%), dysmenorrhea (5.7%), acne (4.6%), migraine (4.4%), breast tenderness (3.5%), weight increased (3.1%), and depression (2.1%).
Serious Adverse Reactions: pulmonary embolus, cholecystitis.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Jolessa. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: abdominal distension, vomiting
General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain
Immune system disorder: hypersensitivity reactions, including itching, rash, and angioedema
Investigations: blood pressure increased
Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity
Nervous system disorders: dizziness, loss of consciousness
Psychiatric disorders: insomnia
Reproductive and breast disorders: dysmenorrhea
Skin and subcutaneous tissue disorders: alopecia
Vascular disorders: thrombosis, pulmonary embolism, pulmonary thrombosis
Jolessa contraindications
See also:
What is the most important information I should know about Jolessa?
Combination oral contraceptives should not be used in women with any of the following conditions:
• Thrombophlebitis or thromboembolic disorders
• History of deep-vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or past history)
• Valvular heart disease with thrombogenic complications
• Thrombogenic rhythm disorders
• Hereditary or acquired thrombophilias
• Major surgery with prolonged immobilization
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms such as aura
• Uncontrolled hypertension
• Known or suspected carcinoma of the breast or personal history of breast cancer
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior pill use
• Hepatic adenomas or carcinomas, or active liver disease
• Known or suspected pregnancy
• Hypersensitivity to any of the components of Jolessa
• Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
Active ingredient matches for Jolessa:
Ethinyl estradiol/levonorgestrel
03mg;/15mg/ethinyl estradiol/ETHINYL ESTRADIOL 0/levonorgestrel/LEVONORGESTREL 0
7 tablets, inert/84 Tablets, ethinylestradiol/Ethinylestradiol/Levonorgestrel in United States.
List of Jolessa substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Jaimiess | |
| Jolessa extended-cycle | |
| Lessina | |
| Tablet; Oral-21; Ethinyl Estradiol 0.02 mg; Levonorgestrel 0.1 mg (Barr) | |
| Tablet; Oral-28; Ethinyl Estradiol 0.02 mg; Levonorgestrel 0.1 mg (Barr) | |
| Levlen (Australia, New Zealand, United States) | |
| Levlite | |
| Tablet; Oral-21; Ethinyl Estradiol 0.02 mg; Levonorgestrel 0.1 mg (Berlex) | |
| Tablet; Oral-28; Ethinyl Estradiol 0.02 mg; Levonorgestrel 0.1 mg (Berlex) | |
| Levonest | |
| Levonest-28 | |
| Levonorgestrel/ ethinyl estradiol | |
| Levonorgestrel/Ethinyl Estradiol (Thailand) | |
| Levonorgestrel; Ethinyl Estradiol | |
| Tablet; Oral; Ethinyl Estradiol 0.03 mg; Levonorgestrel 0.15 mg | |
| Tablet; Oral-28; Ethinyl Estradiol 0.02 mg; Levonorgestrel 0.1 mg | |
| Tablet; Oral-21; Ethinyl Estradiol 0.02 mg; Levonorgestrel 0.1 mg | |
| Levora | |
| Tablet; Oral-21; Ethinyl Estradiol 0.03 mg; Levonorgestrel 0.15 mg (Watson) | |
| Tablet; Oral-28; Ethinyl Estradiol 0.03 mg; Levonorgestrel 0.15 mg (Watson) | |
| LEVORA 0.03MG/0.15MG TABLET 1 strip / 10 tablets each (Watson) | $ 0.30 |
| Levora Tablet (Watson) | $ 0.03 |
| Levora 0.15/30 | |
| Lillow | |
| Liogynon (Austria) | |
| Lo Simpesse | |
| LoJaimiess | |
| Loseasonique | |
| Tablet; Oral; Ethinyl Estradiol 0.02 mg; Ethinyl Estradiol 0.01 mg; Levonorgestrel 0.1 mg | |
| LoSeasonique extended-cycle | |
| Lutera | |
| Tablet; Oral; Ethinyl Estradiol; Levonorgestrel (Watson) | |
| Lybrel | |
| Tablet; Oral; Ethinyl Estradiol 0.09 mg; Levonorgestrel 0.02 mg (Wyeth) | |
| LYNA | |
| LYNA TABLET 1 strip / 21 tablets each (West-Coast Pharmaceutical Works Ltd) | $ 0.66 |
| MALA D | |
| MALA D TABLET 1 strip / 28 tablets each (Deys Medical) | $ 0.03 |
| Mala D Tablet (Deys Medical) | $ 0.00 |
| Marlissa | |
| Min-Ovral 21 | |
| Min-Ovral 28 | |
| Minigynon (Venezuela) | |
| Tablet, Sugar-Coated; Oral; Ethinyl Estradiol 0.03 mg; Levonorgestrel 0.15 mg (Schering) | |
| Minigynon Cada Dia | |
| Tablet, Sugar-Coated; Oral; Ethinyl Estradiol 0.03 mg; Levonorgestrel 0.15 mg | |
| Minisistone | |
| Tablet, Sugar-Coated; Oral; Ethinyl Estradiol 0.03 mg; Levonorgestrel 0.125 mg | |
| Minizistone 20 Fem | |
| Dragee; Oral; Ethinyl Estradiol 0.02 mg; Levonorgestrel 0.1 mg | |
| Minizistone Fem | |
| Dragee; Oral; Ethinyl Estradiol 0.02 mg; Levonorgestrel 0.1 mg | |
| Modutrol (Chile) | |
| 6 Blue Dragee; Oral; Ethinyl Estradiol 0.03 mg; Levonorgestrel 0.05 mg / 5 Yellow Dragee; Oral; Ethinyl Estradiol 0.04 mg; Levonorgestrel 0.075 mg / 10 Red Dragee; Oral; Ethinyl Estradiol 0.03 mg; Levonorgestrel 0.125 mg (Gynopharm) | |
| Neo-Primovlar (Finland) | |
| Neo-Stediril (Germany, Netherlands, Switzerland) | |
| Dragee; Oral; Ethinyl Estradiol; Levonorgestrel (Wyeth) | |
| Neogentrol (Denmark) | |
See 191 substitutes for Jolessa | |
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).
- PubChem. "ethinyl estradiol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Jolessa are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Jolessa. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
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Information checked by Dr. Sachin Kumar, MD Pharmacology
