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Ethinyl estradiol and levonorgestrel

Tyblume · Dolishale · Jaimiess · Twirla

Combined estrogen/progestin prescription contraception with product-specific cyclic, continuous, extended-cycle and transdermal schedules.

Class
Combined hormonal contraceptive
Reviewed routes
Oral tablets and transdermal patch
Pack distinction
Placebo, estrogen-only and continuous sequences differ
Essential safety

Assess clot risk and product eligibility

Estrogen-containing contraception increases thrombotic risk. Do not use current modern CHCs in smokers over 35; Twirla is additionally contraindicated at BMI ≥ 30 kg/m². Product-specific start and missed-dose rules matter.

Warnings and precautions
01

Indications

Ethinyl estradiol plus levonorgestrel is a combined hormonal contraceptive.

Approved purpose and population

Selected U.S. oral products prevent pregnancy in females of reproductive potential. Postmenarcheal adolescents can use an appropriate eligible product; these labels do not indicate use before menarche or after menopause. Neither STI prevention, emergency contraception nor routine menopausal hormone therapy is the selected product indication.

Patch eligibility

Twirla is contraception only for women of reproductive potential with BMI < 30 kg/m² who are otherwise eligible for CHCs. Consider reduced effectiveness at BMI 25 to < 30; BMI ≥ 30 is a formal contraindication. Its June 2026 FDA label states 40 mcg/day levonorgestrel plus 10 mcg/day ethinyl estradiol, distinct from older labeling.

Selected formulation scope

This review distinguishes Tyblume 21/7 cyclic tablets, Dolishale continuous tablets, Jaimiess 84+7 extended-cycle tablets and current Twirla patch. It is not a complete brand/strength directory: other cyclic, triphasic or extended products require their own ordered pack instructions and verified labeling; do not substitute schedules on ingredient names alone.

02

Dosage and administration

Use the exact sequence printed on the dispensed contraceptive pack.

Oral regimen comparison

Take one tablet daily at about the same time and begin the next pack on time. The selected regimens have different hormone-free intervals. Tyblume must be swallowed whole on an empty stomach, or chewed then immediately swallowed with a full 240 mL glass of water on an empty stomach; this food instruction does not automatically apply to other oral products.

Selected oral packExact sequence
Tyblume 28 days21 tablets: LNG 100 mcg/EE 20 mcg each; then 7 hormone-free placebo tablets
Dolishale continuousAll 28 tablets: LNG 90 mcg/EE 20 mcg each; next pack immediately, no tablet-free interval
Jaimiess 91 days84 tablets: LNG 150 mcg/EE 30 mcg each; then 7 EE-only 10 mcg tablets, followed immediately by next pack

Oral initiation and switching

Tyblume permits a Day 1 or Sunday start; Sunday start requires nonhormonal backup for 7 days. Dolishale starts on menstrual Day 1 when initiating without another hormonal method. Jaimiess is Sunday-start with 7 consecutive combination tablets before reliance. Switching instructions depend on the prior method. CDC separately supports clinician-directed quick start when pregnancy can reasonably be excluded; this should be reconciled with product and medical eligibility, rather than silently replace the package sequence.

Missed oral tablets and GI illness

Tyblume: for one missed active tablet, take it promptly and continue, even if two are taken in one day. For two active tablets missed in Weeks 1–2, its label directs two promptly, two the next day, then daily tablets, with 7-day backup. Two missed in Week 3 or three or more missed require the label’s Day 1/Sunday-specific pack restart plus 7-day backup. Missed placebos can be discarded without extending the next-pack start. Its label gives replacement active-tablet instructions if vomiting/acute diarrhea occurs within 3–4 hours. Other pack sequences differ; use that product’s instructions and seek prompt advice about emergency contraception when unprotected sex has occurred. CDC’s general missed-pill algorithm differs from the older Tyblume two-tablet catch-up rule, so obtain one confirmed plan rather than mix algorithms.

Patch schedule and application

Apply one Twirla patch for 7 days each during Weeks 1, 2 and 3; no patch in Week 4. Start the next cycle on schedule and never extend the patch-free interval beyond 7 days. Use clean/dry/intact abdomen, buttock or upper torso excluding breasts; rotate the site, avoid lotions/oils/powders, and never cut or tape it. Check adhesion daily and after prolonged water exposure.

Patch detachment or delay

The current Twirla table directs reapplication/replacement after detachment < 24 hours, maintaining the same change day with no backup. If detached ≥ 24 hours or duration uncertain, apply a new patch, start a new cycle/change day and use nonhormonal backup 7 days. A late Week 1 start requires the same new-cycle/backup response. For Week 2/3 changes delayed < 48 hours, replace promptly and retain the schedule; at ≥ 48 hours, restart the cycle with 7-day backup. These are Twirla-specific rules, rather than CDC’s generic patch 48-hour detachment rule.

03

Safety

Estrogen-containing contraception requires vascular and medical eligibility assessment.

Warnings and precautions

CHCs increase venous/arterial thrombotic risk. Stop and urgently assess suspected thrombosis, stroke symptoms or unexplained vision loss. If feasible, stop selected products 4 weeks before and through 2 weeks after major surgery with increased clot risk; prolonged immobilization also warrants a plan. Reassess significant BP increases, new persistent/severe headache or worsening migraine, jaundice, serious depression and persistent/new irregular bleeding.

Consider gallbladder disease, impaired glucose tolerance, hypertriglyceridemia/pancreatitis risk, hormone-sensitive malignancy, hereditary angioedema and chloasma. Continuous/extended packs change yearly hormonal exposure and bleeding patterns; they are not established as universally safer than cyclic packs. Dolishale contains tartrazine, which can cause allergic/asthmatic reactions in susceptible patients, particularly with aspirin hypersensitivity.

Contraindications

Selected labels prohibit use with high thrombotic risk, including current/prior DVT/PE, cerebrovascular/coronary disease, thrombogenic heart disease or hypercoagulopathy; uncontrolled hypertension; migraine with aura/focal symptoms; major diabetes-related vascular disease; specified liver disease/tumors; current/prior hormone-sensitive breast cancer; unexplained genital bleeding; and ombitasvir/paritaprevir/ritonavir with or without dasabuvir. Modern Tyblume/Twirla labels additionally specify diabetes over age 35 or duration > 20 years and any migraine over 35. Check the exact product contraindications, including hypersensitivity. Twirla additionally prohibits BMI ≥ 30. Stop contraception if pregnancy occurs; pregnancy is formally listed in the selected patch/extended/continuous contraindications.

Boxed warning: smoking and patch BMI

Current modern oral and Twirla labeling warns that smoking increases serious cardiovascular risk; do not use these CHCs in women over 35 who smoke. Dolishale retains older boxed smoking-risk language, which must not be interpreted as permission to ignore current clinical eligibility. Twirla’s box also contraindicates BMI ≥ 30 because of reduced effectiveness and possible greater VTE risk. General CDC obesity classifications do not cancel that product-specific prohibition.

Adverse reactions

Oral products can cause headache, nausea/abdominal symptoms, breast discomfort, acne, mood changes, spotting or amenorrhea. Extended/continuous regimens often produce unscheduled bleeding before adaptation; persistent bleeding still requires assessment. Twirla commonly causes application-site reactions, nausea, headache, dysmenorrhea and weight increase. Serious clotting, liver and vascular events are separate safety risks, and trial rates cannot be compared directly between products.

04

Drug interactions

Enzyme induction can cause contraceptive failure, while estrogen can alter other medicines.

Enzyme inducers and exposure changes

Rifampin/rifabutin, carbamazepine, phenytoin, barbiturates, some other anticonvulsants, bosentan and St. John’s wort can lower hormone exposure and effectiveness. Use an alternative or nonhormonal backup during inducer use and for 28 days after discontinuation under current Tyblume/Twirla instructions. CYP3A inhibitors and some HIV/HCV regimens can change exposure in either direction; consult both product labels rather than assume all antimicrobials have the same effect.

HCV regimen and colesevelam

Ombitasvir/paritaprevir/ritonavir with or without dasabuvir is contraindicated because of ALT elevations. Stop the CHC before this regimen and use a suitable alternative; selected modern labels allow restarting approximately 2 weeks after completion if otherwise eligible. For Tyblume/Twirla with colesevelam, separate administration by at least 4 hours according to their labels.

Lamotrigine, binding proteins and other drugs

Estrogen-containing CHCs can lower lamotrigine exposure and seizure control, potentially requiring an individualized lamotrigine adjustment when starting/stopping contraception. Increased thyroxine/cortisol-binding globulins can increase replacement hormone requirements. Exposure to some drugs, such as cyclosporine, tizanidine or theophylline, may increase; do not interpret the label’s interaction table as an instruction to increase all affected companion drugs. Review their own labels and clinical response.

05

Use in specific populations

Eligibility depends on age, reproductive status, organ disease and product.

Adolescents, age and BMI

Selected products are for postmenarcheal reproductive potential, not premenarcheal or postmenopausal use. Age alone does not replace vascular-risk assessment; smoking and migraine restrictions become especially important with increasing age. Oral Tyblume lacks comparative high-versus-low-BMI safety/efficacy data. Twirla’s BMI < 30 eligibility and reduced effectiveness at 25 to < 30 are product-specific.

Pregnancy, postpartum and breastfeeding

Discontinue if pregnancy occurs; inadvertent early CHC exposure has not been associated with increased major birth defects in the reviewed epidemiology. CHCs can reduce milk supply and hormones/metabolites enter milk; labels advise another method while breastfeeding when possible. Nonbreastfeeding postpartum starts are no earlier than 4 weeks for Tyblume/Dolishale/Twirla and 4–6 weeks for Jaimiess. CDC’s separate eligibility framework prohibits CHCs < 21 days postpartum and adds breastfeeding/VTE-risk restrictions; this does not automatically authorize an earlier start than the selected product instructions.

Renal and hepatic considerations

Selected labels do not provide a validated renal dose-reduction schedule; Jaimiess/Dolishale renal disposition is unstudied. Liver disease may impair steroid metabolism and specified hepatic disease/tumors contraindicate use; stop and evaluate jaundice or significant dysfunction. CDC classifies current nephrotic syndrome and hemodialysis/peritoneal dialysis as category 4 for CHCs (unacceptable risk); other CKD-associated hypertension, diabetes or lupus requires condition-specific evaluation.

06

Clinical pharmacology

Estrogen/progestin contraceptive effects primarily suppress ovulation.

Mechanism

Combined hormones reduce pregnancy risk primarily through suppression of ovulation. Oral labels also describe cervical-mucus and endometrial changes. This does not establish an abortifacient indication; continued dosing in an established pregnancy has no contraceptive purpose.

Oral PK

LNG is highly absorbed and binds primarily to SHBG; EE undergoes gut/liver first-pass metabolism and is mainly albumin-bound. Estrogen-induced SHBG contributes to nonlinear total LNG exposure. EE oxidative metabolism involves CYP3A4, and both hormones undergo conjugation and urinary/fecal elimination. Selected Tyblume steady-state half-lives are about 36 hours for LNG and 18 hours for EE; these are not missed-dose grace periods.

Transdermal exposure

Twirla delivers hormones through skin continuously during 7-day wear; levels reach a plateau around 24–48 hours. Its selected steady-state terminal half-lives are about 41 hours for LNG and 21 hours for EE. The daily delivered 40/10 mcg amounts differ from the total 2.60 mg LNG/2.30 mg EE content of a patch and from an oral tablet dose.

07

Monitoring and counseling

Confirm eligibility, teach the selected pack and provide a plan for errors.

Baseline and follow-up

Assess pregnancy possibility, BP, smoking, migraine/aura, clot/cancer/liver history, diabetes and interacting drugs; measure BMI for Twirla eligibility. CDC requires BP assessment but does not require routine pelvic examination before initiation in a healthy patient. At ongoing care, reassess BP, new conditions/medicines, satisfaction, adherence and bleeding; indicated screening and clinical tests remain individualized.

Urgent symptoms and bleeding

Seek urgent care for severe chest pain/shortness of breath, one-sided leg swelling/pain, sudden severe headache, focal neurological symptoms or visual loss. Promptly report jaundice, severe abdominal pain or serious mood deterioration. Consider pregnancy after missed active dosing, symptoms or absent expected bleeding; continuous packs intentionally lack monthly withdrawal bleeding, so do not use a monthly bleed as the only pregnancy check.

Counseling and error prevention

Explain which tablets contain both hormones, estrogen alone or no hormones; follow pack order and avoid extending hormone-free intervals. Keep written product-specific missed-dose/backup instructions and seek prompt advice when unprotected sex accompanies dosing errors. Check patch adhesion and use condoms appropriately for STI protection. Discuss an alternative method if daily/weekly adherence is difficult.

08

Product identification

Selected strengths, imprints and storage are specific to their manufacturer labels.

Representative product identity

Tyblume active tablets are white/round, marked 30 / L2; inactive tablets are peach/round, marked 1 / L2. A 28-tablet carton is NDC 0642-7471-01. Dolishale active tablets are green/round, marked H1; 28 tablets are NDC 50742-659-28. Current Twirla is a beige round patch etched with 40 mcg/day LNG and 10 mcg/day EE; a 3-patch carton is NDC 71671-100-03. Appearance/NDC must match the actual dispensed product.

Dosage forms and strengths

Reviewed oral active combinations are Tyblume LNG 0.1 mg/EE 0.02 mg; Dolishale LNG 0.09 mg/EE 0.02 mg; Jaimiess LNG 0.15 mg/EE 0.03 mg followed by EE-only 0.01 mg tablets. Jaimiess’s selected repackaged 91-tablet dispenser is NDC 63629-2345-01; its combination tablets are SZ/J4 and EE-only tablets SZ/L1. Twirla’s labeled delivery is 40 mcg LNG/10 mcg EE per day. Do not confuse milligrams, micrograms, patch total content and daily delivery. The FDA approved a revision to the presentation of strength in June 2026. Current package panels state that the original 120/30 mcg/day designation and updated 40/10 designation represent the same potency; the new numbers do not mean a threefold dose reduction.

Storage and handling

Tyblume is stored 20–25°C, protected from light/excess heat, and its label explicitly does not permit temperature excursions. Dolishale specifies 20–25°C. Current selected Jaimiess §16 omits an explicit temperature statement: obtain its actual package/pharmacy instructions rather than assign another brand’s storage range. Twirla remains in the unopened original pouch at 20–25°C, with 15–30°C excursions; fold used adhesive sides together, place in a sturdy preferably child-resistant container and discard in trash, never flush.

09

References

Original sources for the clinical and product information.

  1. Exeltis / DailyMedTyblume · Current full oral label

    Current SPL7 effective August 27, 2026; clinical highlights revised 04/2022 and patient instructions 05/2020, separately retained.

  2. Ingenus / DailyMedDolishale · Current full continuous-use label

    Label issued 12/2024; current SPL2 effective April 1, 2025.

  3. Bryant Ranch Prepack / Xiromed source label / DailyMedJaimiess · Current full extended-cycle label

    Current SPL104 effective January 10, 2024; highlights 01/2024 and full PI footer 06/2022 differ.

  4. FDA / ExeltisTwirla · Current FDA prescribing information and instructions

    June 2026, reference 5819263; labeled delivery 40 mcg LNG/10 mcg EE per day.

  5. CDCCombined hormonal contraceptives ·2024 U.S. Selected Practice Recommendations

    Current public page November 19, 2024; selected initiation, monitoring and missed-dose recommendations reviewed.

  6. CDCCHC eligibility ·2024 U.S. Medical Eligibility Criteria AppendixD

    Current primary condition-specific recommendations reviewed, including BP, smoking, migraine, postpartum and CKD.

  7. FDATwirla · FDA strength-presentation supplement approval

    NDA204017/S-009 approved June 18, 2026; strength presentation revised, with unchanged potency stated in accompanying current package panels.

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