ethinyl estradiol / levonorgestrel
Combination product
Pronunciation: ETH-i-nil es-tra-DYE-oel and lee-voe-nor-JES-trel
Combination of Ethinyl estradiol and Levonorgestrel.
Each component keeps its own pharmacology page; the combination itself adds no new mechanism.
Components (2)
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use; TYBLUME is contraindicated in women over 35 years of age who smoke.
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Prevention of pregnancy | Females of reproductive potential | 1 white active tablet QD ×21 days | Then 1 peach inactive tablet QD ×7 days (28-day cycle); repeat |
Renal Undefined
Hepatic Undefined
Take at intervals not exceeding 24 hours to maintain contraceptive effectiveness.
Instructions
- Swallow whole on an empty stomach, or chew and immediately swallow with a full glass (240 mL) of water on an empty stomach
- Take one tablet at the same time every day at intervals not exceeding 24 hours
- Use back-up nonhormonal contraception per missed-dose instructions
Available strengths
- tab 0.1/0.02, 0.15/0.03 mg
- patch 40/10 mcg/day (LNG/EE)
Contraindications
- A high risk of arterial or venous thrombotic diseases
- Current or history of breast cancer or other estrogen- or progestin-sensitive cancer
- Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis
- Undiagnosed abnormal uterine bleeding
- Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
Cautions
- Thromboembolic/vascular risks — stop if a thrombotic event occurs; stop ≥4 weeks before and 2 weeks after major surgery; consider CV risk factors, particularly >35 years
- Liver disease — discontinue if jaundice occurs
- Hypertension; gallbladder disease
- Adverse carbohydrate and lipid effects
- Headache; bleeding irregularities and amenorrhea; depression
- Cervical cancer; hereditary angioedema; chloasma
Adverse reactions
- Headache, abdominal pain, nausea
- Metrorrhagia/unscheduled bleeding, amenorrhea
- Vaginal moniliasis and pain, vaginitis
- Acne, breast tenderness, mood changes
Pregnancy Discontinue during pregnancy (no use for contraception in pregnancy).
Lactation Advise another method; combination hormonal contraceptives can reduce milk production; hormones/metabolites present in milk.
Cost
ethinyl estradiol / levonorgestrel
| Strength | #/mo | generic $ | CostPlus | |
|---|---|---|---|---|
| 0.1/0.02 mg | tab | 30 qd | not offered | |
| 0.15/0.03 mg | tab | 30 qd | not offered | |
| 40/10 mcg/day | patch | per unit | not offered |
NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. ethinyl estradiol / levonorgestrel is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.
Part D rank #167.