Ortho Tri-Cyclen
Combination product
Pronunciation: ETH-i-nil es-tra-DYE-oel and nor-JES-ti-mayt
Combination of Ethinyl estradiol and Norgestimate.
Each component keeps its own pharmacology page; the combination itself adds no new mechanism.
Es-trojan + North estimator
Components (2)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Prevention of pregnancy | Women of reproductive age | 1 active tablet QD x21 days, then 1 inactive tablet QD x7 days (28-day blister pack); Day-1 or Sunday start | 1 tablet QD at same time daily | 1 tablet QD |
| Prevention of pregnancy | Post-pubertal adolescents <18 y (not indicated before menarche) | Same regimen as adults: 1 tablet QD per 28-day pack | 1 tablet QD | 1 tablet QD |
Renal Undefined
Hepatic Contraindicated in liver disease/liver tumors; discontinue if jaundice occurs; PK not studied in hepatic impairment
Not indicated before menarche or in postmenopausal women
Instructions
- Take at the same time every day, in blister-pack order; do not skip or delay tablets
- Sunday start: backup non-hormonal contraception for first 7 days of first pack
- Missed 1 active tablet: take ASAP, continue pack
- Missed 2 active tablets (week 1-2): take 2 ASAP and 2 the next day, continue pack; backup contraception per label
- Postpartum or after 2nd-trimester abortion/miscarriage: do not start until 4 weeks after (VTE risk); after 1st-trimester abortion may start immediately
- Switching: start on day next dose/application of prior method would have been due (IUD/implant: day of removal)
Available strengths
- tab 0.025/0.18, 0.035/0.18, 0.035/0.25 mg
Contraindications
- High risk of arterial/venous thrombosis: smoking >35 y, current/past DVT or PE, hypercoagulopathies, cerebrovascular disease, CAD, thrombogenic valvular/rhythm disease, uncontrolled hypertension, diabetes with vascular disease
- Migraine with aura (any age); any migraine in women >35 y
- Liver tumors (benign or malignant) or liver disease
- Undiagnosed abnormal uterine bleeding
- Pregnancy
- Current or past breast cancer or other estrogen-/progestin-sensitive cancer
- HCV regimens containing ombitasvir/paritaprevir/ritonavir +/- dasabuvir (ALT elevations)
Cautions
- Stop if arterial/venous thrombotic event, unexplained vision loss, or jaundice occurs
- Stop >=4 weeks before through 2 weeks after major surgery/prolonged immobilization
- Start no earlier than 4 weeks postpartum (non-breastfeeding)
- Well-controlled hypertension: monitor BP; stop if significant rise
- Monitor prediabetic/diabetic users; consider alternative if uncontrolled dyslipidemia
- Evaluate significant headache change; evaluate irregular bleeding or amenorrhea
Adverse reactions
- Common COC class: irregular uterine bleeding, nausea, breast tenderness, headache
- >=2% in trials: headache/migraine, abdominal/GI pain, vaginal infection, genital discharge, breast issues (pain, discharge, enlargement), mood disorders (incl. depression), flatulence, nervousness, rash
Pregnancy Contraindicated; little/no increased birth-defect risk from inadvertent early-pregnancy use; do not use to induce withdrawal bleeding as pregnancy test or treat threatened/habitual abortion
Lactation Not recommended while nursing — can reduce milk production; small hormone amounts in milk; use other contraception until weaned
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 0.025/0.18 mg | tab | 30 qd | not offered | |
| 0.035/0.18 mg | tab | 30 qd | not offered | |
| 0.035/0.25 mg | tab | 30 qd | not offered |
Part D rank #117.