Brand and Other Names:Ortho-Cept, Desogen, more...Apri, Caziant, Cyclessa, Emoquette, Enskyce, Kariva, Mircette, Reclipsen, Solia, Velivet, Viorele, Azurette, Kimidess, Pimtrea
- Classes: Estrogens/Progestins
Dosing & Uses
Dosage Forms & Strengths
- 0.15mg/0.02mg x 21 days, then inert tabs x 2 days, then 0mg/0.01mg x 5 days
- 0.1mg/0.025mg (7 tabs), plus
- 0.125mg/0.025mg (7 tabs), plus
- 0.15mg/0.025mg (7 tabs)
Monophasic (Apri, Cyred, Desogen, Emoquette, Enskyce, Juleber, Ortho-Cept, Reclipsen, Solia)
- 1 tablet PO qDay for 28 days, then start new pack
- Days 1-21: Each tablet contains desogestrel 0.15 mg/ethinyl estradiol (EE) 0.03 mg
- Days 22-28: Inactive tablets
Biphasic (Azurette, Kariva, Kimidess, Mircette, Pimtrea, Viorele)
- 1 tablet PO qDay for 28 days in order indicated on package, then start new pack
- Days 1-21, Each tablet contains 0.15 mg desogestrel/0.02 mg EE
- Days 22-23: Inactive tablets
- Days 24-28: Each tablet contains 0.01 mg ethinyl estradiol
Triphasic (Cyclessa, Velivet, Caziant)
- 1 tablet PO qDay for 28 days in order indicated on package, then start new pack Day 1-7, each tablet contains 0.025 mg ethinyl estradiol and 0.1 mg desogestrel
- Days 8-14, each tablet contains 0.025 mg ethinyl estradiol and 0.125 desogestrel
- Days 15-21, each tablet contains 0.025 mg ethinyl estradiol and 0.15 desogestrel
- Days 22-28: Inactive tablets
Other Indications & Uses
Off-label: Dysmenorrhea, dysfunctional uterine bleeding, endometriosis, polycystic ovarian syndrome, acne
Premenarche: Not recommended
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
Application site rxn (if transdermal preparation)
Black Box Warnings
Cigarette smoking & risk of cardiovascular disease
- Cigarette smoking increases risk of serious cardiovascular adverse effects from combination hormonal contraceptive use
- This risk increases with age (>35 yr) and with heavy smoking (15 or more cigarettes/day)
- Advise women who use hormonal oral contraceptives not to smoke
Active or history of breast cancer
Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease
Liver disease, liver tumors
Undiagnosed abnormal vaginal bleeding
Uncontrolled hypertension (ie, persistent BP values >160 mm Hg systolic or >100 mg Hg diastolic)
Diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use
Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)
Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception
Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery
Discontinue 4 week before major surgery or prolonged immobilization
Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)
Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk
Woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity
Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk
Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use
Risk of venous thromboembolism (VTE) is highest in first year of use and when a combination oral contraceptive is started or re-started after a break in use of four weeks or more
CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)
Pregnancy & Lactation
Pregnancy Category: X
Lactation: enters breast milk/not recommended (AAP Committee states "compatible with nursing")
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Ethinyl estradiol (EE): Reduces LHRH release from hypothalamus, reduces gonadotropin release from pituitary; increase synthesis of DNA, RNA, and various proteins in target tissues
Desogestrel: Progestin; inhibits gonadotropin secretion from pituitary; prevents follicular maturation & ovulation, stimulates growth of mammary tissues
Peak plasma time: Etonogestrel 1-1.5 hr; EE 1-1.5 hr
Peak plasma concentration: Etonogestrel 2100-3800 pg/mL (dose-dependent); EE 90 pg/mL
AUC: Etonogestrel 200-250 pg.hr/mL/mcg; EE 26-29 pg.hr/mL/mcg
Protein Bound: Etonogestrel 98% bound to SHBG; EE extensively bound to serum albumin
Desogestrel: Metabolized by hepatic P450 enzyme CYP2C9 to etonogestrel (active metabolite)
EE: Metabolized by hepatic CYP3A4 to estriol, estrone
Half-Life: Etonogestrel: 38 hr; EE: 28 hr
Excretion: Urine, feces
When initially starting, use additional contraceptive method during first consecutive 7 days of administration
Start on 1st day of menstrual cycle or on Sunday immediately following onset of menses
- If 1 menstrual period is missed and all doses have been taken on schedule (ie, no missed tablets), continue with next dosing cycle (pack)
- If 2 consecutive menstrual periods are missed, a pregnancy test is required before beginning the next dosing cycle (pack)
Initiating after pregnancy
- Increased risk for venous thromboembolism (VTE) following delivery with combined hormonal contraceptives; risk declines rapidly after 21 days, but does not return to normal until 42 days after delivery
- CDC guidelines recommend waiting 3-6 weeks in postpartum women without additional VTE risks (MMWR July 7, 2011)
- Initiating after vaginal birth: Wait at least 3 weeks
- Initiating after caesarean section birth: Wait at least 6 weeks
- Women with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptives
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