levonorgestrel oral (Plan B One-Step, Next Choice One Dose, My Way, Aftera, Econtra EZ, Fallback Solo, Opcicon One-Step, React, Take Action)
Classes: Progestins; Contraceptives, Oral
Dosing and uses of Plan B One-Step, Next Choice One Dose (levonorgestrel oral)
Adult dosage forms and strengths
tablet
- 1.5mg
Emergency Post-coital Contraception
Progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
1 tablet (1.5 mg) PO as soon as possible within 72 hr of unprotected coitus
Most effective if taken as soon as possible after unprotected intercourse
Pediatric dosage forms and strengths
tablet
- 1.5mg
Emergency Post-coital Contraception
Progestin-only emergency contraceptive indicated for prevention of pregnancy in postmenarchal adolescents following unprotected intercourse or a known or suspected contraceptive failure
1 tablet (1.5 mg) PO as soon as possible within 72 hr of unprotected coitus
Most effective if taken as soon as possible after unprotected intercourse
Dosing Considerations
Age restriction for exclusivity expired April 30, 2016
All of products listed are available OTC without age restrictions
Plan B One-Step, Next Choice One Dose (levonorgestrel oral) adverse (side) effects
>10%
Headache (12%)
Acne (15%)
Ovarian cysts (13%)
Enlarged follicles (12%)
Amenorrhea (1-12%)
Abdominal pain (12%)
Uterine/vaginal bleeding alterations (52%)
Intermenstrual bleeding/spotting (23%)
Vulvovaginitis (20%)
Ectopic pregnancy (≤50%)
1-10%
Depression (4%)
Migraine (2%)
Alopecia (1%)
Dysmenorrhea (9%)
Menorrhagia (6%)
Breast tenderness (3-9%)
Pelvic pain (6%)
Leukorrhea (5%)
Vaginal discharge (4%)
Pelvic infection (1%)
<1%
Angioedema
Cervical perforation
Failed insertion
Sepsis
Uterine bleeding
Device breakage
Warnings
Contraindications
Documented hypersensitivity
Cautions
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
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).
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.
Pregnancy and lactation
Pregnancy category: X
Lactation: controversial; not recommended as contraceptive method of choice during lactation by mfr
Pregnancy categories
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.
Pharmacology of Plan B One-Step, Next Choice One Dose (levonorgestrel oral)
Mechanism of action
Synthetic progestin, ovulation is inhibited from a negative feedback mechanism on hypothalamus, leading to reduced secretion of FSH and LH
Absorption
Peak Plasma Time: 1.4-2.5 hr
Distribution
Protein Bound: 50%
Vd: 1.6-1.9 L/kg
Metabolism
Metabolized in liver
Metabolites: Tetrahydrolevonorgestrels, hydroxynorgestrel, conjugates of sulfate or glucuronide
Elimination
Half-Life: 11-45 hr
Excretion: Urine (40-50%), feces (32%)
