levonorgestrel oral (Rx, OTC)

Brand and Other Names:Plan B One-Step, Next Choice One Dose, more...My Way, Aftera, Econtra EZ, Fallback Solo, Opcicon One-Step, React, Take Action, Preventeza
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Dosing & Uses

AdultPediatric

Dosage Forms & 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

Dosage Forms & 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

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Interactions

Interaction Checker

and levonorgestrel oral

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse 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

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            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

            Delay product insertion a minimum of six weeks or until involution complete following a delivery or a second trimester abortion

            Lactation at time of insertion of an IUD/IUS associated with increased risk of perforation

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            Pregnancy & Lactation

            Pregnancy

            Use of is contraindicated in pregnancy or with a suspected pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant and therapy may cause adverse pregnancy outcomes; if a woman becomes pregnant likelihood of ectopic pregnancy is increased and there is increased risk of miscarriage, sepsis, premature labor, and premature delivery; remove product if possible, if pregnancy occurs in a woman; if product cannot be removed, follow pregnancy closely

            Studies report no adverse effects on fetal and infant development associated with long-term use of contraceptive doses of oral progestins in a pregnant woman; however, there have been reported cases of masculinization of external genitalia of female fetus following exposure to progestins at doses greater than those currently used for oral contraception; animal reproduction studies not conducted

            Lactation

            Published studies report presence of LNG in human milk; small amounts of progestins (approximately 0.1% of total maternal doses) were detected in breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the breastfed infants; there are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives; isolated cases of decreased milk production reported with a LNG-releasing IUS; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child therapy or from underlying maternal condition

            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.

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            Pharmacology

            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%)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.