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norethindrone/ethinylestradiol (Rx)Brand and Other Names:Aranelle, Balziva 28, more...Alyacen 1/35, Alyacen 7/7/7, Briellyn, Brevicon, Cyclafem 7/7/7, Cyclafem 0.5/35, Cyclafem 1/35, Dasetta 1/35, Dasetta 7/7/7, Gildagia, Leena, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norethin 1/35E, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35-28, Ortho Novum 7/7/7, Ovcon 35, Ovcon 50, Philith, Pirmella 1/35, Pirmella 7/7/7, Modicon 28, TriNorinyl, Wera, Zenchent

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

norethindrone/ethinyl estradiol

tablet, monophasic

  • 0.4 mg/35mcg (Balziva-28, Briellyn, Gildagia, Ovcon 35, Philith, Zenchent)
  • 0.5mg/35mcg (Brevicon, Cyclafem 0.5/35, Modicon, Necon 0.5/35, Nortrel 0.5/35, Wera)
  • 1mg/35mcg (Alyacen 1/35, Brevicon, Cyclafem 1/35, Dasetta 1/35, Necon 1/35, Norinyl 1+35, Nortrel 1/35, Ortho Novum 1/35, Pirmella 1/35)
  • 1mg/50mcg (Brevicon)

tablet, biphasic (Necon 10/11)

  • 0.5mg/35mcg (10 tabs)
  • 1mg/35mcg (11 tabs)
  • Inert tabs (7 tabs)

tablet, multiphasic (Aranelle, Leena, Tri-Norinyl)

  • 0.5mg/35mcg (7 tabs)
  • 1mg/35mcg (9 tabs)
  • 0.5mg/35mcg (5 tabs)
  • Inert tabs (7 tabs)

tablet, triphasic (Alyacen 7/7/7, Cyclafem 7/7/7, Dasetta 7/7/7, Nortrel 7/7/7, Ortho Novum 7/7/7, Pirmella 7/7/7)

  • 0.5mg/35mcg (7 tabs)
  • 0.75mg/35mcg (7 tabs)
  • 1mg/35mcg (7 tabs)
  • Inert tabs (7 tabs)
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Oral Contraceptive

Monophasic kit: 1 active tablet PO qDay for days 1-21, then 1 inert tablet qDay (or no tablets) for Days 22-28, and then restart with new pill pack

See package insert for multiphasic, biphasic, and triphasic dosing

Follow Manufacturer's color-coding for sequence

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

Renal Impairment

Use caution; monitor blood pressure

Hepatic Impairment

Do not administer

Not recommended premenarche

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Interactions

Interaction Checker

norethindrone/ethinylestradiol and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Edema

            Weakness

            Anorexia

            Amenorrhea

            Breakthrough bleeding

            Change in menstrual flow

            Spotting

            Frequency Not Defined

            Deep vein thrombosis

            Thrombophlebitis

            Depression

            Dizziness

            Headache

            Nervousness

            Somnolence

            Breast tenderness

            Galactorrhea

            Abdominal pain

            Nausea

            Vomiting

            Weight change

            Cholestatic jaundice

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            Warnings

            Black Box Warnings

            Cardiovascular Risks

            • Estrogens with or without progestins should not be used to prevent cardiovascular disease
            • Estrogens plus progestins: Women’s Health Initiative (WHI) Estrogen Plus Progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (aged 50-79 yr) during 5.6 yr of treatment with daily PO conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) compared with placebo
            • Estrogens alone: The estrogen alone substudy of the WHI Study reported increased risks of stroke and DVT in postmenopausal women (aged 50-79 yr) during 6.8 yr of treatment with oral conjugated estrogens (0.625 mg/day) alone compared with placebo

            Dementia Risks

            • Estrogens with or without progestins should not be used to prevent dementia
            • Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women aged 65 yr or older during 4 yr of treatment w/ daily CE 0.625 mg combined with MPA 2.5 mg, compared with placebo
            • Estrogens alone: A substudy of the WHIMS reported an increased risk of developing probable dementia in postmenopausal women aged 65 yr or older during 5.2 yr of treatment with conjugated estrogens 0.625 mg alone compared with placebo
            • Unknown whether these findings apply to younger postmenopausal women

            Dose & Duration

            • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations adn dosage forms of estrogens and progestins
            • Because of these risks, estrogens with or without progestins should be prescribed at lowest effective dose and for shortest duration consistent with treatment goals and individual risks

            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

            Contraindications

            Documented hypersensitivity

            Active or history of breast cancer

            Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

            Estrogen-dependent neoplasia

            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

            Cautions

            Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception

            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

            Risk of thromboembolic disease associated with oral contraceptives gradually disppears after combined oral contraceptive (COC) use is stopped; VTE risk is highest in first year of use and when restarting hormonal contraception after a break of four weeks or longer

            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

            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)

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)

            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

            Ethinyl Estradiol (EE): Reduces LHRH release from hypothalamus, reduces gonadotropin release from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues

            Norethindrone: progestin; inhibits gonadotropin secretion of gonadotropins from pituitary; prevents follicular maturation and ovulation, stimulates growth of mammary tissues

            Pharmacokinetics

            Peak Plasma Time: 8 hr (ethinyl estradiol ); 1-2 hr (norethindrone)

            Protein binding: 80% (ethinyl estradiol); 61% (norethindrone)

            Both components are metabolized in the liver; estradiol undergoes extensive first-pass metabolism

            Bioavailability: 43-55% (ethinyl estradiol)

            Vd: 2-4 L/kg (ethinyl estradiol)

            Ethinyl estradiol metabolites: Estriol, estrone

            Norethindrone metabolites: Sulfate and glucuronide metabolites (inactive)

            Half-life: 4-13 hr (norethindrone); 19-24 hr (ethinyl estradiol)

            Excretion

            • Ethinyl estradiol: Urine as conjugates, most estrogens are also excreted in bile and undergo enterohepatic recycling
            • Norethindrone: 33-81% (urine); 35-43% (feces)
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            Formulary

            FormularyPatient Discounts

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            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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