norgestimate/ethinylestradiol (Rx)

Brand and Other Names:Mononessa, Ortho Cyclen-28, more...Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Estarylla, Tri-Estarylla, Tri-Lo-Estarylla, Mili, Mono-Linyah, Tri-Linyah, Previfem, Sprintec 28, TriCyclen, Tri-Lo Sprintec, Tri-Mili, Tri-Lo-Mili, Trinessa, TriNessa Lo, TriPrevifem, TriSprintec
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Dosing & Uses

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Dosage Forms & Strengths

norgestimate/ethinyl estradiol

tablet, monophasic (Estarylla, Mili, MonoNessa, Previfem, Sprintec)

  • Days 1-21: 0.25mg/35mcg
  • Days 22-28: Inert tablets

tablet, triphasic (Ortho Tri-Cyclen, Tri-Estarylla, Tri-Mili, Trinessa, Tri-Sprintec, Tri-Previfem)

  • Days 1-7: 0.18mg/35mcg
  • Days 8-14: 0.215mg/35mcg
  • Days 15-21: 0.25mg/35mcg
  • Days 22-28: Inert tablets

tablet, triphasic (Ortho Tri-Cyclen Lo, Tri-Lo-Estarylla, Tri-Lo-Mili)

  • Days 1-7: 0.18mg/25mcg
  • Days 8-14: 0.215mg/25mcg
  • Days 15-21: 0.25mg/25mcg
  • Days 22-28: Inert tablets
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Contraception

Sunday starter: 1 hormonally active tablet daily for 21 days, then 1 inert tablet daily for 7 days; cycle repeated; start Sunday after onset of menstruation; if menstrual period occurs on Sunday, start that very same day; take additional method of contraception until after first 7 days of consecutive administration

Day 1 starter: Take first dose on the day of the menstrual cycle and continue to take 1 tablet daily

21-tablet package: Take 1 tablet for 21 days followed by 7 days off the medication

28-tablet package: Take 1 tablet daily without interruption

Missed dose monophasic

  • One dose missed: Take dose as soon as remembered or take 2 tablets next day
  • Two consecutive doses missed: Take 2 tablets as soon as remembered or 2 tablets next two days; use additional method of contraception for 7 days after missed dose
  • Two consecutive doses missed in week three or three doses missed at any time: Use additional method of contraception for 7 days after missed dose
  • Start a new pack if two doses missed in third week or three doses missed at any time as follows
  • Sunday starter: Continue daily dose until Sunday, then discard the rest of the pack and start a new pack that same day
  • Day 1 starter: Discard current pack and start a new pack that same day

Missed dose biphasic/triphasic formulations

  • One dose missed: Take dose as soon as remembered or take 2 tablets next day
  • Two consecutive doses missed in week 1 or 2 of the pack: Take 2 tablets as soon as remembered and 2 tablets the next day; continue taking 1 tablet daily until pack is empty; use additional method of contraception for 7 days after missed dose
  • Two consecutive doses missed in week three of the pack: Use additional method of contraception for 7 days after missed dose
  • Start a new pack if two doses missed in week 3 of the pack
  • Sunday starter: Continue daily dose until Sunday, then discard the rest of the pack and start a new pack that same day
  • Day 1 starter: Discard current pack and start a new pack that same day

Dosage Modifications

Renal impairment: Use with caution; monitor blood pressure

Hepatic impairment: Do not administer

Dosing Considerations

Follow manufacturer's color-coding for sequence of administration (especially with triphasic formulations)

Safety and efficacy not established

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Interactions

Interaction Checker

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            Adverse Effects

            Frequency Not Defined

            Amenorrhea

            Anorexia

            Aterial thromboembolism

            Cerebral hemorrhage

            Crebral thrombosis

            Retinal thrombosis

            Breakthrough bleeding

            Change in menstrual flow

            Gallbladder disease

            Edema

            Spotting

            Weakness

            Abdominal pain

            Breast tenderness

            Cholestatic jaundice

            Deep vein thrombosis (DVT)

            Depression

            Dizziness

            Galactorrhea

            Headache

            Nausea

            Nervousness

            Somnolence

            Thrombophlebitis

            Varicose vein aggravation

            Vomiting

            Weight change

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            Warnings

            Black Box Warnings

            Cigarette smoking and risk of cardiovascular disease

            • Cigarette smoking increases risk of serious cardiovascular adverse effects from use of combination hormonal contraceptives
            • Risk increases with age (>35 years) and with heavy smoking (≥15 cigarettes/day)
            • Women who use hormonal oral contraceptives are advised not to smoke

            Contraindications

            Documented hypersensitivity

            Active or history of breast cancer

            Arterial thromboembolic disease (stroke, myocardial infarction [MI]), thrombophlebitis, DVT/pulmonary embolism (PE), thrombogenic valvular disease

            Estrogen-dependent neoplasia

            Liver disease, liver tumors

            Undiagnosed abnormal uterine bleeding

            Uncontrolled hypertension (ie, persistent BP values >160 mm Hg systolic or >100 mg Hg diastolic)

            Diabetes mellitus with vascular involvement

            Jaundice with previous oral contraceptive use

            Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

            Women > 35 years who smoke

            Cerebrovascular and/or coronary artery disease, disease, headaches with focal neurological symptoms, migraine headaches with auro or migraine headaches if >35 years of age

            Cautions

            Use caution in family history of breast cancer and or DVT/PE, current or previous depression, endometriosis, diabetes mellitus, hypertension, bone mineral density changes, renal or hepatic impairment, bone metabolic disease, systemic lupus erythematosus (SLE), conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

            Monitor prediabetic and diabetic women on therapy; consider alternate contraceptive method for women with uncontrolled dyslipidemia

            Headache: Evaluate significant change in headaches and discontinue therapy if indicated

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

            Discontinue if any of the following develop: Jaundice, visual problems (may cause contact lens intolerance), signs of venous thromboembolism, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

            Discontinue 4 weeks before major surgery or prolonged immobilization

            Patients on warfarin or oral anticoagulants: Increase in anticoagulant dosage may be warranted

            Some studies link oral contraceptive use with increased risk of breast cancer, whereas others do not; risk depends on conditions where naturally high hormone levels persist for long periods, including early-onset menstruation (age <12 years), late-onset menopause (age >55 years), first child after age 30 years, nulliparity

            Increased risk of cervical cancer with oral contraceptive use, however, human papillomavirus (HPV) remains primary risk factor for this cancer

            Long-term (≥5years) use of oral contraceptives may be associated with increased risk

            Increased risk of liver cancer with oral contraceptive use; risk increases with duration of use

            Discontinue hormonal therapy prior to starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with combination drug regimen

            Chloasma associated with combination hormonal contraceptives, as well as pregnancy and sun exposure; avoid sun exposure or ultraviolet radiation during therapy

            Risk of cholestasis increased with prior history of cholestasis with prior contraceptive use or previous cholestasis of pregnancy

            Combination hormonal contraceptives may adversely affect lipid levels; consider alternative contraception for women with uncontrolled dyslipidemia

            Retinal vascular thrombosis reported in patients receiving estrogens; discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine; if examination reveals papilledema or retinal vascular lesions, estrogens should be discontinued

            Breakthrough or intracyclic bleeding and spotting may occur, especially during first 3 months of therapy; missed periods may also occur occasionally; evaluate and rule out malignancy if irregular or unresolving vaginal bleeding occurs

            There are, possible risks that may be associated with use of progestins with estrogens compared to estrogen-alone regimens, including a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL), and impairment of glucose tolerance

            Risk of ovarian or endometrial cancer decreased in women using combination hormonal contraceptives

            May increase risk of gallbladder disease or may worsen gallbladder disease

            Use of combination hormonal contraceptives associated with hepatic adenomas; rupture may cause fatal intra-abdominal hemorrhage; long term use may be associated with increased risk of hepatocellular carcinoma

            Estrogens may induce or exacerbate symptoms in women with hereditary angioedema

            Risk of hypertension may be increased with age, dose, and duration of use; not for use in women with hypertension oand vascular disease

            Use of combination hormonal contraceptives not recommended in women with complicated organ transplant; medical complications reported

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            Pregnancy & Lactation

            Pregnancy category: X

            Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality or quantity of milk; may be prudent to use other forms of birth control until full weaning (American Academy of Pediatrics committee states that agent is compatible with nursing); not recommended

            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: Reduces release of luteinizing hormone-releasing hormone (LHRH) from hypothalamus; reduces release of gonadotropin from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues

            Norgestimate: Inhibits secretion of gonadotropin from pituitary; prevents follicular maturation and ovulation; stimulates growth of mammary tissues

            Absorption

            Peak plasma time: 2 hr

            Distribution

            Protein bound: >97% (ethinyl estradiol)

            Metabolism

            Metabolized in liver by CYP3A4 to estriol, estrone (ethinyl estradiol)

            Elimination

            Half-life: Ethinyl estradiol, 10-16 hr; norgestimate, 18-25 hr; norgestrel, 38-45 hr

            Excretion (ethinyl estradiol): Urine as conjugates; most estrogens are also excreted in bile and undergo enterohepatic recycling

            Excretion (norgestimate): Urine (47%) and feces (37%) as metabolites

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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.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the 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.