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norethindrone acetate (Rx)Brand and Other Names:Aygestin, Norlutate

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 5mg
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Amenorrhea or Uterine Bleeding

2.5-10 mg/day PO for 5-10 days during latter part of cycle

Expect withdrawal bleeding within 3-7 days after stopping norethindrone

Endometriosis

5 mg PO qDay for 14 days, may increase by 2.5 mg up to 15 mg/day PO for 6-9 months

Pre-menarche: Not recommended

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Interactions

Interaction Checker

norethindrone acetate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Edema

            Weakness

            Anorexia

            Amenorrhea

            Breakthrough bleeding

            Change in menstrual flow

            Spotting

            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

            Contraindications

            Documented hypersensitivity

            Estrogen-dependent neoplasia

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

            Estrogen-dependent neoplasia, liver disease, liver tumors

            Undiagnosed abnormal vaginal bleeding

            Diabetes mellitus with vascular involvement

            Jaundice with prior oral contraceptive use

            Missed abortion or as diagnostic test for pregnancy

            Cautions

            Norethindrone acetate is 2 times as potent as norethindrone

            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.

            Rare hepatic adenomas and focal modular hyperplasia, resulting in fatal intra-abdominal hemorrhage reported with therapy

            Irregular menstrual bleeding is common with progestin only contraceptives; rule out nonpharmacologic causes of abnormal bleeding

            Not for use prior to menarche

            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.

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: Excreted in breast milk; use caution

            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

            Progestin; inhibits secretion of gonadotropins from pituitary gland; prevents follicular maturation & ovulation, stimulates growth of mammary tissues

            Absorption

            Bioavailability: 64%

            Peak Plasma Time: 1-2 hr

            Distribution

            Vd: 4 L/kg

            Protein Bound: 61%

            Metabolism

            Liver

            Metabolites: Sulfate and glucuronide metabolites (inactive)

            Elimination

            Half-Life: 4-13 hr

            Excretion: Urine 33-81%; feces 35-43%

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            Images

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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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