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conjugated estrogens/medroxyprogesterone (Rx)Brand and Other Names:Premphase, Prempro

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

conjugated estrogens/medroxyprogesterone

tablet

  • 0.3 mg/1.5mg
  • 0.45 mg/1.5mg
  • 0.625 mg/2.5mg
  • 0.625 mg/5mg
  • 0.625 mg/5mg plus conjugated estrogen 0.625 mg (Premphase)
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Menopause

Indicated in women who have a uterus for the treatment of moderate-to-severe vasomotor symptoms or vulvar and vaginal atrophy associated with the menopause

Also indicated for prevention of postmenopausal osteoporosis; when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and nonestrogen medications should be carefully considered

Premphase (biphasic regimen)

  • 1 pure estrogen tablet qDay Days 1-14, THEN
  • 1 combo tablet PO qDay on days 15-28 of cycle

Prempro

  • 1 tablet PO qDay

Not recommended

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Interactions

Interaction Checker

conjugated estrogens/medroxyprogesterone 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%

            Abdominal pain

            Breast enlargement

            Breast tenderness

            Bloating

            Nausea/vomiting

            Peripheral edema

            Frequency Not Defined

            Amenorrhea

            Breakthrough bleeding

            Depression

            Headache

            Melasma

            Spotting

            Weight changes

            Postmarketing Reports

            Ischemic colitis

            Growth potentiation of benign meningioma

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            Warnings

            Contraindications

            Known anaphylactic reaction or angioedema

            Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

            Pregnancy

            Estrogen-dependent neoplasia

            Current/history of DVT/PE, arterial thromboembolic disease, breast cancer, liver disease/tumors

            Undiagnosed abnormal vaginal bleeding

            Cautions

            Bone mineral density changes, current/history of depression, diabetes mellitus, HTN, hyperlipidemia, hypertriglyceridemia, obesity, endometriosis, family history of breast cancer and/or DVT/PE, smoking, severe hypocalcemia, ovarian cancer

            Discontinue if the following develop: jaundice, visual problems, 4 wk before major surgery or prolonged immobilization, any symptoms of VTE, massive BP increase, unusually severe migraines or first-time migraines, depression

            Increased risk of post-op thromboembolic complications, MI, stroke, pulmonary emboli, DVT, Alzheimer's disease, cardiovascular disorders, probable dementia, and endometrial cancer

            Conditions exacerbated by fluid retention (eg, asthma, migraine, cardiac/renal dysfunction, epilepsy)

            Patients on warfarin/oral anticoagulants: estrogens increase thromboembolic risk; increase in anticoagulant dose may be warranted

            Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: controversial; estrogens are excreted into breast milk in small quantities, 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

            Estradiol: Endogenous estrogen; reduces the release of gonadotropin-releasing hormone from hypothalamus, reduces release of LH and FSH from pituitary gland; increases synthesis of DNA, RNA, and various proteins in target tissues

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

            Absorption

            Bioavailability: Readily absorbed from GI tract (conjugated estrogens)

            Onset: 2-4 wk (conjugated estrogens)

            Peak Plasma: 8 hr (conjugated estrogens)

            Distribution

            Protein Bound: 80% (conjugated estrogens); 90% (medroxyprogesterone)

            Metabolism

            Conjugated estrogens metabolized in liver to inactive sulfates and glucuronides

            Medroxyprogesterone metabolized in liver

            Metabolites: Estradiol, estrone, estriol (conjugated estrogens)

            Elimination

            Excretion (conjugated estrogens): Urine, most estrogens are also excreted in bile and undergo enterohepatic recycling

            Excretion (medroxyprogesterone): Urine

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            Images

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            Formulary

            FormularyPatient Discounts

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            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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