conjugated estrogens/medroxyprogesterone (Rx)

Brand and Other Names:Premphase, Prempro
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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

and conjugated estrogens/medroxyprogesterone

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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

            Use caution in patients with 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

            Discontinue before 4 wk before major surgery or prolonged immobilization or there are any symptoms of VTE, massive BP increase, unusually severe migraines or first-time migraines, depression

            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

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

            Manage appropriately risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus)

            Use caution in patients with 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

            Not for use with conditions that predispose to hyperkalemia

            Increased risk of ovarian cancer reported in women who used hormonal therapy for menopausal symptoms

            A 2 to 4-fold increase in risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens reported

            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

            In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications

            Estrogens may be poorly metabolized in patients with impaired liver function; exercise caution in patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy; in the case of recurrence, discontinue medication

            Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of thyroid replacement therapy; these patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range

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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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            Formulary

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            Tier Description
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