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estropipate (Rx)Brand and Other Names:Ortho Est, Ogen 5, more...Ogen 2.5, Ogen 1.25, Ogen 0.625

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 0.75mg
  • 1.5mg
  • 3mg
  • 6mg
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Menopause

0.75-6 mg PO qDay; taper at 3-6 month intervals

Cream: 2-4 g intravaginal 3 weeks on, 1 week off

Ovarian Failure

1.5-9 mg PO qDay for 3 weeks, then off for 8 days; repeat if necessary

Osteoporosis, Prevention

0.75 mg PO qDay for 25 days, then off for 6 days; repeat

Other Indications & Uses

Vasomotor symptoms associated with menopause; ovarian failure; osteoporosis, treatment of female hypogonadism due to castration, or primary ovarian failure, menopausal atrophic vaginitis (vaginal cream) daily

Safety & efficacy not established

Osteoporosis, prevention

0.75 mg PO qDay for 25 days, then off for 6 days; repeat

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Interactions

Interaction Checker

estropipate 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

            Peripheral edema

            Depression

            Headache

            Melasma

            Bloating

            Nausea & vomiting

            Breast enlargement & tenderness

            Amenorrhea

            Breakthrough bleeding

            Spotting

            Weight changes

            Corneal curvation change

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            Warnings

            Black Box Warnings

            Estrogens increase risk of endometrial cancer

            • Close clinical surveillance of all women taking estrogens is important
            • Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding
            • There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses

            Cardiovascular risks

            • Estrogens with and 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: A substudy of the WHI Study reported increased risk for 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 and 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 and 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

            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

            Diabetes mellitus with vascular involvement

            Jaundice with prior oral contraceptive use

            Cautions

            Diabetes mellitus, endometriosis, hyperlipidemias, HTN, hypothyroidism, elderly, hepatic/renal impairment, uterine leiomyomata, porphyria, patients with defects of lipoprotein metabolism, hypertriglyceridemia, ovarian cancer, exacerbation of endometriosis or other conditions, smoking and >35 years old, SLE, depression

            Fluid retention may exacerbate asthma, epilepsy, migraines, & cardiac or renal dysfunction

            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.

            Hypercalcemia may occur in patients with breast cancer and bone metastases

            Increased risk of endometrial and ovarian cancer in postmenopausal women

            Long-term postmenopausal estrogen treatment has been associated with increased risk of breast cancer, MI, stroke, DVT, PE, and dementia

            May increase risk of thromboembolic disorders, may need to increase anticoagulant dose when administering concomitantly with anticoagulants

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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

            Semisynthetic conjugate of estrone with piperazine; 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

            Pharmacokinetics

            Half-Life: IM: 1.5-5 hr

            Bioavailability: Readily absorbed through GI tract, skin, mucous membrane

            Protein bound: 50-80%

            Metabolism: Undergoes rapid and extensive first-pass metabolism in liver to less active products such as estriol; kidneys, gonads, and muscle tissues may be involved in metabolism to some extent

            Metabolites: Estriol

            Excretion: Mainly in urine as conjugates with small amount of unchanged drug, most estrogens are also excreted in bile and undergo enterohepatic recycling

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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.
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