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PREMPHASE
Menopause and HRT
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Drug Name:

PREMPHASE Rx

Generic Name and Formulations:
Conjugated estrogens 0.625mg (14 tabs); conjugated estrogens 0.625mg, medroxyprogesterone acetate 5mg (14 tabs).

Company:
Pfizer Inc.

Therapeutic Use:

Indications for PREMPHASE:

In women with an intact uterus: moderate to severe vasomotor symptoms due to menopause; moderate to severe vulvar and vaginal atrophy due to menopause; postmenopausal osteoporosis prevention (consider alternative therapies).

Adult:

1 tab daily in correct order; repeat.

Children:

Not applicable.

Contraindications:

Known, suspected, or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Pulmonary embolism/DVT (active or history of). Arterial thromboembolism (eg, stroke, MI; active or history of). Protein C, protein S, or antithrombin deficiency, or other known thromboembolic disorders. Liver dysfunction or disease. Known or suspected pregnancy (Cat.X).

Warnings/Precautions:

Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reevaluate periodically. Gallbladder disease. Hypercalcemia in breast cancer or bone metastases. Conditions aggravated by fluid retention. Familial hyperlipoproteinemia. Hypercoagulation states. Mastodynia. Hereditary angioedema. Do initial complete physical and repeat at least yearly (include BP and PAP smear). Discontinue if cardiovascular events or visual abnormalities occur or are suspected; if jaundice occurs; and during immobilization for at least 4–6 weeks before surgery associated with thromboembolism. May interfere with lab tests; see literature. Nursing mothers: not recommended.

Pharmacological Class:

Estrogen + progestin.

Adverse Reactions:

See literature. Increased risk of cardiovascular events, breast cancer (in prolonged use). GI upset, hepatic impairment, mastodynia, breakthrough bleeding, altered cervical secretion, vaginal infections, edema, worsening of porphyria, headache, migraine, dizziness, dementia, changes in vision, intolerance to contact lenses, hair loss, weight or libido changes, anaphylactic reactions, angioedema.

How Supplied:

Blister card (28 tabs)—1

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