Trade Names:Premphase- Tablets 0.625 mg conjugated estrogens and 0.625 mg conjugated estrogens/5 mg medroxyprogesterone acetate
Trade Names:Prempro- Tablets 0.625 mg conjugated estrogens/5 mg medroxyprogesterone acetate- Tablets 0.625 mg conjugated estrogens/2.5 mg medroxyprogesterone acetatePremplus (Canada)
Conjugated estrogens: promotes growth and development of female reproductive system and secondary sex characteristics; affects release of pituitary gonadotropins; inhibits ovulation and prevents postpartum breast engorgement; conserves calcium and phosphorus and encourages bone formation; overrides stimulatory effects of testosterone; progesterone: inhibits secretion of pituitary gonadotropins, thereby preventing follicular maturation and ovulation (contraceptive effect); inhibits spontaneous uterine contraction; transforms proliferative endometrium into secretory endometrium.
Treatment of moderate-to-severe vasomotor symptoms associated with menopause; treatment of vulval and vaginal atrophy; osteoporosis prevention.
Treatment of hypercholesterolemia in postmenopausal women.
Do not use combined estrogens/progestins in conditions or circumstances of: 1) known or suspected pregnancy; 2) known or suspected cancer of the breast; 3) known or suspected estrogen-dependent neoplasm; 4) undiagnosed abnormal genital bleeding; 5) active or past history of thrombophlebitis; thromboembolic disorders, or stroke; 6) liver dysfunction or disease; 7) hypersensitivity to ingredients of tablets.
Revaluate patient at 3- to 6-mo intervals to determine need for continued treatment.Osteoporosis
Monitor women with intact uterus closely for signs of endometrial cancer, evaluate recurrent or persistent abnormal vaginal bleeding to rule out malignancy.PremproAdults
PO One 0.625 mg conjugated estrogen/2.5 mg medroxyprogesterone once daily.PremphaseAdults
PO One 0.625 mg conjugated estrogen once daily on days 1 through 14 and one 0.625 mg conjugated estrogen/5 mg medroxyprogesterone once daily on days 15 through 28.
Store at controlled room temperature. Do not remove tablet from dispensing dial until ready to administer.
May decrease estrogen levels.Corticosteroids
Pharmacologic and adverse reactions of corticosteroids may be increased.Hydantoins (eg, phenytoin)
Loss of seizure control or decreased estrogenic effects may occur.Tricyclic antidepressants
Estrogens may alter effects and increase toxicity.Medroxyprogesterone Aminoglutethimide
May increase metabolism and decrease effect of medroxyprogesterone.
Endocrine and liver function test results may be affected; possible increased PT and increased platelet aggregability; increased thyroid binding globulin and total T 4 ; impaired glucose tolerance; increased corticosteroid binding globulin and sex-hormone binding globulin; increased plasma HDL concentration; reduced LDL cholesterol concentrations; increased triglyceride levels; reduced response to metyrapone test; reduced folate concentration.
Change in BP; thrombophlebitis; cerebral thrombosis and embolism; pulmonary embolism.
Headache; depression; dizziness; hypertonia; nervousness; migraine; chorea; insomnia; somnolence; change in libido.
Pruritus; rash; chloasma; erythema multiforme; erythema nodosum; hemorrhagic eruption; alopecia; hirsutism; itching; urticaria; acne.
Pharyngitis; rhinitis; sinusitis; retinal thrombosis; optic neuritis; contact lenses intolerance.
Abdominal pain and cramps; diarrhea; dyspepsia; flatulence; nausea; changes in appetite; vomiting; bloating.
Breast pain; cervix disorder; dysmenorrhea; leukorrhea; vaginal hemorrhage; vaginitis; abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; changes in cervical secretion; premenstrual-like syndrome; cystitis-like syndrome; vaginal candidiasis; amenorrhea; changes in cervical erosion; breast tenderness and enlargement; galactorrhea.
Peripheral edema; increase or decrease in weight; edema; reduced carbohydrate tolerance.
Accidental injury; back pain; flu-like syndrome; infection; pain; pelvic pain; arthralgia; leg cramps; gallbladder disease; pancreatitis; fatigue; aggravation of porphyria; anaphylactoid reaction; anaphylaxis.
Ensure that breast, abdominal, and pelvic examination and Pap smear have been completed and documented before starting therapy.Adverse reactions
Notify health care provider of pain, swelling, redness, or warmth in calves; sudden severe headache; visual disturbances; weakness or numbness of arms or legs; signs of liver dysfunction (eg, dark urine, jaundice); or signs of depression.
Category X .
Excreted in breast milk.
Carefully observe patients with history of depression.
Increased BP during estrogen replacement has been attributed to idiosyncratic reactions. Assess BP at beginning of therapy and periodically during treatment.
May be associated with massive elevations of plasma triglycerides.
Use with caution when conditions that might be affected by fluid retention are present (eg, asthma, cardiac, or renal function impairment, epilepsy).
Risk of gallbladder disease may increase in women receiving postmenopausal estrogens.
Monitor blood sugar in diabetic patient when drug is started or dose is changed. Report significant changes to health care provider. A worsening of glucose tolerance has occurred.
In patients with breast cancer or bone metastases, severe hypercalcemia has occurred with estrogen therapy.
May increase risk of endometrial cancer or other carcinomas.
Certain patients may develop abnormal uterine bleeding.
Discontinue medication if there are any sudden changes in vision, sudden onset of proptosis, diplopia, migraine, papilledema, or retinal vascular lesions.
Nausea, vomiting, withdrawal bleeding.
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