Yes

Estrogen Derivative

Women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with the menopause; treatment of atrophic vaginitis; primary ovarian failure; osteoporosis prophylactic

X

Pregnancy; thrombophlebitis; hypersensitivity to estrogens or medroxyprogesterone or any component; cerebral apoplexy; undiagnosed vaginal bleeding; thrombophlebitis; liver disease; carcinoma of the breast; estrogen dependent tumor

Use with caution in patients with asthma, epilepsy, migraine, diabetes, cardiac or renal dysfunction. Estrogens may cause premature closure of the epiphyses in young individuals. Estrogens have been reported to increase the risk of endometrial carcinoma. Pretreatment exams should include Pap smear, physical exam of breasts and pelvic areas. May increase serum cholesterol and LDL, decrease HDL and triglycerides. Use of any progestin during the first 4 months of pregnancy is not recommended. May lead to severe hypercalcemia in patients with breast cancer and bone metastases. Occasional blood pressure increases during estrogen replacement therapy have been attributed to idiosyncratic reactions to estrogens.

>10%:

Cardiovascular: Edema, peripheral edema

Endocrine & metabolic: Breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, enlargement of breasts, breast tenderness

Gastrointestinal: Anorexia, nausea, bloating

Local: Pain at injection site

Neuromuscular & skeletal: Weakness

1% to 10%:

Cardiovascular: Edema, central thrombosis

Central nervous system: Mental depression, fever, insomnia, headache

Dermatologic: Melasma, chloasma, allergic rash with or without pruritus

Endocrine & metabolic: Increased breast tenderness, increased libido

Gastrointestinal: Weight gain or loss, vomiting, diarrhea

Genitourinary: Changes in cervical erosion and secretions

Hepatic: Cholestatic jaundice

Local: Thrombophlebitis

Respiratory: Embolism

Decreased effect: Rifampin, barbiturates, phenytoin, carbamazepine decrease estrogen serum concentrations; estrogens may decrease effect of sulfonylureas; aminoglutethimide may decrease effect by increasing hepatic metabolism

Estrogens may increase metabolism of some benzodiazepines (lorazepam, oxazepam, temazepam), but decrease metabolism of others

Increased toxicity: Hydrocortisone increases corticosteroid toxic potential; increases potential for thromboembolic events with anticoagulants

Oral:

Prempro™: Dosage as above with the exception that the white 2.5 mg Cycrin® tablet (medroxyprogesterone acetate) is taken on a daily basis with the maroon Premarin® tablet (conjugated estrogen) and not just on days 15-28

Administration with food decreases nausea, administer with food

May cause insomnia, anxiety, or depression

Barbiturates and carbamazepine may decrease the effects of estrogens; estrogens may affect metabolism of benzodiazepines; monitor for clinical effect

No information available to require special precautions

No effects or complications reported

Take this as prescribed; maintain schedule. If also taking supplemental calcium as part of osteoporosis prevention, consult prescriber for recommended amounts. Periodic gynecologic exam and breast exams are important. You may experience nausea or vomiting (small frequent meals may help); dizziness or mental depression (use caution when driving); rash, loss of scalp hair, enlargement/tenderness of breasts, or increased/decreased libido. Report significant swelling of extremities; sudden acute pain in legs or calves, chest or abdomen; shortness of breath; severe headache or vomiting; sudden blindness; weakness or numbness of arm or leg; unusual vaginal bleeding; yellowing of skin or eyes; or unusual bruising or bleeding. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month following therapy. Consult prescriber for instruction on appropriate contraceptive measures. Consult prescriber if breast-feeding.

Prempro™ is now a single-tablet product which replaces the two-tablet product

Premphase™: Two separate tablets in therapy pack: Conjugated estrogens 0.625 mg [Premarin®] (28s) taken orally for 28 days and medroxyprogesterone acetate [Cycrin®] 5 mg (14s) which are taken orally with a Premarin® tablet on days 15 through 28

Prempro™: Conjugated estrogens 0.625 mg and medroxyprogesterone acetate 2.5 mg (14s)