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PREMARIN
Breast cancer
Menopause and HRT
Prostate and other male cancers
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Drug Name:

PREMARIN Rx

Generic Name and Formulations:
Conjugated estrogens 0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg; tabs.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for PREMARIN:

Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.

Adult:

10mg 3 times daily for at least 3mos.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal genital bleeding. Breast cancer (except in select patients being treated for metastatic disease) or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.

Warnings/Precautions:

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not recommended.

Interactions:

May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

Pharmacological Class:

Estrogen.

Adverse Reactions:

Abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, vaginitis; thromboembolism, neoplasms, anaphylaxis, angioedema (permanently discontinue if occurs).

How Supplied:

Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000
0.45mg, 0.9mg—100

Indications for PREMARIN:

Moderate to severe vasomotor symptoms of menopause. Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Prevention of postmenopausal osteoporosis. Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

Adult:

Menopausal symptoms, vaginal atrophy, osteoporosis: initially 0.3mg once daily; give continuously or cyclically (25 days on, 5 days off). Supplement diet with calcium 1.5g/day and Vit. D 400–800IU/day for osteoporosis. Female hypogonadism: 0.3–0.625mg once daily, given cyclically (3 weeks on, 1 week off). Female castration, ovarian failure: 1.25mg once daily, cyclically. For all: adjust as needed; periodically reassess need if dose is increased.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal genital bleeding. Breast cancer (except in select patients being treated for metastatic disease) or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.

Warnings/Precautions:

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not recommended.

Interactions:

May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

See Also:

PREMARIN VAGINAL CREAM

Pharmacological Class:

Estrogen.

Adverse Reactions:

Abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, vaginitis; thromboembolism, neoplasms, anaphylaxis, angioedema (permanently discontinue if occurs).

How Supplied:

Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000; 0.45mg, 0.9mg—100; Cream—30g (w. applicator)

Indications for PREMARIN:

Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).

Adult:

1.25mg—2.5mg 3 times daily.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal genital bleeding. Breast cancer (except in select patients being treated for metastatic disease) or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.

Warnings/Precautions:

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not recommended.

Interactions:

May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

Pharmacological Class:

Estrogen.

Adverse Reactions:

Abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, vaginitis; thromboembolism, neoplasms, anaphylaxis, angioedema (permanently discontinue if occurs).

How Supplied:

Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000
0.45mg, 0.9mg—100

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