Premarin

— THERAPEUTIC CATEGORIES —
  • Breast cancer
  • Menopause and HRT
  • Prostate and other male cancers

Premarin Generic Name & Formulations

General Description

Conjugated estrogens 0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg; tabs.

Pharmacological Class

Estrogen.

See Also

    How Supplied

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

    Manufacturer

    Premarin Indications

    Indications

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

    Premarin Dosage and Administration

    Adult

    10mg 3 times daily for at least 3mos.

    Children

    Not applicable.

    Premarin Contraindications

    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.

    Premarin Boxed Warnings

    Boxed Warning

    Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.

    Premarin Warnings/Precautions

    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.

    Premarin Pharmacokinetics

    See Literature

    Premarin Interactions

    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).

    Premarin Adverse Reactions

    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).

    Premarin Clinical Trials

    See Literature

    Premarin Note

    Not Applicable

    Premarin Patient Counseling

    See Literature

    Premarin Generic Name & Formulations

    General Description

    Conjugated estrogens 0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg; tabs.

    Pharmacological Class

    Estrogen.

    How Supplied

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

    Manufacturer

    Premarin Indications

    Indications

    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.

    Premarin Dosage and Administration

    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.

    Premarin Contraindications

    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.

    Premarin Boxed Warnings

    Boxed Warning

    Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.

    Premarin Warnings/Precautions

    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.

    Premarin Pharmacokinetics

    See Literature

    Premarin Interactions

    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).

    Premarin Adverse Reactions

    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).

    Premarin Clinical Trials

    See Literature

    Premarin Note

    Not Applicable

    Premarin Patient Counseling

    See Literature

    Premarin Generic Name & Formulations

    General Description

    Conjugated estrogens 0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg; tabs.

    Pharmacological Class

    Estrogen.

    See Also

      How Supplied

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

      Manufacturer

      Premarin Indications

      Indications

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

      Premarin Dosage and Administration

      Adult

      1.25mg—2.5mg 3 times daily.

      Children

      Not applicable.

      Premarin Contraindications

      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.

      Premarin Boxed Warnings

      Boxed Warning

      Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.

      Premarin Warnings/Precautions

      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.

      Premarin Pharmacokinetics

      See Literature

      Premarin Interactions

      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).

      Premarin Adverse Reactions

      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).

      Premarin Clinical Trials

      See Literature

      Premarin Note

      Not Applicable

      Premarin Patient Counseling

      See Literature

      Images