Premarin® is a drug of the pharmacological group of antineoplastic hormonal agents and hormone antagonists, as well as of the pharmacological group of estrogens, progestins, their homologues and antagonists. Premarin® tablets for oral administration contains a mixture of conjugated estrogens that are obtained exclusively from natural sources. It is prescribed to the patients in case of malignant neoplasm of prostate, ovarian dysfunction, post menopause osteoporosis, in case of absence of menstruation or scanty and rare menstruation and other abnormal bleedings from the uterus and vagina, and in case of dysmenorrheal unspecified and menopausal status in women. Premarin® relieves or eliminates the menopausal symptoms (hot flashes, sweating, dizziness, irritability, depression). It also prevents the osteoporosis development and reproductive organs involution, normalizes the menstrual cycle in women of childbearing age. It also reduces the testosterone level in men.
Name of Drug
Premarin® Tablets: Premarin® Tablets are also known as, Synthetic Conjugated Estrogen A and Synthetic Conjugated Estrogens
PREMARIN Rx
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PREMARIN
Breast cancer
Menopause and HRT
Prostate and other male cancers Only 4 drugs may be compared at once
Generic Name and Formulations:
Conjugated estrogens 0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg; tabs.
Company:
Pfizer Inc.
Select therapeutic use: Breast cancer
Menopause and HRT
Prostate and other male cancers
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 3 months.
Children:
Not applicable.
Contraindications:
Known, suspected, or history of breast cancer, except in appropriately selected patients being treated for metastatic disease. 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). Liver dysfunction or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy (Cat.X).
Warnings/Precautions:
Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reeva luate periodically. Patients with an intact uterus should almost always receive a progestin with systemic estrogens to avoid endometrial hyperplasia. Discontinue if cardiovascular events occur or are suspected; if jaundice occurs; and during immobilization or at least 4–6 weeks before surgery associated with thromboembolism. Hepatic dysfunction. Conditions aggravated by fluid retention. Gallbladder disease. Bone disease associated with hypercalcemia. Hereditary angioedema. Do initial complete physical and repeat annually (include BP, mammogram, PAP smear). Adolescents. Nursing mothers: not recommended.
Pharmacological Class:
Estrogen.
Adverse Reactions:
See literature. Increased risk of cardiovascular events, estrogen-dependent carcinoma, gallbladder disease, thromboembolic disorders, hepatic tumors. GI upset, breakthrough bleeding, edema, weight changes, mastodynia, hypertension, depression, anaphylactic reactions, angioedema, intolerance to contact lenses.
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. Postmenopausal osteoporosis prevention (consider alternative treatments). Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
Adult:
Menopausal symptoms or vaginal atrophy: 0.3mg/day. Osteoporosis: 0.3mg/day; supplement diet with calcium 1.5g/day and Vit. D 400–800IU/day. Give cyclically (25 days on, 5 days off) or continuously. Hypoestrogenism due to hypogonadism, castration, ovarian failure: 0.3–0.625mg/day, given cyclically (3 weeks on, 1 week off). Female castration, ovarian failure: 1.25mg/day, cyclically. For all: adjust as needed; periodically reassess need if dose is increased.
Children:
Not applicable.
Contraindications:
Known, suspected, or history of breast cancer, except in appropriately selected patients being treated for metastatic disease. 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). Liver dysfunction or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy (Cat.X).
Warnings/Precautions:
Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reeva luate periodically. Patients with an intact uterus should almost always receive a progestin with systemic estrogens to avoid endometrial hyperplasia. Discontinue if cardiovascular events occur or are suspected; if jaundice occurs; and during immobilization or at least 4–6 weeks before surgery associated with thromboembolism. Hepatic dysfunction. Conditions aggravated by fluid retention. Gallbladder disease. Bone disease associated with hypercalcemia. Hereditary angioedema. Do initial complete physical and repeat annually (include BP, mammogram, PAP smear). Adolescents. Nursing mothers: not recommended.
Pharmacological Class:
Estrogen.
Adverse Reactions:
See literature. Increased risk of cardiovascular events, estrogen-dependent carcinoma, gallbladder disease, thromboembolic disorders, hepatic tumors. GI upset, breakthrough bleeding, edema, weight changes, mastodynia, hypertension, depression, anaphylactic reactions, angioedema, intolerance to contact lenses.
How Supplied:
Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000
0.45mg, 0.9mg—100
Cream—42.5g (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:
Known, suspected, or history of breast cancer, except in appropriately selected patients being treated for metastatic disease. 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). Liver dysfunction or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy (Cat.X).
Warnings/Precautions:
Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reeva luate periodically. Patients with an intact uterus should almost always receive a progestin with systemic estrogens to avoid endometrial hyperplasia. Discontinue if cardiovascular events occur or are suspected; if jaundice occurs; and during immobilization or at least 4–6 weeks before surgery associated with thromboembolism. Hepatic dysfunction. Conditions aggravated by fluid retention. Gallbladder disease. Bone disease associated with hypercalcemia. Hereditary angioedema. Do initial complete physical and repeat annually (include BP, mammogram, PAP smear). Adolescents. Nursing mothers: not recommended.
Pharmacological Class:
Estrogen.
Adverse Reactions:
See literature. Increased risk of cardiovascular events, estrogen-dependent carcinoma, gallbladder disease, thromboembolic disorders, hepatic tumors. GI upset, breakthrough bleeding, edema, weight changes, mastodynia, hypertension, depression, anaphylactic reactions, angioedema, intolerance to contact lenses.
How Supplied:
Tabs 0.3mg, 0.625mg, 1.25mg—100, 1000
0.45mg, 0.9mg—100 |
