Premphase

— THERAPEUTIC CATEGORIES —
  • Bone disorders
  • Menopause and HRT
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Premphase Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Conjugated estrogens 0.625mg (14 tabs); conjugated estrogens 0.625mg, medroxyprogesterone acetate 5mg (14 tabs).

    Pharmacological Class

    Estrogen + progestin.

    How Supplied

    Blister card (28 tabs)—1

    Manufacturer

    Pfizer Inc.

    Mechanism of Action

    Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH, through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these gonadotropins seen in postmenopausal women. Medroxyprogesterone acetate (MPA) inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation. It may achieve its beneficial effect on the endometrium in part by decreasing nuclear estrogen receptors and suppression of epithelial DNA synthesis in endometrial tissue.

    Premphase Indications

    Indications

    Prevention of postmenopausal osteoporosis. 

    Premphase Dosage and Administration

    Adult

    1 tab daily in correct order; repeat.

    Children

    Not applicable.

    Premphase Contraindications

    Contraindications

    Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Active DVT, PE, or history of. Active arterial thromboembolic disease (eg, stroke, MI) or a history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy.

    Premphase Boxed Warnings

    Boxed Warning

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

    Premphase 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. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Preexisting hypertriglyceridemia. History of cholestatic jaundice. Discontinue if pancreatitis, hypercalcemia, or recurrence of cholestatic jaundice occurs. 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.

    Premphase Pharmacokinetics

    Metabolism

    Hepatic.

    Elimination

    Renal.

    Premphase 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. Concomitant aminoglutethimide: may reduce bioavailability of medroxyprogesterone. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

    Premphase Adverse Reactions

    Adverse Reactions

    Abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, pruritus, breast pain, dysmenorrhea, leukorrhea; thromboembolism, neoplasms, anaphylaxis, angioedema (permanently discontinue if occurs).

    Premphase Clinical Trials

    See Literature

    Premphase Note

    Not Applicable

    Premphase Patient Counseling

    See Literature

    Premphase Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Conjugated estrogens 0.625mg (14 tabs); conjugated estrogens 0.625mg, medroxyprogesterone acetate 5mg (14 tabs).

    Pharmacological Class

    Estrogen + progestin.

    How Supplied

    Blister card (28 tabs)—1

    Manufacturer

    Pfizer Inc.

    Mechanism of Action

    Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH, through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these gonadotropins seen in postmenopausal women. Medroxyprogesterone acetate (MPA) inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation. It may achieve its beneficial effect on the endometrium in part by decreasing nuclear estrogen receptors and suppression of epithelial DNA synthesis in endometrial tissue.

    Premphase Indications

    Indications

    Moderate to severe vasomotor symptoms of menopause. Moderate to severe vulvar and vaginal atrophy due to menopause. 

    Premphase Dosage and Administration

    Adult

    1 tab daily in correct order; repeat.

    Children

    Not applicable.

    Premphase Contraindications

    Contraindications

    Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Active DVT, PE, or history of. Active arterial thromboembolic disease (eg, stroke, MI) or a history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy.

    Premphase Boxed Warnings

    Boxed Warning

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

    Premphase 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. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Preexisting hypertriglyceridemia. History of cholestatic jaundice. Discontinue if pancreatitis, hypercalcemia, or recurrence of cholestatic jaundice occurs. 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.

    Premphase Pharmacokinetics

    Metabolism

    Hepatic.

    Elimination

    Renal.

    Premphase 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. Concomitant aminoglutethimide: may reduce bioavailability of medroxyprogesterone. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

    Premphase Adverse Reactions

    Adverse Reactions

    Abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, pruritus, breast pain, dysmenorrhea, leukorrhea; thromboembolism, neoplasms, anaphylaxis, angioedema (permanently discontinue if occurs).

    Premphase Clinical Trials

    See Literature

    Premphase Note

    Not Applicable

    Premphase Patient Counseling

    See Literature

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