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Prempro, Premphase Drug Description
PREMPRO®
(conjugated estrogens/medroxyprogesterone acetate) Tablets
PREMPHASE®
(conjugated estrogens plus medroxyprogesterone acetate) Tablets


WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL
CANCER and PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention
of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported
an increased risk of deep vein thrombosis (DVT), pulmonary embolism, stroke
and myocardial infarction in postmenopausal women (50 to 79 years of age)
during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625
mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to
placebo [see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of
the WHI reported an increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 4 years of treatment with daily CE (0.625
mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women [see WARNINGS AND PRECAUTIONS,
Use in Specific Populations, and Clinical
Studies].
Breast Cancer
The WHI estrogen plus progestin substudy demonstrated an increased risk
of invasive breast cancer [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and MPA and other combinations and dosage forms of estrogens
and progestins.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus
who uses unopposed estrogens. Adding a progestin to estrogen therapy has been
shown to reduce the risk of endometrial hyperplasia, which may be a precursor
to endometrial cancer. Adequate diagnostic measures, including directed or
random endometrial sampling when indicated, should be undertaken to rule out
malignancy in postmenopausal women with undiagnosed persistent or recurring
abnormal genital bleeding [see WARNINGS AND PRECAUTIONS].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular
disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The WHI estrogen-alone substudy reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
during 7.1 years of treatment with daily oral CE (0.625 mg), relative to placebo
[see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHIMS estrogen-alone ancillary study of WHI reported an increased
risk of developing probable dementia in postmenopausal women 65 years of age
or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative
to placebo. It is unknown whether this finding applies to younger postmenopausal
women [see WARNINGS AND PRECAUTIONS, Use
in Specific Populations, and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.

DRUG DESCRIPTION



What are the possible side effects of conjugated estrogens and medroxyprogesterone (Premphase, Prempro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and call your doctor at once if you have any of these serious side effects:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the...
Read All Potential Side Effects for Prempro, Premphase »




Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin.
Medroxyprogesterone acetate is a derivative of progesterone. It is a white
to off-white, odorless, crystalline powder, stable in air, melting between 200°C
and 210°C. It is freely soluble in chloroform, soluble in acetone and in
dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether,
and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione,
17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4,
with a molecular weight of 386.53. Its structural formula is:








PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, yellow iron oxide, and black iron oxide.
PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, red ferric oxide, and black iron oxide.
PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No. 2, and black iron oxide.
PREMPHASE
Each maroon Premarin tablets for oral administration contain 0.625 mg of conjugated estrogens and the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, titanium dioxide, FD&C Blue No. 2, and FD&C Red No. 40. These tablets comply with USP Dissolution Test 5.
Each light-blue tablet for oral administration contains 0.625 mg of conjugated
estrogens, 5 mg of medroxyprogesterone acetate, and the following inactive ingredients:
calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl
monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze,
polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No.
2, and black iron oxide.



PREMPRO


Tablet Strength
Tablet Color Contains


0.3 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.45 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.625 mg/2.5 mg
Red ferric oxide and black iron oxide


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide


PREMPHASE


Tablet Strength
Tablet Color Contains


0.625 mg
FD&C Blue No. 2 and FD&C Red No. 40


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide



Last reviewed on RxList: 1/20/2010




Prempro, Premphase Drug Description
PREMPRO®
(conjugated estrogens/medroxyprogesterone acetate) Tablets
PREMPHASE®
(conjugated estrogens plus medroxyprogesterone acetate) Tablets


WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL
CANCER and PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention
of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported
an increased risk of deep vein thrombosis (DVT), pulmonary embolism, stroke
and myocardial infarction in postmenopausal women (50 to 79 years of age)
during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625
mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to
placebo [see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of
the WHI reported an increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 4 years of treatment with daily CE (0.625
mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women [see WARNINGS AND PRECAUTIONS,
Use in Specific Populations, and Clinical
Studies].
Breast Cancer
The WHI estrogen plus progestin substudy demonstrated an increased risk
of invasive breast cancer [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and MPA and other combinations and dosage forms of estrogens
and progestins.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus
who uses unopposed estrogens. Adding a progestin to estrogen therapy has been
shown to reduce the risk of endometrial hyperplasia, which may be a precursor
to endometrial cancer. Adequate diagnostic measures, including directed or
random endometrial sampling when indicated, should be undertaken to rule out
malignancy in postmenopausal women with undiagnosed persistent or recurring
abnormal genital bleeding [see WARNINGS AND PRECAUTIONS].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular
disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The WHI estrogen-alone substudy reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
during 7.1 years of treatment with daily oral CE (0.625 mg), relative to placebo
[see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHIMS estrogen-alone ancillary study of WHI reported an increased
risk of developing probable dementia in postmenopausal women 65 years of age
or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative
to placebo. It is unknown whether this finding applies to younger postmenopausal
women [see WARNINGS AND PRECAUTIONS, Use
in Specific Populations, and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.

DRUG DESCRIPTION



What are the possible side effects of conjugated estrogens and medroxyprogesterone (Premphase, Prempro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and call your doctor at once if you have any of these serious side effects:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the...
Read All Potential Side Effects for Prempro, Premphase »




Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin.
Medroxyprogesterone acetate is a derivative of progesterone. It is a white
to off-white, odorless, crystalline powder, stable in air, melting between 200°C
and 210°C. It is freely soluble in chloroform, soluble in acetone and in
dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether,
and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione,
17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4,
with a molecular weight of 386.53. Its structural formula is:








PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, yellow iron oxide, and black iron oxide.
PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, red ferric oxide, and black iron oxide.
PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No. 2, and black iron oxide.
PREMPHASE
Each maroon Premarin tablets for oral administration contain 0.625 mg of conjugated estrogens and the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, titanium dioxide, FD&C Blue No. 2, and FD&C Red No. 40. These tablets comply with USP Dissolution Test 5.
Each light-blue tablet for oral administration contains 0.625 mg of conjugated
estrogens, 5 mg of medroxyprogesterone acetate, and the following inactive ingredients:
calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl
monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze,
polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No.
2, and black iron oxide.



PREMPRO


Tablet Strength
Tablet Color Contains


0.3 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.45 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.625 mg/2.5 mg
Red ferric oxide and black iron oxide


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide


PREMPHASE


Tablet Strength
Tablet Color Contains


0.625 mg
FD&C Blue No. 2 and FD&C Red No. 40


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide



Last reviewed on RxList: 1/20/2010




Prempro, Premphase Drug Description
PREMPRO®
(conjugated estrogens/medroxyprogesterone acetate) Tablets
PREMPHASE®
(conjugated estrogens plus medroxyprogesterone acetate) Tablets


WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL
CANCER and PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention
of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported
an increased risk of deep vein thrombosis (DVT), pulmonary embolism, stroke
and myocardial infarction in postmenopausal women (50 to 79 years of age)
during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625
mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to
placebo [see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of
the WHI reported an increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 4 years of treatment with daily CE (0.625
mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women [see WARNINGS AND PRECAUTIONS,
Use in Specific Populations, and Clinical
Studies].
Breast Cancer
The WHI estrogen plus progestin substudy demonstrated an increased risk
of invasive breast cancer [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and MPA and other combinations and dosage forms of estrogens
and progestins.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus
who uses unopposed estrogens. Adding a progestin to estrogen therapy has been
shown to reduce the risk of endometrial hyperplasia, which may be a precursor
to endometrial cancer. Adequate diagnostic measures, including directed or
random endometrial sampling when indicated, should be undertaken to rule out
malignancy in postmenopausal women with undiagnosed persistent or recurring
abnormal genital bleeding [see WARNINGS AND PRECAUTIONS].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular
disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The WHI estrogen-alone substudy reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
during 7.1 years of treatment with daily oral CE (0.625 mg), relative to placebo
[see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHIMS estrogen-alone ancillary study of WHI reported an increased
risk of developing probable dementia in postmenopausal women 65 years of age
or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative
to placebo. It is unknown whether this finding applies to younger postmenopausal
women [see WARNINGS AND PRECAUTIONS, Use
in Specific Populations, and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.

DRUG DESCRIPTION



What are the possible side effects of conjugated estrogens and medroxyprogesterone (Premphase, Prempro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and call your doctor at once if you have any of these serious side effects:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the...
Read All Potential Side Effects for Prempro, Premphase »




Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin.
Medroxyprogesterone acetate is a derivative of progesterone. It is a white
to off-white, odorless, crystalline powder, stable in air, melting between 200°C
and 210°C. It is freely soluble in chloroform, soluble in acetone and in
dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether,
and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione,
17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4,
with a molecular weight of 386.53. Its structural formula is:








PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, yellow iron oxide, and black iron oxide.
PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, red ferric oxide, and black iron oxide.
PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No. 2, and black iron oxide.
PREMPHASE
Each maroon Premarin tablets for oral administration contain 0.625 mg of conjugated estrogens and the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, titanium dioxide, FD&C Blue No. 2, and FD&C Red No. 40. These tablets comply with USP Dissolution Test 5.
Each light-blue tablet for oral administration contains 0.625 mg of conjugated
estrogens, 5 mg of medroxyprogesterone acetate, and the following inactive ingredients:
calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl
monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze,
polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No.
2, and black iron oxide.



PREMPRO


Tablet Strength
Tablet Color Contains


0.3 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.45 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.625 mg/2.5 mg
Red ferric oxide and black iron oxide


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide


PREMPHASE


Tablet Strength
Tablet Color Contains


0.625 mg
FD&C Blue No. 2 and FD&C Red No. 40


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide



Last reviewed on RxList: 1/20/2010




Prempro, Premphase Drug Description
PREMPRO®
(conjugated estrogens/medroxyprogesterone acetate) Tablets
PREMPHASE®
(conjugated estrogens plus medroxyprogesterone acetate) Tablets


WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL
CANCER and PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention
of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported
an increased risk of deep vein thrombosis (DVT), pulmonary embolism, stroke
and myocardial infarction in postmenopausal women (50 to 79 years of age)
during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625
mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to
placebo [see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of
the WHI reported an increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 4 years of treatment with daily CE (0.625
mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women [see WARNINGS AND PRECAUTIONS,
Use in Specific Populations, and Clinical
Studies].
Breast Cancer
The WHI estrogen plus progestin substudy demonstrated an increased risk
of invasive breast cancer [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and MPA and other combinations and dosage forms of estrogens
and progestins.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus
who uses unopposed estrogens. Adding a progestin to estrogen therapy has been
shown to reduce the risk of endometrial hyperplasia, which may be a precursor
to endometrial cancer. Adequate diagnostic measures, including directed or
random endometrial sampling when indicated, should be undertaken to rule out
malignancy in postmenopausal women with undiagnosed persistent or recurring
abnormal genital bleeding [see WARNINGS AND PRECAUTIONS].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular
disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The WHI estrogen-alone substudy reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
during 7.1 years of treatment with daily oral CE (0.625 mg), relative to placebo
[see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHIMS estrogen-alone ancillary study of WHI reported an increased
risk of developing probable dementia in postmenopausal women 65 years of age
or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative
to placebo. It is unknown whether this finding applies to younger postmenopausal
women [see WARNINGS AND PRECAUTIONS, Use
in Specific Populations, and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.

DRUG DESCRIPTION



What are the possible side effects of conjugated estrogens and medroxyprogesterone (Premphase, Prempro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and call your doctor at once if you have any of these serious side effects:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the...
Read All Potential Side Effects for Prempro, Premphase »




Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin.
Medroxyprogesterone acetate is a derivative of progesterone. It is a white
to off-white, odorless, crystalline powder, stable in air, melting between 200°C
and 210°C. It is freely soluble in chloroform, soluble in acetone and in
dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether,
and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione,
17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4,
with a molecular weight of 386.53. Its structural formula is:








PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, yellow iron oxide, and black iron oxide.
PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, red ferric oxide, and black iron oxide.
PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No. 2, and black iron oxide.
PREMPHASE
Each maroon Premarin tablets for oral administration contain 0.625 mg of conjugated estrogens and the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, titanium dioxide, FD&C Blue No. 2, and FD&C Red No. 40. These tablets comply with USP Dissolution Test 5.
Each light-blue tablet for oral administration contains 0.625 mg of conjugated
estrogens, 5 mg of medroxyprogesterone acetate, and the following inactive ingredients:
calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl
monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze,
polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No.
2, and black iron oxide.



PREMPRO


Tablet Strength
Tablet Color Contains


0.3 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.45 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.625 mg/2.5 mg
Red ferric oxide and black iron oxide


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide


PREMPHASE


Tablet Strength
Tablet Color Contains


0.625 mg
FD&C Blue No. 2 and FD&C Red No. 40


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide



Last reviewed on RxList: 1/20/2010




Prempro, Premphase Drug Description
PREMPRO®
(conjugated estrogens/medroxyprogesterone acetate) Tablets
PREMPHASE®
(conjugated estrogens plus medroxyprogesterone acetate) Tablets


WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL
CANCER and PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention
of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported
an increased risk of deep vein thrombosis (DVT), pulmonary embolism, stroke
and myocardial infarction in postmenopausal women (50 to 79 years of age)
during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625
mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to
placebo [see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of
the WHI reported an increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 4 years of treatment with daily CE (0.625
mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women [see WARNINGS AND PRECAUTIONS,
Use in Specific Populations, and Clinical
Studies].
Breast Cancer
The WHI estrogen plus progestin substudy demonstrated an increased risk
of invasive breast cancer [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and MPA and other combinations and dosage forms of estrogens
and progestins.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus
who uses unopposed estrogens. Adding a progestin to estrogen therapy has been
shown to reduce the risk of endometrial hyperplasia, which may be a precursor
to endometrial cancer. Adequate diagnostic measures, including directed or
random endometrial sampling when indicated, should be undertaken to rule out
malignancy in postmenopausal women with undiagnosed persistent or recurring
abnormal genital bleeding [see WARNINGS AND PRECAUTIONS].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular
disease or dementia [see WARNINGS AND PRECAUTIONS,
and Clinical Studies].
The WHI estrogen-alone substudy reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
during 7.1 years of treatment with daily oral CE (0.625 mg), relative to placebo
[see WARNINGS AND PRECAUTIONS, and Clinical
Studies].
The WHIMS estrogen-alone ancillary study of WHI reported an increased
risk of developing probable dementia in postmenopausal women 65 years of age
or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative
to placebo. It is unknown whether this finding applies to younger postmenopausal
women [see WARNINGS AND PRECAUTIONS, Use
in Specific Populations, and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman.

DRUG DESCRIPTION



What are the possible side effects of conjugated estrogens and medroxyprogesterone (Premphase, Prempro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and call your doctor at once if you have any of these serious side effects:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the...
Read All Potential Side Effects for Prempro, Premphase »




Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin.
Medroxyprogesterone acetate is a derivative of progesterone. It is a white
to off-white, odorless, crystalline powder, stable in air, melting between 200°C
and 210°C. It is freely soluble in chloroform, soluble in acetone and in
dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether,
and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione,
17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4,
with a molecular weight of 386.53. Its structural formula is:








PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, yellow iron oxide, and black iron oxide.
PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, red ferric oxide, and black iron oxide.
PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No. 2, and black iron oxide.
PREMPHASE
Each maroon Premarin tablets for oral administration contain 0.625 mg of conjugated estrogens and the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, titanium dioxide, FD&C Blue No. 2, and FD&C Red No. 40. These tablets comply with USP Dissolution Test 5.
Each light-blue tablet for oral administration contains 0.625 mg of conjugated
estrogens, 5 mg of medroxyprogesterone acetate, and the following inactive ingredients:
calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl
monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze,
polyethylene glycol, sucrose, povidone, titanium dioxide, FD&C Blue No.
2, and black iron oxide.



PREMPRO


Tablet Strength
Tablet Color Contains


0.3 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.45 mg/1.5 mg
Yellow ferric oxide and black iron oxide


0.625 mg/2.5 mg
Red ferric oxide and black iron oxide


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide


PREMPHASE


Tablet Strength
Tablet Color Contains


0.625 mg
FD&C Blue No. 2 and FD&C Red No. 40


0.625 mg/5 mg
FD&C Blue No. 2 and black iron oxide



Last reviewed on RxList: 1/20/2010





Other reviews about Prempro, Premphase on wordpress

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  by kanlayanee
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  by Liz
Quotation marks are used to signal the reader that something is important. Sometimes their use works counter to their intention. In this highly sarcastic editorial in Menopause Management, […]


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  by bodylogicmd
We've mentioned that the FDA has approved over 20 bioidentical hormones and now want to share some of the hormones on that list, specifically those meant to treat […]


Premarin Mares and Foals: Aprela, the Lesser Evil?
  by Vivian
Written by JANE ALLIN Research Analyst | Int'l Fund for Horses Despite the tainted history of Premarin┬« and its acknowledged contribution to a plethora of cancers and other maladies […]


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  by Vivian
Written by JANE ALLIN Research Analyst | Int'l Fund for Horses Page 1 Despite the tainted history of Premarin┬« and its acknowledged contribution to a plethora of cancers and other […]


What You Can Do
  by Vivian
HOW YOU CAN HELP Talk to Your Doctor Talk to your doctor. Ask him not to prescribe any of the Premarin┬« family of drugs, and explain why. You […]



Other reviews about Prempro, Premphase on web:

Learn about the prescription medication Prempro, Premphase (Conjugated Estrogens, Medroxyprogesterone Acetate), drug uses, dosage, side effects, drug interactions, warnings ... Prempro, Premphase (Conjugated Estrogens, Medroxyprogesterone ...


Users share their experience with Prempro, Premphase and comment on drug side effects, effectiveness, and treatment knowledge Prempro, Premphase Drug and Medication User Reviews on RxList


Accurate, FDA approved Premphase Prempro information for healthcare professionals and patients - brought to you by Drugs.com. Premphase Prempro Official FDA information, side effects and uses.


Prempro or Premphase is a combination of two hormones, an estrogen and a progestin, used to reduce moderate to severe menopausal symptoms and treat itching, burning, and ... Prempro


Consumer information about the medication CONJUGATED ESTROGENS/MEDROXYPROGESTERONE- ORAL (Premphase, Prempro), includes side effects, drug interactions, recommended dosages ... CONJUGATED ESTROGENS/MEDROXYPROGESTERONE- ORAL (Premphase, Prempro ...


Product Name : Premia (Marketed as Premphase in the US) Product Type : Premarin 14 Tablets (.625mg) Maroon Tablets + 14 Tablets (.625mg/5mg) Light Blue Tablets Inhouse Drugstore PREMPRO - PREMPHASE


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Comprehensive and accurate Premphase Prempro side effects information for consumers and healthcare professionals. Premphase Prempro Side Effects | Drugs.com


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