Reviews Estradiol Transdermal System


No reviews yet.

Alora Drug Description
Alora®
(estradiol) Transdermal System
Continuous Delivery for Twice Weekly Dosing

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.
Close clinical surveillance of all women taking estrogens is important. Adequate
diagnostic measures, including endometrial sampling when indicated, should
be undertaken to rule out malignancy in all cases of undiagnosed persistent
or recurring abnormal vaginal bleeding. There is currently no evidence that
the use of "natural" estrogens results in a different endometrial
risk profile than synthetic estrogens of equivalent estrogen dose. (See WARNINGS,
Malignant neoplasms, Endrometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the prevention
of cardiovascular disease or dementia. (See WARNINGS,
Cardiovascular disorders and Dementia.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal women (50 to 79 years of age) during 5 years
of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone
acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical
Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms,
Breast cancer.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal women 65
years of age or older during 4 years of treatment with oral conjugated estrogens
plus medroxyprogesterone acetate relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY,
Clinical Studies and WARNINGS, Dementia and PRECAUTIONS,
Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate,
and other combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical trials and, in the absence of comparable data, these
risks should be assumed to be similar. Because of these risks, 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 estradiol transdermal?

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.
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 body;
sudden headache, confusion, problems with vision, speech, or...
Read All Potential Side Effects for Alora »




Alora (estradiol transdermal system) is designed to deliver estradiol continuously
and consistently over a 3 or 4-day interval upon application to intact skin.
Four strengths of Alora are available, having nominal in vivo delivery
rates of 0.025, 0.05, 0.075, and 0.1 mg estradiol per day through skin of average
permeability (inter-individual variation in skin permeability is approximately
20%). Alora has contact surface areas of 9, 18, 27, and 36 cm2 and
contains 0.77, 1.5, 2.3, and 3.1 mg of estradiol, USP, respectively. The composition
of the estradiol transdermal systems per unit area is identical. Estradiol,
USP is a white, crystalline powder that is chemically described as estra-1,3,5(10)-triene-3,
17β-diol, has an empirical formula of C18H24O2
and has molecular weight of 272.39. The structural formula is:








Alora consists of three layers. Proceeding from the polyethylene backing film
as shown in the cross-sectional view below, the adhesive matrix drug reservoir
that is in contact with the skin consists of estradiol, USP and sorbitan monooleate
dissolved in an acrylic adhesive matrix. The polyester overlapped release liner
protects the adhesive matrix during storage and is removed prior to application
of the system to the skin.







Last reviewed on RxList: 10/23/2008




Alora Drug Description
Alora®
(estradiol) Transdermal System
Continuous Delivery for Twice Weekly Dosing

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.
Close clinical surveillance of all women taking estrogens is important. Adequate
diagnostic measures, including endometrial sampling when indicated, should
be undertaken to rule out malignancy in all cases of undiagnosed persistent
or recurring abnormal vaginal bleeding. There is currently no evidence that
the use of "natural" estrogens results in a different endometrial
risk profile than synthetic estrogens of equivalent estrogen dose. (See WARNINGS,
Malignant neoplasms, Endrometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the prevention
of cardiovascular disease or dementia. (See WARNINGS,
Cardiovascular disorders and Dementia.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal women (50 to 79 years of age) during 5 years
of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone
acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical
Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms,
Breast cancer.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal women 65
years of age or older during 4 years of treatment with oral conjugated estrogens
plus medroxyprogesterone acetate relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY,
Clinical Studies and WARNINGS, Dementia and PRECAUTIONS,
Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate,
and other combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical trials and, in the absence of comparable data, these
risks should be assumed to be similar. Because of these risks, 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 estradiol transdermal?

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.
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 body;
sudden headache, confusion, problems with vision, speech, or...
Read All Potential Side Effects for Alora »




Alora (estradiol transdermal system) is designed to deliver estradiol continuously
and consistently over a 3 or 4-day interval upon application to intact skin.
Four strengths of Alora are available, having nominal in vivo delivery
rates of 0.025, 0.05, 0.075, and 0.1 mg estradiol per day through skin of average
permeability (inter-individual variation in skin permeability is approximately
20%). Alora has contact surface areas of 9, 18, 27, and 36 cm2 and
contains 0.77, 1.5, 2.3, and 3.1 mg of estradiol, USP, respectively. The composition
of the estradiol transdermal systems per unit area is identical. Estradiol,
USP is a white, crystalline powder that is chemically described as estra-1,3,5(10)-triene-3,
17β-diol, has an empirical formula of C18H24O2
and has molecular weight of 272.39. The structural formula is:








Alora consists of three layers. Proceeding from the polyethylene backing film
as shown in the cross-sectional view below, the adhesive matrix drug reservoir
that is in contact with the skin consists of estradiol, USP and sorbitan monooleate
dissolved in an acrylic adhesive matrix. The polyester overlapped release liner
protects the adhesive matrix during storage and is removed prior to application
of the system to the skin.







Last reviewed on RxList: 10/23/2008




Alora Drug Description
Alora®
(estradiol) Transdermal System
Continuous Delivery for Twice Weekly Dosing

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.
Close clinical surveillance of all women taking estrogens is important. Adequate
diagnostic measures, including endometrial sampling when indicated, should
be undertaken to rule out malignancy in all cases of undiagnosed persistent
or recurring abnormal vaginal bleeding. There is currently no evidence that
the use of "natural" estrogens results in a different endometrial
risk profile than synthetic estrogens of equivalent estrogen dose. (See WARNINGS,
Malignant neoplasms, Endrometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the prevention
of cardiovascular disease or dementia. (See WARNINGS,
Cardiovascular disorders and Dementia.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal women (50 to 79 years of age) during 5 years
of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone
acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical
Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms,
Breast cancer.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal women 65
years of age or older during 4 years of treatment with oral conjugated estrogens
plus medroxyprogesterone acetate relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY,
Clinical Studies and WARNINGS, Dementia and PRECAUTIONS,
Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate,
and other combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical trials and, in the absence of comparable data, these
risks should be assumed to be similar. Because of these risks, 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 estradiol transdermal?

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.
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 body;
sudden headache, confusion, problems with vision, speech, or...
Read All Potential Side Effects for Alora »




Alora (estradiol transdermal system) is designed to deliver estradiol continuously
and consistently over a 3 or 4-day interval upon application to intact skin.
Four strengths of Alora are available, having nominal in vivo delivery
rates of 0.025, 0.05, 0.075, and 0.1 mg estradiol per day through skin of average
permeability (inter-individual variation in skin permeability is approximately
20%). Alora has contact surface areas of 9, 18, 27, and 36 cm2 and
contains 0.77, 1.5, 2.3, and 3.1 mg of estradiol, USP, respectively. The composition
of the estradiol transdermal systems per unit area is identical. Estradiol,
USP is a white, crystalline powder that is chemically described as estra-1,3,5(10)-triene-3,
17β-diol, has an empirical formula of C18H24O2
and has molecular weight of 272.39. The structural formula is:








Alora consists of three layers. Proceeding from the polyethylene backing film
as shown in the cross-sectional view below, the adhesive matrix drug reservoir
that is in contact with the skin consists of estradiol, USP and sorbitan monooleate
dissolved in an acrylic adhesive matrix. The polyester overlapped release liner
protects the adhesive matrix during storage and is removed prior to application
of the system to the skin.







Last reviewed on RxList: 10/23/2008




Alora Drug Description
Alora®
(estradiol) Transdermal System
Continuous Delivery for Twice Weekly Dosing

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.
Close clinical surveillance of all women taking estrogens is important. Adequate
diagnostic measures, including endometrial sampling when indicated, should
be undertaken to rule out malignancy in all cases of undiagnosed persistent
or recurring abnormal vaginal bleeding. There is currently no evidence that
the use of "natural" estrogens results in a different endometrial
risk profile than synthetic estrogens of equivalent estrogen dose. (See WARNINGS,
Malignant neoplasms, Endrometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the prevention
of cardiovascular disease or dementia. (See WARNINGS,
Cardiovascular disorders and Dementia.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal women (50 to 79 years of age) during 5 years
of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone
acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical
Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms,
Breast cancer.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal women 65
years of age or older during 4 years of treatment with oral conjugated estrogens
plus medroxyprogesterone acetate relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY,
Clinical Studies and WARNINGS, Dementia and PRECAUTIONS,
Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate,
and other combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical trials and, in the absence of comparable data, these
risks should be assumed to be similar. Because of these risks, 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 estradiol transdermal?

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.
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 body;
sudden headache, confusion, problems with vision, speech, or...
Read All Potential Side Effects for Alora »




Alora (estradiol transdermal system) is designed to deliver estradiol continuously
and consistently over a 3 or 4-day interval upon application to intact skin.
Four strengths of Alora are available, having nominal in vivo delivery
rates of 0.025, 0.05, 0.075, and 0.1 mg estradiol per day through skin of average
permeability (inter-individual variation in skin permeability is approximately
20%). Alora has contact surface areas of 9, 18, 27, and 36 cm2 and
contains 0.77, 1.5, 2.3, and 3.1 mg of estradiol, USP, respectively. The composition
of the estradiol transdermal systems per unit area is identical. Estradiol,
USP is a white, crystalline powder that is chemically described as estra-1,3,5(10)-triene-3,
17β-diol, has an empirical formula of C18H24O2
and has molecular weight of 272.39. The structural formula is:








Alora consists of three layers. Proceeding from the polyethylene backing film
as shown in the cross-sectional view below, the adhesive matrix drug reservoir
that is in contact with the skin consists of estradiol, USP and sorbitan monooleate
dissolved in an acrylic adhesive matrix. The polyester overlapped release liner
protects the adhesive matrix during storage and is removed prior to application
of the system to the skin.







Last reviewed on RxList: 10/23/2008




Alora Drug Description
Alora®
(estradiol) Transdermal System
Continuous Delivery for Twice Weekly Dosing

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.
Close clinical surveillance of all women taking estrogens is important. Adequate
diagnostic measures, including endometrial sampling when indicated, should
be undertaken to rule out malignancy in all cases of undiagnosed persistent
or recurring abnormal vaginal bleeding. There is currently no evidence that
the use of "natural" estrogens results in a different endometrial
risk profile than synthetic estrogens of equivalent estrogen dose. (See WARNINGS,
Malignant neoplasms, Endrometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the prevention
of cardiovascular disease or dementia. (See WARNINGS,
Cardiovascular disorders and Dementia.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal women (50 to 79 years of age) during 5 years
of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone
acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical
Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms,
Breast cancer.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal women 65
years of age or older during 4 years of treatment with oral conjugated estrogens
plus medroxyprogesterone acetate relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY,
Clinical Studies and WARNINGS, Dementia and PRECAUTIONS,
Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate,
and other combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical trials and, in the absence of comparable data, these
risks should be assumed to be similar. Because of these risks, 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 estradiol transdermal?

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.
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 body;
sudden headache, confusion, problems with vision, speech, or...
Read All Potential Side Effects for Alora »




Alora (estradiol transdermal system) is designed to deliver estradiol continuously
and consistently over a 3 or 4-day interval upon application to intact skin.
Four strengths of Alora are available, having nominal in vivo delivery
rates of 0.025, 0.05, 0.075, and 0.1 mg estradiol per day through skin of average
permeability (inter-individual variation in skin permeability is approximately
20%). Alora has contact surface areas of 9, 18, 27, and 36 cm2 and
contains 0.77, 1.5, 2.3, and 3.1 mg of estradiol, USP, respectively. The composition
of the estradiol transdermal systems per unit area is identical. Estradiol,
USP is a white, crystalline powder that is chemically described as estra-1,3,5(10)-triene-3,
17β-diol, has an empirical formula of C18H24O2
and has molecular weight of 272.39. The structural formula is:








Alora consists of three layers. Proceeding from the polyethylene backing film
as shown in the cross-sectional view below, the adhesive matrix drug reservoir
that is in contact with the skin consists of estradiol, USP and sorbitan monooleate
dissolved in an acrylic adhesive matrix. The polyester overlapped release liner
protects the adhesive matrix during storage and is removed prior to application
of the system to the skin.







Last reviewed on RxList: 10/23/2008





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