CLIMARA PRO- estradiol and levonorgestrel patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Available from:

Physicians Total Care, Inc.

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 4.4 mg

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

In women with an intact uterus, Climara Pro is indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with menopause. - Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women. Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, pre

Product summary:

Climara Pro (Estradiol/Levonorgestrel Transdermal System) 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel – each 22 cm2 system contains 4.4 mg of estradiol and 1.39 mg of levonorgestrel. NDC 54868-5570-0    Individual Carton of 4 systems Storage Conditions: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP controlled Room Temperature]. Do not store unpouched.

Authorization status:

New Drug Application

Summary of Product characteristics

CLIMARA PRO - ESTRADIOL AND LEVONORGESTREL PATCH
PHYSICIANS TOTAL CARE, INC.
----------
CLIMARA PRO
PRESCRIBING INFORMATION
CLIMARA PRO
(ESTRADIOL/LEVONORGESTREL TRANSDERMAL SYSTEM)
RX ONLY
WARNINGS
Estrogens and 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 STUDIES and WARNINGS, Cardiovascular disorders and Malignant
neoplasms,
Breast cancer.)
The WHI study reported increased risks of stroke and deep vein
thrombosis in postmenopausal
women (50 to 79 years of age) during 6.8 years of treatment with oral
conjugated estrogens (CE
0.625 mg) relative to placebo. (See CLINICAL STUDIES and WARNINGS,
Cardiovascular
disorders.)
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 CE 0.625 mg combined with MPA 2.5 mg and
during 5.2 years of treatment
with CE 0.625 mg alone, relative to placebo. It is unknown whether
this finding applies to
younger postmenopausal women. (See CLINICAL STUDIES, 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 indi