FEMHRT- norethindrone acetate/ethinyl estradiol tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

থেকে পাওয়া:

Physicians Total Care, Inc.

INN (আন্তর্জাতিক নাম):

NORETHINDRONE ACETATE

রচনা:

NORETHINDRONE ACETATE 1 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

femhrt is indicated in women with an intact uterus for the: - Treatment of moderate to severe vasomotor symptoms associated with the 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. 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 1500 mg/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, previou

পণ্য সারাংশ:

femhrt ® tablets are available in the following strength and package sizes: Blister card of 28 D-shaped white tablets with 1 mg norethindrone acetate and 5 mcg ethinyl estradiol; imprinted with WC on one side and 144 on the other. Rx only Keep this drug and all drugs out of the reach of children. Store at 25° C (77° F); excursions permitted to 15 - 30° C (59 - 86° F) [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

FEMHRT - NORETHINDRONE ACETATE/ETHINYL ESTRADIOL TABLET
PHYSICIANS TOTAL CARE, INC.
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FEMHRT
(NORETHINDRONE ACETATE/ETHINYL ESTRADIOL TABLETS)
WARNING
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 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, 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.
DESCRIPTION
_femhrt_
(norethindrone acetate/ethinyl estradiol tablets) is a continuous
dosage regimen of a progestin-
estrogen combination for oral administration.
The following two strengths of _femhrt _tablets are available:
_femhrt_ (0.5 mg/2.5 mcg): Each white oval tablet contains 0.5