PROMETRIUM progesterone capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

progesterone (UNII: 4G7DS2Q64Y) (progesterone - UNII:4G7DS2Q64Y)

Inapatikana kutoka:

Avera McKennan Hospital

INN (Jina la Kimataifa):

progesterone

Tungo:

progesterone 100 mg

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

New Drug Application

Tabia za bidhaa

PROMETRIUM- PROGESTERONE CAPSULE
AVERA MCKENNAN HOSPITAL
----------
PROMETRIUM®
(PROGESTERONE, USP)
CAPSULES 100 MG
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE
DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA
Estrogens plus progestin therapy should not be used for the prevention
of cardiovascular disease
or dementia. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR
DISORDERS and
PROBABLE DEMENTIA.)
The Women's Health Initiative (WHI) estrogen plus progestin substudy
reported increased risks
of deep vein thrombosis, 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 estrogens (CE) [0.625 mg] combined with medroxyprogesterone
acetate (MPA)
[2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS,
CARDIOVASCULAR
DIS ORDERS .)
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
CLINICAL STUDIES and WARNINGS, PROBABLE DEMENTIA and PRECAUTIONS,
GERIATRIC
US E.)
BREAST CANCER
The WHI estrogen plus progestin substudy also demonstrated an
increased risk of invasive breast
cancer. (See CLINICAL STUDIES and WARNINGS, MALIGNANT NEOPLASMS,
_BREAST CANCER_.)
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.
Progestins with estrogens should be prescribed at the lowest effective
doses and for the shortest
duration consistent with treatment goals and risks for the individual
woman.
DESCRIPTION
PROMETRIUM (progesterone, USP) Capsules contain micronized
progesterone for oral
administration. Progesterone has a molecu