PROGESTERONE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)

Saadav alates:

Amneal Pharmaceuticals LLC

INN (Rahvusvaheline Nimetus):

PROGESTERONE

Koostis:

PROGESTERONE 100 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea. Progesterone capsules should not be used in women with any of the following conditions: 1.      Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. 2.      Undiagnosed abnormal genital bleeding. 3.      Known, suspected, or history of breast cancer. 4.      Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5.      Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. 6.      Known liver dysfunction or disease. 7.      Known or suspected pregnancy.

Toote kokkuvõte:

Progesterone capsules, 100 mg, are supplied as round, light orange soft gelatin capsules, printed with “A87”. They are available as follows: Bottles of 100:                        NDC 65162-807-10 Bottles of 500:                        NDC 65162-807-50 Progesterone capsules, 200 mg, are supplied as oval, light orange soft gelatin capsules, printed with “A80”. They are available as follows: Bottles of 100:                        NDC 65162-808-10 Bottles of 500:                        NDC 65162-808-50 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert. Keep out of reach of children. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2024-02

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

PROGESTERONE- PROGESTERONE CAPSULE
AMNEAL PHARMACEUTICALS LLC
----------
PROGESTERONE CAPSULES (PROGESTERONE, USP), 100 MG AND 200 MG
RX ONLY
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 DISORDERS).
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
USE).
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
Progesterone capsules contain progesterone, USP for oral
administration.
Progesterone, USP has a molecul