PROGESTERONE- progesterone capsule, liquid filled

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Teva Pharmaceuticals USA, Inc.

INN (International ime):

PROGESTERONE

Sastav:

PROGESTERONE 100 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Progesterone Capsules, 100 mg are available as oval, soft gelatin, peach opaque capsules filled with white to off-white suspension imprinted in black ink “TV” over “A18”, containing 100 mg of micronized progesterone USP, packaged in bottles of 100 capsules (NDC 0093-5353-01). Progesterone Capsules, 200 mg are available as oval, soft gelatin, pale yellow opaque capsules filled with white to off-white suspension imprinted in black ink “TV” over “A19”, containing 200 mg of micronized progesterone USP, packaged in bottles of 100 capsules (NDC 0093-5354-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured By: CATALENT PHARMA SOLUTIONS St. Petersburg, FL 33716 Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. B 5/2016

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

PROGESTERONE- PROGESTERONE CAPSULE, LIQUID FILLED
TEVA PHARMACEUTICALS USA, INC.
----------
PROGESTERONE CAPSULES
5353
5354
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
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
Progesterone capsules contain micronized progesterone USP for oral
administration. Progesterone
(pregn-4-ene-