PROGESTERONE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Virtus Pharmaceuticals

INN (International Name):

Progesterone

Composition:

Progesterone 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Progesterone, USP 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, USP Capsules should not be used in women with any of the following conditions:

Product summary:

Progesterone, USP Capsules 100 mg are round, peach-colored capsules branded with black imprint "SV." NDC 69543-374-10 (Bottle of 100) Progesterone, USP Capsules 200 mg are oval, pale yellow-colored capsules branded with black imprint "SV2." NDC 69543-375-10 (Bottle of 100) Store at 25°C (77°F); excursions permitted to 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.

Authorization status:

New Drug Application

Summary of Product characteristics

PROGESTERONE- PROGESTERONE CAPSULE
VIRTUS PHARMACEUTICALS
----------
PROGESTERONE, USP
CAPSULES 100 MG
CAPSULES 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
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, USP Capsules contain micronized progesterone for oral
administration. Progesterone has
a molecular w