PROGESTERONE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Banner Pharmacaps

INN (International Name):

PROGESTERONE

Composition:

PROGESTERONE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - Progesterone capsules should not be used in patients with known hypersensitivity to itsingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of breast cancer. - Active deep vein thrombosis, pulmonary embolism or history of these conditions. - Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. - Known liver dysfunction or disease. - Known or suspected pregnancy.

Product summary:

Progesterone, capsules 100 mg are available as an oval orange, opaque, capsule imprinted with P-1 in black ink. NDC 10888-7135-2 (Bottle of 100) Progesterone, capsules 200 mg are available as an oval red, opaque, capsule imprinted with P-2 in black ink. NDC 10888-7136-2 (Bottle of 100) Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature] Protect from excessive moisture Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert. Manufactured by: Banner Pharmacaps Inc. High Point, NC 27265 November 2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROGESTERONE - PROGESTERONE CAPSULE
BANNER PHARMACAPS
----------
BOXED WARNING
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 STUDIESand 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 weight of 314.47 and a molecular formula of C
H