PROGESTERONE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Progesterone (UNII: 4G7DS2Q64Y) (Progesterone - UNII:4G7DS2Q64Y)

Available from:

Akorn

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 its ingredients. 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 round, pink-colored capsules branded with black imprint “AK” NDC 17478-766-10 ....................................................... (Bottle of 100) Progesterone Capsules 200 mg are oval, beige-colored capsules branded with black imprint “AK2” NDC 17478-767-10 ....................................................... (Bottle of 100)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROGESTERONE- PROGESTERONE CAPSULE
AKORN
----------
PROGESTERONE
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 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 micronized progesterone for oral
administration.
Progesterone has a molecular weight of 314.47 and a molecu