PROMETRIUM- progesterone capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Physicians Total Care, Inc.

DCI (Dénomination commune internationale):

PROGESTERONE

Composition:

PROGESTERONE 100 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

PROMETRIUM 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. PROMETRIUM Capsules should not be used in women with any of the following conditions: - PROMETRIUM Capsules should not be used in patients with known hypersensitivity to its ingredients. PROMETRIUM Capsules contain peanut oil and should never be used by patients allergic to peanuts. - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of cancer of the breast. - Active deep vein thrombosis, pulmonary embolism or history of these conditions. - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - Liver dysfunction or disease. - Known or suspected pregnancy. There is no indication for PROMETRIUM Capsules in pregnancy. There appears to be little or no increased risk of birth defects in chi

Descriptif du produit:

PROMETRIUM® (progesterone, USP) Capsules 100 mg are round, peach-colored capsules branded with black imprint “SV.” PROMETRIUM® (progesterone, USP) Capsules 200 mg are oval, pale yellow-colored capsules branded with black imprint “SV2.” 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. Manufactured by: Catalent Pharma Solutions St. Petersburg, FL 33716 Marketed by: Solvay Pharmaceuticals, Inc. Marietta, GA 30062 © 2008 Solvay Pharmaceuticals, Inc. All rights reserved. 500032 Rev Jan 2008 500033 Rev Jan 2008 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

PROMETRIUM - PROGESTERONE CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
500032 Rev Jan 2008
WARNINGS
Progestins and estrogens should not be used for the prevention of
cardiovascular disease. (See
WARNINGS, CARDIOVASCULAR DISORDERS.)
The Women's Health Initiative (WHI) study reported increased risks of
myocardial infarction,
stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal
women (50 to 79 years of age) during 5 years of treatment with oral
conjugated estrogens (CE
0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg)
relative to placebo. (See
CLINICAL PHARMACOLOGY, CLINICAL STUDIES.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI,
reported increased
risk of developing probable dementia in postmenopausal women 65 years
of age or older during 4
years of treatment with oral conjugated estrogens plus
medroxyprogesterone acetate relative to
placebo. It is unknown whether this finding applies to younger
postmenopausal women. (See
CLINICAL PHARMACOLOGY, CLINICAL STUDIES.)
Other doses of oral conjugated estrogens with medroxyprogesterone and
other combinations and
dosage forms of estrogens and progestins were not studied in the WHI
clinical trials. In the
absence of comparable data and product-specific studies, the relevance
of the WHI findings to
other products has not been established. Therefore, the risks should
be assumed to be similar for
all estrogen and progestin products. Because of these risks, estrogens
with or without progestins
should be prescribed at the lowest effective doses and for the
shortest duration consistent with
treatment goals and risks for the individual woman.
DESCRIPTION
PROMETRIUM® (progesterone, USP) Capsules contain micronized
progesterone for oral
administration. Progesterone has a molecular weight of 314.47 and a
molecular formula of C
H O .
Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white,
odorless, crystalline powder
practically insoluble in water, soluble in alcohol, acetone and
dioxa