Drug Catalog - Product Detail
PROGESTERONE CP 100MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69543-0374-10 | VIRTUS PHARMACEUTICALS | 100 | 100MG | CAPSULE |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Progesterone, USP Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C 21 H 30 O 2 . 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 dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is: Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone, USP Capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone, USP Capsules contain 100 mg or 200 mg micronized progesterone. The inactive ingredients for Progesterone, USP Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, FD&C Red No. 40, and D&C Yellow No. 10. The inactive ingredients for Progesterone, USP Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6. Chemical Structure
How Supplied
HOW SUPPLIED 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.
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Prevention of Endometrial Hyperplasia Progesterone, USP Capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to a postmenopausal woman with a uterus who is receiving daily conjugated estrogens tablets. Treatment of Secondary Amenorrhea Progesterone, USP Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing Progesterone, USP Capsules. For these women, Progesterone, USP Capsules should be taken with a glass of water while in the standing position.