Drug Catalog - Product Detail
PROGESTERONE USP IN SESAME OIL FOR INJECTION INJECT. 500MG/10ML 1X10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00143-9725-01 | HIKMA PHARMACEUTICALS USA | 10 | 50MG/ML | OIL |
PACKAGE FILES
Generic Name
PROGESTERONE
Substance Name
PROGESTERONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR
Application Number
ANDA091033
Description
DESCRIPTION Progesterone injection, USP, a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use. Progesterone occurs as a white or creamy white, crystalline powder. It is odorless and is stable in air. Practically insoluble in water, it is soluble in alcohol, acetone, and dioxane and sparingly soluble in vegetable oils. It has the following structural formula: C 21 H 30 O 2 M.W. 314.47 Pregn-4-ene-3, 20-dione Each mL contains: Progesterone 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s. Progesterone structural formula.
How Supplied
HOW SUPPLIED Progesterone Injection, USP, 50 mg/mL is available in 10 mL multiple dose vials, individually boxed. (NDC 0143-9725-01) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured By: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, Portugal Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: January 2021 PIN258-WES/5
Indications & Usage
INDICATIONS AND USAGE This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
Dosage and Administration
DOSAGE AND ADMINISTRATION Progesterone Injection, USP is administered by intramuscular injection. It differs from other commonly used steroids in that it is irritating at the place of injection. Amenorrhea: Five to 10 mg are given for six to eight consecutive days. If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding forty-eight to seventy-two hours after the last injection. This may be followed by spontaneous normal cycles. Functional Uterine Bleeding: Five to 10 mg are given daily for six doses. Bleeding may be expected to cease within six days. When estrogen is given as well, the administration of progesterone is begun after two weeks of estrogen therapy. If menstrual flow begins during the course of injections of progesterone, they are discontinued. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.