HYDROXYPROGESTERONE CAPROATE injection

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

HYDROXYPROGESTERONE CAPROATE (UNII: 276F2O42F5) (HYDROXYPROGESTERONE - UNII:21807M87J2)

Sẵn có từ:

Mylan Institutional LLC

INN (Tên quốc tế):

HYDROXYPROGESTERONE CAPROATE

Thành phần:

HYDROXYPROGESTERONE CAPROATE 250 mg in 1 mL

Tuyến hành chính:

INTRAMUSCULAR

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation. Hydroxyprogesterone caproate is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug. Hydroxyprogesterone caproate is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders.

Tóm tắt sản phẩm:

Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. The product is available as a single, multiple-dose, 5 mL vial (NDC 67457-886-05). Storage Hydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25°C (68° to 77°F). Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water. Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. by: McGuff Pharmaceuticals, Inc. Santa Ana, CA 92704 U.S.A. DRW-0025 Rev.02 Revised: 11/2021 MCG:HPCIJ:R2

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

HYDROXYPROGESTERONE CAPROATE- HYDROXYPROGESTERONE
CAPROATE INJECTION
MYLAN INSTITUTIONAL LLC
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DESCRIPTION
Hydroxyprogesterone Caproate Injection, USP is a sterile, long-acting
preparation of the
caproate ester of the naturally-occurring progestational hormone,
hydroxyprogesterone, in an oil solution for intramuscular use.
The chemical name for hydroxyprogesterone caproate is
pregn-4-ene-3,20-dione, 17[(1-
oxohexyl)oxy]. It has an empirical formula of C
H
O and a molecular weight of
428.60. Hydroxyprogesterone caproate exists as white to creamy white
crystalline
powder.
The structural formula is:
Each 5 mL multiple-dose vial contains hydroxyprogesterone caproate,
250 mg/mL, in
castor oil (28.6% v/v) and benzyl benzoate (46% v/v) with the
preservative benzyl
alcohol (2% v/v).
CLINICAL PHARMACOLOGY
Hydroxyprogesterone is a potent, long-acting, progestational steroid
ester which
transforms proliferative endothelium into secretory endothelium,
induces mammary
gland duct development, and inhibits the production and/or release of
gonadotropic
hormone; it also shows slight estrogenic, androgenic, or corticoid
effects as well, but
should not be relied upon for these effects.
In advanced adenocarcinoma of the uterine corpus, Hydroxyprogesterone
Caproate
Injection in a dosage of 1,000 mg or more, one or more times each
week, often induces
regressive changes.
_Absorption:_ Peak serum levels of hydroxyprogesterone caproate
appeared after 3 to 7
days in non-pregnant female subjects following a single intramuscular
injection of 1,000
mg hydroxyprogesterone caproate. The pharmacokinetics of the 250 mg
dose of
hydroxyprogesterone caproate has not been evaluated in a study.
_Metabolism:_ The conjugated metabolites include sulfated and
glucuronidated products.
_In vitro_ data indicate that the metabolism of hydroxyprogesterone
caproate is
predominantly mediated by CYP3A4 and CYP3A5.
_Excretion:_ Both conjugated metabolites and free steroids are
excreted in the urine and
feces, with the conjugated metabolites being promine