HYDROXYPROGESTERONE CAPROATE injection

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

AuroMedics Pharma LLC

Administracija rute:

INTRAMUSCULAR

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth. Do not use hydroxyprogesterone caproate in women with any of the following conditions: - Current or history of thrombosis or thromboembolic disorders - Known or suspected breast cancer, other hormone-sensitive cancer, or

Proizvod sažetak:

Hydroxyprogesterone caproate injection, single-dose vials (for intramuscular injection) Hydroxyprogesterone caproate injection, USP is a sterile, non-pyrogenic, clear pale yellow to yellow color oily solution and is supplied as 1 mL of a sterile solution in a single-dose glass vial. Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v). 250 mg per mL: 1 mL Single Dose Vial Packaged Individually                                         NDC 55150-309-01 1 mL Single Dose Vials in a Carton of 4                                                   NDC 55150-309-04 Store at 20° to 25°C (68° to 77°F). Do not refrigerate or freeze. Caution: Protect vial from light. Store vial in its box. Store upright. The vial stopper is not made with natural rubber latex.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

HYDROXYPROGESTERONE CAPROATE - HYDROXYPROGESTERONE CAPROATE INJECTION
AUROMEDICS PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROXYPROGESTERONE CAPROATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
HYDROXYPROGESTERONE
CAPROATE INJECTION.
HYDROXYPROGESTERONE CAPROATE INJECTION, FOR INTRAMUSCULAR USE.
INITIAL U.S. APPROVAL: 1956
RECENT MAJOR CHANGES
Dosage and Administration, Dosing (2.1) 02/2018
Dosage and Administration, Preparation & Administration (2.2) 02/2018
INDICATIONS AND USAGE
Hydroxyprogesterone caproate injection is a progestin indicated to
reduce the risk of preterm birth in women with a
singleton pregnancy who have a history of singleton spontaneous
preterm birth (1). The effectiveness of
hydroxyprogesterone caproate injection is based on improvement in the
proportion of women who delivered < 37 weeks
of gestation (14). There are no controlled trials demonstrating a
direct clinical benefit, such as improvement in neonatal
mortality and morbidity.
LIMITATION OF USE: HYDROXYPROGESTERONE CAPROATE INJECTION IS NOT
INTENDED FOR USE IN WOMEN WITH MULTIPLE
GESTATIONS OR OTHER RISK FACTORS FOR PRETERM BIRTH. (1)
DOSAGE AND ADMINISTRATION
Hydroxyprogesterone caproate injection (Single-dose vials): Administer
intramuscularly at a dose of 250 mg (1 mL)
once weekly in the upper outer quadrant of the gluteus maximus (2.1)
Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of
gestation (2.1)
Continue administration once weekly until week 37 (through 36 weeks, 6
days) of gestation or delivery, whichever
occurs first (2.1)
DOSAGE FORMS AND STRENGTHS
1 mL single-dose vial for intramuscular use contains 250 mg of
hydroxyprogesterone caproate. (3)
CONTRAINDICATIONS
Current or history of thrombosis or thromboembolic disorders (4)
Known or suspected breast cancer, other hormone-sensitive cancer, or
history of these conditions (4)
Undiagnosed abnormal vaginal bleeding unrelated to pregnancy (4)
Cholestati