HYDROXYPROGESTERONE CAPROATE injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Slayback Pharma LLC

Адміністрація маршрут:

INTRAMUSCULAR

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 injection in women with any of the following conditions: - Current or history of thrombosis or thromboembolic disorders - Known or suspected breast cancer, other hormone-s

Огляд продуктів:

Hydroxyprogesterone caproate injection multi-dose vials (for intramuscular injection) Hydroxyprogesterone caproate injection, USP (NDC 71225-104-01) is supplied as 5 mL of a sterile clear yellow solution in a multi-dose glass vial. Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v). Single unit carton: Contains one 5 mL multi-dose vial of Hydroxyprogesterone caproate injection, USP (250 mg/mL) containing 1250 mg of hydroxyprogesteronecaproate. Store at 20°C to 25°C (68°F to 77°F). Do not refrigerate or freeze. Use multi-dose vials within 5 weeks after first use. Caution: Protect vial from light. Store vial in its box. Store upright.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

HYDROXYPROGESTERONE CAPROATE - HYDROXYPROGESTERONE CAPROATE INJECTION
SLAYBACK PHARMA LLC
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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. (1)
LIMITATION OF USE: HYDROXYPROGESTERONE CAPROATE INJECTION IS NOT
INTENDED FOR USE IN WOMEN WITH MULTIPLE
GESTATIONS OR OTHER RISK FACTORS FOR PRETERM BIRTH. (1) (1)
DOSAGE AND ADMINISTRATION
• Hydroxyprogesterone caproate injection (Multi-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) (2)
DOSAGE FORMS AND STRENGTHS
5 mL multi-dose vial for intramuscular use contains 1250 mg of
hydroxyprogesterone caproate (250 mg/mL). (3) (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 vagin