HYDROXYPROGESTERONE CAPROATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Regent, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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-sensitive cancer,

Product summary:

Hydroxyprogesterone caproate injection, USP (NDC 0517-1791-01) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial. Each 1 mL vial contains hydroxyprogesterone caproate, 250 mg/mL (25% w/v), in castor oil (30.6% v/v) and benzyl benzoate (46% v/v). Single unit carton: Contains one 1 mL single-dose vial of hydroxyprogesterone caproate injection containing 250 mg of hydroxyprogesterone caproate. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Caution: Protect vial from light. Store vial in its box. Store upright.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYPROGESTERONE CAPROATE- HYDROXYPROGESTERONE CAPROATE INJECTION
AMERICAN REGENT, INC.
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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
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
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
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)
Cholestatic jaundice of pregnancy (4)
Liver tumors, benign or malignant, or active liver disease (4)
Uncontrolled hypertension (4)
WARNINGS AND PRECAUTIONS
Thromboembolic disorders: Discontinue if thrombosis or throm