Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
HYDROXYPROGESTERONE CAPROATE (UNII: 276F2O42F5) (HYDROXYPROGESTERONE - UNII:21807M87J2)
AuroMedics Pharma LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Prečítajte si celý dokument