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Hydroxyprogesterone auto-injector: Administer subcutaneously using Hydroxyprogesterone auto-injector at a dose of 275 mg (1.1 mL) once weekly, in the back of either upper arm

Hydroxyprogesterone (single- and multi-dose vials): Administer intramuscularly at a dose of 250 mg (1 mL) once weekly in the upper outer quadrant of the gluteus maximus 

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

 

Pediatric Use: Hydroxyprogesterone is not indicated for use in women under 16 years of age. Safety and effectiveness in patients less than 16 years of age have not been established. A small number of women under age 18 years were studied; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and older

Hepatic Impairment: No studies have been conducted to examine the pharmacokinetics of Hydroxyprogesterone in patients with hepatic impairment. Hydroxyprogesterone is extensively metabolized and hepatic impairment may reduce the elimination of Hydroxyprogesterone .

 

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