Indication

  1. Indicated for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
  2. Indicated for prevention of preterm labor in a singleton pregnancy for patients aged 16 years or older who have a history of spontaneous preterm birth


Dosage & Administration

Dosage
Administer intramuscularly at a dose of 500 mg (2 mL) once weekly. 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.


Administration
1. Clean the ampoule top with an alcohol swab before using ampoule breaker .
2. Draw up 2 ml of drug into the provided syringe.
3. After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over one minute or longer) is recommended.
4. Applying pressure to the injection site may minimize bruising and swelling.


Precautions

Thromboembolic disorders: Discontinue if thrombosis or thromboembolism occurs. 

Allergic reactions: Consider discontinuing if allergic reactions occur. 

Decreased glucose tolerance: Monitor pre-diabetic and diabetic women receiving Hydroxyprogesterone Caproate. 

Fluid retention: Monitor women with conditions that may be affected by fluid retention, such as pre-eclampsia, epilepsy, cardiac or renal dysfunction. 

Depression: Monitor women with a history of clinical depression; discontinue Hydroxyprogesterone Caproate if depression recurs. Jaundice: Carefully monitor women who develop jaundice while receiving Hydroxyprogesterone Caproate and consider whether the benefit of use warrants continuation. 

Hypertension: Carefully monitor women who develop hypertension while receiving Hydroxyprogesterone Caproate and consider whether the benefit of use warrants continuation. 

Pregnancy Category

Pregnancy category B.


Product Details


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