Prodrox

Hydroxyprogesterone is a prescription hormone medication used in pregnant women to lower the risk of delivering a baby too early. Hydroxyprogesterone belongs to a group of drugs called progestin hormones. It is not known how progestins work to prevent preterm labor.

Hydroxyprogesterone is a prescription medication used to prevent preterm delivery (having a baby too soon) in pregnant women who:

• Are pregnant with one baby
• Have had a preterm delivery of one baby in the past

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The recommended dose of hydroxyprogesterone to prevent preterm delivery is 250 mg (1 mL) once a week.

Hydroxyprogesterone should not be used if you:

• Have now or have had a history of blood clots or other blood clotting problems
• Have now or have had a history of breast cancer or other hormone-sensitive cancers
• Have unusual vaginal bleeding not related to your current pregnancy
• Have yellowing of your skin due to liver problems during your pregnancy
• Have liver problems, including liver tumors
• Have uncontrolled high blood pressure

Hydroxyprogesterone may cause serious side effects, including:

• Blood clots. Symptoms of a blood clot may include:

• Leg swelling
• Redness in your leg
• A spot on your leg that is warm to touch
• Leg pain that worsens when you bend your foot

• Allergic reactions. Symptoms of an allergic reaction may include:

• Hives
• Itching
• Swelling of the face

• Depression
• Yellowing of your skin and the whites of your eyes

The most common side effects of hydroxyprogesterone include:

• Pain, swelling, itching, bruising or a hard bump at the injection site
• Hives
• Itching
• Nausea
• Diarrhea

Call your healthcare provider if you have the following at your injection site:

• Increased pain over time
• Oozing of blood or fluid
• Swelling

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of hydroxyprogesterone. For more information, ask your healthcare provider or pharmacist.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received hydroxyprogesterone compared to women who did not receive hydroxyprogesterone, including:

• Miscarriage (pregnancy loss before 20 weeks of pregnancy)
• Stillbirth (fetal death occurring after the 20th week of pregnancy)
• Hospital admission for preterm labor
• Preeclampsia (high blood pressure and too much protein in your urine)
• Gestational hypertension (high blood pressure caused by pregnancy)
• Gestational diabetes
• Oligohydramnios (low amniotic fluid levels)

Call your healthcare provider for medical advice about side effects or pregnancy complications. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• theophylline (Theo-24, Elixophyllin, Theolair)
• tizanidine (Zanaflex)
• clozapine (Clozaril, Fazaclo)
• acetaminophen (Tylenol)
• nicotine (Nicotrol)
• efavirenz (Sustiva, in Atripla)
• bupropion (Aplenzin, Fortivo XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL)
• methadone (Methadose, Dolophine)

This is not a complete list of hydroxyprogesterone drug interactions. Ask your doctor or pharmacist for more information.

Hydroxyprogesterone is intended for use during pregnancy to help prevent giving birth to a baby too soon. Hydroxyprogesterone is not intended for use in the first trimester. Hydroxyprogesterone should be started between weeks 16 and 21 of pregnancy.

You will likely stop taking hydroxyprogesterone at 37 weeks of gestation or when the baby is born. This medication, a progestin hormone, is likely to be excreted in breast milk as progestins are known to pass through breast milk in small amounts.

Hydroxyprogesterone is not intended for use in the first trimester. Hydroxyprogesterone should be started between weeks 16 and 21 of pregnancy.

You will likely stop taking hydroxyprogesterone at 37 weeks of gestation or when the baby is born.

Do not give yourself hydroxyprogesterone injections. A healthcare professional will give you the hydroxyprogesterone injection into your hip area (upper outer area of the buttocks) once a week.

Hydroxyprogesterone may cause serious side effects, including blood clots.