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Pronunciation: hye DROX ee pro JES te rone

Brand: Makena, Prodrox

What is the most important information I should know about hydroxyprogesterone?

You should not use this medicine if you are allergic to hydroxyprogesterone or castor oil, or if you have unusual vaginal bleeding, liver disease or liver cancer, breast cancer, uterine cancer, uncontrolled high blood pressure, a history of jaundice caused by pregnancy, or a history of stroke, blood clot, or circulation problems.

What is hydroxyprogesterone?

Hydroxyprogesterone is a form of progestin, a manmade form of a female hormone called progesterone.

Hydroxyprogesterone is used to lower the risk of premature birth in a woman who has already had one premature baby. This medication will not stop premature labor that has already begun.

Hydroxyprogesterone is not for use in women who are pregnant with more than one baby (twins, triplets, etc).

Hydroxyprogesterone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving hydroxyprogesterone?

You should not receive this medicine if you are allergic to hydroxyprogesterone or castor oil, or if you have:

  • unusual vaginal bleeding that has not been checked by a doctor;
  • liver disease or liver cancer;
  • a history of hormone-related cancer such as breast or uterine cancer;
  • severe or uncontrolled high blood pressure;
  • a history of jaundice caused by pregnancy; or
  • a history of a stroke, blood clot, or circulation problems.

Hydroxyprogesterone is not approved for use by anyone younger than 16 years old.

To make sure hydroxyprogesterone is safe for you, tell your doctor if you have:

  • eclampsia or preeclampsia of pregnancy;
  • kidney disease;
  • high blood pressure, heart disease;
  • migraine headaches;
  • a personal or family history of diabetes;
  • asthma;
  • epilepsy or other seizure disorder;
  • depression; or
  • fluid retention.

It is not known whether hydroxyprogesterone will prevent any medical problems in a newborn baby. Talk to your doctor about your baby's individual risk.

Hydroxyprogesterone can pass into breast milk, but it is not known whether this could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is hydroxyprogesterone given?

Hydroxyprogesterone is injected into a muscle. A healthcare provider will give you this injection.

The first hydroxyprogesterone injection is usually given during the 16th through the 20th week of pregnancy. The usual dosing schedule is one injection per week until the 37th week or until your baby is born. Follow your doctor's instructions.

Your doctor will need to check your progress on a regular basis while you are using hydroxyprogesterone. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.

If you store hydroxyprogesterone at home, keep the medicine vial in the box it came in. Store in an upright position at room temperature away from moisture, heat, and light.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

The multi-dose vial contains enough medicine for 5 injections. Throw away any medicine left in the vial 5 weeks after the first use.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of hydroxyprogesterone.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving hydroxyprogesterone?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of hydroxyprogesterone?

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • swelling, oozing, bleeding, or worsening pain where the injection was given;
  • jaundice (yellowing of the skin or eyes);
  • symptoms of depression (sleep problems, weakness, mood changes);
  • swelling in your hands, ankles, or feet;
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs; or
  • increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety.

Common side effects may include:

  • soreness, bruising, or itching where the medicine was injected;
  • nausea, diarrhea; or
  • skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect hydroxyprogesterone?

Other drugs may interact with hydroxyprogesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about hydroxyprogesterone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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