Hydroxyprogesterone

Generic Name: hydroxyprogesterone (hye-DROX-ee-proe-JES-ter-one)
Brand Name: Makena

Hydroxyprogesterone is used for:

Reducing the risk of delivering a baby too early (preterm birth). Hydroxyprogesterone should only be used by women who are pregnant with one baby and have had a preterm delivery of one baby in the past.

Hydroxyprogesterone is a synthetic hormone (progestin). How it works to reduce the risk of recurrent preterm birth is not known.

Do NOT use hydroxyprogesterone if:

  • you are allergic to any ingredient in hydroxyprogesterone, including castor oil
  • you are pregnant with more than one baby or you have other risk factors for preterm birth
  • you have never had a preterm delivery of one baby in the past
  • you have blood clots, blood clotting problems, breast cancer or other hormone-sensitive cancers, or if you have a history of these conditions
  • you have undiagnosed abnormal vaginal bleeding not related to pregnancy, yellowing of the eyes or skin caused by pregnancy, liver tumors or other liver problems, or uncontrolled high blood pressure
  • you have been through menopause

Contact your doctor or health care provider right away if any of these apply to you.

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Before using hydroxyprogesterone:

Some medical conditions may interact with hydroxyprogesterone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have diabetes or high blood sugar, edema (swelling), preeclampsia, or migraine headaches
  • if you have a history of epilepsy (seizures); asthma; heart, liver, or kidney problems; high blood pressure; or mental or mood problems (eg, depression)

Some MEDICINES MAY INTERACT with hydroxyprogesterone. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Rifamycins (eg, rifampin) because they may decrease hydroxyprogesterone's effectiveness
  • Acetaminophen, bupropion, clozapine, efavirenz, halothane, methadone, nicotine products (eg, gum, patch), theophylline, or tizanidine because their effectiveness may be decreased by hydroxyprogesterone

This may not be a complete list of all interactions that may occur. Ask your health care provider if hydroxyprogesterone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use hydroxyprogesterone:

Use hydroxyprogesterone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with hydroxyprogesterone. Talk to your pharmacist if you have questions about this information.
  • Hydroxyprogesterone is usually given as an injection every 7 days at your doctor's office, hospital, or clinic.
  • Hydroxyprogesterone should appear as a clear, yellow solution. Do not use hydroxyprogesterone if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of hydroxyprogesterone, contact your doctor right away.

Ask your health care provider any questions you may have about how to use hydroxyprogesterone.

Important safety information:

  • Hydroxyprogesterone is not intended for use to stop active preterm labor. Discuss any questions or concerns with your doctor.
  • Diabetes patients - Hydroxyprogesterone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests information required for safe and proper use.
  • Hydroxyprogesterone should not be used in women who have been through menopause; safety and effectiveness in these patients have not been confirmed.
  • Hydroxyprogesterone should not be used in CHILDREN younger than 16 years; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Hydroxyprogesterone is intended for use in pregnant women. Discuss with your doctor the benefits and risks of using hydroxyprogesterone while you are pregnant. Hydroxyprogesterone is found in breast milk. If you are or will be breast-feeding while you use hydroxyprogesterone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of hydroxyprogesterone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; mild bruising, itching, or pain at the injection site; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); calf or leg pain, redness, swelling, tenderness, or warmth; chest pain; coughing up blood; hard bump, increased pain over time, oozing of blood or fluid, or swelling at the injection site; mental or mood problems (eg, depression); severe or persistent headache or dizziness; shortness of breath; swelling of the hands, ankles, or feet; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of hydroxyprogesterone:

Hydroxyprogesterone is usually handled and stored by a health care provider. If you are using hydroxyprogesterone at home, store hydroxyprogesterone as directed by your pharmacist or health care provider. Keep hydroxyprogesterone out of the reach of children and away from pets.

General information:

  • If you have any questions about hydroxyprogesterone, please talk with your doctor, pharmacist, or other health care provider.
  • Hydroxyprogesterone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take hydroxyprogesterone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about hydroxyprogesterone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hydroxyprogesterone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using hydroxyprogesterone.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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