hydroxyprogesterone injection (Delta-Lutin, Duralutin, Hylutin)

Brand Names: Delta-Lutin, Duralutin, Hylutin, Hyprogesterone, Makena, Makena Auto-Injector, Prodrox

Generic Name: hydroxyprogesterone injection

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. Hydroxyprogesterone 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 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:

Common side effects may include:

  • pain, swelling, itching, rash, or a lump where the medicine was injected;
  • nausea; or
  • diarrhea.

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 is the most important information I should know about hydroxyprogesterone?

You should not use this medicine if you have: uncontrolled high blood pressure, unusual vaginal bleeding, liver disease or liver cancer, jaundice caused by your pregnancy, or if you have ever had circulation problems, a stroke or blood clot, or cancer of the breast, uterus/cervix, or vagina.

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

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

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

Tell your doctor if you have ever had:

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.

How is hydroxyprogesterone given?

Hydroxyprogesterone is injected under the skin or into a muscle.

A healthcare provider will give you this injection.

The first hydroxyprogesterone injection is usually given during the second trimester 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. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.

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What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your hydroxyprogesterone injection.

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 other drugs will affect hydroxyprogesterone?

Other drugs may affect hydroxyprogesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines 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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Reviewed on 11/15/2021

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