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Makena

"On February 3, 2011, the U.S. Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals,"...

Makena

MAKENA®
(hydroxyprogesterone caproate) Injection

Makena

DRUG DESCRIPTION

The active pharmaceutical ingredient in Makena is hydroxyprogesterone caproate.

The chemical name for hydroxyprogesterone caproate is pregn-4-ene-3,20dione, 17[(1-oxohexyl)oxy]. It has an empirical formula of C27H40O4 and a molecular weight of 428.60. Hydroxyprogesterone caproate exists as white to practically white crystals or powder with a melting point of 120°-124°C. The structural formula is:

MAKENA® (hydroxyprogesterone caproate) Structural Formula Illustration

Makena is a clear, yellow, sterile, non-pyrogenic solution for intramuscular injection. Each 5 mL multidose vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).

What are the possible side effects of hydroxyprogesterone (Makena, Prodrox)?

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

Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • swelling, oozing, bleeding, or worsening pain where the injection was given;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • jaundice (yellowing...

Read All Potential Side Effects and See Pictures of Makena »

What are the precautions when taking hydroxyprogesterone caproate injection (Makena)?

Before using hydroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, blood clots or other blood clotting problems, cancer (especially of the breast or other female organs), depression, diabetes, severe headaches/migraines, heart problems, high blood pressure, kidney problems, liver problems, seizure disorder, unusual vaginal bleeding, yellowing eyes/skin (jaundice) during pregnancy.

If you have diabetes, this medication may make it harder to control your blood sugar....

Read All Potential Precautions of Makena »

Last reviewed on RxList: 9/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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Makena - User Reviews

Makena User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Makena sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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