Makena

DRUG DESCRIPTION

The active pharmaceutical ingredient in Makena is hydroxyprogesterone caproate.

The chemical name for hydroxyprogesterone caproate is pregn-4-ene-3,20-dione, 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 120-124C.

The structural formula is:

MAKENA (hydroxyprogesterone caproate) Structural Formula - llustration

Makena (hydroxyprogesterone caproate injection) 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 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


Makena Consumer (continued)

SIDE EFFECTS: Pain, swelling, itching, bruising, or a lump at the injection site may occur. Nausea or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: dark urine, mental/mood changes (such as depression, nervousness), persistent nausea/vomiting, stomach/abdominal pain, unusual vaginal bleeding, yellowing eyes/skin.

This drug may rarely cause blood clots. Get medical help right away if any of these serious side effects occur: chest/jaw/left arm pain, confusion, pain/swelling/redness/warmth in the leg, slurred speech, sudden shortness of breath, sudden vision changes (such as partial/complete blindness), weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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. Check your blood sugar level regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst and urination. Your doctor may need to adjust your diabetes medication or diet.

Tell your doctor if you will be having surgery or will be confined to a chair or bed for a long time (such as a long plane flight). You may need to take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is used to prevent preterm birth during pregnancy. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk. However, it is not used after 37 weeks of pregnancy, or after delivery. Consult your doctor before breast-feeding.



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