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Hydroxyprogesterone caproate (Injection)

Hydroxyprogesterone Caproate (hye-drox-ee-proe-JES-ter-one KAP-roe-ate)

Used in pregnant women to help lower the risk of delivering a baby too early (preterm birth). This medicine is given to pregnant women who are pregnant with one baby and who have had a preterm delivery of one baby in the past.

Brand Name(s):

Makena

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not receive this medicine if you have had an allergic reaction to hydroxyprogesterone caproate, or if you have unusual vaginal bleeding. You should not receive this medicine if you have uncontrolled high blood pressure, breast cancer (now or in the past), liver disease (including tumors or cancer), or a history of blood clots. Do not receive this medicine if you have ever had cholestasis (bile problem) caused by pregnancy.

How to Use This Medicine:

Injectable

  • Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
  • A nurse or other health provider will give you this medicine.
  • This medicine is given once a week (every 7 days). You will begin receiving this medicine between 16 weeks and 0 days of your pregnancy, and 20 weeks and 6 days of your pregnancy.
  • You will continue to receive this medicine once a week until week 37 (through 36 weeks, 6 days of your pregnancy) of pregnancy or until you give birth.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

If a dose is missed:

  • It is very important that you do not miss a dose and that you continue to receive this medicine weekly. If you miss a dose, call your doctor.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are also using acetaminophen (Tylenol®), bupropion (Wellbutrin®), clozapine (Clozaril®), efavirenz (Sustiva®), halothane (Fluothane®), methadone (Dolophine®), nicotine, theophylline (Theo-Dur®), or tizanidine (Zanaflex®).

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, asthma, diabetes, epilepsy or seizures, fluid retention (swelling or edema), heart problems, high blood pressure, migraine headaches, preeclampsia (high blood pressure during pregnancy), or a history of depression. Tell your doctor if you have had an allergic reaction to castor oil.
  • Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while receiving this medicine.
  • This medicine may cause serious allergic reactions. Stop using this medicine and check with your doctor right away if you have a rash, itching, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs after you receive the medicine.
  • This medicine may cause pain, soreness, itching, swelling, or bruising. Call your doctor right away if you have increased pain or discomfort, oozing of blood or fluid, or swelling at the injection site.
  • This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
  • Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain, shortness of breath, or coughing up blood.
  • Dark-colored urine or pale stools.
  • Fast or slow heartbeat.
  • Increased hunger or thirst.
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach.
  • Numbness or weakness in your arm or leg, or on one side of your body.
  • Pain in your lower leg (calf).
  • Pain, itching, bruising, swelling, or a lump under your skin where the shot is given.
  • Seizures.
  • Sudden or severe headache, or problems with vision, speech, or walking.
  • Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

  • Diarrhea.
  • Itching or skin rash.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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


Last Updated: 7/4/2014


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