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Hydroxyprogesterone caproate (United States: Withdrawn from market): Patient drug information

Hydroxyprogesterone caproate (United States: Withdrawn from market): Patient drug information

(For additional information see "Hydroxyprogesterone caproate (United States: Withdrawn from market): Drug information" and see "Hydroxyprogesterone caproate (United States: Withdrawn from market): Pediatric drug information")

You must carefully read the "Consumer Information Use and Disclaimer" below in order to understand and correctly use this information.

Brand Names: US
  • Makena [DSC]
What is this drug used for?
  • It delays a baby's birth when it is too early.
  • It is used to treat some uterine cancers.
  • It is used to treat abnormal period (menstrual) cycles.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • For all uses of this drug:
  • If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have a blood clot, have ever had a blood clot, or have been told you are at risk of getting a blood clot.
  • If you have any of these health problems: Liver disease or liver tumors.
  • If you have high blood pressure.
  • If you have unexplained vaginal bleeding.
  • If you have ever had breast cancer or another cancer where hormones make it grow.
  • If you turned yellow while pregnant or with estrogen use like hormonal birth control.
  • For delaying a baby’s birth:
  • If you are pregnant with more than 1 baby.
  • If you are not pregnant.
  • For all uses of this drug other than delaying a baby’s birth:
  • If you are pregnant or may be pregnant. Do not use this drug if you are pregnant.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • For all uses of this drug:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor.
  • This drug is not approved for use if you are going through or have been through menopause.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • For delaying a baby’s birth:
  • This drug is not approved for use in children younger than 16 years of age. Talk with the doctor.
  • This drug is not approved to stop labor that has already started. Talk with your doctor.
  • Some severe pregnancy-related effects may happen more often while taking this drug. These may include high blood pressure, diabetes, low amniotic fluid levels, miscarriage, and stillbirth. If you have questions, talk with your doctor.
  • For all uses of this drug other than delaying a baby’s birth:
  • This drug is not for use as a pregnancy test. Talk with your doctor.
  • Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
  • Have your blood work and other lab tests checked as you have been told by your doctor.
  • This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • This drug is not approved for use in children. Talk with the doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • For all uses of this drug:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, unusual thirst or hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Depression.
  • Swelling where this drug is used.
  • Oozing of blood or fluid where the shot was given.
  • Yellow skin or eyes.
  • Vaginal bleeding that is not normal.
  • This drug may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.
  • Blood clots have happened with this drug. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.
  • For all uses of this drug other than delaying a baby’s birth:
  • No menstrual period.
  • A deep voice or more facial hair.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • For delaying a baby’s birth:
  • Pain, itching, or other irritation where the injection was given.
  • Upset stomach.
  • Diarrhea.
  • For all uses of this drug other than delaying a baby’s birth:
  • Pain, itching, or other irritation where the injection was given.
  • Upset stomach or throwing up.
  • Stomach cramps.
  • Bloating.
  • Breast soreness.
  • Vaginal bleeding or spotting.
  • Weight gain or loss.
  • Headache.
  • Hair loss.
  • Change in sex interest.
  • Appetite changes.
  • Feeling dizzy, tired, or weak.
  • Back pain.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Auto-injector shot:
  • It is given as a shot into the fatty part of the skin.
  • Vials:
  • It is given as a shot into a muscle.
What do I do if I miss a dose?
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Last Reviewed Date2021-11-15
Consumer Information Use and Disclaimer
  • This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider's examination and assessment of a patient's specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.
  • © 2024 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.
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