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 last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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: nausea/vomiting that doesn’t stop, dark urine, mental/mood changes (such as depression, nervousness), 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, trouble speaking, 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 or at www.fda.gov/medwatch.

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

Uses

This medication is used in women who are pregnant with a single baby, and who have delivered a baby too early (preterm) in the past. It is used to help lower the risk of having a preterm baby again. Hydroxyprogesterone is a man-made form of a hormone (progestin). It is not known how it works to prevent preterm births.This medication is not intended to prevent preterm birth in women pregnant with more than one baby (such as twins, triplets). It is also not intended to stop active preterm labor.This drug has been withdrawn from the US market due to problems with safety or effectiveness.

How to use HYDROXYPROGESTERONE CAPROATE Vial

Read the Patient Information Leaflet if available from your pharmacist before you start using hydroxyprogesterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection as directed by your doctor, usually once a week (every 7 days). The injection is given by a health care professional, either under the skin of your upper arm or into the muscle of your buttocks. You will start receiving injections any time from the 16th week through the 20th week of your pregnancy. You will continue to receive injections once a week until week 37 of your pregnancy or when your baby is delivered, whichever comes first.

Use this medication regularly to get the most benefit from it.

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 affect your blood sugar. Check your blood sugar 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/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor’s office and will not be stored at home.