Delta-Lutin

Hydroxyprogesterone is a prescription medication used to prevent preterm delivery (having a baby too soon) in pregnant women who:

• Are pregnant with one baby
• Have had a preterm delivery of one baby in the past

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Hydroxyprogesterone may cause serious side effects, including:

• Blood clots. Symptoms of a blood clot may include:

• Leg swelling
• Redness in your leg
• A spot on your leg that is warm to touch
• Leg pain that worsens when you bend your foot

• Allergic reactions. Symptoms of an allergic reaction may include:

• Hives
• Itching
• Swelling of the face

• Depression
• Yellowing of your skin and the whites of your eyes

The most common side effects of hydroxyprogesterone include:

• Pain, swelling, itching, bruising or a hard bump at the injection site
• Hives
• Itching
• Nausea
• Diarrhea

Call your healthcare provider if you have the following at your injection site:

• Increased pain over time
• Oozing of blood or fluid
• Swelling

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of hydroxyprogesterone. For more information, ask your healthcare provider or pharmacist.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received hydroxyprogesterone compared to women who did not receive hydroxyprogesterone, including:

• Miscarriage (pregnancy loss before 20 weeks of pregnancy)
• Stillbirth (fetal death occurring after the 20th week of pregnancy)
• Hospital admission for preterm labor
• Preeclampsia (high blood pressure and too much protein in your urine)
• Gestational hypertension (high blood pressure caused by pregnancy)
• Gestational diabetes
• Oligohydramnios (low amniotic fluid levels)

Call your healthcare provider for medical advice about side effects or pregnancy complications. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• theophylline (Theo-24, Elixophyllin, Theolair)
• tizanidine (Zanaflex)
• clozapine (Clozaril, Fazaclo)
• acetaminophen (Tylenol)
• nicotine (Nicotrol)
• efavirenz (Sustiva, in Atripla)
• bupropion (Aplenzin, Fortivo XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL)
• methadone (Methadose, Dolophine)

This is not a complete list of hydroxyprogesterone drug interactions. Ask your doctor or pharmacist for more information.

Before you receive hydroxyprogesterone, tell your healthcare provider if you have:

• An allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in hydroxyprogesterone. 
• Diabetes or prediabetes
• Epilepsy
• Migraine headaches
• Asthma
• Heart problems
• Kidney problems
• Depression
• High blood pressure

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Hydroxyprogesterone may affect the way other medicines work, and other medicines may affect how hydroxyprogesterone works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medication.

Hydroxyprogesterone is intended for use during pregnancy to help prevent giving birth to a baby too soon. Hydroxyprogesterone is not intended for use in the first trimester. Hydroxyprogesterone should be started between weeks 16 and 21 of pregnancy.

You will likely stop taking hydroxyprogesterone at 37 weeks of gestation or when the baby is born. This medication, a progestin hormone, is likely to be excreted in breast milk as progestins are known to pass through breast milk in small amounts.