Hydroxyprogesterone

Hydroxyprogesterone may be found in some form under the following brand names:

• Delta-Lutin

• Duralutin

• Hylutin

• Makena

• Prodrox

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.

Serious side effects have been reported with hydroxyprogesterone including the following:

Blood Clots. Tell your doctor immediately if you experience any of the following:

• 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. Severe and potentially life-threatening allergic reactions are possible during treatment with hydroxyprogesterone. Get emergency medical attention immediately if you develop any of the following symptoms of a severe allergic reaction:

• sudden difficulty breathing
• sudden and abnormal swelling of the face, lips, tongue, and/or throat
• hives
• sudden development of a red blister-like skin rash
• sudden drop in blood pressure

Depression. Tell your doctor immediately if you notice a change in your mood. 

Reduced glucose tolerance. Hydroxyprogesterone can reduce your body's ability to tolerate large amounts of glucose. Be sure to inform your physician if you have diabetes or prediabetes, as this can affect how your body responds to this medication.

Jaundice. Tell your doctor immediately if you notice yellowing of your skin and the whites of your eyes. 

Hydroxyprogesterone can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Makena affects you.

Do not receive hydroxyprogesterone if you:

• are allergic to hydroxyprogesterone or to any of its ingredients 
• have or suspect you may have breast cancer or any other hormone-sensitive cancers
• have unusual vaginal bleeding due to an unknown cause
• have a medical condition called cholestatic jaundice of pregnancy (yellowing of your skin due to liver problems during your pregnancy)
• have liver tumors or any active liver disease
• have untreated high blood pressure
• have or have a history of blood clots

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 20 of pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of hydroxyprogesterone to prevent preterm delivery is 250 mg (1 mL) once a week.

You should not receive this medicine if you are allergic to hydroxyprogesterone or castor oil, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease or liver cancer;

• a history of hormone-related cancer such as breast or uterine cancer;

• severe or uncontrolled high blood pressure;

• a history of jaundice caused by pregnancy; or

• a history of a stroke, blood clot, or circulation problems.

Hydroxyprogesterone is not approved for use by anyone younger than 16 years old.

To make sure hydroxyprogesterone is safe for you, tell your doctor if you have:

• eclampsia or preeclampsia of pregnancy;

• kidney disease;

• high blood pressure, heart disease;

• migraine headaches;

• a personal or family history of diabetes;

• asthma;

• epilepsy or other seizure disorder;

• depression; or

• fluid retention.

It is not known whether hydroxyprogesterone will prevent any medical problems in a newborn baby. Talk to your doctor about your baby's individual risk.

Hydroxyprogesterone can pass into breast milk, but it is not known whether this could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Applies to hydroxyprogesterone: compounding powder, intramuscular solution

Genitourinary

Genitourinary side effects have included admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios. Postmarketing side effects include urinary tract infection, cervical incompetence, premature rupture of membranes, cervical dilation, and shortened cervix.[Ref]

Local

Local side effects have included injection site pain, swelling, pruritus, and nodules. Postmarketing side effects include local injection site reactions of erythema, urticaria, rash, irritation, hypersensitivity, and warmth.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea. Postmarketing side effects include vomiting.[Ref]

Dermatologic

Dermatologic side effects have included pruritus and urticaria. Postmarketing side effects include rash.[Ref]

Nervous system

Nervous system side effects include postmarketing reports of headache and dizziness.

Respiratory

Respiratory side effects include postmarketing reports of dyspnea and chest discomfort.

Other

Other side effects include postmarketing reports of fatigue, fever, and hot flashes/flushes.

Some side effects of hydroxyprogesterone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available