Generic Name: hydroxyprogesterone (hye DROX ee pro JES te rone)Brand Names: Makena, Prodrox
What is hydroxyprogesterone?
Hydroxyprogesterone is a form of progestin, a manmade form of a female hormone called progesterone.
Hydroxyprogesterone is used to lower the risk of premature birth in a woman who has already had one premature baby. This medication will not stop premature labor that has already begun.
Hydroxyprogesterone is not for use in women who have had more than one pregnancy.
Hydroxyprogesterone may also be used for purposes not listed in this medication guide.
What is the most important information I should know about hydroxyprogesterone?You should not use this medication if you are allergic to hydroxyprogesterone or castor oil, or if you have unusual vaginal bleeding, liver disease or liver cancer, breast cancer, uterine cancer, uncontrolled high blood pressure, a history of jaundice caused by pregnancy, or a history of stroke, blood clot, or circulation problems.
Before you receive hydroxyprogesterone, tell your doctor if you have eclampsia or preeclampsia, kidney disease, high blood pressure, heart disease, migraine headaches, a personal or family history of diabetes, asthma, seizures, depression, or fluid retention.
Your doctor will need to check your progress on a regular basis while you are using this medication. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.Call your doctor at once if you have sudden numbness or weakness, confusion, problems with vision or speech, jaundice (yellowing of the skin or eyes), swelling in your hands or feet, pain or redness in one or both legs, or symptoms of depression (sleep problems, weakness, mood changes).
There are many other drugs that may interact with hydroxyprogesterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.Do not start a new medication during pregnancy without telling your doctor.
What should I discuss with my healthcare provider before receiving hydroxyprogesterone?You should not receive this medication 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 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.
To make sure you can safely use hydroxyprogesterone, tell your doctor if you have any of these other conditions:
eclampsia or preeclampsia of pregnancy-
high blood pressure, heart disease-
a personal or family history of diabetes-
Hydroxyprogesterone passes into breast milk, but it is not known whether this could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How is hydroxyprogesterone given?
Hydroxyprogesterone is injected into a muscle. You will receive this injection in a clinic or doctor's office.Hydroxyprogesterone is usually started during the 16th week of pregnancy and given once per week until the 37th week or until your baby is born. Follow your doctor's instructions.
Your doctor will need to check your progress on a regular basis while you are using this medication. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your hydroxyprogesterone injection.
What happens if I overdose?Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving hydroxyprogesterone?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Hydroxyprogesterone side effectsGet emergency medical help if you have any of these signs of an allergic reaction: hives- difficulty breathing- swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
sudden numbness or weakness, especially on one side of the body-
swelling, oozing, bleeding, or worsening pain where the injection was given-
sudden severe headache, confusion, problems with vision, speech, or balance-
pain, swelling, warmth, or redness in one or both legs-
jaundice (yellowing of the skin or eyes)-
swelling in your hands, ankles, or feet- or
symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
nausea, diarrhea- or
pain, bruising, itching, swelling, or a hard lump where the injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect hydroxyprogesterone?
Tell your doctor about all other medicines you use, especially:
betaxolol (Kerlone) or propranolol (Inderal, InnoPran)-
cyclophosphamide (Gengraf, Neoral, Sandimmune)-
efavirenz (Sustiva, Atripla)-
methadone (Methadose, Diskets, Dolophine)-
nicotine (Nicorette, Commit, Habitrol, Nicotrol, Nicoderm)-
rifabutin (Mycobutin) or rifampin (Rifater, Rifadin, Rifamate)-
selegiline (Eldepryl, Emsam, Zelapar)-
an antidepressant such as bupropion (Wellbutrin), clomipramine (Anafranil), doxepin (Adapin, Sinequan), duloxetine (Cymbalta), fluvoxamine (Luvox), or mirtazepine (Remeron),
asthma medication such as aminophylline (Phyllocontin, Truphylline) or theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl)-
cancer medicine such as dacarbazine (DTIC-Dome), flutamide (Eulexin), or irinotecan (Camptosar)-
medicines to treat psychiatric disorders, such as clozapine (Clozaril, FazaClo), pimozide (Orap), promethazine (Phenergan), thiothixene (Navane), or trifluoperazine (Stelazine)- or
a muscle relaxer such as cyclobenzaprine (Flexeril) or tizanidine (Zanaflex).
This list is not complete and other drugs may interact with hydroxyprogesterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your doctor or pharmacist can provide more information about hydroxyprogesterone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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