HYDROXYPROGESTERONE

(hye DROX ee pro JES te rone) Brand: Makena, Prodrox

What is the most significant information I must know about hydroxyprogesterone?

• You must not use this medicine if you are allergic to hydroxyprogesterone or castor oil, or if you have unusual vaginal bleeding, liver malady or liver cancer, breast cancer, uterine cancer, uncontrolled tall blood pressure, a history of jaundice caused by pregnancy, or a history of stroke, blood clot, or circulation problems.

• Till you receive hydroxyprogesterone, speak your doctor if you have eclampsia or preeclampsia, kidney malady, tall blood pressure, heart malady, migraine headaches, a private 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 medicine. Do not miss any scheduled appointments. Each woman must stay 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 foots, pain or redness in one or both legs, or symptoms of depression (sleep problems, weakness, mood changes).

• There are much another drugs that may interact with hydroxyprogesterone. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity.

Do not start a new medicine during pregnancy without telling your doctor.

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 child. This medicine 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 medicine guide.

What must I discuss with my healthcare provider till receiving hydroxyprogesterone?

• You must 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 malady or liver cancer;

· a hormone related cancer such as breast or uterine cancer;

· severe or uncontrolled tall blood pressure;

· a history of jaundice caused by pregnancy; or

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

• To create certain you can safely use hydroxyprogesterone, speak your doctor if you have any of these another conditions:

· eclampsia or preeclampsia of pregnancy;

· kidney disease;

· tall blood pressure, heart disease;

· migraine headaches;

· a private or family history of diabetes;

· asthma;

· seizures;

· depression; or

· fluid retention.

Hydroxyprogesterone passes into breast milk, but it is not known whether this could harm a nursing child. Do not use this medicine 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 generally started during the 16th week of pregnancy and given once for week before the 37th week or before your child is born. Follow your doctor's instructions.

• Your doctor will need to check your progress on a regular basis while you are using this medicine. Do not miss any scheduled appointments. Each woman must stay 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?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while receiving hydroxyprogesterone?

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of hydroxyprogesterone?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, 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 foots; or

· symptoms of depression (sleep problems, weakness, mood changes).

• Smaller serious side effects may include:

· mild itching;

· nausea, diarrhea; or

· pain, bruising, itching, swelling, or a heavy 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect hydroxyprogesterone?

• Speak your doctor about all another medicines you use, especially:

· acetaminophen (Tylenol);

· alosetron (Lotronex);

· betaxolol (Kerlone) or propranolol (Inderal, InnoPran);

· cyclophosphamide (Gengraf, Neoral, Sandimmune);

· efavirenz (Sustiva, Atripla);

· methadone (Methadose, Diskets, Dolophine);

· mexiletine (Mexitil);

· nicotine (Nicorette, Commit, Habitrol, Nicotrol, Nicoderm);

· rifabutin (Mycobutin) or rifampin (Rifater, Rifadin, Rifamate);

· riluzole (Rilutek);

· ropinirole (Requip);

· selegiline (Eldepryl, Emsam, Zelapar);

· tacrine (Cognex);

· an antidepressant such as bupropion (Wellbutrin), clomipramine (Anafranil), doxepin (Adapin, Sinequan), duloxetine (Cymbalta), fluvoxamine (Luvox), or mirtazepine (Remeron),

· asthma medicine such as aminophylline (Phyllocontin, Truphylline) or theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

· cancer medication 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 another drugs may interact with hydroxyprogesterone. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about hydroxyprogesterone.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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