Prorone-50 intramuscular

Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus).

Progesterone must not be used to test for pregnancy.

Progestins are not effective in preventing miscarriages.

How to use Prorone-50 Oil

Read the Patient Information Leaflet provided by your pharmacist before you start using progesterone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is given by injection into a muscle as directed by your doctor, usually once daily. This medication is usually given for 6 to 8 days. Dosage is based on your medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Before injecting each dose, the injection site should be cleaned with rubbing alcohol. It is important to change the location of the injection site daily to avoid problem areas in the muscle.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition persists or worsens.

Pain/swelling at injection site, breast tenderness, headache, weight gain/loss, acne, nausea, increased body/facial hair, loss of scalp hair, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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: unusual vaginal bleeding/discharge (e.g., breakthrough bleeding, spotting), stopped menstrual periods (amenorrhea), breast lumps, swelling of the ankles/feet, mental/mood changes (e.g., depression, nervousness), dark patches on the skin/face, frequent/painful urination, dark urine, yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting.

This drug may rarely cause blood clots. Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, vision changes (e.g., blurred/double vision, loss of vision), confusion, pain/redness/swelling of arms or legs, trouble breathing, sudden severe headache, fainting.

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.

Before using progesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, history of bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion").

Before using this medication, tell your doctor or pharmacist your medical history, especially of: migraine headaches, seizures, asthma, heart disease (e.g., coronary artery disease, congestive heart failure), kidney disease, depression, diabetes, high blood levels of cholesterol/triglycerides.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), tell your doctor beforehand. Special precautions may be needed.

Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.

If you have diabetes, this product 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.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy because it may harm an unborn baby, especially during the first 4 months of pregnancy. Consult your doctor for more details. If you become pregnant or think you may be pregnant, tell your doctor right away.

This drug passes into breast milk. Consult your doctor before breast-feeding.

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.

Some products that may interact with this drug include: drugs affecting liver enzymes that remove progesterone from your body (such as azole antifungals including itraconazole, rifamycins including rifabutin, St. John's wort, certain anti-seizure medicines including carbamazepine/phenytoin).

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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.

Notes

Do not share this medication with others.

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals (e.g., once a year) or as directed by your doctor. Follow your doctor's instructions on how to examine your own breasts and report any lumps right away. You should also be regularly screened for cervical cancer (e.g., Pap test) and have periodic mammograms as determined by your doctor. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.