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|Progesterone Oil

Progesterone Oil

Progesterone Oil is used for:

Treating certain types of abnormal uterine bleeding or the absence of menstrual bleeding in certain women. It may also be used for other conditions as determined by your doctor.

Progesterone Oil is a progestin hormone. It works by affecting the lining of the uterus and other hormone-sensitive tissues to decrease pain associated with endometriosis and to help regulate the menstrual cycle.

Do NOT use Progesterone Oil if:

• you are allergic to any ingredient in Progesterone Oil
• you have a history of bleeding in the brain or stroke; brain blood vessel problems; breast cancer; liver problems; cancer of the ovary, uterus, or cervix; undiagnosed vaginal bleeding; miscarriage; or blood clots
• you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Progesterone Oil:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of cancer, an abnormal mammogram, fibrocystic breast disease, lumps in the breast, bleeding from your nipples, kidney problems, high blood pressure, migraine headaches, asthma, heart problems, seizures, diabetes, or mental or mood problems (eg, depression)
• if you have a family history of breast cancer

Some MEDICINES MAY INTERACT with Progesterone Oil. Tell your health care provider if you are taking any of the following medicines.

• Aminoglutethimide or rifampin because they may decrease Progesterone Oil"s effectiveness and side effects, such as menstrual irregularities (spotting, breakthrough bleeding) may occur
• Aminoglutethimide because it may decrease Progesterone Oil"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Progesterone Oil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Progesterone Oil:

Use Progesterone Oil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Progesterone Oil. Talk to your pharmacist if you have questions about this information.
• Progesterone Oil is usually given as an injection at your doctor"s office, hospital, or clinic. If you will be using Progesterone Oil at home, a health care provider will teach you how to use it. Be sure you understand how to use Progesterone Oil. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Progesterone Oil if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Progesterone Oil is given every 3 months. It is very important that you return to your doctor"s office for your next injection promptly at the end of the 3-month interval.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Progesterone Oil, contact your doctor as soon as possible.

Ask your health care provider any questions you may have about how to use Progesterone Oil.

Important safety information:

• Progesterone Oil may cause drowsiness, dizziness, lightheadedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Oil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Progesterone Oil may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
• Progesterone Oil may cause a decrease in the amount of calcium in your bones. A decrease in bone calcium is of most concern if you have the following risk factors: adolescence, bone disease, anorexia nervosa (an eating disorder), a strong family history of osteoporosis, taking certain medicines (eg, for epilepsy or steroids), or drinking a lot of alcohol or smoking cigarettes often. When Progesterone Oil is stopped, the calcium in bones begins to come back. Your health care provider may recommend that you take calcium or vitamin D to help lower the amount of calcium lost from your bones.
• Diabetes patients - Progesterone Oil may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Progesterone Oil may interfere with certain lab tests, including urinary steroid levels, gonadotropin and other hormone levels, thyroid function, blood clotting tests, and blood cholesterol. Be sure your doctor and lab personnel know you are using Progesterone Oil.
• Lab tests, including breast exams, pap smears, pelvic exams, and blood calcium and bone density tests, may be performed while you use Progesterone Oil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Progesterone Oil should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Progesterone Oil if you are pregnant. If you think you may be pregnant, contact your doctor right away. Progesterone Oil is found in breast milk. If you are or will be breast-feeding while you use Progesterone Oil, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Progesterone Oil:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; dizziness; drowsiness; fever; headache; hot flashes; nausea; nervousness; pain, redness, and swelling at injection site; sleeplessness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood clots; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; chest pain; mental or mood changes; partial or complete loss of vision or changes in vision; severe dizziness or fainting; severe stomach pain; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache or vomiting; swelling of fingers or ankles; unusual weight gain or loss; weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Progesterone Oil at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Progesterone Oil out of the reach of children and away from pets.

General information:

• If you have any questions about Progesterone Oil, please talk with your doctor, pharmacist, or other health care provider.
• Progesterone Oil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Progesterone Oil. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.