progesterone

proe-JES-ter-one

Oral route(Capsule, Liquid Filled)

Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported with estrogen plus progestin therapy. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration possible .

Commonly used brand name(s)

In the U.S.

• Prometrium

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Progestin

Uses For progesterone

Progesterone is used to help prevent changes in the uterus (womb) in women who are taking conjugated estrogens after menopause. It is also used to properly regulate the menstrual cycle and treat unusual stopping of menstrual periods (amenorrhea) in women who are still menstruating.

progesterone is available only with your doctor's prescription.

Before Using progesterone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For progesterone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to progesterone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of progesterone is not indicated in children. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of progesterone have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving progesterone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of progesterone. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or


• Allergy to peanuts or peanut oil or


• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), active or history of or


• Breast cancer, known, suspected, or a history of or


• Heart attack, active or history of or


• Liver disease or


• Stroke, active or history of—Should not be used in patients with these conditions.

• Asthma or


• Diabetes or


• Edema (fluid retention or body swelling) or


• Endometriosis or


• Epilepsy (seizures) or


• Heart disease or


• Hypercalcemia (high calcium in the blood) or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hypertension (high blood pressure) or


• Kidney disease or


• Migraine headache or


• Systemic lupus erythematosus (SLE) or


• Thyroid problems—Use with caution. May make these conditions worse.

Proper Use of progesterone

It is very important that you use progesterone only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

progesterone comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

For women who use progesterone after menopause, it will be given together with an estrogen medicine. Carefully follow the schedule your doctor gives you for both medicines.

If you have trouble swallowing progesterone, take it with a glass of water while standing up. Talk to your doctor or pharmacist if this does not help.

Dosing

The dose of progesterone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of progesterone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For prevention of thickening of the lining of the uterus (endometrial hyperplasia):
    
    • Adults—200 milligrams (mg) per day, taken as a single dose at bedtime, for 12 continuous days per 28-day menstrual cycle.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • For treatment of unusual stopping of menstrual period (amenorrhea):
    
    • Adults—400 milligrams (mg) per day, taken as a single dose at bedtime, for 10 days.
    
    
    • Children—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of progesterone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using progesterone

It is very important that your doctor check your progress at regular visits to make sure progesterone is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise.

Using progesterone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Stop using progesterone and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using progesterone.

There is a very slight chance that progesterone could increase the risk of breast cancer and endometrial (lining of the uterus) cancer in some women. Talk to your doctor about this risk. Make sure your doctor knows if anyone in your family has had breast cancer or endometrial cancer.

Using large doses of progesterone over a long period of time and using it with an estrogen medicine may increase your risk of heart attack, stroke, blood clots, or dementia. Talk with your doctor about these risks.

Your risk of heart disease or stroke from progesterone is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Tell the medical doctor or dentist in charge that you are using progesterone before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using progesterone.

Stop using progesterone and check with your doctor immediately if sudden loss of vision or any other change in vision occurs while you are using progesterone. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

progesterone may cause some people to become dizzy or drowsy. Make sure you know how you react to progesterone before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Before you have any medical tests, tell the medical doctor in charge that you are taking progesterone. The results of some tests may be affected by progesterone.

progesterone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chest pain


• chills


• cold or flu-like symptoms


• cough or hoarseness


• fever


• problems with urination

Less common

• Clear or bloody discharge from the nipple


• dimpling of the breast skin


• inverted nipple


• lump in the breast or under the arm


• persistent crusting or scaling of the nipple


• redness or swelling of the breast


• sore on the skin of the breast that does not heal

Incidence not known

• Abdominal or stomach pain


• bloating


• blurred vision


• change in vaginal discharge


• clay-colored stools


• cleft lip or palate


• confusion


• constipation


• darkened urine


• diarrhea


• difficult or labored breathing


• difficulty with swallowing


• difficulty with walking


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast, pounding, or irregular heartbeat or pulse


• headache


• hives


• indigestion


• irregular heartbeat


• irritation


• itching


• joint pain, stiffness, or swelling


• lightheadedness


• loss of appetite


• nausea


• nervousness


• noisy breathing


• numbness or tingling in the face, arms, or legs


• pain or feeling of pressure in the pelvis


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rash


• redness of the skin


• shortness of breath


• slow heartbeat


• spontaneous abortion


• stomach or pelvic discomfort, aching, or heaviness


• sweating


• swelling of the eyelids, face, lips, hands, or feet


• tightness in the chest


• trouble speaking, thinking, or walking


• unpleasant breath odor


• unusual tiredness or weakness


• vaginal bleeding


• vomiting


• vomiting of blood


• wheezing


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Breast pain or tenderness


• depression


• muscle or joint pain


• white or brownish vaginal discharge


• worry

Incidence not known

• Attack, assault, or force


• blurred or loss of vision


• change in walking and balance


• changes in behavior


• changes in patterns and rhythms of speech


• choking


• clumsiness or unsteadiness


• confusion about identity, place, and time


• continuing ringing or buzzing or other unexplained noise in the ears


• decreased awareness or responsiveness


• difficulty with moving


• disturbed color perception


• double vision


• drowsiness


• extreme dizziness or drowsiness


• feeling drunk


• feeling of constant movement of self or surroundings


• feeling of unreality


• hair loss or thinning of the hair


• halos around lights


• hearing loss


• hives or welts


• longer or heavier menstrual periods


• loss of consciousness


• muscle cramps


• muscle stiffness


• night blindness


• normal menstrual bleeding occurring earlier, possibly lasting longer than expected


• overbright appearance of lights


• redness of the skin


• relaxed and calm


• sensation of spinning


• sense of detachment from self or body


• severe sleepiness


• sleepiness


• slurred speech


• swollen tongue


• thoughts of killing oneself


• tunnel vision


• weight changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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