Description
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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
- Capsule
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of progesterone in the geriatric population. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving progesterone.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Apalutamide
- Avacopan
- Cannabidiol
- Carbamazepine
- Clarithromycin
- Conivaptan
- Eslicarbazepine Acetate
- Fedratinib
- Fexinidazole
- Fosnetupitant
- Insulin Aspart, Recombinant
- Itraconazole
- Letermovir
- Lonafarnib
- Melatonin
- Mifepristone
- Netupitant
- Omaveloxolone
- Phenobarbital
- Primidone
- Tazemetostat
- Voriconazole
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Kratom
Other Interactions
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 this medicine. 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 (eg, 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
- Obesity or
- Smoke tobacco or
- Systemic lupus erythematosus (SLE) or
- Thyroid problems—Use with caution. May make these conditions worse.
Proper Use
Take this medicine 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.
This medicine 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 this medicine 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 this medicine, take it with a glass of water while standing up.
Dosing
The dose of this medicine 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 this medicine. 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) 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) taken as a single dose at bedtime, for 10 days.
- Children—Use is not recommended.
- For prevention of thickening of the lining of the uterus (endometrial hyperplasia):
Missed Dose
If you miss a dose of this medicine, 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
It is very important that your doctor check your progress at regular visits to make sure this medicine 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. Be sure to keep all appointments.
Using this medicine 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.
Using this medicine may increase your risk for having blood clots, stroke, or heart attack. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol, diabetes, overweight, or you smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscles, or an inability to speak.
Using this medicine over a long period of time and using it together with estrogen may increase your risk of breast or ovarian cancer. Talk with your doctor about these risks.
Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.
Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- Bloating
- blurred vision
- change in vaginal discharge
- chest tightness
- 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
- slow heartbeat
- spontaneous abortion
- stomach or pelvic discomfort, aching, or heaviness
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- trouble breathing
- trouble speaking, thinking, or walking
- unpleasant breath odor
- unusual tiredness or weakness
- vaginal bleeding
- vomiting
- vomiting of blood
- 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
- longer or heavier menstrual periods
- loss of consciousness
- muscle cramps or 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.
DRG-20075298
