Pronunciation:

proe-JES-ter-one

Brand Names:

• Prometrium

Dosage Forms:

• Capsule, Liquid Filled
• Capsule

Warnings:

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 .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Progestin

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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

Older adults—

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.

Breast-feeding—

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

Other 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. 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
• Carbamazepine
• Clarithromycin
• Conivaptan
• Eslicarbazepine Acetate
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Itraconazole
• Mavacamten
• Netupitant
• Omaveloxolone
• Phenobarbital
• Primidone

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 (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 This Medicine:

It is very important that you use 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. Talk to your doctor or pharmacist if this does not help.

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) 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 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 While Using This Medicine:

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.

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.

Stop using this medicine 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 this medicine.

There is a very slight chance that this medicine 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 this medicine 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 this medicine 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 this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine.

Stop using this medicine and check with your doctor immediately if 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.

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

Side Effects of This Medicine:

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.