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Progesterone (Oral route)

Pronunciation:

proe-JES-ter-one

Brand Names:

  • Prometrium

Dosage Forms:

  • Capsule, Liquid Filled
  • Capsule

Warnings:

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 .

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal 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.

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.

  • Dabrafenib
  • Eslicarbazepine Acetate

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.


Last Updated: 11/4/2014

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