Pronunciation:

me-drox-ee-proe-JES-ter-one AS-e-tate

Brand Names:

• Provera
• Alti-Mpa

Dosage Forms:

• Tablet

Warnings:

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Studies have demonstrated an increased risk of DVT, pulmonary embolism, stroke and myocardial infarction in postmenopausal women during treatment with daily oral conjugated estrogens combined with medroxyPROGESTERone acetate, relative to placebo. Studies have also demonstrated estrogen plus progestin increases risk of developing probable dementia in postmenopausal women 65 years of age or older. It is unknown whether this finding applies to younger postmenopausal women. An increased risk of invasive breast cancer has also been found in studies. In the absence of comparable data, these risks should be assumed to be similar for other doses of estrogens and progestins, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Medroxyprogesterone

Uses of This Medicine:

Medroxyprogesterone is used to treat amenorrhea (unusual stopping of menstrual periods) and abnormal uterine bleeding. It is also used to prevent endometrial hyperplasia (thickening of the lining of the uterus or womb) in women who are taking conjugated estrogens. This medicine is a progestin hormone.

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 medroxyprogesterone 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 medroxyprogesterone 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 medroxyprogesterone.

Breast-feeding—

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.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranexamic Acid

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.

• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Belzutifan
• Bexarotene
• Bosentan
• Carbamazepine
• Cenobamate
• Clobazam
• Dabrafenib
• Darunavir
• Dexamethasone
• Efavirenz
• Elagolix
• Elvitegravir
• Enasidenib
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Fosaprepitant
• Fosphenytoin
• Griseofulvin
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lorlatinib
• Lumacaftor
• Mavacamten
• Meropenem
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolic Acid
• Nafcillin
• Nevirapine
• Oxcarbazepine
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Prednisone
• Primidone
• Red Clover
• Repotrectinib
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rufinamide
• Secobarbital
• St John's Wort
• Sugammadex
• Tazemetostat
• Telaprevir
• Theophylline
• Topiramate
• Ulipristal

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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

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
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, or history of or
• Cancer (estrogen-dependent or progesterone-dependent), or history of or
• Heart attack, history of or
• Liver disease or
• Stroke, history of—Should not be used in patients with these conditions.

• Asthma or
• Diabetes 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.

If you are taking this medicine together with an estrogen medicine, carefully follow the schedule your doctor gives you for both medicines.

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 (tablets):
  • For prevention endometrial hyperplasia:
    • Adults—At first, 5 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, dose is usually not more than 10 mg per day. It is usually taken everyday for 12 to 14 consecutive days per month.
    • Children—Use is not recommended.
  • For treatment of amenorrhea and abnormal uterine bleeding:
    • Adults—At first, 5 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, dose is usually not more than 10 mg per day. It is usually taken everyday for 5 to 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.

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.

Using this medicine may increase your risk of heart attack, stroke, blood clots, dementia, breast cancer, or uterine cancer. 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.

Check with your doctor right away if a severe headache or a sudden loss of vision or any 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).

Pancreatitis may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

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.

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:

Incidence not known

Abdominal or stomach pain

absent, missed, or irregular menstrual periods

anxiety

blurred vision

breast pain or tenderness

changes in skin color

chills

clay-colored stools

cough

dark urine

decrease in amount of urine

diarrhea

difficulty swallowing

dizziness or lightheadedness

eye pain

fainting

fast heartbeat

fever

headache

hives or welts, itching, redness, swelling, or skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

menstrual changes

nausea

noisy, rattling breathing

pain in the chest, groin, or legs, especially the calves

pain, tenderness, or swelling of the foot or leg

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

severe, sudden headache

shortness of breath

slurred speech

stopping of menstrual bleeding

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sudden, unexplained shortness of breath

swelling of the fingers, hands, feet, or lower legs

troubled breathing at rest

unexpected or excess milk flow from the breasts

unpleasant breath odor

unusual tiredness or weakness

vaginal bleeding or spotting

vision changes

vomiting of blood

weight gain

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:

Incidence not known

Blemishes on the skin

discouragement

feeling sad or empty

hair loss, thinning of hair

increased hair growth, especially on the face

irritability

lack of appetite

loss of interest or pleasure

nervousness

pimples

sleepiness or unusual drowsiness

tiredness

trouble concentrating

trouble sleeping

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.