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Medroxyprogesterone (Oral route)

Pronunciation:

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

Brand Names:

  • Provera
  • Alti-Mpa

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Do not use estrogens with progestins for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) reported increased risk of myocardial infarction, stroke, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) taking daily oral conjugated estrogens combined with medroxyPROGESTERone acetate. The WHI also reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older taking daily conjugated estrogen combined with medroxyPROGESTERone acetate. It is unknown whether this finding applies to younger postmenopausal women. Lastly, the WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. These risks should be assumed to be similar for other doses of conjugated estrogens and medroxyPROGESTERone acetate and other combinations and dosage forms of estrogens and progestins. Prescribe estrogens with progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual .

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.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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 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.

  • Carbamazepine
  • Dabrafenib
  • Darunavir
  • Isotretinoin
  • Theophylline

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.

  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Colesevelam
  • Cyclosporine
  • Delavirdine
  • Efavirenz
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Griseofulvin
  • Lamotrigine
  • Licorice
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Prednisolone
  • Primidone
  • Rifapentine
  • Ritonavir
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • Telaprevir
  • Topiramate
  • Troleandomycin
  • Warfarin

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.


Last Updated: 9/15/2016
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