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medroxyprogesterone

Generic Name: medroxyprogesterone (oral) (me DROX ee proe JES ter one)
Brand Name: Provera

What is medroxyprogesterone?

Medroxyprogesterone is a progestin (a form of progesterone), a female hormone that helps regulate ovulation (the release of an egg from an ovary) and menstrual periods.

Medroxyprogesterone is used to treat conditions such as absent or irregular menstrual periods, or abnormal uterine bleeding. Medroxyprogesterone is also used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens.

Medroxyprogesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Medroxyprogesterone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about medroxyprogesterone?

You should not use this medicine if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor.

Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. Long-term use of medroxyprogesterone may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risk.

What should I discuss with my healthcare provider before taking medroxyprogesterone?

Medroxyprogesterone can cause birth defects. Do not use if this medicine you are pregnant. Tell your doctor right away if you become pregnant during treatment.

You should not use this medicine if you are allergic to medroxyprogesterone, or if you have:

  • abnormal vaginal bleeding that has not been diagnosed;

  • a hormone-related cancer such as breast or uterine cancer;

  • liver disease; or

  • a history of stroke or blood clot.

To make sure medroxyprogesterone is safe for you, tell your doctor if you have:

  • heart disease, congestive heart failure, recent stroke or heart attack

  • high blood pressure;

  • high cholesterol or triglycerides;

  • low levels of calcium in your blood;

  • severe pelvic pain;

  • recent miscarriage or abortion;

  • epilepsy;

  • asthma;

  • migraine headaches;

  • a thyroid disorder;

  • kidney disease,

  • diabetes; or

  • lupus.

Medroxyprogesterone may increase your risk of developing a condition that can lead to uterine cancer. To help lower this risk, your doctor may prescribe a progestin for you to take with medroxyprogesterone. Report any unusual vaginal bleeding right away.

Medroxyprogesterone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Medroxyprogesterone will not prevent heart disease, breast cancer, or dementia, and may actually increase the risk of developing these conditions in post-menopausal women. Medroxyprogesterone may also increase the risk of uterine or ovarian cancer in some women. Long-term treatment with estrogens and progestins (such as medroxyprogesterone) may also increase your risk of heart attack, blood clot, or stroke.

Talk to your doctor about your specific risks and benefits of taking this medicine, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

How should I take medroxyprogesterone?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Medroxyprogesterone is usually given for only a few days in a row each month. You may need to start taking the medication on a certain day of your menstrual cycle, depending on why you are taking medroxyprogesterone. Follow your doctor's instructions.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using medroxyprogesterone.

This medicine can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking medroxyprogesterone.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking medroxyprogesterone?

Avoid smoking while you are taking this medicine. Smoking greatly increases your risk of blood clots.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Medroxyprogesterone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • vaginal bleeding if you have already gone through menopause;

  • a light-headed feeling, like you might pass out;

  • a breast lump;

  • symptoms of depression (sleep problems, dizziness, mood changes, headache);

  • fever;

  • jaundice (yellowing of the skin or eyes);

  • swelling in your hands, ankles, or feet;

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • spotting or breakthrough bleeding;

  • changes in your menstrual periods;

  • vaginal itching or discharge;

  • breast tenderness or discharge;

  • headache, dizziness, feeling nervous or depressed;

  • bruising or swelling of your veins;

  • premenstrual type symptoms (bloating, fluid retention, mood changes);

  • sleep problems (insomnia);

  • itching, rash, acne, hair growth, loss of scalp hair;

  • stomach discomfort, bloating, nausea;

  • weight gain; or

  • vision changes and difficulty wearing contact lenses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

Medroxyprogesterone dosing information

Usual Adult Dose for Endometriosis:

104 mg subcutaneously once every 3 months (12 to 14 weeks)
Duration of therapy: No longer than two years

Comments:
-For sexually active women having regular menses, the first injection should only be given within the first 5 days of a normal menstrual period or at 6 weeks postpartum, if the patient is breast feeding.
-If the period between injections is more than 14 weeks, pregnancy should be ruled out prior to administering.
-The impact of long-term use of the subcutaneous injection on bone mineral density (BMD) should be considered.
-If symptoms return after discontinuation of treatment, BMD should be evaluated prior to retreatment.

Use: Management of endometriosis-associated pain

Usual Adult Dose for Endometrial Hyperplasia -- Prophylaxis:

Oral tablets:
5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16 th day of the cycle

Comments:
-Postmenopausal woman with a uterus taking estrogens should also initiate progestin therapy to reduce the risk of endometrial cancer.
-Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration. Starting dose should be the lowest.
-Periodically re-evaluation (e.g., 3 to 6 month intervals) to determine if treatment is still necessary is recommended.
-In women with uterus, endometrial sampling should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Use: Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets

Usual Adult Dose for Contraception:

Intramuscular injection:
-150 mg once every 3 months (13 weeks) in the gluteal or deltoid muscle

Subcutaneous injection:
-104 mg once every 3 months (12 to 14 weeks) into the anterior thigh or abdomen

First injection:
-Ensure the patient is not pregnant at the time of the first injection.
-The first injection should be given only during the first 5 days of a normal menstrual period, within the first 5-days postpartum if not breast-feeding, and at the sixth postpartum week if breast-feeding.

Switching from other methods of contraception:
-IM injection: The first injection should be given on the day after the last active contraception tablet, or at the latest, on the day following the final inactive contraception tablet.
-SC injection: The first injection should be given within 7 days after the last day taking the last active contraceptive tablet, or after removing the patch or ring. Similarly, contraceptive coverage will be maintained when switching from 150 mg IM injection, provided the next injection is given within the prescribed dosing period for the IM injection.

Comments:
-If the time interval between injections is greater than 13 weeks, pregnancy should be excluded before administering the drug.
-The efficacy of the IM suspension depends on adherence to the dosage schedule of administration.
-The risk/benefit of loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, should be assessed when using this IM injection long-term.

Use: Prevention of pregnancy in women of child bearing potential

Usual Adult Dose for Abnormal Uterine Bleeding:

Oral tablets:
-5 or 10 mg daily for 5 to 10 days, beginning on the 16 th or 21 st day of the menstrual cycle

-Dose to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen: 10 mg daily for 10 days beginning on the 16 th day of the cycle

Comments:
-Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with the oral tablets.
-Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with the oral tablets.

Use: Abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

Usual Adult Dose for Amenorrhea:

Oral tablets:
-5 or 10 mg daily for 5 to 10 days

Dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen:
-10 mg daily for 10 day

Comments:
-Therapy may be started at any time.
-Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with this drug.

Use: Treatment of secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

Usual Adult Dose for Renal Cell Carcinoma:

Initial dose: 400 to 1000 mg IM once a week
Maintenance dose: Reduce dose to 400 mg IM once a month to maintain improvement

Comments:
-This drug is not recommended as primary therapy.
-Greater sensitivity in the geriatric population cannot be ruled out.
-The frequency of administration may be reduced if improvement or stabilization occurs, usually within a few weeks to months.

Use: Adjunctive therapy and palliative treatment in advanced inoperable cases including those with recurrent or metastatic endometrial or renal carcinoma

Usual Adult Dose for Endometrial Carcinoma:

Initial dose: 400 to 1000 mg IM once a week
Maintenance dose: Reduce dose to 400 mg IM once a month to maintain improvement

Comments:
-This drug is not recommended as primary therapy.
-Greater sensitivity in the geriatric population cannot be ruled out.
-The frequency of administration may be reduced if improvement or stabilization occurs, usually within a few weeks to months.

Use: Adjunctive therapy and palliative treatment in advanced inoperable cases including those with recurrent or metastatic endometrial or renal carcinoma

Usual Pediatric Dose for Contraception:

Postmenarchal children and adolescents:
Intramuscular injection:
-150 mg once every 3 months (13 weeks) in the gluteal or deltoid muscle

Subcutaneous injection:
-104 mg once every 3 months (12 to 14 weeks) into the anterior thigh or abdomen

First injection:
-Ensure the patient is not pregnant at the time of the first injection.
-The first injection should be given only during the first 5 days of a normal menstrual period, within the first 5-days postpartum if not breast-feeding, and at the sixth postpartum week if breast-feeding.

Switching from other methods of contraception:
-IM injection: The first injection should be given on the day after the last active contraception tablet, or at the latest, on the day following the final inactive contraception tablet.
-SC injection: The first injection should be given within 7 days after the last day taking the last active contraceptive tablet, or after removing the patch or ring. Similarly, contraceptive coverage will be maintained when switching from 150 mg IM injection, provided the next injection is given within the prescribed dosing period for the IM injection.

Comments:
-If the time interval between injections is greater than 13 weeks, pregnancy should be excluded before administering the drug.
-The efficacy of the IM suspension depends on adherence to the dosage schedule of administration.
-The risk/benefit of loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, should be assessed when using the injection long-term.

Use: Prevention of pregnancy in women of child bearing potential

What other drugs will affect medroxyprogesterone?

Other drugs may interact with medroxyprogesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about medroxyprogesterone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.03.

Last reviewed: August 05, 2015
Date modified: December 03, 2017

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