Generic Name: Medroxyprogesterone Brand Name(s): Generics only. No brands available.

Uses

What is Medroxyprogesterone used for?

Medroxyprogesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. This medication has several uses. In women who are not pregnant and not going through menopause, this medication is used to treat abnormal bleeding from the uterus and to restore normal menstrual periods in women who have stopped having them for several months (amenorrhea).

Medroxyprogesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Medroxyprogesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus.

This medication must not be used to test for pregnancy.

How should I take Medroxyprogesterone?

Take this medication by mouth as directed by your doctor. Follow the dosing schedule carefully. Ask your doctor if you have any questions. The dosage is based on your medical condition and response to therapy.

For use in combination hormone replacement therapy with estrogens, take this medication usually once daily for the prescribed number of days each month as directed.

For the treatment of stopped menstrual periods (amenorrhea) and abnormal bleeding from the uterus, take this drug usually once daily for 5-10 days during the second half of the planned menstrual cycle or as directed by your doctor. Withdrawal bleeding usually occurs within 3-7 days after you stop taking the medication.

Inform your doctor if your condition does not improve or if it worsens.

How do I store Medroxyprogesterone?

Medroxyprogesterone is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Medroxyprogesterone in the bathroom or the freezer. There may be different brands of Medroxyprogesterone that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Medroxyprogesterone down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Medroxyprogesterone?

Before taking medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Some Canadian brands of this product may contain inactive ingredients (such as soybean), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, history of bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus (“missed abortion”), recent stroke or heart attack (within 1 year).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), kidney disease, obesity, heart disease (e.g., past heart attacks, coronary artery disease, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details.

Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

This medication must not be used during pregnancy because it may harm an unborn baby, especially during the first 4 months of pregnancy. If you become pregnant or think you may be pregnant, inform your doctor right away.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Medroxyprogesterone during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Medroxyprogesterone. Medroxyprogesterone is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Medroxyprogesterone?

Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, drowsiness, or weight gain/loss may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: unusual vaginal bleeding (e.g., spotting, breakthrough bleeding), mental/mood changes (e.g., depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, unusual tiredness.

This medication may rarely cause very serious (possibly fatal) problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs or legs, blindness). Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Medroxyprogesterone?

Some products that may interact with this drug include: aminoglutethimide, drugs affecting liver enzymes that remove medroxyprogesterone from your body (such as rifampin, St. John’s wort, azole antifungals including itraconazole, certain anti-seizure medicines including carbamazepine/phenobarbital/phenytoin).

This medication can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this medication.

Medroxyprogesterone may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Medroxyprogesterone?

Medroxyprogesterone may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Medroxyprogesterone?

Medroxyprogesterone may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Medroxyprogesterone.

What is the dose of Medroxyprogesterone for an adult?

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

Renal Dose Adjustments

No studies have been performed.

Liver Dose Adjustments

Contraindicated in liver impairment or disease.

Other Comments

Administration advice:

Injection:

-Shake vigorously before use to create a uniform suspension.

-Rotate the sites with every injection.

-Dosage does not need to be adjusted for body weight.

-Do not use as a long-term birth control method (i.e. longer than 2 years) unless other birth control methods are considered inadequate.

-To avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary, particularly for gluteal IM injection.

-The lowest effective doses and the shortest duration of therapy is recommended

General:

-A complete personal and family medical history should be taken, before initiating or reinstituting therapy with this drug.

-Annual history and physical examinations (e.g., blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests) in patients using this drug is recommended.

Monitoring:

-Musculoskeletal: Bone mineral density

-Cardiovascular: Blood pressure.

-Carbohydrate metabolism: Monitor diabetic patients carefully

Patient advice:

-Patients should report exposure to this drug in early pregnancy.

-Patients taking hormonal contraceptive should have a yearly visit with their healthcare provider for a blood pressure check and for other indicated healthcare.

-The IM injection does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

-At the beginning of the treatment, menstrual cycle may be disrupted causing irregular and unpredictable bleeding or spotting that usually decreases as treatment continues.

-Use a back-up method or alternative method of contraception when enzyme inducers are used with this drug.

What is the dose of Medroxyprogesterone for a child?

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

How is Medroxyprogesterone available?

Medroxyprogesterone is available in the following dosage forms and strengths:

  • Oral tablet,
  • Intramuscular suspension,
  • Subcutaneous suspension,
  • Compounding powder.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Medroxyprogesterone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 23, 2018 | Last Modified: March 23, 2018

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