Medroxyprogesterone

Medroxyprogesterone may be found in some form under the following brand names:

• Amen

• Curretab

• Cycrin

• Depo-Provera

• depo-subQ provera

• Lunelle

• Prempro

• Provera

The following side effects have been reported with the use of medroxyprogesterone alone:

• Breast tenderness
• Breast milk secretion
• Breakthrough bleeding
• Spotting (minor vaginal bleeding)
• Irregular periods
• Amenorrhea (absence of menstrual periods)
• Vaginal secretions
• Headaches
• Nervousness
• Dizziness
• Depression
• Insomnia, sleepiness, fatigue
• Premenstrual syndrome-like symptoms
• Thrombophlebitis (inflamed veins)
• Blood clot
• Itching, hives, skin rash
• Acne
• Hair loss, hair growth
• Abdominal discomfort
• Nausea
• Bloating
• Fever
• Increase in weight
• Swelling
• Changes in vision and sensitivity to contact lenses

The following side effects have been reported with the use of medroxyprogesterone with an estrogen.

Side effects are grouped by how serious they are and how often they happen when you are treated:

Serious but less common side effects of estrogen include:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer
• High blood pressure
• Liver problems
• High blood sugar
• Enlargement of benign tumors of the uterus ("fibroids")

Some of the warning signs of these serious side effects include:

• Breast lumps
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vomiting
• Yellowing of the skin, eyes or nail beds

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Less serious but common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection

These are not all the possible side effects of medroxyprogesterone with or without estrogen. For more information, ask your healthcare provider or pharmacist.

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.

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.

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.

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

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

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 medroxyprogesterone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medroxyprogesterone 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.

Pediatric

Use of medroxyprogesterone is not indicated in children. Safety and efficacy have not been established.

Geriatric

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with 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 medroxyprogesterone, 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 medroxyprogesterone 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 medroxyprogesterone 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.

• Aprepitant
• Carbamazepine
• Dabrafenib
• Darunavir
• Isotretinoin
• Theophylline

Using medroxyprogesterone 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
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Colesevelam
• Cyclosporine
• Delavirdine
• Efavirenz
• Fosamprenavir
• Fosaprepitant
• Lamotrigine
• Licorice
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Prednisolone
• Rifapentine
• Ritonavir
• Rosuvastatin
• Rufinamide
• Selegiline
• Telaprevir
• Troleandomycin
• Warfarin

Interactions with Food/Tobacco/Alcohol

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 medroxyprogesterone 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 medroxyprogesterone, 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 medroxyprogesterone. 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.

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:

• 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:

• 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.

Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.

Medroxyprogesterone acetate tablets are available in the following strengths and package sizes:

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

"Keep out of reach of children"

Rx only

LAB-0145-6.0
August 2017

NDC 59762-3740-1
100 Tablets

GREENSTONE® BRAND

medroxy-
progesterone
acetate
tablets, USP

2.5 mg

Rx only

NDC 59762-3742-2
100 Tablets

GREENSTONE® BRAND

medroxy-
progesterone
acetate
tablets, USP

10 mg

Rx only

NDC 59762-3742-2
100 Tablets

GREENSTONE® BRAND

medroxy-
progesterone
acetate
tablets, USP

10 mg

Rx only