Medroxyprogesterone Acetate (Page 5 of 6)

The Women’s Health Initiative Memory Study

In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo. (See WARNINGS, Probable Dementia.)

Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women. (See WARNINGS, Probable Dementia.)

ADVERSE REACTIONS

See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice

The following adverse reactions have been reported in women taking MPA tablets, without concomitant estrogens treatment:

1. Genitourinary system

Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.

2. Breasts

Breast tenderness, mastodynia or galactorrhea has been reported.

3. Cardiovascular

Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.

4. Gastrointestinal

Nausea, cholestatic jaundice.

5. Skin

Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.

6. Eyes

Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.

7. Central nervous system

Mental depression, insomnia, somnolence, dizziness, headache, nervousness.

8. Miscellaneous

Hypersensitivity reactions (for example, anaphylaxis and anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance.

The following adverse reactions have been reported with estrogen plus progestin therapy.

1. Genitourinary system

Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.

2. Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

3. Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

4. Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.

5. Skin

Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.

6. Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

7. Central nervous system

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

8. Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

Secondary Amenorrhea

MPA tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of MPA daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing MPA therapy.

Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology

Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of medroxyprogesterone acetate may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of medroxyprogesterone acetate daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with MPA tablets. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with MPA tablets.

Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary (see WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

MPA tablets may be given in dosages of 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 16th day of the cycle.

Patients should be started at the lowest dose.

The lowest effective dose of MPA has not been determined.

HOW SUPPLIED

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

2.5 mg (scored, round, orange, imprinted G3740)
Bottles of 100 NDC 59762-3740-1
Bottles of 1000 NDC 59762-3740-5

NDC 69189-3740-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

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

“Keep out of reach of children”

Rx only

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LAB-0145-5.0
February 2016

PATIENT INFORMATION

Medroxyprogesterone Acetate Tablets, USP

Read this Patient Information before you start taking medroxyprogesterone acetate tablets and read what you get each time you refill your medroxyprogesterone acetate tablets prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about MPA (a progestin hormone)?

Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).

Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.

Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older.

You and your healthcare provider should talk regularly about whether you still need treatment with medroxyprogesterone acetate tablets.

What are medroxyprogesterone acetate tablets?

Medroxyprogesterone acetate tablets are a medicine that contains medroxyprogesterone acetate, a progestin hormone.

What are medroxyprogesterone acetate tablets used for?

Medroxyprogesterone acetate tablets are used to:

  • Treat menstrual periods that have stopped or to treat abnormal uterine bleeding. Women with a uterus who are not pregnant, who stop having regular menstrual periods or who begin to have irregular menstrual periods may have a drop in their progesterone level. Talk with your healthcare provider about whether medroxyprogesterone acetate tablets are right for you.
  • Reduce your chances of getting cancer of the uterus (womb). In postmenopausal women with a uterus who use estrogens, taking progestin in combination with estrogen will reduce your chance of getting cancer of the uterus (womb).

Who should not take medroxyprogesterone acetate tablets?

Do not start taking medroxyprogesterone acetate tablets if you:

  • have unusual vaginal bleeding
  • currently have or have had certain cancers.
    Estrogen plus progestin may increase your chance of getting certain types of cancers, including cancer of the breast. If you have or have had cancer, talk with your healthcare provider about whether you should use medroxyprogesterone acetate tablets.
  • had a stroke or heart attack
  • currently have or have had blood clots
  • currently have or have had liver problems
  • are allergic to MPA or any of its ingredients
    See the list of ingredients in MPA at the end of this leaflet.
  • think you may be pregnant
    MPA is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use MPA if the test is positive and talk to your healthcare provider. There may be an increased risk of minor birth defects in children whose mothers take MPA during the first 4 months of pregnancy.
    Medroxyprogesterone acetate tablets should not be used as a test for pregnancy.

What should I tell my healthcare provider before taking MPA? Before you take MPA, tell your healthcare provider if you:

  • have any other medical problems
    Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis (severe pelvic pain), lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium in your blood.
  • are going to have surgery or will be on bed rest
    Your healthcare provider will let you know if you need to stop taking MPA
  • are breast feeding
    The hormone in MPA can pass into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how MPA works. MPA may also affect how other medicines work.

How should I take medroxyprogesterone acetate tablets?

Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. The lowest effective dose of medroxyprogesterone acetate has not been determined. You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether you still need treatment with medroxyprogesterone acetate tablets.

  1. Absence of menstrual period: Medroxyprogesterone acetate tablets may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.
  2. Abnormal Uterine Bleeding: Medroxyprogesterone acetate tablets may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.
  3. Overgrowth of the lining of the uterus: When used in combination with oral conjugated estrogens in postmenopausal women with a uterus, medroxyprogesterone acetate tablets may be given in doses ranging from 5 or 10 mg daily for 12 to 14 straight days per month.

What are the possible side effects of medroxyprogesterone acetate tablets?

The following side effects have been reported with the use of medroxyprogesterone acetate tablets 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

Call your healthcare provider right away if you get hives, problems breathing, swelling of the face, mouth, tongue or neck

The following side effects have been reported with the use of medroxyprogesterone acetate tablets 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 include:

  • heart attack
  • stroke
  • blood clots
  • dementia
  • breast cancer
  • cancer of the uterus
  • cancer of the ovary
  • high blood pressure
  • high blood sugar
  • gallbladder disease
  • liver problems
  • changes in your thyroid hormone levels
  • enlargements of benign tumors (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

  • new breast lumps
  • unusual vaginal bleeding
  • changes in vision and speech
  • sudden new severe headaches
  • severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
  • memory loss or confusion

Less serious but common side effects include:

  • headache
  • breast pain
  • irregular vaginal bleeding or spotting
  • stomach/or abdominal cramps, bloating
  • nausea and vomiting
  • hair loss
  • fluid retention
  • vaginal yeast infection

These are not all the possible side effects of medroxyprogesterone acetate tablets with or without estrogen. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have side effect that bothers you or does not go away. You may report side effects to Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with medroxyprogesterone acetate tablets?

  • Talk with your healthcare provider regularly about whether you should continue taking medroxyprogesterone acetate tablets. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).
  • See your healthcare provider right away if you get vaginal bleeding while taking medroxyprogesterone acetate tablets.
  • Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
  • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chance of getting heart disease.

General information about safe and effective use of medroxyprogesterone acetate tablets

  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
  • Do not take medroxyprogesterone acetate tablets for conditions for which it was not prescribed.
  • Do not give medroxyprogesterone acetate tablets to other people, even if they have the same symptoms you have. It may harm them.

Keep medroxyprogesterone acetate tablets out of the reach of children.

This leaflet provides a summary of the most important information about medroxyprogesterone acetate tablets. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about medroxyprogesterone acetate tablets that is written for health professionals. You can get more information by calling the toll-free number, 1-800-438-1985.

What are the ingredients in medroxyprogesterone acetate tablets?

Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate.

Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc. The 2.5 mg tablet contains FD&C Yellow No. 6.

This product’s label may have been updated. For current full prescribing information, please visit www.greenstonellc.com

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LAB-0147-5.0June 2015

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