Alti-Mpa Oral

In the U.S.

• Provera

In Canada

• Alti-Mpa

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Medroxyprogesterone

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.

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

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

This medicine can pass into body fluids (including 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.

Get emergency medical help if you have any signs of an allergic reaction to medroxyprogesterone: 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 medroxyprogesterone 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.

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

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

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.

Substance Name

Medroxyprogesterone Acetate

CAS Registry Number

71-58-9

Drug Class

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Hormones

Progesterone Congeners