Provera (Medroxyprogesterone Acetate)

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Provera 2.5mg

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Provera 10mg

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Provera 5mg

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Provera 5mg

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Medroxyprogesterone 2.5mg

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Medroxyprogesterone 5mg

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Medroxyprogesterone 10mg

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Medroxyprogesterone 2.5mg

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Provera (Medroxyprogesterone Acetate) Dosage and Side Effects

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.

Warnings and Precautions

Serious Warnings and Precautions

The Women's Health Initiative (WHI) trial is a large clinical study that assessed the benefits and risks of oral combined estrogen plus progestin therapy and oral estrogen-alone therapy compared with placebo (a pill with no active ingredients) in postmenopausal women.

The WHI trial indicated an increased risk of myocardial infarction (heart attack), stroke, breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in postmenopausal women taking oral combined estrogen plus progestin.

The WHI trial indicated an increased risk of stroke and deep vein thrombosis in postmenopausal women with prior hysterectomy (surgical removal of the uterus) taking oral estrogen-alone.

Therefore, you should highly consider the following:

  • There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.
  • There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy.
  • Estrogens with or without progestins should not be used for the prevention of heart disease or stroke.
  • Estrogens with or without progestins should be used at the lowest effective dose and for the shortest period of timepossible. Regular medical follow-up is advised.

Breast Cancer:

The results of the WHI trial indicated an increased risk of breast cancer in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo. The results of the WHI trial indicated no difference in the risk of breast cancer in postmenopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

Estrogens with or without progestins should not be taken by women who have a personal history of breast cancer.

In addition, women with a family history of breast cancer or women with a history of breast lumps, breast biopsies or abnormal mammograms (breast x-rays) should consult with their doctor before starting HRT.

Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their doctor. Regular breast examinations by a doctor and regular breast self-examinations are recommended for all women. You should review technique for breast self-examination with your doctor.

Overgrowth of the Lining of the Uterus and Cancer of the Uterus:

The use of estrogen-alone therapy by post menopausal women who still have a uterus increases the risk of developing endometrial hyperplasia (overgrowth of the lining of the uterus), which increases the risk of endometrial cancer (cancer of the lining of the uterus).

The purpose of adding a progestin medication to estrogen therapy is to reduce the risk of endometrial hyperplasia.

You should discuss progestin therapy and risk factors for endometrial hyperplasia and endometrial carcinoma with your doctor. You should also report any unexpected or unusual vaginal bleeding to your doctor.

If you have had your uterus removed, you are not at risk of developing endometrial hyperplasia or endometrial carcinoma. Progestin therapy is therefore not generally required in women who have had a hysterectomy.

Ovarian Cancer:

In some studies, the use of estrogen-alone and estrogen plus progestin therapies for 5 or more years has been associated with an increased risk of ovarian cancer.

Heart Disease and Stroke:

The results of the WHI trial indicated an increased risk of stroke and coronary heart disease in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated an increased risk of stroke, but no difference in the risk of coronary heart disease in post-menopausal women with prior hysterectomy taking estrogen alone compared to women taking placebo.

Abnormal Blood Clotting:

The results of the WHI trial indicated an increased risk of blood clots in the lungs and large veins in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated an increased risk of blood clots in the large veins, but no difference in the risk of blood clots in the lungs in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

The risk of blood clots also increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery. You should discuss risk factors for blood clots with your doctor since blood clots can be life threatening or cause serious disability.

Gallbladder Disease:

The use of estrogens by postmenopausal women has been associated with an increased risk of gallbladder disease requiring surgery.

Dementia:

The Women's Health Initiative Memory Study (WHIMS) was a substudy of the WHI trial and indicated an increased risk of dementia (loss of memory and intellectual function) in postmenopausal women age 65 and over taking oral combined estrogen plus progestin compared to women taking placebo. The WHIMS indicated no difference in the risk of dementia in post-menopausal women age 65 and over with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.

BEFORE you use PROVERA talk to your doctor or pharmacist if:

  • have a history of allergy or intolerance to any medications or other substances
  • have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer
  • have experienced any unusual or undiagnosed vaginal bleeding
  • have a history of uterine fibroids or endometriosis
  • have a history of liver disease, jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy
  • have a history of migraine headache
  • have a history of high blood pressure
  • have a personal or family history of blood clots, or a personal history of heart disease or stroke
  • have a history of kidney disease, asthma or epilepsy (seizures)
  • have a history of bone disease (this includes certain metabolic conditions or cancers that can affect blood levels of calcium and phosphorus)
  • have been diagnosed with diabetes
  • have been diagnosed with porphyria (a disease of blood pigment)
  • have a history of high cholesterol or high triglycerides
  • are pregnant or may be pregnant
  • have had a hysterectomy (surgical removal of the uterus)
  • smoke

Side Effects

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

  • Breast tenderness;
  • Breast milk secretion;
  • Breakthrough bleeding;
  • Spotting (minor vaginal bleeding);
  • Irregular menstrual periods;
  • Amenorrhea (absence of menstrual periods);
  • Vaginal secretions;
  • Headaches;
  • Nervousness;
  • Dizziness;
  • Insomnia, sleepiness, fatigue;
  • Premenstrual syndrome-like symptoms;
  • Itching, hives, skin rash;
  • Acne;
  • Hair loss, hair growth;
  • Abdominal discomfort; nausea; bloating;
  • Fever;
  • Increase in weight;
  • Swelling;
  • Moon shaped face.
  • If you experience any of these side effects, contact your doctor or pharmacist.
  • The side effects listed in the table below have been observed with estrogen/progestin combination in general, but not necessarily with PROVERA.

Interactions with this medication

Tell your doctor or pharmacist if you are taking any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products.

Drugs that may interact with PROVERA include:

  • Preparations inducing liver enzymes e.g., barbiturates, hydantoins, carbamazepine, meprobamates, phenylbutazone or rifampin);
  • Aminoglutethimide;
  • Some herbal (e.g., St. John's wort) and natural products which are bought without a prescription.

Proper Use of this medication

PROVERA should be taken by mouth.

PROVERA can be taken with or without food.

Usual dose:

  1. Hormonal Replacement Therapy for Menopause: The recommended dose for women is 5 to 10 mg daily for 12 to 14 days.
  2. Functional Menstrual Disorders due to Hormonal Imbalance:
    1. Secondary amenorrhea (absence of menstrual period): After ruling out pregnancy, PROVERA, may be administered in doses ranging from 5 to 10 mg daily for 12 to 14 days every month.
    2. Dysfunctional uterine bleeding: PROVERA may be given in doses ranging from 5 to 10 mg daily for 10 to 14 days, beginning on the 12th to 16th day of the cycle. This regimen should be repeated for 2 subsequent cycles or longer if necessary.
  3. Endometrial Cancer: The recommended dose is 200 to 400 mg daily.
  4. Breast Cancer: The recommended dose is 400 mg daily, given in divided doses.

It is important that you take PROVERA regularly at the same time each day.

Overdose:

Symptoms:

Overdosage may result in a period of amenorrhea (absence or cessation of menstrual period) and may be followed by irregular menses for several cycles.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Missed dose:

Do not take a double dose to make up for a forgotten tablet. If you miss a dose, take it as soon as you can if it is within 12 hours of the missed dose. If it is over 12 hours since your missed dose, skip the missed dose and go back to your usual dosing times.

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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