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TEVA-MEDROXYPROGESTERONE is a brand name for Medroxyprogesterone (also known as Medroxyprogesterone Acetate), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ); • Known, suspected, or past history of breast cancer, unless TEVA-MEDROXYPROGESTERONE is being used as a treatment for breast cancer in postmenopausal women (see 1 INDICATIONS); • Undiagnosed abnormal genital bleeding; • Known or suspected pregnancy; • Active or past history of arterial thromboembolic disease (e.g.…
Verbatim from this product's HC label. Tap a section to expand.
). Upon sequential administration of TEVA-MEDROXYPROGESTERONE to women with adequate levels of estrogen (endogenous or exogenous), withdrawal bleeding usually occurs within 7 days after stopping TEVA-MEDROXYPROGESTERONE. Bleeding that occurs during TEVA- MEDROXYPROGESTERONE administration period indicates a need for a longer duration, or a higher dose of TEVA-MEDROXYPROGESTERONE.
Hematologic Venous thromboembolism Available epidemiological data indicate that use of estrogen with or without progestin by postmenopausal women is associated with an increased risk of developing venous thromboembolism (VTE). In the estrogen plus progestin arm of the WHI trial, among 10,000 women on combined HRT over a one-year period, there were 18 more cases of venous thromboembolism, including 8 more cases of pulmonary embolism.
TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) Page 16 of 42 In the estrogen-alone arm of the WHI trial, among 10,000 women on estrogen therapy over a one-year period, there were 7 more cases of venous thromboembolism, although there was no statistically significant difference in the rate of pulmonary embolism.
Generally recognized risk factors for VTE include a personal history, a family history (the occurrence of VTE in a direct relative at a relatively early age may indicate genetic predisposition) and severe obesity (body mass index > 30 kg/m2) and systemic lupus erythematosus.
The risk of VTE also increases with age and smoking. The risk of VTE may be temporarily increased with prolonged immobilization, major surgery or trauma. In women on HRT, attention should be given to prophylactic measures to prevent VTE following surgery.
Also, patients with varicose veins should be closely supervised. The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, retinal thrombosis, cerebral embolism and pulmonary embolism). If these occur or are suspected, hormone therapy should be discontinued immediately, given the risks of long-term disability or fatality.
If feasible, estrogens with or without progestins should be discontinued at least 4 weeks before major surgery which may be associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. Hepatic/Biliary/Pancreatic Gallbladder diseases A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in women receiving postmenopausal estrogens has been reported.
4 Geriatrics. 2. g. g. stroke, myocardial TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) Page 6 of 42 infarction, coronary heart disease); • Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis; • Partial or complete loss of vision due to ophthalmic vascular disease.
Medroxyprogesterone acetate is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3. Serious Warnings and Precautions Box Serious Warnings and Precautions The Women’s Health Initiative (WHI) trial examined the health benefits and risks of oral combined estrogen plus progestin therapy (n=16,608) and oral estrogen-alone therapy (n=10,739) in postmenopausal women aged 50 to 79 years.
2 years compared to those receiving placebo. 8 years compared to those receiving placebo. Therefore, the following should be given serious consideration at the time of prescribing: • Estrogens with or without progestins should not be prescribed for primary or secondary prevention of cardiovascular diseases.
• Estrogens with or without progestins should be prescribed at the lowest effective dose for the approved indication. • Estrogens with or without progestins should be prescribed for the shortest period possible for the approved indication.
4. 1. Dosing Considerations 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 TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) Page 7 of 42 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-month to 6-month intervals) to determine if treatment is still necessary (see 7 WARNINGS AND PRECAUTIONS).
). There is a need for caution in prescribing estrogens with or without progestins for women with known risk factors associated with the development of breast cancer, such as strong family history of breast cancer (first degree relative) or who present a breast condition with an increased risk (abnormal mammograms and/or atypical hyperplasia at breast biopsy).
Other known risk factors for the development of breast cancer such as nulliparity, obesity, early menarche, late age at first full term pregnancy and at menopause should also be evaluated. It is recommended that women undergo a mammography prior to the start of HRT treatment and at regular intervals during treatment, as deemed appropriate by the treating physician and according to the perceived risks for each patient.
The overall benefits and possible risks of hormone replacement therapy should be fully considered and discussed with patients. It is important that the modest increased risk of being diagnosed with breast cancer after 4 years of treatment with combined estrogen plus progestin HRT (as reported in the results of the WHI trial) be discussed with the patient and weighed against its known benefits.
Instructions for regular self-examination of the breasts should be included in this counselling. Endometrial hyperplasia & endometrial carcinoma The incidence of estrogen-associated endometrial hyperplasia was assessed in 2 large, long- term, randomized clinical trials.
The first study demonstrated that combining conjugated estrogens with medroxyprogesterone acetate or micronized progesterone protected the endometrium from hyperplastic changes associated with estrogen-only therapy. 001) than in women treated with conjugated estrogen alone (see 14 CLINICAL TRIALS).
Ovarian cancer Some recent epidemiologic studies have found that the use of postmenopausal hormone replacement therapy (estrogen alone and estrogen plus progestin therapies) in particular for five or more years has been associated with an increased risk of ovarian cancer.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Jaundice Caution is advised in patients with a history of liver and/or biliary disorders. If cholestatic jaundice develops during treatment, the treatment should be discontinued and appropriate investigations carried out. Liver function tests Liver function tests should be done periodically in subjects who are suspected of having hepatic disease.
For information on endocrine and liver function tests, see section 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests. Immune Anaphylactic/Anaphylactoid reactions TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) Page 17 of 42 Anaphylactic and anaphylactoid reactions have occasionally been reported in patients treated with medroxyprogesterone acetate tablets.
Monitoring and Laboratory Tests Before TEVA-MEDROXYPROGESTERONE is administered, the patient should have a complete physical examination including a blood pressure determination. Breasts and pelvic organs should be appropriately examined and a Papanicolaou smear should be performed.
Endometrial biopsy should be done only when indicated. Baseline tests should include mammography, measurements of blood glucose, calcium, triglycerides and cholesterol, and liver function tests. The first follow-up examination should be done within 3-6 months after initiation of treatment to assess response to treatment.
Thereafter, examinations should be made at intervals at least once a year. Appropriate investigations should be arranged at regular intervals as determined by the physician. The importance of regular self-examination of the breasts should be discussed with the patient.
Neurologic Cerebrovascular insufficiency Patients who develop visual disturbances (including sudden partial or complete loss of vision or sudden onset of proptosis, diplopia), classical migraine, transient aphasia, paralysis, or loss of consciousness should discontinue medication.
Patients with a previous history of classical migraine and who develop a recurrence or worsening of migraine symptoms should be reevaluated. Dementia Available epidemiological data indicate that the use of combined estrogen plus progestin in women age 65 and over may increase the risk of developing probable dementia.
The Women’s Health Initiative Memory Study (WHIMS), a clinical substudy of the WHI, was designed to assess whether postmenopausal hormone replacement therapy (oral estrogen plus progestin or oral estrogen-alone) reduces the risk of dementia in women aged 65 and over (age range 65-79 years) and free of dementia at baseline.
05 years. The results, when extrapolated to 10,000 women treated over a one-year period showed: TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) Page 18 of 42 • 23 more cases of probable dementia (45 on combined HRT versus 22 on placebo).
21 years. The results, when extrapolated to 10,000 women treated over a one-year period showed: • 12 more cases of probable dementia (37 on estrogen-alone versus 25 on placebo), although this difference did not reach statistical significance.
When data from the estrogen plus progestin arm of the WHIMS and the estrogen alone arm of the WHIMS were combined, as per the […]
For women with intact uteri, 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. Patients should be started at the lowest dose.
The lowest effective dose of TEVA-MEDROXYPROGESTERONE has not been determined. 2. Recommended Dose and Dosage Adjustment 1.
Hormone Replacement Therapy: (a) Progestin Challenge Test:
The progestin challenge test may be considered for amenorrheic women with intact uteri. TEVA-MEDROXYPROGESTERONE 10 mg daily should be administered for 10 days. A negative test is identified by the absence of withdrawal bleeding, and implies the absence of endometrial stimulation due to insufficient estrogen secretion.
A positive test is indicated by the presence of withdrawal bleeding which occurs within 7 days after stopping TEVA-MEDROXYPROGESTERONE treatment. Withdrawal bleeding implies the presence of sufficient endogenous estrogen to stimulate the endometrium.
(b) Sequential Therapy: Days of the Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Sequential Estrogen - 25 days Start TEVA- MEDROXYPROGESTERONE 5 -10 mg/day Continuous Estrogen – everyday TEVA- MEDROXYPROGESTERON E 5 -10 mg/day Stop In women with intact uteri receiving estrogen replacement therapy, TEVA- MEDROXYPROGESTERONE tablets may be given in a dosage of 5 - 10 mg daily for 12 - 14 days.
TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) Page 8 of 42 The recommended starting dose for TEVA-MEDROXYPROGESTERONE should be 10 mg/day, administered for 12 - 14 days. A dose of 5 mg/day TEVA-MEDROXYPROGESTERONE for 12 - 14 days may be appropriate for some women.
Note:
The lowest dose of TEVA-MEDROXYPROGESTERONE required to protect the endometrium from estrogenic-hyperstimulation should be used. A good indicator is the lowest dose of TEVA- MEDROXYPROGESTERONE that will consistently result in withdrawal bleeding within 7 days after stopping TEVA-MEDROXYPROGESTERONE treatment.
Bleeding that occurs during the TEVA-MEDROXYPROGESTERONE treatment indicates a need for a longer duration, or higher dose of TEVA-MEDROXYPROGESTERONE. 2.
Functional Menstrual Disorders: (a) Secondary Amenorrhea:
After ruling out pregnancy, TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) may be administered in doses ranging from 5 - 10 mg daily […]
Cardiovascular The results of the Heart and Estrogen/progestin Replacement Studies (HERS and HERS II) and the Women’s Health Initiative (WHI) trial indicate that the use of estrogen plus progestin is associated with an increased risk of coronary heart disease (CHD) in postmenopausal women.
The results of the WHI trial indicate that the use of estrogen-alone and estrogen plus progestin is associated with an increased risk of stroke in postmenopausal women. TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) Page 13 of 42 WHI trial findings In the combined estrogen plus progestin arm of the WHI trial, among 10,000 women over a one- year period, there were: • 8 more cases of stroke (29 on combined HRT versus 21 on placebo) • 7 more cases of CHD (37 on combined HRT versus 30 on placebo).
In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10,000 women over a one-year period, there were/was: • 12 more cases of stroke (44 on estrogen-alone therapy versus 32 on placebo) • no statistically significant difference in the rate of CHD.
5 mg oral medroxyprogesterone acetate (MPA) demonstrated no cardiovascular benefit. 1 years, treatment with CEE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the hormone treated group than in the placebo group in year 1, but not during the subsequent years.
From the original HERS trial, 2321 women consented to participate in an open label extension of HERS known as HERS II. 8 years overall. 8 years, hormone therapy did not reduce the risk of cardiovascular events in women with CHD. Blood pressure Women using hormone replacement therapy sometimes experience increased blood pressure.
Blood pressure should be monitored with HRT use. Elevation of blood pressure in previously normotensive or hypertensive patients should be investigated and HRT may have to be discontinued. Endocrine and Metabolism Adrenocortical function Clinical suppression of adrenocortical function has not been observed at low dose levels.
However, the high doses of TEVA-MEDROXYPROGESTERONE used in the treatment of certain TEVA-MEDROXYPROGESTERONE (medroxyprogesterone acetate tablets) Page 14 of 42 cancers may, in some cases, produce Cushingoid symptoms (eg, "moon" facies, fluid retention, glucose intolerance, and blood pressure elevation).
Glucose and lipid metabolism A worsening of glucose tolerance and lipid metabolism have been observed in a significant percentage of peri-and post-menopausal patients. Therefore, diabetic patients or those with a predisposition to diabetes should be observed closely to detect any alterations in carbohydrate or lipid metabolism, especially in triglyceride blood levels.
Women with familial hypertriglyceridemia need special surveillance. Lipid-lowering measures are recommended additionally, before treatment is started. Heme metabolism Women with porphyria need special surveillance. Other Conditions TEVA-MEDROXYPROGESTERONE contains lactose.
In patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption, the severity of the condition should be taken into careful consideration before prescribing TEVA-MEDROXYPROGESTERONE. The patients should be closely monitored.
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