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AA-MEDROXY 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: AA-MEDROXY (medroxyprogesterone acetate tablets) is indicated for: • Hormonal replacement therapy, to oppose the effects of estrogen on the endometrium and significantly reduce the risk of hyperplasia and carcinoma; • Functional menstrual disorders due to hormonal imbalance in non-pregnant women, in the absence of…
Verbatim from this product's HC label. Tap a section to expand.
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 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). 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 medroxyprogesterone acetate tablets has AA-MEDROXY (Medroxyprogesterone Acetate Tablets) Page 6 of 39 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. AA-MEDROXY 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 AA-MEDROXY 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 AA-MEDROXY 5 - 10 mg/day Continuous Estrogen - everyday AA-MEDROXY 5 - 10 mg/day Stop In women with intact uteri receiving estrogen replacement therapy, AA-MEDROXY tablets may be given in a dosage of 5 to 10 mg daily for 12 to 14 days.
The recommended starting dose for AA-MEDROXY should be 10 mg/day, administered for 12 to 14 days. A dose of 5 mg/day AA-MEDROXY for 12 to 14 days may be appropriate for some women.
1 Adverse Reaction Overview See 7 WARNINGS AND PRECAUTIONS regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives.
Overview of Adverse Drug Reactions with medroxyprogesterone acetate tablets use:
The following adverse reactions have been reported with the use of medroxyprogesterone acetate tablets: AA-MEDROXY (Medroxyprogesterone Acetate Tablets) Page 17 of 39 Breast - tenderness, galactorrhea; Reproductive System - breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, changes in cervical erosion and cervical secretions; Central Nervous System - headache, nervousness, dizziness, depression, insomnia, somnolence, fatigue, premenstrual syndrome-like symptoms; Thromboembolic phenomena - including thrombophlebitis and pulmonary embolism; Skin and Mucous Membranes - sensitivity reactions ranging from pruritus, urticaria, angioneurotic edema to generalized rash and anaphylaxis; acne, alopecia, hirsutism; Gastrointestinal - abdominal discomfort, nausea, bloating; Miscellaneous - pyrexia, increase in weight, peripheral edema, "moon" facies.
7 Drug-Laboratory Tests Interactions) Cardiac disorders Palpitations; increase in blood pressure (see 7 WARNINGS AND PRECAUTIONS); coronary thrombosis. Endocrine disorders Increased blood sugar levels; decreased glucose tolerance. g.
retinal thrombosis, optic neuritis); visual disturbances; steepening of the corneal curvature; intolerance to contact lenses. Gastrointestinal disorders Nausea; vomiting; abdominal discomfort (cramps, pressure, pain); bloating. General disorders and administration site conditions Fatigue; changes in appetite; changes in body weight; change in libido.
Hepatobiliary disorders Gallbladder disorder; asymptomatic impaired liver function; cholestatic jaundice. Musculoskeletal and connective tissue disorders Musculoskeletal pain including leg pain not related to thromboembolic disease (usually transient, lasting 3 to 6 weeks) may occur.
, Neurologic, Meningioma 03/2025 7. 1. of the PM Guidance) or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics ..............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ...............................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 5 4 DOSAGE AND ADMINISTRATION ............................................................................... 1 Dosing Considerations ..........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ...................................................................................................... 5 Missed Dose ..........................................................................................................
7 5 OVERDOSAGE ........................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 8 7 WARNINGS AND PRECAUTIONS ................................................................................
g. , stroke, myocardial infarction, coronary heart disease); • Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis; AA-MEDROXY (Medroxyprogesterone Acetate Tablets) Page 5 of 39 • Partial or complete loss of vision due to ophthalmic vascular disease.
Medroxyprogesterone acetate tablets 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Medroxyprogesterone in Canada.
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Note:
The lowest dose of AA-MEDROXY required to protect the endometrium from estrogenic-hyperstimulation should be used. A good indicator is the lowest dose of AA- MEDROXY that will consistently result in withdrawal bleeding within 7 days after stopping AA-MEDROXY treatment.
Bleeding that occurs during the AA-MEDROXY treatment indicates a need for a longer duration, or higher dose of AA-MEDROXY. 2.
Functional Menstrual Disorders: (a) Secondary Amenorrhea:
After ruling out pregnancy, AA-MEDROXY (medroxyprogesterone acetate) may be administered in doses ranging from 5 to 10 mg daily depending upon the degree of progestational effect desired. The dose should be given daily for 12 to 14 days every month.
AA-MEDROXY (Medroxyprogesterone Acetate Tablets) Page 7 of 39 Note:
In patients with poorly developed endometria, conventional estrogen therapy should be given in conjunction with AA-MEDROXY. (b) Dysfunctional Uterine Bleeding: In dysfunctional uterine bleeding, AA-MEDROXY may be given in doses ranging from 5 to 10 mg/day, for 10 to 14 days, beginning on the assumed or calculated 12 to 16th day of the cycle.
This regimen should be repeated for 2 subsequent cycles or longer if necessary. When bleeding is due to a deficiency of both ovarian hormones, as indicated by a poorly developed proliferative endometrium, conventional estrogen therapy should be given in conjunction with AA-MEDROXY.
If bleeding is controlled satisfactorily, at least 2 subsequent cycles of treatment should be given. If dysfunctional uterine bleeding is not controlled by hormone therapy, appropriate diagnostic measures should be undertaken to rule out uterine pathology.
3. Endometrial Cancer: 200 to 400 mg/day is the usual dose. It is suggested that if neither subjective nor objective improvement is noted within 2 to 3 months, therapy should be discontinued. Where improvement is noted and the disease process appears to be stabilized, it may be possible to maintain this improvement with a 200 mg/day dose.
4.
Breast Cancer:
The recommended dose is 400 mg daily, given in divided doses. The patient should be continued on therapy as long as she is responding to treatment. Although doses of up to 2400 mg daily have been reported, controlled studies using 800 mg daily did not demonstrate any appreciable increase in response rates compared to the 400 mg daily dose.
AA-MEDROXY is not recommended as primary therapy, but as adjunctive and palliative treatment in advanced, inoperable cases including those with recurrent metastatic disease.
Note:
Response to hormonal therapy for endometrial or breast cancer may not be evident until 8 to 10 weeks of therapy. Rapid progression of disease at any time during therapy should result in termination of treatment with AA-MEDROXY. 4 Administration AA-MEDROXY (medroxyprogesterone acetate tablets) is administered orally.
5 Missed Dose If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.
AA-MEDROXY (Medroxyprogesterone Acetate Tablets) Page 8 of 39
Nervous system disorders Aggravation of migraine episodes; headaches; dizziness; neuritis. AA-MEDROXY (Medroxyprogesterone Acetate Tablets) Page 18 of 39 Psychiatric disorders Mental depression; nervousness; irritability. Renal and urinary disorders Cystitis; dysuria; sodium retention; edema.
Reproductive system and breast disorders Breakthrough bleeding; spotting; change in menstrual flow; dysmenorrhea; vaginal itching/discharge; dyspareunia; endometrial hyperplasia; pre-menstrual-like syndrome; reactivation of endometriosis; changes in cervical erosion and amount of cervical secretion; breast swelling and tenderness.
Skin and subcutaneous tissue disorders Chloasma or melasma; which may persist when drug is discontinued; erythema multiform; erythema nodosum; haemorrhagic eruption; loss of scalp hair; hirsutism and acne. Vascular disorders Isolated cases of: thrombophlebitis; thromboembolic disorders.
5 Post-Market Adverse Reactions Adverse events reported during worldwide post-marketing experience, regardless of causality and frequency, are listed below. It should be noted that the nature of post-marketing surveillance makes it difficult to determine if a reported event was actually caused by medroxyprogesterone acetate tablets.
g. fine-hand tremors, sweating, cramps in calves in night) Psychiatric disorders: euphoria Renal and urinary system disorders: glycosuria AA-MEDROXY (Medroxyprogesterone Acetate Tablets) Page 19 of 39 If adverse symptoms persist, the prescription of the HRT should be re-considered.
1 Special Populations ............................................................................................. 1 Pregnant Women ................................................................................................ 2 Breast-feeding ....................................................................................................
3 Pediatrics ............................................................................................................ 4 Geriatrics .............................................................................................................
16 8 ADVERSE REACTIONS .............................................................................................. 1 Adverse Reaction Overview ................................................................................ 5 Post-Market Adverse Reactions ..........................................................................
18 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview ................................................................................ 4 Drug-Drug Interactions .......................................................................................
5 Drug-Food Interactions ....................................................................................... 6 Drug-Herb Interactions ....................................................................................... 7 Drug-Laboratory Test Interactions ......................................................................
19 10 CLINICAL PHARMACOLOGY ..................................................................................... 1 Mechanism of Action .......................................................................................... 2 Pharmacodynamics .............................................................................................
3 Pharmacokinetics ................................................................................................ 22 11 STORAGE, STABILITY AND DISPOSAL ....................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS .........................................................................
23 PART II: SCIENTIFIC INFORMATION ....................................................................................... 24 13 PHARMACEUTICAL INFORMATION .......................................................................... 24 14 CLINICAL TRIALS ......................................................................................................
2 Comparative Bioavailability Studies .................................................................... 26 15 MICROBIOLOGY ...................................................................................................... 29 16 NON-CLINICAL TOXICOLOGY ...................................................................................
29 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................. 30 PATIENT MEDICATION INFORMATION .................................................................................. 31 AA-MEDROXY (Medroxyprogesterone Acetate Tablets) Page 4 of 39 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AA-MEDROXY (medroxyprogesterone acetate tablets) is indicated for: • Hormonal replacement therapy, to oppose the effects of estrogen on the endometrium and significantly reduce the risk of hyperplasia and carcinoma; • Functional menstrual disorders due to hormonal imbalance in non-pregnant women, in the absence of organic […]