Medroxyprogesterone Acetate Tablets USP

mg, 5 mg, 10 mg and 100 mg

PROGESTIN

APOTEX INC. DATE OF PREPARATION:

Signet Drive

October 10, 2001

Weston, Ontario DATE OF REVISION:

M9L 1T9

February 21, 2006

Control No. : 097671

Table of Contents

PART I: HEALTH PROFESSIONAL INFORMATION 3

SUMMARY PRODUCT INFORMATION 3 INDICATIONS AND CLINICAL USE 3 CONTRAINDICATIONS 4 WARNINGS AND PRECAUTIONS 5 ADVERSE REACTIONS 10 DRUG INTERACTIONS 12 DOSAGE AND ADMINISTRATION 13 OVERDOSAGE 15 ACTION AND CLINICAL PHARMACOLOGY. 16 STORAGE AND STABILITY 19 DOSAGE FORMS, COMPOSITION AND PACKAGING 19

PART II: SCIENTIFIC INFORMATION 20

PHARMACEUTICAL INFORMATION 20 CLINICAL TRIALS 21 DETAILED PHARMACOLOGY 24 TOXICOLOGY 24 REFERENCES 24

PART III: CONSUMER INFORMATION. 32

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APO-MEDROXY

Medroxyprogesterone Acetate

PART I: HEALTH PROFESSIONAL INFORMATION

Warning

As the Women's Health Initiative (WHI) study results indicated increased risk of myocardial infarction (MI), stroke, invasive breast cancer, pulmonary emboli and deep venous thrombosis in postmenopausal women during 5 years of treatment with combined 0.625 mg conjugated equine estrogens and 2.5 mg medroxyprogesterone acetate compared to those receiving placebo tablets, the following should be highly considered: Estrogens with or without progestins should not be prescribed for primary or secondary prevention of cardiovascular diseases.

Other combinations of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective dose and for the shortest duration possible for the recognized indication.

SUMMARY PRODUCT INFORMATION

CONTRAINDICATIONS

Estrogen and Estrogen/Progestin combinations are contraindicated in patients with any of the following disorders:

1. Active hepatic dysfunction or disease, especially of the obstructive type,

2. Personal history of known or suspected estrogen/progestin-dependent neoplasia such as breast or endometrial cancer,

3. Undiagnosed abnormal genital bleeding,

4. Known or suspected pregnancy,

5. A history of cerebrovascular accident, coronary thrombosis, or in the presence of classical migraine,

6. Active thrombophlebitis, thrombosis, or thromboembolic disorders, or a history of these conditions,

7. Partial or complete loss of vision due to ophthalmic vascular disease,

8. Known or suspected hypersensitivity to any component of the product.

WARNINGS AND PRECAUTIONS

Warning

As the Women's Health Initiative (WHI) study results indicated increased risk of myocardial infarction (MI), stroke, invasive breast cancer, pulmonary emboli and deep venous thrombosis in postmenopausal women during 5 years of treatment with combined 0.625 mg conjugated equine estrogens and 2.5 mg medroxyprogesterone acetate compared to those receiving placebo tablets, the following should be highly considered: Estrogens with or without progestins should not be prescribed for primary or secondary prevention of cardiovascular diseases. Other combinations of estrogens and progestins were not studied in the WHI and, in the

absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective dose and for the shortest duration possible for the recognized indication.

WARNINGS

When medroxyprogesterone acetate tablets are used for adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or hormonally-dependent, recurrent metastatic carcinoma of the breast in post-menopausal women, the risk of cardiovascular disorders and breast cancer should be weighed against the potential benefits of this treatment to the patient.

Cardiovascular Disorders

Available epidemiological data indicate that use of estrogen with or without progestin is associated with an increased risk of stroke, and coronary heart disease. The WHI trial results concluded that there are more risks than benefits among women using combined Hormone Replacement Therapy (HRT), consisting of 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate, compared to the group using placebo. In 10,000 women on this combined HRT over a one year period, there were seven more cases of coronary heart disease (37 on combined HRT versus 30 on placebo per 10,000 person years) and eight more cases of strokes (29 versus 21 per 10,000 person years).

Breast Cancer

Current epidemiological data indicate that the use of combined HRT is associated with an increased risk of invasive breast cancer. The WHI trial results concluded that there are more risks than benefits among women using combined HRT (0.625 mg conjugated equine estrogens / 2.5 mg medroxyprogesterone acetate), compared to the group using placebo. In 10,000 women on combined HRT over one year period, there were eight more cases of invasive breast cancer (38 on combined HRT versus 30 on placebo per 10,000 person years). It is recommended that estrogens not be given to women with existing breast cancer or those with a previous history of the disease. There is a need for caution in prescribing estrogens 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 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 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.

Venous Thromboembolism

Recent epidemiological data indicate that use of estrogen with or without progestin is associated with an increased risk of developing venous thromboembolism (VTE). The WHI trial results concluded that there are more risks than benefits among women using combined HRT (0.625 mg conjugated equine estrogens / 2.5 mg medroxyprogesterone acetate), compared to the group using placebo. In 10,000 women on combined HRT over a period of one year, there were eighteen more cases of total blood clots in the lungs and legs (34 on combined HRT versus 16 on placebo per 10,000 person years). 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). The risk of VTE also increases with age and smoking. The risk of VTE may be temporarily increased with prolonged immobilization, major elective surgery or posttraumatic surgery, or major trauma (if feasible, estrogens 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). 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.

Dementia

Current epidemiological evidence indicates that the use of combined HRT is associated with a significantly increased risk of developing probable dementia. The Women's Health Initiative Memory Study, a clinical substudy of the WHI, followed 4532 post-menopausal women age 65 and over and free of dementia at baseline. There was a reported two-fold increase in the relative risk of developing probable dementia after an average follow-up of 4.05 years in the group treated with daily 0.625 mg conjugated equine estrogen plus 2.5 mg medroxyprogesterone versus those treated with placebo (hazard ratio [HR] 2.05, 95% confidence interval [CI], 1.21-3.48). This increased risk would result in an additional 23 cases of dementia per 10 000 women per year (45 vs. 22 per 10,000 person years; P=0.01).

PRECAUTIONS

Before medroxyprogesterone acetate 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 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 and should include at least those procedures outlined above.

It is important that patients are encouraged to practice frequent self-examination of the breasts.

Abnormal vaginal bleeding, due to its prolongation, irregularity or heaviness, occurring during therapy should prompt diagnostic measures like hysteroscopy, endometrial biopsy or curettage to rule out the possibility of uterine malignancy and the treatment should be re-evaluated. Patients who develop visual disturbances, classical migraine, transient aphasia, paralysis, or loss of consciousness should discontinue medication. Women using hormonal replacement therapy (HRT) sometimes experience increased blood pressure. Research indicates that medroxyprogesterone acetate has little, if any, adverse effect on blood pressure. Results from studies show no significant difference between estrogen-treated and estrogen-medroxyprogesterone acetate-treated patients for the development of hypertension. Blood pressure should be monitored with HRT use. Elevation of blood pressure in previously normotensive or hypertensive patients should be investigated and HRT therapy may have to be discontinued. Progestins may cause fluid retention. Therefore, particular caution is indicated in cardiac or renal dysfunction, epilepsy or asthma. Treatment should be stopped if there is an increase in epileptic seizures. If, in any of the above-mentioned conditions, a worsening of the underlying disease is diagnosed or suspected during treatment, the benefits and risks of treatment should be reassessed based on the individual case. Because the prolonged use of progestins influences the metabolism of calcium and phosphorus, progestins should be used with caution in patients with metabolic and malignant bone diseases associated with hypercalcemia and in patients with renal insufficiency. A worsening of glucose tolerance and lipid metabolism has 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 or porphyria need special surveillance. Lipid- lowering measures are recommended additionally, before treatment is started. 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 the section under Laboratory Tests.

Decrease in Bone Mineral Density

There are no available studies on the effects of orally administered medroxyprogesterone acetate (MPA) as a single agent, on bone mineral density. However, it may be suspected that for specific medical conditions, when MPA is administered over a prolonged period of time at a dose that is high enough to suppress endogenous estrogen production (eg. pre-menopausal women), it could result in a decrease in bone mineral density. In these circumstances, adequate calcium and vitamin D intake should be considered.

Other Precautions

1. Patients should be advised of the menstrual bleeding patterns expected with the sequential regimen (see DOSAGE AND ADMINISTRATION).

Upon sequential administration of medroxyprogesterone acetate to women with adequate levels of estrogen (endogenous or exogenous), withdrawal bleeding usually occurs within 7 days after stopping medroxyprogesterone acetate. Bleeding that occurs during medroxyprogesterone acetate administration period indicates a need for a longer duration, or a higher dose of medroxyprogesterone acetate. Patients who have a history of mental depression should be carefully monitored while receiving therapy with medroxyprogesterone acetate. Some patients may complain of premenstrual like depression while on medroxyprogesterone acetate. The age of the patient constitutes no absolute limiting factor although treatment with progestins may mask the onset of the climacteric. Usage in pregnancy is not recommended. Progestational agents are also not recommended as a diagnostic test for pregnancy. If the patient is exposed to medroxyprogesterone acetate during pregnancy or if she becomes pregnant while taking the drug, she should be apprised of the potential risk to the fetus. Clinical suppression of adrenocortical function has not been observed at low dose levels. However, the high doses of medroxyprogesterone acetate used in the treatment of certain cancers may, in some cases, produce Cushingoid symptoms (e.g., "moon" facies, fluid retention, glucose intolerance, and blood pressure elevation). Detectable amounts of progestin have been identified in the milk of mothers receiving the drug. Infants exposed to medroxyprogesterone via breast milk have been studied for developmental and behavioral effects through puberty. No adverse effects have been noted. Anaphylactic and anaphylactoid reactions have occasionally been reported in patients treated with medroxyprogesterone acetate.

DRUG INTERACTIONS

Preparations inducing liver enzymes (e.g., barbiturates, hydantoins, carbamazepine, meprobamates, phenylbutazone or rifampicin) may interfere with the activity of orally administered progestins. Concomitant administration of aminoglutethimide with medroxyprogestrone acetate (MPA), may significantly reduce the bioavailability of MPA. It was found that some herbal products (e.g. St. John's wort) which are available as OTC products might affect metabolism, and therefore, efficacy and safety of estrogen/progestin products. Physicians and other health care providers should be aware of other non-prescription products concomitantly used by the patient, including herbal and natural products, obtained from the widely spread Health Stores.

Laboratory Tests

The results of certain endocrine and liver function tests may be affected by estrogen/progestin- containing products:

• Increased sulfobromophthalein retention;

• Increased prothrombin time and partial thromboplastin time; increased levels of fibrinogen and fibrinogen activity; increased coagulation factors VII, VIII, IX, X; increased norepinephrine-induced platelet aggregability; decreased antithrombin III;

• Increased thyroxine-binding globulin (TBG), leading to increased circulating total thyroid hormone (T4) as measured by column or radioimmunoassay; free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered;

• Other binding proteins may be elevated in serum ie, corticosteroid binding globulin (CBG), sex-hormone binding globulin (SHBG), leading to increased circulating corticosteroids and sex steroids, respectively; free or biologically active hormone concentrations are unchanged;

• Reduced response to the METOPIRONE test;

• Impaired glucose tolerance;

• Reduced serum folate concentration;

• Increased serum triglycerides and phospholipids concentration.

The results of the above laboratory tests should not be considered reliable unless therapy has been discontinued for 2 to 4 weeks. The pathologist should be informed that the patient is receiving HRT therapy when relevant specimens are submitted.

DOSAGE AND ADMINISTRATION

Hormone Replacement Therapy

Progestin Challenge Test

Subsequent to the diagnosis of menopause, the progestin challenge test is recommended for amenorrheic women with an intact uterus. APO-MEDROXY (medroxyprogesterone acetate) 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. In these women, hormone replacement therapy consisting of estrogen therapy, and concurrent APO-MEDROXY, should be considered. A positive test is indicated by the presence of withdrawal bleeding which occurs within 7 days after stopping APO-MEDROXY treatment. Withdrawal bleeding implies the presence of sufficient endogenous estrogen to stimulate the endometrium. APO- MEDROXY therapy should be administered, as above, until withdrawal bleeding no longer occurs. This cessation of withdrawal bleeding indicates the absence of endometrial stimulation due to a decline in estrogen secretion. In these women, hormone replacement therapy consisting of estrogen therapy, and concurrent APO-MEDROXY, should be considered.

Sequential Therapy

In women with an intact uterus receiving estrogen replacement therapy, APO- MEDROXY tablets may be given in a dosage of 5 - 10 mg daily for 12 - 14 days. The recommended starting dose for APO-MEDROXY should be 10 mg/day, administered for 12 - 14 days. A dose of 5 mg/day APO-MEDROXY for 12 - 14 days may be appropriate for some women.

Note:

The lowest dose of APO-MEDROXY required to protect the endometrium from estrogenic-hyperstimulation should be used. A good indicator is the lowest dose of APO-MEDROXY that will consistently result in withdrawal bleeding within 7 days after stopping APO-MEDROXY treatment. Bleeding that occurs during the APO- MEDROXY treatment indicates a need for a longer duration, or higher dose of APO- MEDROXY.

Functional Menstrual Disorders

Secondary Amenorrhea

After ruling out pregnancy, APO-MEDROXY may be administered in doses ranging from 5 - 10 mg daily depending upon the degree of progestational effect desired. The dose should be given daily for 12 - 14 days every month.

Note:

In patients with poorly developed endometria, conventional estrogen therapy should be given in conjunction with APO-MEDROXY.

Dysfunctional Uterine Bleeding

In dysfunctional uterine bleeding, APO-MEDROXY may be given in doses ranging from 5 - 10 mg/day, for 10 - 14 days, beginning on the assumed or calculated 12 - 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 APO-MEDROXY. If bleeding is controlled satisfactorily, at least two 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.

Endometrial Cancer

200 - 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 appears to be stabilized, it may be possible to maintain this improvement with a 200 mg/day dose.

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. APO-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 APO-MEDROXY.

OVERDOSAGE

Symptoms

In female patients, overdosage may result in a period of amenorrhea of a variable length and may be followed by irregular menses for several cycles. No cases of overdosage in male patients have been reported. However, such overdosage, if it were to occur, would not likely result in any particular symptomatology.

Treatment

There is no known therapy for overdosage of medroxyprogesterone. Doses as high as 1000 mg for the therapy of endometrial carcinoma have been used without adverse effect.

ACTION AND CLINICAL PHARMACOLOGY

Medroxyprogesterone acetate is an orally-active progestational steroid (progestin) derived from a natural source (soybeans) and devoid of androgenic and estrogenic activity.

Clinical Pharmacology of Medroxyprogesterone Acetate Tablets Osteoporosis/Osteopenia

Presently there are no conclusive data concerning the mechanism of action of progestins on bone. Clinically, research to date has shown women treated with medroxyprogesterone acetate to prevent estrogenic hyperstimulation of the endometrium do not lose protection against osteoporosis.

Urogenital Symptoms

Medroxyprogesterone acetate, when administered to women with adequate levels of estrogen (endogenous or exogenous), transforms a proliferative endometrium into a secretory endometrium. Withdrawal bleeding is anticipated within 7 days after stopping medroxyprogesterone acetate. Microscopically, the secretory change is associated with glycoprotein-rich stromal cells which surround the glands and vessels and assist them in maintaining their integrity during hormonal withdrawal. The result is an orderly regression and remodelling, and preservation of the functional layer of the endometrium. Medroxyprogesterone acetate decreases both cytoplasmic and nuclear estrogen receptors in endometrial cells. In addition, medroxyprogesterone acetate induces estradiol dehydrogenase (E2DH) activity, the enzyme mechanism by which endometrial cells metabolize and excrete estrogens. Oral medroxyprogesterone acetate also produces typical progestational changes in the cervical mucous (inhibits ferning) and increases the intermediate cell count in the maturation index of the vaginal epithelium.

Metabolism

In studies which examined metabolic changes, a decrease in glucose tolerance has been associated with progestins, including medroxyprogesterone acetate. Medroxyprogesterone acetate shows small or undetectable effects on lipoproteins when used at therapeutic dosages. Furthermore, research demonstrates that the use of medroxyprogesterone acetate with estrogen in hormone replacement therapy maintains the estrogenic effects on lipid profile.

Hemostatic Factors

There is no conclusive evidence that medroxyprogesterone acetate produces adverse coagulation changes in women receiving the progestin alone, or as part of a sequential regimen with estrogen.

Endocrine

Medroxyprogesterone acetate in appropriate doses, suppresses the secretion of pituitary gonadotropins which in turn, prevents follicular maturation, producing anovulation in the pre- menopausal woman. The anti-cancer activity of medroxyprogesterone acetate at pharmacologic doses may be dependent upon its effect on the hypothalamic/pituitary/gonadal axis, estrogen receptors and the metabolism of steroids at the tissue level. Like progesterone, medroxyprogesterone acetate is thermogenic. At the very high dosage levels used in the treatment of certain cancers (500 mg/day or more), corticoid-like activity may be manifest. Medroxyprogesterone acetate in appropriate doses suppresses the Leydig cell function in the male (i.e., suppresses endogenous testosterone production).

Pharmacokinetics of Medroxyprogesterone Acetate

In a randomized, cross-over study using 22 healthy male volunteers, the pharmacokinetics of medroxyprogesterone acetate 2.5 mg and medroxyprogesterone acetate 10 mg tablets were studied following 10 mg single oral doses in the following regimens:

1. four medroxyprogesterone acetate 2.5 mg tablets or,

2. one medroxyprogesterone acetate 10 mg tablet as a single dose during a fasting period which began 9 hours before and lasted until 4 hours after the dose. Treatment phases were separated by a 14-day washout period. Blood samples were collected prior to and at the following times after drug administration: 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0,

16.0, 24.0, 36.0, 72.0, 96.0, and 120.0 hours. The resulting serum samples were analysed for medroxyprogesterone using a radioimmunoassay procedure. Relevant bioavailability parameters are included in Table 1:

Table 1: Pharmacokinetic parameters of medroxyprogesterone acetate following oral administration

Medroxyprogesterone acetate

T

max

C

max

AUC

Dose (mg) (hr) (ng/mL) (ng/hr/mL)

The pharmacokinetics of medroxyprogesterone acetate 100 mg tablets was assessed in a clinical study using 16 healthy, male volunteers. A single dose of medroxyprogesterone acetate 100 mg was administered orally to subjects who fasted overnight and for 2 hours after the dose was administered. Blood samples were collected prior to, and at the following times, after drug administration: 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 26.0, 32.0, 50.0, 74.0, 98.0, and 170.0 hours. Serum samples were analysed for medroxyprogesterone using a radioimmunoassay procedure. Relevant bioavailability parameters are included in Table 2.

Table 2: Pharmacokinetic parameters of medroxyprogesterone acetate following oral administration

Medroxyprogesterone acetate

T

max

C

max

AUC

Dose (mg) (hr) (ng/mL) (ng/hr/mL)

Medroxyprogesterone acetate has an apparent half-life of about 30 hours.

Absorption and Metabolism

Medroxyprogesterone acetate is rapidly absorbed from the gastrointestinal tract and metabolized in the liver to several progestin metabolites. The major drug-related material found in circulation following oral administration has been characterized as both free and glucuronide-conjugated metabolites of medroxyprogesterone acetate.

Excretion

Medroxyprogesterone acetate is primarily eliminated via fecal excretion, to which biliary secretion may contribute. Approximately 44% of an oral dose is eliminated through urinary excretion in the form of metabolites. The only metabolite of medroxyprogesterone acetate that has been isolated and unequivocally identified is 6a-methyl-6b,17a,21-trihydroxy-4-pregnene-3,20-dione-17-acetate, and appears to be the primary urinary metabolite. This metabolite accounts for approximately 8% of an oral dose, and is excreted as a glucuronide conjugate.

STORAGE AND STABILITY

Store at room temperature 15deg - 30degC (59deg-86degF).

DOSAGE FORMS, COMPOSITION AND PACKAGING

Composition

In addition to medroxyprogesterone acetate, each tablet contains the following non-medicinal ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, sodium lauryl sulfate and colloidal silicon dioxide. The 2.5 mg tablet also contains the colouring agents D&C yellow #10 and FD&C yellow #6. The 5 mg tablet also contains the colouring agent FD&C blue #2.

Availability

APO-MEDROXY 2.5 mg:

each round, pink orange, biconvex tablet scored and engraved "MED" over "2.5" on one side and "APO" on the other, contains 2.5 mg medroxyprogesterone acetate. Available in bottles of 100 and 500.

APO-MEDROXY 5 mg:

each round, blue, biconvex tablet scored and engraved "MED" over "5" on one side and "APO" on the other, contains 5 mg medroxyprogesterone acetate. Available in bottles of 100 and 500.

APO-MEDROXY 10 mg:

each round, white, biconvex tablet scored and engraved "APO" over "10" on one side and plain on the other, contains 10 mg medroxyprogesterone acetate. Available in bottles of 100 and 500.

APO-MEDROXY 100 mg:

each round, white, bevelled edge tablet scored and engraved "MED" over "100" on one side and "APO" on the other, contains 100 mg medroxyprogesterone acetate. Available in bottles of 100 and 500.