INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PROVERA™ 5 (Tablets)
PROVERA™ 10 (Tablets)
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PROVERA™ 5 (Tablets)
PROVERA™ 10 (Tablets)

COMPOSITION:
PROVERA 5: Each tablet contains 5 mg medroxyprogesterone acetate.
PROVERA 10: Each tablet contains 10 mg medroxyprogesterone acetate.

PHARMACOLOGICAL CLASSIFICATION:
A 21.8.2 Progesterone with or without oestrogens

PHARMACOLOGICAL ACTION:
Medroxyprogesterone acetate is a progestin which transforms proliferative into secretory endometrium in women with adequate endogenous oestrogen.
Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant oestrogenic activity. Parenterally administered medroxyprogesterone acetate inhibits gonadotropin production, which in turn prevents ovulation and follicular maturation.
PROVERA induses withdrawal bleeding in amenorrhoeic anovulatory women. It also produces secretory changes and a luteal type of vaginal smear in anovulatory patients with adequate oestrogens.

INDICATIONS:
• Dysfunctional uterine bleeding.
• Mild to moderate endometriosis.
• To oppose the endometrial effects of oestrogen in menopausal women treated with oestrogen.
• Alleviation of menopausal vasomotor symptoms.
• Diagnostic uses:
  Primary amenorrhoea
  Secondary amenorrhoea

CONTRA-INDICATIONS
- Thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a past history of these conditions.
- Liver dysfunction or disease.
- Known or suspected malignancy of breast or genital organs
- Undiagnosed vaginal bleeding.
- Missed or incomplete abortion.
- In patients who are known to be sensitive to medroxyprogesterone acetate or any of the tablets’excipients.
- Pregnancy.

WARNING:
The doctor should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism and retinal thrombosis). Should any of these occur or be suspected, the medicine should be discontinued immediately.

DOSAGE AND DIRECTIONS FOR USE:
Dysfunctional uterine bleeding: In dysfunctional uterine bleeding PROVERA may be given in doses ranging from 5 to 10 mg for 5 to 10 days beginning on the assumed or calculated 16th to 21st day of the cycle.
When bleeding is due to a deficiency of both ovarian hormones, as indicated by a poorly developed proliferative endometrium, oestrogens should be used in conjunction with medroxyprogesterone acetate. If bleeding is controlled satisfactorily, two subsequent cycles of treatment should be given.
Endometriosis: Beginning on the first day of the menstrual cycle, 10 mg of PROVERA may be given three times a day for 90 consecutive days.
To oppose the endometrial effects of oestrogen in oestrogen-treated post menopausal women: 5 to 10 mg PROVERA per day for at least 10 days beginning on the 16th day of a 25 day course of oestrogen therapy. Progestin withdrawal bleeding should occur, beginning on the 3rd to 7th day post PROVERA treatment.
Menopause: 10 to 20 mg PROVERA per day given continuously.
Primary and secondary amenorrhoea: 5 to 10 mg PROVERA per day for 10 days. Progestin withdrawal bleeding should ensue within 3-7 days if the endometrium has been previously primed with adequate endogenous oestrogen. Pregnancy must be excluded before administration of PROVERA.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The following medical events, listed in order of seriousness rather than frequency of occurrence, have been associated with the use of progestogens:
- Anaphylaxis and anaphylactoid reactions.
- Thromboembolic phenomena - thrombophlebitis, cerebral thrombosis and pulmonary embolism.
- Central nervous system - nervousness, insomnia, somnolence, fatigue, depression, dizziness and headache.
- Skin and mucous membranes - urticaria, pruritus, oedema, rash (allergic) with or without pruritus, melasma or chloasma, acne, hirsutism and alopecia.
- Gastro-intestinal nausea.
- Breast tenderness and galactorrhoea.
- Miscellaneous:
  pyrexia                                breakthrough bleeding
  changes in weight (increase or decrease)         spotting
  changes in menstrual flow         amenorrhoea
  moon faces         neonatal jaundice
  changes in cervical erosion and cervical secretions         cholestatic jaundice
Pregnancy:
Cases of clitoral hypertrophy have been reported in newborn females, whose mothers received Provera (medroxyprogesterone acetate) during pregnancy. Prolonged postpartum bleeding, postabortal bleeding and missed abortion have been reported. Female foetal masculinization has been observed in patients receiving progestins. Available evidence is suggestive of an association for the following serious adverse reactions:
Neuro-ocular lesions, e.g. retinal thrombosis and optic neuritis.
The following adverse reactions have been observed in patients receiving oestrogen progestin combination drugs:
  rise in blood pressure         backache
  premenstrual-like         erythema multiforme
          syndrome         erythema nodosum
  changes in libido         haemorrhagic eruption
  changes in appetite         cystitis-like syndrome
In view of these observations, patients on progestin therapy should be carefully observed.

PRECAUTIONS:
Discontinue medication if there is sudden partial or complete loss of vision, or if there is sudden onset of proptosis, diplopia or migraine.
Because this drug may cause some degree of fluid retention, it should be used with care in epilepsy, migraine, asthma and cardiac or renal dysfunction.
A decrease in glucose tolerance has been observed in some patients on oestrogen/progestin combination drugs. The mechanism of this decrease is obscure. For this reason diabetic patients should be carefully observed while receiving progestin therapy.
Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
Aminoglutethimide administered concomitantly with PROVERA may significantly depress the bioavailability of PROVERA.
Progestins may mask the onset of the climacteric.
PROVERA should not be given to lactating mothers.
Breakthrough bleeding is likely to occur in patients treated for endometriosis.
The pathologist should be advised of progestin therapy when relevant specimens are submitted.
The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear.
The following laboratory results may be altered by the use of oestrogen progestin combination drugs:
1. Gonadotropin levels.
2. Plasma progesterone levels.
3. Urinary pregnanediol levels.
4. Plasma testosterone levels (in the male).
5. Plasma oestrogen levels (in the female).
6. Plasma cortisol levels.
7. Glucose tolerance test.
8. Metyrapone test: pregnanediol determination.
9. Increased sulfobromophthalein and other hepatic function tests.
10 Coagulation tests: increase in prothrombin factors VII, VIII, IX and X.
11. Thyroid function: increase in PBI and butanol extractable protein bound iodine and decrease in T3 uptake values.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment should be symptomatic and supportive.

IDENTIFICATION:
PROVERA 5: A blue, circular, half-oval, compressed tablet, impressed with U286 on one side and scored on the reverse side.
PROVERA 10: A white, round, semi-oval, convex tablet, scored on one side and marked “Upjohn 50”on the reverse.

PRESENTATION:
PROVERA 5 mg tablets are available in blister packs of 30 and 100 tablets.
PROVERA 10 mg tablets are available in blister packs of 30 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 30°C.
Keep out of reach of children.
Protect from light.

APPLICATION NUMBERS:
PROVERA 5         G2988 (Act/101/1965)
PROVERA 10         Z/21.8.2/363

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Limited
Alphen West G
George Street
MIDRAND
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 1997

TM = Trademark

New addition to this site: February 2005
Source: Pharmaceutical Industry

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