DEPO-PROVERA
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Package(a):
VIALS: 500 mg (3.3 ml x 150 mg/ml).
Dosage(a):
I.M administration only. Endometrial or renal carcinoma: 400-1000 mg initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month. Not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease.
Breast cancer: 500 mg/day for 28 days. Patient should then be placed on a maintenance schedule of 500 mg 2 x weekly as long as she is responding to the treatment.
Prescribing Restrictions:
Package(b):
VIALS: 1000 mg (6.7 ml x 150 mg/ml).
Dosage(b):
I.M administration only. Endometrial or renal carcinoma: 400-1000 mg initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month. Not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease.
Breast cancer: 500 mg/day for 28 days. Patient should then be placed on a maintenance schedule of 500 mg 2 x weekly as long as she is responding to the treatment.
Prescribing Restrictions:
Indications:
Adjunctive therapy and palliative treatment of inoperable, recurrent and metastatic carcinoma of endometrium, breast, ovary and kidney.
Contra-Indications:
Known or suspected pregnancy or as a diagnostic test for pregnancy. Undiagnosed vaginal bleeding. Known or suspected malignancy of breast. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. Liver dysfunction or disease. Known hypersensitivity to any of the components.
Special Precautions:
If abnormal bleeding persists or is severe, appropriate investigation should be instituted to rule out the possibility of organic pathology. Use may be considered among the risk factors for development of osteoporosis. Long-term case-controlled surveillance of users found slight or no increased overall risk of breast cancer and no overall increased risk of ovarian, liver, or cervical cancer. Thromboembolic disorders. Ocular disorders: Medication should not be readministered pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia or migraine. Accidental pregnancies: Infants from accidental pregnancies that occur 1-2 months after injection may be at increased risk of low birth weight. Such pregnancies are uncommon. Ectopic pregnancy. The pretreatment and annual physical examination should include special reference to breast and pelvic organs, as well as a Papanicolaou smear. Fluid retention. Weight changes. Return of fertility: In a large U.S. study, 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection. The median time to conception for those who do conceive is 10 months following the last injection. Lactation: Adverse effects have not been determined. Patients who have a history of psychic depression should be carefully observed. A decrease in glucose tolerance has been observed, diabetic patients should therefore be carefully observed while receiving such therapy. If jaundice develops, consideration should be given to not readministering the drug. The effect of prolonged use is not known.
Side Effects:
More than 5% of subjects: weight changes, headache, nervousness, abdominal pain or discomfort, dizziness, asthenia. 1%-5%: Insomnia, leukorrhea, acne, vaginitis, pelvic pain, decreased libido or anorgasmia, backache, leg cramps, depression, nausea, edema, hot flashes, arthralgia, breast pain, no hair growth or alopecia, bloating rash. Rise in blood pressure in suceptible individuals, premenstrual syndrome, changes in libido, changes in appetite, cystitis-like syndrome. Fatigue, hirsutism, erythema multiforma, erythema nodosum, hemorrhagic eruption, itching.
Drug Interactions:
Rifampicin, griseofulvin, barbiturates, phenytoin, primidone, carbamazepine.
