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warnings
WARNINGS 1. Thromboembolic Disorders The physician should be alert to the earliest manifestations of thrombotic disorder (thrombophlebitis, cerebrovascular disorder, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. 2. Ocular Disorders Medication should be discontinued 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. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn. 3. Multi-dose Use Multi-dose use of DEPO-PROVERA Sterile Aqueous Suspension from a single vial requires special care to avoid contamination. Although initially sterile, any multi-dose use of vials may lead to contamination unless strict aseptic technique is observed.
ADVERSE REACTIONS See PRECAUTIONS for possible adverse effects on the fetus Reproductive System and Breast Disorders – breakthrough bleeding – spotting – change in menstrual flow – amenorrhea – changes in cervical erosion and cervical secretions – breast tenderness and galactorrhea – erectile dysfunction Nervous System Disorders – headache – dizziness – somnolence – convulsions Psychiatric Disorders – nervousness – euphoria – mental depression – insomnia General Disorders and Administration Site Conditions – edema – pyrexia – fatigue – malaise – injection site reaction, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling, lipodystrophy acquired, injection site nodule/lump In a few instances there have been undesirable sequelae at the site of injection, such as residual lump, change in color of skin, or sterile abscess. Investigations – change in weight (increase or decrease) Hepatobiliary Disorders – cholestatic jaundice, including neonatal jaundice Skin and Subcutaneous Tissue Disorders – skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash – acne, alopecia and hirsutism – rash (allergic) with and without pruritis Immune System Disorders – anaphylactoid reactions and anaphylaxis – angioedema Gastrointestinal Disorders – nausea Endocrine Disorders – corticoid-like effects (e.g., Cushingoid syndrome) Metabolism and Nutrition Disorders – hypercalcemia A statistically significant association has been demonstrated between use of estrogen-pro-gestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g. retinal thrombosis and optic neuritis. The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: – rise in blood pressure in susceptible individuals – premenstrual syndrome – changes in libido – changes in appetite – cystitis-like syndrome – headache – nervousness – fatigue – backache – hirsutism – loss of scalp hair – erythema multiforma – erythema nodosum – hemorrhagic eruption – itching – dizziness The following laboratory results may be altered by the use of estrogen-progestin combination drugs: – increased sulfobromophthalein retention and other hepatic function tests – coagulation tests: increase in prothrombin factors VII, VIII, IX, and X – metyrapone test – pregnanediol determinations – thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T 3 uptake values