Medicinal Products

DEPO-PRODASONE 250 mg / 5 mL

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Medroxyprogesterone
laboratory: Pfizer Holding France

IM Injectable Suspension
Box of 1 bottle of 5 ml
All forms

Indication

This medicine is indicated in the following situations:

· Treatment of metastatic hormone-dependent breast cancer,

· Treatment of endometrial cancers after surgery,

· Endometriosis.

Dosage DEPO-PRODASONE 250 mg / 5 mL Suspension for injection IM Box of 1 vial of 5 ml

Administration mode

· This medicine must be injected intramuscularly deep.

· Do not inject intravenously.

· Shake the bottle well before use.

· A strict asepsis should be observed.

Dosage

· Treatment of metastatic hormone-dependent breast cancer: 500 to 1000 mg per week,

· Treatment of endometrial cancers after surgery: 500 to 1000 mg per week,

· Endometriosis: 150 to 250 mg per month.

Hepatic insufficiency :

No clinical studies have evaluated the impact of hepatic impairment on the pharmacokinetics of medroxyprogesterone acetate. However, medroxyprogesterone acetate, which is almost exclusively eliminated by hepatic metabolism, is reported to be weakly metabolized in patients with severe hepatic insufficiency (see Contraindications - contraindications).

Renal failure :

No clinical studies have evaluated the impact of renal impairment on the pharmacokinetics of medroxyprogesterone acetate.

However, since medroxyprogesterone acetate is almost exclusively eliminated by hepatic metabolism, no dose adjustment should be required in patients with renal impairment.

Against indications

This medicine is contraindicated in the following situations:

· Hypersensitivity to the active substance or to any of the excipients,

· Accidents or history of venous thromboembolic events (phlebitis, pulmonary embolism),

· Accidents or arterial thromboembolic history (particularly myocardial infarction, stroke),

· Severe liver test abnormalities, severe liver injury,

· Undiagnosed female haemorrhages,

· Association with St. John's Wort (see section Interactions with other medicinal products and other forms of interaction ).

Depo-Prodasone side effects

The reported adverse effects are presented in the table below:

System

Side effects

Immune system disorders

Hypersensitivity reactions related to the presence of propyl and methyl parahydroxybenzoate, possibly delayed and exceptionally, bronchospasm

Endocrine disorders

Corticosteroid-like effects (Cushing syndrome type)

Metabolism and nutrition disorders

Weight change, Aggravation of diabetes, edema / fluid retention

Psychiatric disorders

Depression, Nervousness, Confusion, Libido Modification, Insomnia

Nervous system disorders

Dizziness, Headache, Loss of concentration, Somnolence, Cerebral infarction, Adrenergic-like effects (fine hand tremor, sweating, night cramps in the calves)

Eye disorders

Vision Disorders, Diabetic Cataract, Thrombosis, Retinal

Heart conditions

Myocardial infarction, Congestive heart failure, Palpitations, Tachycardia

Vascular disorders

Augmentation of functional symptoms related to venous insufficiency of the lower extremities, Thromboembolic disorders, Thrombophlebitis

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

Gastrointestinal disorders

Constipation, Diarrhea, Dry mouth, Nausea, Vomiting

Hepatobiliary disorders

Hepatic involvement including cholestatic

Skin and subcutaneous tissue disorders

Acne, Alopecia, Hirsutism, Pruritus, Eruption, Urticaria, Chloasma

Renal and urinary disorders

glycosuria

Disorders of reproductive organs and breast

Menstrual cycle disorder (irregularity, increased or decreased bleeding), Amenorrhea, Meningorrhagia, Disturbance of cervical (cervico-vaginal) secretions, Cervical erosions, Prolonged anovulation, Galactorrhea, Mastodynia, Breast strain

General disorders and administration site conditions

Fatigue, Injection site reaction, Malaise, Fever

investigations

Appetite change, Abnormal liver function tests, Decreased glucose tolerance, Increased blood pressure, Decreased biological markers of endocrine activity: plasma and urinary steroids, plasma and urinary gonadotropins, hormone-binding proteins Decreased blood levels of ACTH and hydrocortisol

During post-marketing surveillance, rare cases of osteoporosis including osteoporotic fractures have been reported.

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