Generic drug of the therapeutic class: Contraception and termination of pregnancy
active ingredients: Medroxyprogesterone
laboratory: Pfizer Holding France
IM Injectable Suspension
Bottle of 3 ml
Long-acting contraceptive (3 months) when it is not possible to use other contraceptive methods.
Dosage DEPO-PROVERA 150 mg / 3 mL Suspension for injection IM 3 ml bottle
This medication should be administered intramuscularly deep into the gluteal or deltoid muscles.
To ensure a regular resorption of the product, it is absolutely necessary to inject beyond the adipose panniculus into the muscular masses.
Do not administer intravenously.
Shake the bottle well before use. A strict asepsis must be observed.
An injection of 3 ml of suspension, ie 150 mg of medroxyprogesterone acetate, allows a contraceptive coverage of three months.
The first dose should be administered within 3 to 5 days after the onset of menstruation.
· Hypersensitivity to the active substance or to any of the excipients;
· Abnormal liver tests, liver damage;
· History or history of venous thromboembolic events (phlebitis, pulmonary embolism),
· Arterial thromboembolic events or antecedents (especially myocardial infarction, stroke)
· Undiagnosed genital haemorrhages;
· Breast and endometrial cancer
· Diabetes, due to a decrease in glucose tolerance;
· Uterine fibroids ;
· Association with St. John's wort (see section Interactions with other medicinal products and other forms of interaction ).
Depo-Provera side effects
The reported adverse effects are presented in the table below:
Immune system disorders
Hypersensitivity reactions related to the presence of propyl and methyl parahydroxybenzoate, possibly delayed and exceptionally, bronchospasm
Metabolism and nutrition disorders
Fluid retention, weight gain
Decreased libido or anorgasmia, Insomnia, Depression, Nervousness
Nervous system disorders
Seizures, vertigo, headache, drowsiness
Arterial and venous thromboembolic disorders, Hot flashes
Abdominal pain, Bloating, Nausea
Hepatic involvement including cholestatic
Skin and subcutaneous tissue disorders
Acne, Alopecia, Hirsutism, Pruritus, Eruption, Urticaria
Musculoskeletal and systemic disorders
Arthralgia, back pain, cramps of the lower limbs
Disorders of reproductive organs and breast
Vaginitis, menstrual cycle disorders (irregularity, increased or decreased bleeding), amenorrhoea, menometrorrhagia, leucorrhoea, pelvic pain, prolonged anovulation, galactorrhea, pain or breast tenderness
General disorders and administration site conditions
Fatigue, asthenia, injection site reactions, fever
Loss of bone mineral density. Decreased glucose tolerance. Anomaly of liver tests. Decreased biological markers of endocrine activity include plasma and urinary steroids, plasma and urinary gonadotropins, sex hormone binding proteins.
During post-marketing surveillance, rare cases of osteoporosis including osteoporotic fractures have been reported.