Generic drug of the therapeutic class: Contraception and termination of pregnancy
active ingredients: Medroxyprogesterone
laboratory: Pfizer Holding France
Bottle of 3 ml
All forms
Indication
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
Administration mode
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.
Dosage
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.
Against indications
· 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
· Obesity
· Diabetes, due to a decrease in glucose tolerance;
· Hypertension;
· 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:
System | Side effects |
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 |
Psychiatric disorders | Decreased libido or anorgasmia, Insomnia, Depression, Nervousness |
Nervous system disorders | Seizures, vertigo, headache, drowsiness |
Vascular disorders | Arterial and venous thromboembolic disorders, Hot flashes |
Gastrointestinal disorders | Abdominal pain, Bloating, Nausea |
Hepatobiliary disorders | 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 |
investigations | 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.
