Medicinal Products

DEPO-PROVERA 150 mg / 3 mL

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
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.

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