Medroxyprogesterone acetate 150 mg/mL

Basic Info

CAS Number	71-58-9
Active Ingredient	Medroxyprogesterone acetate (MPA)
Dosage Form	Aqueous suspension
Specification & Packaging	Strength: 150 mg/mL Pack: 1 vial Group: 01 Item No.: 17

Storage & Common Excipients

Storage Conditions	Tightly closed, protected from light, 15–25 °C. Aqueous suspensions must not be frozen (they may not redisperse); follow the label
Common Excipients	Typical aqueous suspension: povidone (PVP), polysorbate 80, sodium chloride, benzyl alcohol, methylcellulose/carboxymethylcellulose sodium, edetate disodium; confirm against COA

Product Introduction

A synthetic progestogen with a long clinical history spanning contraception, gynaecological oncology and endometriosis. The entries here are intramuscular microsuspension/long-acting injectable presentations

Therapeutic Use

Long-acting contraception (every 3 months), palliative treatment of advanced breast cancer, endometrial cancer, adjunctive treatment of endometriosis, uterine fibroids, and high-dose regimens in some central precocious puberty; indications follow the locally approved label

Mode of Action

High progestogenic with low androgenic activity; long oral half-life (up to tens of hours); suppresses gonadotropins and ovulation; at high doses exerts anti-androgenic and anti-oestrogenic effects

Administration & Monitoring

Administer on the defined cycle; monitor menstrual pattern, blood pressure, weight, blood glucose and lipids; assess bone density during long-term use (especially adolescent girls); perform routine gynaecological and cervical screening

Important Safety Information

Prescription medicine. Contraindicated in smokers (not recommended in women over 35) because of raised cardiovascular and stroke risk. Contraindicated in previous breast cancer or venous thrombosis. Contraindicated during breastfeeding

Adverse Reactions

Menstrual disturbance and spotting; breast tenderness; nausea and headache; mood changes; acne and hirsutism; weight gain and fluid retention; venous thrombosis; osteoporosis with long-term use; cervical intraepithelial neoplasia debate (screening per label)

Important Risks

Venous thrombosis and stroke risk (higher with smoking, obesity and older age); osteoporosis; metabolic and weight effects; tumour risk related to prolonged hormonal exposure; prolonged suppression of ovulation with delayed recovery after discontinuation

Contraindications

Known or suspected breast cancer; active or previous venous thrombosis/thromboembolism; known or suspected endometrial cancer or uterine abnormality; severe hepatic impairment; pregnancy (absolute in contraceptive use); lactation; smoking in women over 35; unexplained vaginal bleeding before malignancy has been excluded; recent ischaemic heart disease or stroke

Special Populations

Use with caution in adolescents (effects on bone development and density); contraceptive use in women of childbearing potential; substantially higher cardiovascular risk above 45 years; dose adjustment or avoidance in hepatic/renal impairment

Usage Limitations

Prescription-only, with cycle management; deep intramuscular injection; periodic follow-up for long-term users. Note for athletes: some progestogens fall within WADA monitoring or review scope — check the current-year list

Anti-Doping Testing

Medroxyprogesterone acetate was formerly on the WADA Prohibited List S3 (hormones and hormonal metabolism modulators) and was moved to the Monitoring Program in 2009. It is not currently prohibited but remains within Monitoring Program scope, and athletes must declare its use when sampled

Product Quality Testing

Identification (FTIR/HPLC/MS), assay and content uniformity, related substances, particle-size distribution (suspension forms), pH, fill volume, withdrawability/reconstitution ease, sterility and endotoxin, residual solvents, stability including in-use stability; COA