Progesterone 50 mg/mL

Basic Info

CAS Number	57-83-0
Active Ingredient	Progesterone (pregn-4-ene-3,20-dione)
Dosage Form	Oil vial
Specification & Packaging	Strength: 50 mg/mL Pack: 1 × 10 mL vial Group: 02 Item No.: 25

Storage & Common Excipients

Storage Conditions	Tightly closed, protected from light, 15–25 °C; vegetable-oil injectables are generally stored at room temperature — follow the label
Common Excipients	Typical oil formulation: sesame/sunflower/olive oil, polysorbate 80, benzyl alcohol, benzyl benzoate, edetate disodium; confirm against COA

Product Introduction

An endogenous progestogen. Injectable progesterone is a long-established dosage form, while micronised oral, vaginal and combined (with oestrogen) products are now more common

Therapeutic Use

Support of threatened and habitual miscarriage, luteal insufficiency, menstrual irregularity/ dysfunctional uterine bleeding, adjunct in endometriosis, menopausal hormone therapy (with oestrogen), and some gynaecological oncology settings; indications follow the local approved label

Mode of Action

Low oral bioavailability owing to extensive first-pass metabolism, hence injection or specialised formulations; acts through the progesterone receptor to upregulate progestogenic target genes; has progestogenic with mild anti-androgenic and anti-oestrogenic activity

Administration & Monitoring

As prescribed (commonly intermittent intramuscular dosing — every other day or weekly — to maintain concentrations); monitor luteal-function indicators and bleeding patterns; note interactions with ovulation-induction agents and oestrogens

Important Safety Information

Prescription medicine. Use with caution or avoid in patients with a history of thrombosis, breast cancer or other hormone-sensitive tumours. True progesterone allergy is rare, but oil excipients can cause hypersensitivity

Adverse Reactions

Injection-site pain, induration, abscess; breast tenderness, mood swings, somnolence; headache; rare thromboembolic events; hypersensitivity (usually excipient-related)

Important Risks

Thrombosis and thromboembolism risk, particularly with a history of thrombosis, obesity or smoking; may mask progression of endometriosis or malignancy; gynaecological review required for long-term use

Contraindications

Hypersensitivity; known or suspected breast, endometrial or other hormone-dependent malignancy; active thrombosis or history of thromboembolism; unexplained vaginal bleeding before malignancy has been excluded; severe hepatic or renal impairment; lactation (particularly transdermal preparations)

Special Populations

Pregnancy is the principal treatment population, under specialist supervision; not recommended in lactation; used in women planning pregnancy as directed; not applicable to children

Usage Limitations

Prescription-only; administration requires professional technique with site rotation; periodic gynaecological review for long-term therapy. Note for athletes: progesterone itself is not on the WADA Prohibited List, but progestogens may feature in the Monitoring Program

Anti-Doping Testing

Progesterone is not on the WADA Prohibited List; it is, however, among the substances covered by the WADA Monitoring Program, so blood and urine samples may be collected to establish baseline concentrations

Product Quality Testing

Identification (HPLC/MS/FTIR), assay and content uniformity, related substances, clarity and particulate matter, fill volume, sterility and endotoxin, residual solvents, stability; COA