📋 Clinical Overview

Progesterone (50mg/ml) is a sterile, micronized, injectable formulation of the natural female sex hormone, progesterone. It is a key therapeutic agent in gynecology and reproductive medicine, primarily used for luteal phase support, secondary amenorrhea, and dysfunctional uterine bleeding. The micronized formulation in oil (typically sesame or castor oil) ensures sustained release and prolonged action, making it a cornerstone for hormonal replacement therapy (HRT) and assisted reproductive technology (ART) protocols in India.

💊 Dosage & Administration

Adult: Luteal Support (ART): 50-100 mg IM daily, starting on the day of oocyte retrieval or embryo transfer, continued for up to 10-12 weeks of gestation. Secondary Amenorrhea: 5-10 mg IM daily for 6-8 consecutive days. Dysfunctional Uterine Bleeding: 5-10 mg IM daily for 6 days. HRT (with estrogen): 50 mg IM every 4 weeks or as per regimen.

Note: For DEEP INTRAMUSCULAR INJECTION ONLY, preferably in the upper outer quadrant of the gluteus maximus. Use a 21-23 gauge, 1.5-inch needle. Aspirate before injection to ensure needle is not in a blood vessel. Inject slowly. Rotate injection sites. Do not administer intravenously. Warm the vial between palms to reduce viscosity.

⚠️ Contraindications

Known hypersensitivity to progesterone, peanuts, or sesame oil (common vehicle)
Undiagnosed abnormal genital bleeding
Known or suspected carcinoma of the breast
Active or history of thromboembolic disorders (e.g., DVT, PE, stroke, MI)
Severe hepatic dysfunction or disease (e.g., liver tumors)
Missed abortion
Known or suspected pregnancy in the absence of a clear indication (e.g., for luteal support)

🔬 Mechanism of Action

Progesterone is the principal endogenous progestogen. It transforms the estrogen-primed proliferative endometrium into a secretory one, which is essential for implantation and maintenance of pregnancy. It decreases myometrial excitability and contractility. It also promotes mammary gland development and exerts negative feedback on the hypothalamic-pituitary-ovarian axis, inhibiting gonadotropin secretion.

🤕 Side Effects

Pain, swelling, redness at injection site
Drowsiness, somnolence
Dizziness
Breast tenderness
Headache
Bloating, abdominal cramping
Mood swings, irritability

🤰 Special Populations

Pregnancy: US FDA Category B. Used therapeutically for luteal phase support in early pregnancy under strict medical supervision. Not indicated for use in all trimesters. Risk of hypospadias in male fetuses with first-trimester use is debated but considered low.

Driving: May cause drowsiness and dizziness. Patients should not drive or operate machinery until they know how the drug affects them.

🔄 Drug Interactions

Ketoconazole, Itraconazole, Fluconazole	Increased progesterone levels due to CYP3A4 inhibition	Moderate
Rifampicin, Carbamazepine, Phenytoin, St. John's Wort	Decreased progesterone efficacy due to CYP3A4 induction	Moderate
Other CNS Depressants (Alcohol, Benzodiazepines, Opioids)	Additive sedative effects	Moderate
Enzyme Inducing Anti-Epileptic Drugs (e.g., Phenobarbital)	Reduced contraceptive efficacy if used for that purpose	Moderate

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