Progesterone

Progesterone (500mg)
Price: ₹180 - ₹350 per strip of 10 capsules (200mg)
Mfr: Macleods Pharmaceuticals Ltd. | Form: Soft Gelatin Capsules

📋 Clinical Overview

Progesterone 500mg is a high-dose, micronized, oral formulation of the natural female sex hormone, progesterone. It is a progestogen used primarily in hormone replacement therapy (HRT) and for the treatment of secondary amenorrhea. The micronization process enhances its oral bioavailability by improving dissolution and absorption. In the Indian context, it is a critical component of assisted reproductive technology (ART) protocols and is widely used in gynecological endocrinology.

💊 Dosage & Administration

Adult: Secondary Amenorrhea: 400 mg daily at bedtime for 10 days. HRT (Sequential): 200 mg daily for the last 12-14 days of each estrogen cycle. Luteal Phase Support (ART): 400-600 mg daily in divided doses, starting after oocyte retrieval and continuing for up to 10-12 weeks of pregnancy.

Note: Take orally, preferably at bedtime to minimize dizziness and drowsiness. Can be taken with or without food, but taking with food may improve tolerance. Swallow the soft gelatin capsule whole with a full glass of water. Do not crush or chew.

⚠️ Contraindications

  • Known hypersensitivity to progesterone or any component
  • Undiagnosed abnormal genital bleeding
  • Known, suspected, or history of hormone-dependent neoplasia (e.g., breast cancer, endometrial cancer)
  • Active or history of arterial thromboembolic disease (e.g., MI, stroke)
  • Active or recent (within 6 months) venous thromboembolism (DVT, PE)
  • Severe hepatic dysfunction or disease (e.g., hepatocellular carcinoma, active hepatitis)
  • Porphyria
  • Missed abortion
  • Ectopic pregnancy

🔬 Mechanism of Action

Progesterone binds to and activates the intracellular progesterone receptor (PR), a nuclear hormone receptor. The hormone-receptor complex translocates to the nucleus, binds to specific progesterone response elements (PREs) on DNA, and modulates the transcription of target genes. This results in the transformation of the estrogen-primed proliferative endometrium into a secretory one, inhibition of gonadotropin secretion (LH surge), and maintenance of pregnancy.

🤕 Side Effects

  • Drowsiness, somnolence
  • Dizziness
  • Headache
  • Breast tenderness or pain
  • Bloating, abdominal cramping
  • Mood swings, irritability
  • Fatigue
  • Nausea
  • Breakthrough bleeding or spotting

🤰 Special Populations

Pregnancy: US FDA Category B. Progesterone is used extensively to support pregnancy in ART. It is considered safe when used as indicated. However, it should not be used to prevent habitual abortion without confirmation of progesterone deficiency.

Driving: May cause significant drowsiness and dizziness. Patients should be cautioned against driving or operating heavy machinery, especially when initiating therapy or taking the dose during daytime.

🔄 Drug Interactions

Ketoconazole, Itraconazole, FluconazoleIncreased progesterone levels due to CYP3A4 inhibition. Risk of enhanced side effects.Major
Rifampicin, Carbamazepine, Phenytoin, St. John's WortDecreased progesterone levels due to CYP3A4 induction. May lead to therapeutic failure.Major
Midazolam, TriazolamEnhanced sedative effect of benzodiazepines due to additive CNS depression.Moderate
WarfarinProgesterone may alter anticoagulant effect; monitor INR closely.Moderate
AntihypertensivesProgesterone may blunt the effect, leading to increased blood pressure.Moderate
Insulin, Oral HypoglycemicsProgesterone may decrease glucose tolerance; monitor blood sugar.Moderate

🔁 Alternatives to Progesterone

Same composition (Progesterone (500mg)), different brands:

Susten Progeffik Lutogest Utrogestan