Progesterone Micronized (Capsule)

Generic Details

Generic Name

Progesterone Micronized Capsule

Other Names

  • Micronized Progesterone Capsule
  • Micronized Progesterone Softgel

Drug Class

  • Progestin
  • Hormone

Chemical Formula

C21H30O2

Molecular Weight

314.46 g/mol

Mechanism of Action

  • Binds to progesterone receptors, modulating gene expression and inhibiting ovulation

Indications

  • Hormone replacement therapy in menopausal women
  • Support of pregnancy in assisted reproductive technology (ART) procedures
  • Treatment of irregular menstrual cycles
  • Prevention of endometrial hyperplasia in menopausal women receiving estrogen therapy

Common Dosage Forms

  • 100 mg
  • 200 mg

Typical Dosage

  • 100-200 mg once daily at bedtime for hormone replacement therapy
  • 400 mg per day in divided doses for ART support

Pediatric Dosage

  • Not established

Geriatric Dosage

  • Adjust dosage based on individual patient needs and response

Side Effects

  • Breast tenderness
  • Headache
  • Nausea
  • Dizziness
  • Fatigue
  • Irregular vaginal bleeding

Contraindications

  • Known or suspected pregnancy
  • Breast cancer
  • Liver disease
  • Undiagnosed vaginal bleeding

Pregnancy Category

  • Category B - Progesterone is generally considered safe for use during pregnancy

Lactation Safety

  • Not recommended during breastfeeding due to potential risk to the infant

Drug Interactions

  • Warfarin
  • Corticosteroids
  • Theophylline

Overdose Symptoms

  • Dizziness
  • Fatigue
  • Nausea
  • Breast tenderness

Antidote for Overdose

No specific antidote; symptomatic and supportive care

Storage Conditions

  • Store at controlled room temperature between 20-25°C (68-77°F)
  • Protect from light and moisture

Pharmacokinetics

  • Absorption: Well absorbed orally
  • Distribution: Highly bound to plasma proteins
  • Metabolism: Metabolized in the liver
  • Excretion: Mainly excreted in urine

Precautions

  • Monitor lipid profiles in patients with hyperlipidemia
  • Monitor liver function tests in patients with hepatic impairment

Warnings

  • Increased risk of breast cancer
  • Increased risk of cardiovascular events in postmenopausal women with or without a uterus

Others

  • It is important to inform the healthcare provider about all other medications, including over-the-counter drugs and herbal supplements, before starting progesterone therapy.