Medroxyprogesterone acetate (10mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Medroxyprogesterone acetate (MPA) is a synthetic derivative of progesterone, a naturally occurring female sex hormone. It is a potent progestin used primarily for secondary amenorrhea, abnormal uterine bleeding, and as part of hormone replacement therapy (HRT). In the Indian context, it is a widely prescribed, cost-effective option for menstrual regulation and endometrial protection.

OnsetDurationBioavailability
Therapeutic effects on endometrium are typically observed within 24-48 hours. Full therapeutic effect for menstrual regulation may take 3-5 days of therapy.Approximately 24 hours per oral dose. Its prolonged action on endometrial tissue can last for several days after discontinuation.Oral bioavailability is nearly complete, approaching 100%.

2. Mechanism of Action

Medroxyprogesterone acetate transforms proliferative endometrium into secretory endometrium. It inhibits the secretion of pituitary gonadotropins (LH and, to a lesser extent, FSH), preventing follicular maturation and ovulation at higher doses. It also exerts an anti-estrogenic effect on the endometrium, making it useful in treating estrogen-induced endometrial hyperplasia.

3. Indications & Uses

  • Secondary Amenorrhea
  • Abnormal Uterine Bleeding due to hormonal imbalance (e.g., anovulatory cycles, endometrial hyperplasia without atypia)

4. Dosage & Administration

Adult Dosage: For secondary amenorrhea: 5-10 mg daily for 5-10 days. Bleeding usually occurs within 3-7 days after discontinuation. For abnormal uterine bleeding: 5-10 mg daily for 5-10 days beginning on day 16 or 21 of the cycle. For endometrial protection with estrogen HRT: 10 mg daily for the last 10-14 days of each estrogen cycle.

Administration: Take orally with or without food, preferably at the same time each day. For cyclic therapy, follow the prescribed schedule strictly (e.g., days 16-25 of a 28-day cycle). A calendar may be helpful.

5. Side Effects

Common side effects may include:

  • Breakthrough bleeding/spotting
  • Amenorrhea (during therapy)
  • Menstrual flow changes
  • Breast tenderness/pain
  • Headache
  • Dizziness
  • Nausea
  • Bloating/abdominal cramps
  • Fatigue
  • Weight changes
  • Acne

6. Drug Interactions

DrugEffectSeverity
AminoglutethimideDecreases MPA levels by inducing hepatic metabolism.Moderate
Rifampicin, RifabutinSignificantly reduce MPA plasma levels via CYP3A4 induction, potentially reducing efficacy.Major
Phenytoin, Carbamazepine, PhenobarbitalReduce MPA plasma levels via enzyme induction.Major
Ketoconazole, ItraconazoleMay increase MPA levels by inhibiting CYP3A4.Moderate
Warfarin and other Coumarin anticoagulantsMPA may decrease anticoagulant effect; monitor INR closely.Moderate
Insulin, Oral HypoglycemicsMPA may decrease glucose tolerance; monitor blood glucose.Moderate
CyclosporineMPA may inhibit metabolism, increasing cyclosporine levels and toxicity risk.Moderate

7. Patient Counselling

  • DO take the medicine exactly as prescribed, at the same time each day.
  • DO use a non-hormonal contraceptive method (barrier) if sexually active, as this dose is not for birth control.
  • DO report any severe headache, chest pain, leg swelling, shortness of breath, or vision changes immediately.
  • DONT take if you are pregnant or suspect pregnancy.
  • DONT smoke, as it greatly increases the risk of serious cardiovascular side effects.
  • DONT start any new medicine (including OTC, herbal like St. John's Wort) without consulting your doctor.

8. Toxicology & Storage

Overdose: Acute oral overdose is unlikely to be life-threatening. Symptoms may include nausea, vomiting, drowsiness, dizziness, and possibly withdrawal bleeding in females. No specific teratogenic effects are expected from a single acute overdose in a non-pregnant woman.

Storage: Store below 30°C. Protect from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.