Mtpill

Description

Mtpill Tablet (Mifepristone)

Mtpill 200mg Tablet, manufactured by Cipla Ltd., is available in Nepal. Its generic name is Mifepristone.

Indications

Mtpill Tablet is primarily used for:

• Medical termination of intrauterine pregnancy (up to 70 days gestation) in combination with misoprostol.
• It also has indications in labor induction, cervical softening and dilatation, and postcoital contraception, though its primary listed use in this context is pregnancy termination.

Dosage Information

Adult Dosing (for Pregnancy Termination – up to 70 days gestation)

The regimen involves two medications: Mifepristone (Mtpill) and Misoprostol.

• Day 1:
  • Take 200 mg of Mifepristone (Mtpill) orally as a single dose, under the supervision of a physician.
• Days 2-3:
  • Take 800 mcg of Misoprostol buccally as a single dose.
  • Misoprostol must be administered a minimum of 24 hours and a maximum of 48 hours following the mifepristone dose on Day 1.
• Days 7-14:
  • Follow-up visit is mandatory to confirm complete termination of pregnancy. This can be done through medical history, clinical examination, hCG testing, or ultrasonographic scan.
  • If complete expulsion has not occurred, but the pregnancy is not ongoing, an additional dose of misoprostol 800 mcg buccally may be given, with follow-up in approximately 7 days.
  • Lack of bleeding after treatment usually indicates failure. However, prolonged or heavy bleeding does not necessarily confirm a complete abortion.
  • Surgical evacuation is recommended for ongoing pregnancies after medical abortion.

Pediatric Dose, Renal Dose

• Specific pediatric and renal dosing information for Mifepristone is not provided in the original text, however, contraindications for renal impairment are noted.

Administration

• Mtpill (Mifepristone) may be taken with or without food.
• Mifepristone (200 mg): Given orally as a single dose by a healthcare provider in a clinic, medical office, or hospital.
• Misoprostol (Buccal Administration):
  • Administer 24-48 hours after Mifepristone. Effectiveness may be lower if misoprostol is given outside this window.
  • Patients should be advised that expulsion of the pregnancy typically occurs within 2-24 hours after taking misoprostol, and they should choose an appropriate location considering expulsion could start within 2 hours of administration.
  • Instruct the patient to place two 200 mcg misoprostol tablets (total 400 mcg per cheek, 800 mcg total) in each cheek pouch (between the cheek and gums) for 30 minutes, then swallow any remaining remnants with water or another liquid.
  • Medication for cramps or gastrointestinal symptoms may be needed shortly after misoprostol administration.

Contraindications

Mtpill Tablet is contraindicated in patients with:

• Confirmed or suspected ectopic pregnancy.
• Chronic adrenal failure.
• Concurrent long-term corticosteroid therapy.
• History of allergy to mifepristone, misoprostol, or other prostaglandins.
• Hemorrhagic disorders or concurrent anticoagulant therapy.
• Porphyria.
• Hepatic or renal impairment.
• Pregnancy and lactation (for pregnancy termination, this refers to situations beyond the specified gestational limits or other specific conditions).
• Intrauterine device (IUD) in place.
• Undiagnosed adnexal mass.

Precautions

Use Mtpill Tablet with caution in:

• Patients with hemostatic disorders or anemia.
• Patients with malnutrition.
• Patients taking strong CYP3A4 inhibitors (when used in the treatment of Cushing’s syndrome – Note: While Mifepristone has this additional indication, the primary use listed for Mtpill is pregnancy termination.).
• Hepatic and renal impairment (note: severe impairment is a contraindication).
• Lactation (see detailed note below).

Monitoring Parameters:

• For Termination of Pregnancy: Monitor hemoglobin (Hb), hematocrit, and red blood cell (RBC) count in cases of heavy bleeding. Conduct a clinical exam and/or ultrasound to confirm complete termination.
• For Cushing’s Syndrome: Monitor thyroid function, serum glucose, psychiatric symptoms, and signs/symptoms of adrenal insufficiency/cushingoid appearance (These parameters apply when Mifepristone is used for Cushing’s syndrome, not typically for pregnancy termination).

Pregnancy and Lactation

• Lactation: Mifepristone is distributed into human milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
• Pregnancy: Contraindicated for pregnancy termination beyond 70 days gestation or in cases of ectopic pregnancy.

Drug Interactions

• Increased Serum Levels of Mifepristone: With CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin).
• Decreased Serum Levels of Mifepristone: With CYP3A4 inducers (e.g., dexamethasone, rifampicin, phenytoin).
• Potentially Fatal Interactions:
  • Increased risk of adverse effects with simvastatin, lovastatin, and CYP3A4 substrates with a narrow therapeutic range (e.g., ciclosporin, pimozide, ergotamine).
  • Antagonizes the effect of glucocorticoids.
  • Increased risk of vaginal bleeding with anticoagulants.

Adverse Effects

Side effects of Mifepristone:

Very Common (>10%):

• Abdominal pain, cramping (96%)
• Uterine cramping (83%)
• Nausea (43-61%)
• Headache (2-31%)
• Vomiting (1-26%)
• Diarrhea (12-20%)
• Dizziness (1-12%)

Common (1-10%):

• Fatigue (10%)
• Back pain (9%)
• Decreased hemoglobin >2 g/dL (6%)
• Uterine hemorrhage (5%)
• Viral infection (4%)
• Dyspepsia (3%)
• Insomnia (3%)
• Rigors (3%)
• Vaginitis (3%)
• Anemia (2%)
• Anxiety (2%)
• Fainting (2%)
• Leg pain (2%)
• Leukorrhea (2%)
• Pelvic pain (2%)
• Sinusitis (2%)
• Weakness (2%)

Mechanism of Action

Mifepristone acts as a progesterone antagonist with antiglucocorticoid activity. It binds to the intracellular progesterone receptor, where it competitively inhibits progesterone attachment. It also exhibits partial progesterone agonist activity.

Disclaimer: This information is for general knowledge and is not intended for diagnosis, medical advice, or treatment. It is not a substitute for professional medical judgment. Always consult with a healthcare professional for any medical concerns