Pregno

Description

Pregno Tablet, containing Mifepristone, is used for:

• Termination of pregnancy
• Labour induction
• Cervical softening and dilatation
• Postcoital contraception

It is manufactured by OHM Pharmaceuticals Lab Pvt. Ltd. and is available in Nepal.

Dosage and Administration

Adults: For Pregnancy Termination

• Mifepristone is indicated for the medical termination of intrauterine pregnancy through 70 days gestation, in combination with misoprostol.
  • Day 1: Take 200 mg of mifepristone orally (PO) as a single dose under physician supervision.
  • Days 2-3: Take 800 mcg of MISOPROSTOL buccally once as a single dose. This must be administered a minimum of 24 hours and a maximum of 48 hours following the mifepristone dose on Day 1.
  • Days 7-14: You must return for a follow-up visit to confirm complete termination has occurred by medical history, clinical examination, hCG testing, or ultrasonographic scan.
    • If complete expulsion has not occurred, but the pregnancy is not ongoing, women may be treated with another dose of misoprostol 800 mcg buccally with follow-up in approximately 7 days.
    • Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion.
    • Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion.

Administration Details (Oral and Buccal):

• Oral (Mifepristone): 200 mg PO once, given by a healthcare provider in a clinic, medical office, or hospital.
• Buccal (Misoprostol): Administer misoprostol 800 mcg buccally within 24-48 hours after taking Mifeprex. The effectiveness of the regimen may be lower if misoprostol is administered less than 24 hours or greater than 48 hours after mifepristone administration.
  • Place two 200 mcg misoprostol tablets in each cheek pouch (the area between the cheek and gums) for 30 minutes and then swallow any remnants with water or another liquid.
  • Discuss with the patient an appropriate location for her to be when she takes the misoprostol, as expulsion could begin within 2 hours of administration and most women will expel the pregnancy within 2-24 hours of taking misoprostol.
  • During the period immediately following the administration of misoprostol, the patient may need medication for cramps or gastrointestinal symptoms.

Child Dose:

• Information not provided in the text.

Special Populations

• Renal Dose:
  • Information not provided in the text.
• Hepatic and Renal Impairment: This medication is contraindicated in hepatic or renal impairment.

Important Considerations

• Administration: May be taken with or without food.
• Contraindications: Do not use Pregno if you have confirmed or suspected ectopic pregnancy, chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or other prostaglandin, haemorrhagic disorders or concurrent anticoagulant therapy, porphyria, hepatic or renal impairment, an IUD in place, or an undiagnosed adnexal mass. This medication is also contraindicated during pregnancy and lactation.
• Precautions: Use with caution in patients with hemostatic disorders or anemia and malnutrition. Also, use with caution in patients taking strong CYP3A4 inhibitors (when used in the treatment of Cushing’s syndrome).
• Pregnancy-Lactation: This medication is contraindicated during pregnancy and lactation. Mifepristone is distributed in human milk; due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
• Monitoring Parameters:
  • Termination of pregnancy: Monitor hemoglobin (Hb), hematocrit, and red blood cell (RBC) count in cases of heavy bleeding; complete blood count (CBC) in patients who show signs of infection. Conduct clinical exam and/or ultrasound to confirm complete termination of pregnancy.
  • Cushing’s syndrome (if applicable for other uses of Mifepristone): Monitor thyroid function, serum glucose, psychiatric symptoms, and signs/symptoms of adrenal insufficiency; cushingoid appearance.

Drug Interactions

• Increased serum levels: With CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin).
• Decreased serum levels: With CYP3A4 inducers (e.g., dexamethasone, rifampicin, phenytoin).
• Potentially Fatal:
  • 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 can include:

• >10%: Abdominal pain, cramping (96%), uterine cramping (83%), nausea (43-61%), headache (2-31%), vomiting (1-26%), diarrhea (12-20%), dizziness (1-12%).
• 1-10% (Mifeprex): 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 is a progesterone antagonist with antiglucocorticoid activity. It binds to the intracellular progesterone receptor where it competitively inhibits progesterone attachment. It is also a partial progesterone agonist.

This information on Pregno Tablet is for general understanding and is not intended for diagnosis, medical advice, or treatment; neither intended to be a substitute for the exercise of professional judgment.