Mariprist

Description

Mariprist Tablet: Clinical Information

Indications: Mariprist Tablet, a combination of Mifepristone and Misoprostol, is indicated for:

• Medical termination of intrauterine pregnancy up to 63 days (9 weeks) of gestation.
• Early menstrual regulation.

Dosage and Administration (Adults):

The regimen involves a two-step process under medical supervision:

Day 1 (First Visit): Mifepristone Administration

• One tablet of Mifepristone (200 mg) is administered as a single oral dose. This must be taken in a clinical setting (clinic, medical office, or hospital) under the direct supervision of a qualified medical professional.

Day 2 (Second Visit): Misoprostol Administration

• Approximately 24-48 hours after ingesting Mifepristone, the patient takes four tablets of Misoprostol (200 micrograms each, totaling 800 micrograms) buccally.
• The patient can self-administer Misoprostol by placing two tablets on each side of the cheek and gum. The tablets should remain in place for 30 minutes.
• During the period immediately following Misoprostol administration, patients may require medication for cramps or other gestational symptoms.
• Patients should be provided with a contact number for any questions or concerns after Misoprostol administration.

Day 10 to 14 (Follow-up Visit):

• Patients must return to the clinic, medical office, or hospital within 10 to 14 days after Mifepristone administration.
• This follow-up is crucial to confirm complete termination of pregnancy via clinical examination or ultrasonographic scan.
• In cases of ongoing pregnancy at this visit, there is a risk of fetal malformation due to the treatment. Surgical termination, such as Manual Vacuum Aspiration (MVA), is recommended for management of menstrual regulation/pregnancy termination failures.

Pediatric and Renal Dosing:

• Information regarding pediatric and renal dosing is not provided.

Contraindications: Mariprist Tablet is contraindicated in the following conditions:

• Confirmed or suspected ectopic pregnancy.
• Chronic adrenal failure or concurrent long-term corticosteroid therapy.
• History of allergy or hypersensitivity to mifepristone, misoprostol, or other prostaglandins.
• Haemorrhagic disorders or concurrent anticoagulant therapy.
• Porphyria.
• Significant hepatic or renal impairment.
• Known or suspected pregnancy (other than for the purpose of termination).
• Lactation.
• Presence of an intrauterine device (IUD).
• Undiagnosed adnexal mass.

Precautions:

• Mariprist must not be administered if there is any doubt regarding the existence or gestational age of the pregnancy, or if an extra-uterine pregnancy is suspected. An ultrasound scan and/or quantitative Beta-hCG measurement must be performed prior to administration.
• For first-trimester abortions, Mifepristone is contraindicated if the pregnancy is beyond 49 days of amenorrhoea when used in combination with Misoprostol.
• Mifepristone + Misoprostol should never be prescribed to patients with: chronic adrenal failure, known allergy to Mifepristone or any component of the product, severe asthma uncontrolled by corticosteroid therapy, porphyrias, severe renal or liver failure, or malnutrition.
• Caution is advised in patients with conditions predisposing to diarrhea (e.g., inflammatory bowel disease), cardiovascular disease, or disease states where hypotension may precipitate severe complications (e.g., cerebrovascular disease, coronary artery disease, or severe peripheral vascular disease, including hypertension).
• Exercise caution in patients in whom dehydration would be dangerous.
• Close monitoring is required in patients with renal impairment and during lactation.
• Monitoring Parameters: A pregnancy test should be conducted in women of reproductive potential prior to therapy. When used for labor induction, uterine activity and fetal condition should be monitored.

Pregnancy and Lactation:

• This product is specifically for termination of pregnancy.
• Use during lactation is contraindicated.

Drug Interactions:

• Decreased Efficacy: Concomitant use with aspirin and NSAIDs may decrease the efficacy of Mariprist.
• Corticosteroids: Efficacy of corticosteroids (including inhaled corticosteroids) may be decreased; monitor patients during co-administration and for several days afterward.
• Oxytocin: May enhance the effects of oxytocin.
• Magnesium-containing Antacids: Increased risk of misoprostol-induced diarrhea with concurrent use of magnesium-containing antacids.

Adverse Effects:

Mifepristone:

• The treatment is designed to induce vaginal bleeding and uterine cramping.
• Commonly reported side effects include nausea, vomiting, and diarrhea, pelvic pain.
• Less commonly, fainting, headache, dizziness, and asthenia may occur.

Misoprostol:

• Gastrointestinal: Diarrhea, abdominal pain, nausea, flatulence, dyspepsia, vomiting, constipation.
• General: Shivering, hyperthermia, dizziness.
• Uterine/Vaginal: Pain due to uterine contractions, severe vaginal bleeding, pelvic pain, uterine rupture (potentially requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy).
• Other: Shock.

Mechanism of Action:

• Mifepristone: A synthetic steroid with antiprogestational and antiglucocorticoid activity. It acts as a competitive antagonist at the intracellular progesterone receptor, inhibiting progesterone attachment. It also exhibits partial progesterone agonist activity.
• Misoprostol: A synthetic prostaglandin E1 analogue. It exerts its antisecretory activity by directly binding to specific prostaglandin receptors on gastric parietal cells. It also protects the gastric mucosa by replacing prostaglandins depleted by prostaglandin-inhibiting therapies (e.g., NSAIDs).

Note: Mariprist 200mg + 200mcg Tablet is manufactured by Lomus Pharmaceutical Pvt. Ltd. Its generic name is Mifepristone + Misoprostol. Mariprist is available in Nepal. This information from Farmaco Nepal drug index is for informational purposes only and is not intended for diagnosis, medical advice, or treatment, nor is it a substitute for professional medical judgment.