Mifeprin KIT

Description

Mifeprin KIT Tablet: Clinical Information

Mifeprin KIT Tablet, combining Mifepristone and Misoprostol, is primarily indicated for the medical termination of intrauterine pregnancy up to 63 days (9 weeks) of gestation and for early menstrual regulation.

Dosage and Administration (Adults)

The Mifeprin KIT regimen follows a two-step process, requiring administration under medical supervision:

• Day 1 (First Visit): Mifepristone Administration One Mifepristone (200 mg) tablet is taken orally as a single dose. This must occur in a clinic, medical office, or hospital under the direct supervision of a qualified medical professional.
• Day 2 (Second Visit): Misoprostol Administration24-48 hours after taking the Mifepristone tablet, the patient administers four Misoprostol tablets (200 micrograms each, totaling 800 micrograms) buccally. The patient can place two tablets on each side of the cheek and gum and allow them to dissolve for 30 minutes. Patients may experience cramps or gestational symptoms and might need medication for relief. Patients should receive a phone number for any questions or concerns after Misoprostol administration.
• Day 10 to 14 (Follow-up Visit) A crucial follow-up visit is required 10 to 14 days after Mifepristone administration at the clinic, medical office, or hospital. This visit is essential to confirm complete termination of pregnancy through clinical examination or ultrasonographic scan. If pregnancy continues, there is a risk of fetal malformation due to the treatment. In such cases, surgical termination or Manual Vacuum Aspiration (MVA) is recommended to manage failures of menstrual regulation or pregnancy termination.

Contraindications

Mifeprin KIT Tablet is contraindicated in individuals with:

• 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.
• Existing pregnancy (other than for the purpose of termination) and lactation.
• An intrauterine device (IUD) in place.
• An undiagnosed adnexal mass.

Precautions

• Mifepristone + Misoprostol should 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 with Misoprostol.
• The product 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, malnutrition, or during breastfeeding.
• Exercise caution 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).
• Avoid use in patients where 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 before therapy. If used for labor induction, uterine activity and fetal condition should be monitored.

Interactions

• Decreased efficacy with aspirin and NSAIDs.
• Reduced efficacy of corticosteroids (including inhaled); monitor patients during co-administration and for several days afterward.
• May increase effects of oxytocin.
• 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. Common side effects include nausea, vomiting, and diarrhea, pelvic pain. Rarely, fainting, headache, dizziness, and asthenia may occur.

Misoprostol: Gastrointestinal side effects include diarrhea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting, and constipation. Other effects can include shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, and uterine rupture (potentially requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy).

Mechanism of Action

• Mifepristone: A synthetic steroid with antiprogestational and antiglucocorticoid activity. It binds to the intracellular progesterone receptor, competitively 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: Mifeprin KIT Tablet is manufactured by Sun Pharmaceutical Industries Ltd. Its generic name is Mifepristone + Misoprostol. Mifeprin KIT is available in Nepal. This information from the Farmaco Nepal drug index is for informational purposes only and is not intended for diagnosis, medical advice, or treatment; neither is it a substitute for professional medical judgment.