Medabon

Medabon Tablet: Clinical Information

Medabon Tablet, a combination of Mifepristone and Misoprostol, is primarily used for medical termination of intrauterine pregnancy up to 63 days (9 weeks) of gestation and early menstrual regulation.

Dosage and Administration (Adults)

The regimen for Medabon Tablet involves a two-step process that must be carried out under strict medical supervision:

• Day 1 (First Visit): Mifepristone Administration One Mifepristone (200 mg) tablet is taken as a single oral dose. This must be administered in a clinic, medical office, or hospital by a qualified medical professional.
• Day 2 (Second Visit): Misoprostol Administration 24-48 hours after taking Mifepristone, the patient takes four Misoprostol (200 microgram each, totaling 800 micrograms) tablets buccally. The patient can self-administer these by placing two tablets on each side of the cheek and gum, allowing them to dissolve for 30 minutes. Patients may experience cramps or gestational symptoms following Misoprostol administration and might require medication for relief. Patients should be provided with a phone number for any questions or concerns.
• Day 10 to 14 (Follow-up Visit) A crucial follow-up visit to the clinic, medical office, or hospital is required 10 to 14 days after Mifepristone administration. This visit confirms the complete termination of pregnancy through clinical examination or ultrasonographic scan. If pregnancy continues, there’s a risk of fetal malformation. In such cases, surgical termination or Manual Vacuum Aspiration (MVA) is recommended to manage treatment failures.

Contraindications

Medabon Tablet is contraindicated in patients with:

• Confirmed or suspected ectopic pregnancy.
• Chronic adrenal failure or concurrent long-term corticosteroid therapy.
• History of allergy to mifepristone, misoprostol, or other prostaglandins.
• Haemorrhagic disorders or concurrent anticoagulant therapy.
• Porphyria.
• Significant hepatic or renal impairment.
• Existing pregnancy (other than for termination) and lactation.
• An IUD in place.
• An undiagnosed adnexal mass.

Precautions

• Medabon must not be administered if there is any doubt about the existence or gestational age of the pregnancy, or if an extra-uterine pregnancy is suspected. An ultrasound scan and/or Beta-hCG measurement must be performed beforehand.
• For first-trimester abortions, Mifepristone is contraindicated if the pregnancy is beyond 49 days of amenorrhoea when used with Misoprostol.
• The drug should never be prescribed to patients with chronic adrenal failure, known allergy to Mifepristone or any component, severe asthma uncontrolled by corticosteroid therapy, porphyrias, renal failure, liver failure, malnutrition, or during breastfeeding.
• Use with caution in patients prone to diarrhea (e.g., inflammatory bowel disease); those with cardiovascular disease; or conditions where hypotension could lead to severe complications (e.g., cerebrovascular disease, coronary artery disease, severe peripheral vascular disease, including hypertension).
• Avoid use in patients where dehydration would be dangerous.
• Monitoring Parameters: A pregnancy test should be done before therapy for women of reproductive potential. If used for labor induction, monitor uterine activity and fetal condition.

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 magnesium-containing antacids.

Adverse Effects

Mifepristone: The treatment is designed to induce vaginal bleeding and uterine cramping. Common side effects include nausea, vomiting, diarrhea, and pelvic pain. Rarely, fainting, headache, dizziness, and asthenia can occur.

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

Mechanism of Action

• Mifepristone acts as a progesterone antagonist with antiglucocorticoid activity. It binds to the intracellular progesterone receptor, competitively inhibiting progesterone attachment. It also shows partial progesterone agonist activity.
• Misoprostol, a synthetic prostaglandin E1 analogue, works by acting directly on specific prostaglandin receptors on gastric parietal cells, exerting antisecretory activity. It also protects the mucosa by replacing prostaglandins consumed during therapies like NSAID use.

Note: Medabon 200mg + 200mcg Tablet is manufactured by Sun Pharmaceutical Industries Ltd. Its generic name is Mifepristone + Misoprostol. Medabon 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 judgment.