Misopil

Misopil Tablet (Misoprostol)

Misopil 200mcg Tablet, manufactured by Lomus Pharmaceutical Pvt. Ltd., is available in Nepal. Its generic name is Misoprostol.

Indications

Misopil Tablet is used for:

• Prevention and treatment of NSAID-induced ulcers (gastric and duodenal).
• Medical termination of pregnancy (in combination with mifepristone).
• Induction of labor.
• Prevention of postpartum hemorrhage.
• Treatment of benign gastric and duodenal ulcers.

Dosage Information

Adult Dosing (Oral)

• NSAID-Induced Ulcer (Treatment of benign gastric and duodenal ulceration and NSAID associated ulceration):
  • 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime.
  • Treatment should continue for at least 4 weeks and may extend up to 8 weeks if necessary.
• Prophylaxis of NSAID-Induced Gastric and Duodenal Ulcer:
  • 200 mcg 2-4 times daily taken with NSAID.
  • If this dose is not tolerated, 100 mcg can be used.
  • Misoprostol should be taken for the duration of NSAID therapy.
• Induction of Labor:
  • Initial dose: 100 mcg.
  • If cervical ripening or active labor does not occur, repeat doses of 100-200 mcg can be given every 4 hours until labor is established (evidenced by a Bishop score of 7 or more).
  • Maximum number of doses is 6.
• Termination of Pregnancy (in combination with Mifepristone):
  • Day 1: 200 mg of mifepristone orally as a single dose under physician supervision.
  • Days 2-3: 800 mcg of misoprostol buccally 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: Return for a follow-up visit to confirm complete termination (by medical history, clinical exam, hCG testing, or ultrasound).
  • 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 usually indicates failure; however, prolonged or heavy bleeding is not proof of complete abortion.
  • Surgical evacuation is recommended for ongoing pregnancies after medical abortion.
• Prevention of Postpartum Hemorrhage:
  • 600 mcg orally immediately following delivery.

Pediatric Dose

• Specific pediatric dosing information is not provided in the original text.

Renal Impairment

• Use with caution. Peak plasma concentration, half-life, and bioavailability may be increased, but the clinical relevance of these increases is unclear.

Administration

• Misopil Tablet should be taken with food.
• Buccal Administration (for pregnancy termination): Place two 200 mcg misoprostol tablets in each cheek pouch (between the cheek and gums) for 30 minutes, then swallow any remnants with water or another liquid.

Contraindications

Misopil Tablet is contraindicated in:

• Anyone with a history of allergy to prostaglandins.
• Women of childbearing potential (unless highly effective contraception is used and the patient is fully informed).
• Pregnancy and lactation (except when used specifically for pregnancy termination or labor induction under medical supervision, or for postpartum hemorrhage prevention).

Precautions

Use Misopil Tablet with caution in:

• Women of childbearing potential: Must not be pregnant when Misopil therapy is initiated for ulcer prevention/treatment with NSAIDs, and they must use an effective contraception method while taking misoprostol.
• Conditions where hypotension might precipitate severe complications (e.g., cerebrovascular or cardiovascular disease).
• Inflammatory bowel disease.
• Patients prone to dehydration.
• Elderly patients.
• Renal impairment.

Pregnancy and Lactation

• Lactation: Misoprostol is rapidly metabolized in the mother to misoprostol acid, which is biologically active and excreted in breast milk. Although no published reports of adverse effects in breast-feeding infants exist, caution should be exercised when misoprostol is administered to breastfeeding women.
• Pregnancy: Contraindicated for ulcer indications in pregnant women due to its abortifacient effects. Used specifically for pregnancy termination and labor induction under medical supervision.

Drug Interactions

• May increase effects of oxytocin.

• Increased risk of misoprostol-induced diarrhea with magnesium-containing antacids.

Adverse Effects

Side effects of Misoprostol:

Very Common (>10%):

• Diarrhea (14-40%)

• Abdominal pain (13-20%)

Common (1-10%):

• Headache (2%)

Frequency Not Defined (less common or rare, but serious):

• Anaphylaxis

• Anemia

• Cardiac dysrhythmia

• Chest pain

• Flatulence

• Gastrointestinal hemorrhage

• Hearing loss

• Myocardial infarction

• Nausea

• Rupture of uterus

• Thromboembolic disorder

Mechanism of Action

Misoprostol is a synthetic prostaglandin E1 analogue. It exerts its antisecretory activity by directly acting on specific prostaglandin receptors found on the surface of gastric parietal cells, thereby suppressing gastric acid secretion. It also exerts its protective effects on the mucosa by replacing prostaglandins that are consumed or inhibited during therapies like NSAID use.

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.