Zitotec

Description

Zitotec Tablet: Key Information

Zitotec Tablet contains 100mcg of Misoprostol. It is manufactured by Sun Pharmaceutical Industries Ltd. and is available in Nepal.

Other Available Strengths

Misoprostol is also available as:

• 200mcg Tablet
• 25mcg Tablet

What Zitotec Is Used For (Indications)

Zitotec Tablet is used for:

• Treating NSAID-induced ulcers.
• Termination of pregnancy.
• Treating benign gastric and duodenal ulcers.

Dosage Guidelines

Always follow your doctor’s precise dosage instructions.

Adult Dosing

• NSAID-Induced Ulcer Treatment:
  • 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. Continue for at least 4 weeks, and up to 8 weeks if needed.
  • Prophylaxis (Prevention) of NSAID-induced gastric and duodenal ulcer: 200 mcg 2-4 times daily taken with the NSAID. If this dose is not tolerated, 100 mcg can be used. Misoprostol should be taken for the entire duration of NSAID therapy.
• Induction of Labor:
  • 100 mcg taken orally. If cervical ripening or active labor doesn’t occur, repeat with 100-200 mcg orally every 4 hours until labor is established (Bishop score of 7 or more). Maximum of 6 doses.
• Termination of Pregnancy:
  • Day 1: 200 mg of mifepristone orally as a single dose under physician supervision.
  • Days 2-3: 800 mcg of misoprostol buccally (between cheek and gum) once as a single dose. This must be given at least 24 hours and up to 48 hours after the mifepristone dose on Day 1.
  • Days 7-14: Return for a follow-up visit to confirm complete termination (via medical history, exam, hCG test, or ultrasound). If not complete but pregnancy is not ongoing, another 800 mcg misoprostol buccally dose may be given with follow-up in ~7 days.
  • Lack of bleeding usually means failure; prolonged or heavy bleeding doesn’t guarantee a complete abortion. Surgical evacuation is recommended for ongoing pregnancies after medical abortion.
• Prevention of Postpartum Hemorrhage:
  • 600 mcg orally immediately after delivery.

Child Dose

• Specific dosing for children is not provided.

Renal (Kidney) Impairment

• Use with caution. Peak plasma concentration, half-life, and bioavailability may increase, but the clinical significance is unclear.

Administration

Zitotec Tablet should be taken with food.

Contraindications (Who should NOT use this medication)

Misoprostol is contraindicated in:

• Anyone with a history of allergy to prostaglandins.
• Women of childbearing potential (unless under specific conditions for NSAID use with contraception).
• Pregnant women.
• Lactating (breastfeeding) women.

Important Precautions

• For NSAID-induced ulcer prevention/treatment: Misoprostol is contraindicated in pregnant women and should not be used in women of childbearing potential unless NSAID therapy is required. Such women must be confirmed not pregnant at initiation and must use effective contraception during treatment.
• Use with caution in conditions where low blood pressure (hypotension) could cause severe complications (e.g., cerebrovascular or cardiovascular disease).
• Caution for patients with inflammatory bowel disease or those prone to dehydration.
• Use with caution in elderly patients and those with renal impairment.

Lactation: The drug is rapidly metabolized to misoprostol acid, which is active and excreted in breast milk. Although no published adverse effects in breastfeeding infants exist, caution should be exercised when administered to breastfeeding women.

Drug Interactions

• May increase the effects of oxytocin.
• Increased risk of misoprostol-induced diarrhea with magnesium-containing antacids.

Possible Side Effects (Adverse Effects)

Side effects of Misoprostol include:

Very Common (>10%):

• Diarrhea (14-40%)
• Abdominal pain (13-20%)

Common (1-10%):

• Headache (2%)

Frequency Not Defined (Less Common/Rare):

• Anaphylaxis (severe allergic reaction), Anemia, Cardiac dysrhythmia (irregular heartbeat), Chest pain, Flatulence (gas), Gastrointestinal hemorrhage (bleeding), Hearing loss, Myocardial infarction (heart attack), Nausea, Rupture of uterus, Thromboembolic disorder (blood clots).

How It Works (Mechanism of Action)

Misoprostol is a synthetic prostaglandin E1 analogue. It works by:

• Directly acting on specific prostaglandin receptors on the surface of gastric parietal cells, leading to antisecretory activity (reducing stomach acid).
• Protecting the stomach lining (mucosa) by replacing prostaglandins that are depleted during therapies like NSAID use.

Important Disclaimer

This information about Zitotec 100mcg Tablet from the Farmaco Nepal drug index is for general knowledge only. It is not intended for diagnosis, medical advice, or treatment, nor should it be used as a substitute for professional medical judgment. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.