Diclofenac Sodium + Misoprostol

Generic Details

Generic Name

Diclofenac Sodium Misoprostol

Other Names

  • Arthrotec

Drug Class

  • Nonsteroidal Anti-inflammatory Drug (NSAID)
  • Prostaglandin

Chemical Formula

C22H33NO7

Molecular Weight

441.496 g/mol

Mechanism of Action

  • Diclofenac: inhibits COX enzymes leading to decreased prostaglandin synthesis
  • Misoprostol: prostaglandin analog that protects the stomach lining and reduces acid secretion

Indications

  • Rheumatoid arthritis
  • Osteoarthritis
  • Pain management
  • Prevention of NSAID-induced gastric ulcers

Common Dosage Forms

  • Tablet

Typical Dosage

  • 50 mg diclofenac / 200 mcg misoprostol taken 2-4 times a day with food

Pediatric Dosage

  • Not recommended for children under 18 years

Geriatric Dosage

  • Adjust dosage according to individual patient needs and renal function

Side Effects

  • Nausea
  • Diarrhea
  • Abdominal pain
  • Headache
  • Dizziness

Contraindications

  • Hypersensitivity to NSAIDs
  • Active peptic ulcer disease
  • Pregnancy (category X)

Pregnancy Category

  • Category X - Not recommended for use during pregnancy due to potential risk to fetus

Lactation Safety

  • Misoprostol is excreted in breast milk, caution advised in lactating women

Drug Interactions

  • Avoid concomitant use with other NSAIDs or anticoagulants

Overdose Symptoms

  • Severe stomach pain
  • Vomiting
  • Black, tarry stools

Antidote for Overdose

  • Supportive care and symptomatic treatment

Storage Conditions

  • Store at room temperature away from moisture and heat

Pharmacokinetics

  • Absorption: Both diclofenac and misoprostol are well absorbed orally
  • Distribution: Both drugs widely distribute in the body
  • Metabolism: Diclofenac undergoes hepatic metabolism; misoprostol is metabolized in the liver to its active form
  • Excretion: Both drugs are excreted renally

Precautions

  • Increased risk of cardiovascular events
  • Monitor for signs of gastrointestinal bleeding or ulcers

Warnings

  • Increased risk of serious cardiovascular thrombotic events
  • May cause gastrointestinal bleeding, ulceration, and perforation

Others