Product image of Misofenac (Diclofenac Sodium, Misoprostol) supplied by GNH India

Misofenac

Active Ingredient:
Diclofenac Sodium, Misoprostol
Origin:
EU

Misofenac (Diclofenac Sodium, Misoprostol)

Diclofenac sodium / misoprostol, the active ingredient in Misofenac, is a nonsteroidal anti‑inflammatory drug and prostaglandin E1 analogue presented as an oral dosage form for oral use. It provides analgesic and anti‑inflammatory effects for musculoskeletal pain while simultaneously protecting the gastric mucosa in patients receiving chronic NSAID therapy. The combination is indicated for conditions such as osteoarthritis and rheumatoid arthritis, where inflammation and pain are prominent, and for prophylaxis against NSAID‑induced gastric ulceration.

GNH India supplies Misofenac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Pfizer Italia S.R.L.

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Indications & Clinical Uses

Misofenac combines a NSAID with a gastroprotective prostaglandin analogue and is used for pain, inflammation, and ulcer prevention in musculoskeletal disorders.

  • Osteoarthritis: reduces joint pain and inflammation, improving function and mobility.
  • Rheumatoid arthritis: alleviates inflammatory joint pain and swelling, supporting daily activities.
  • Prevention of NSAID‑induced gastric ulcers: protects gastric mucosa in patients receiving chronic NSAID therapy.

How It Works

  • Diclofenac sodium inhibits cyclo‑oxygenase‑1 and cyclo‑oxygenase‑2 enzymes, decreasing prostaglandin synthesis and thereby reducing pain and inflammation. Misoprostol, a prostaglandin E1 analogue, binds to EP receptors in the gastric lining, stimulating mucus and bicarbonate secretion and enhancing mucosal blood flow, which together protect the stomach from NSAID‑related injury. Both components are absorbed systemically after oral administration, reaching therapeutic concentrations in plasma and target tissues.

Side Effects

Misofenac may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Abdominal pain
  • Dyspepsia
  • Nausea
  • Diarrhea
  • Headache
  • Dizziness

Serious or Rare Side Effects

  • Gastrointestinal ulcer or bleeding
  • Severe liver injury (hepatotoxicity)
  • Acute renal failure or worsening renal function
  • Hypersensitivity reactions such as Stevens‑Johnson syndrome
  • Cardiovascular events (e.g., myocardial infarction, stroke)

Precautions & Warnings

Before prescribing Misofenac, clinicians should consider several precautionary measures to minimize risk.

  • Assess cardiovascular risk: NSAIDs may increase the likelihood of thrombotic events.
  • Monitor renal function: diclofenac can reduce renal perfusion, especially in dehydrated patients.
  • Evaluate hepatic status: both agents may affect liver enzymes and require periodic testing.
  • Contraindicated in pregnancy: category X due to risk of fetal toxicity and premature closure of the ductus arteriosus.
  • Use with caution in the elderly: higher susceptibility to gastrointestinal and renal adverse effects.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light.

Avoid Interactions

Misofenac can interact with other medicines, altering efficacy or safety.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): increased risk of bleeding.
  • Concurrent NSAIDs or COX‑2 inhibitors: additive gastrointestinal toxicity.
  • ACE inhibitors or ARBs: may impair renal function when combined with diclofenac.

Moderate Interactions (Monitor Closely)

  • Lithium: diclofenac may raise lithium serum concentrations.
  • Methotrexate: reduced clearance can lead to toxicity.
  • Corticosteroids: combined use heightens risk of gastric ulceration.

Frequently Asked Questions

Misofenac is prescribed to relieve pain and inflammation associated with musculoskeletal disorders such as osteoarthritis and rheumatoid arthritis. It is also used to protect the stomach lining in patients who require long‑term NSAID therapy, thereby reducing the risk of NSAID‑induced gastric ulcers.

Diclofenac sodium blocks cyclo‑oxygenase‑1 and cyclo‑oxygenase‑2, lowering prostaglandin production and thus reducing pain and inflammation. Misoprostol mimics prostaglandin E1, stimulating gastric mucus and bicarbonate secretion and improving mucosal blood flow, which together safeguard the stomach from NSAID‑related damage.

The appropriate dose of Misofenac is determined by the prescribing healthcare professional based on the individual’s medical condition, response to therapy, and other relevant factors. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Misofenac is classified as pregnancy category X, meaning it is contraindicated during pregnancy because of potential fetal harm, including premature closure of the ductus arteriosus. Use while breastfeeding is not recommended unless the benefits outweigh the risks, and a healthcare provider should be consulted.

To order Misofenac, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials. The team then replies with pricing, availability, shipping details and any required import documentation.

Misofenac uniquely combines diclofenac, a potent NSAID, with misoprostol, a prostaglandin E1 analogue that directly protects the gastric lining. Compared with NSAID‑only products, it offers comparable analgesic efficacy while providing built‑in ulcer prophylaxis, potentially reducing the need for separate proton‑pump inhibitors or H2 blockers.

Misofenac should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and do not use it after the expiry date indicated on the label.

Misofenac is taken orally, usually with a full glass of water. It may be taken with or without food, but patients who experience stomach upset are advised to take it with meals to lessen gastrointestinal discomfort.

Serious risks include gastrointestinal bleeding or ulceration, severe liver injury, acute kidney impairment, hypersensitivity reactions such as Stevens‑Johnson syndrome, and cardiovascular events like heart attack or stroke. Patients should seek immediate medical attention if they notice signs such as black stools, jaundice, sudden swelling, or severe skin rash.

Misofenac should be avoided in individuals with known hypersensitivity to diclofenac, misoprostol, or any component of the formulation. It is also contraindicated in pregnant women, patients with active peptic ulcer disease, severe heart failure, uncontrolled hypertension, and those taking certain interacting medications without close medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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