Europe — EMA
Misofenac (Diclofenac Sodium, Misoprostol)
GNH USA supplies Misofenac (Diclofenac Sodium / Misoprostol), a nonsteroidal anti-inflammatory and gastroprotective drug for musculoskeletal pain and ulcer
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What is 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 USA supplies Misofenac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Diclofenac Sodium, Misoprostol used for?
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.
What are the side effects of Diclofenac Sodium, Misoprostol?
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)
What precautions apply to Diclofenac Sodium, Misoprostol?
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.
What does Diclofenac Sodium, Misoprostol interact with?
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.



