Europe — EMA
Mialdex (Dexketoprofen Trometamol)
GNH USA supplies Mialdex (Dexketoprofen Trometamol), a nonsteroidal anti-inflammatory drug for mild to moderate pain and inflammation.
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What is Dexketoprofen Trometamol?
Dexketoprofen Trometamol, the active ingredient in Mialdex, is a nonsteroidal anti-inflammatory drug (NSAID) presented as an oral formulation for oral use. It is indicated for the relief of mild to moderate pain and for reducing inflammation in various conditions. GNH USA supplies Mialdex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Dexketoprofen Trometamol used for?
Dexketoprofen Trometamol acts as an NSAID to manage pain and inflammation across several clinical settings.
- Mild to moderate pain: provides rapid analgesia for everyday pain complaints. - Musculoskeletal pain: reduces discomfort associated with strains, sprains and arthritis. - Post‑operative pain: helps control pain after surgical procedures. - Inflammatory conditions: diminishes swelling and tenderness in acute inflammatory states.
What are the side effects of Dexketoprofen Trometamol?
Adverse reactions may vary in frequency and severity.
Common Side Effects: - Gastro‑intestinal discomfort: nausea, dyspepsia or abdominal pain. - Headache: mild to moderate intensity. - Dizziness or vertigo. - Skin reactions: mild rash or pruritus. - Elevated liver enzymes: transient increase in hepatic markers.
Serious or Rare Side Effects: - Gastro‑intestinal bleeding or ulceration. - Severe allergic reactions: anaphylaxis, angioedema. - Renal impairment: acute kidney injury. - Hepatotoxicity: significant liver enzyme elevation. - Cardiovascular events: hypertension or thrombotic episodes. - Blood dyscrasias: thrombocytopenia or leukopenia.
What precautions apply to Dexketoprofen Trometamol?
Before prescribing Dexketoprofen Trometamol, clinicians should consider several safety aspects. - Renal function: evaluate baseline kidney status, especially in the elderly. - Hepatic function: assess liver enzymes and avoid use in severe hepatic impairment. - Cardiovascular risk: use the lowest effective dose in patients with hypertension or heart disease. - Gastro‑intestinal history: avoid in individuals with active ulcers or a history of GI bleeding. - Concomitant NSAIDs or anticoagulants: monitor for additive bleeding risk. - Store at ambient temperature: keep in the original packaging, protect from moisture and direct sunlight.
What does Dexketoprofen Trometamol interact with?
Dexketoprofen Trometamol may interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Anticoagulants (e.g., warfarin): increased risk of serious bleeding. - Other NSAIDs or aspirin: heightened gastrointestinal toxicity. - Corticosteroids: synergistic risk of ulceration and bleeding. - ACE inhibitors or ARBs: potential for reduced renal function.
Moderate Interactions (Monitor Closely): - Diuretics: may exacerbate renal impairment. - Lithium: NSAIDs can raise lithium serum levels. - Methotrexate: reduced clearance leading to toxicity. - SSRIs or SNRIs: additive bleeding risk. - Beta‑blockers: possible attenuation of antihypertensive effect.



