Product image of Mialdex (Dexketoprofen Trometamol) supplied by GNH India

Mialdex

Active Ingredient:
Dexketoprofen Trometamol
Origin:
EU

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

Manufacturer / TM Owner

Uab Inteli Generics Nord

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Indications & Clinical Uses

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.

How It Works

  • Dexketoprofen Trometamol exerts its effect by non‑selectively inhibiting cyclooxygenase‑1 (COX‑1) and cyclooxygenase‑2 (COX‑2) enzymes, which blocks the conversion of arachidonic acid to prostaglandins. The resulting decrease in prostaglandin synthesis leads to reduced peripheral sensitisation, pain perception, and inflammatory responses at the site of injury or disease.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

Mialdex contains dexketoprofen trometamol, an NSAID that is used to relieve mild to moderate pain and to reduce inflammation. It is commonly prescribed for musculoskeletal discomfort, post‑operative pain, and acute inflammatory conditions where rapid analgesia is needed.

Dexketoprofen trometamol works by blocking both COX‑1 and COX‑2 enzymes, which are essential for prostaglandin production. By lowering prostaglandin levels, the drug diminishes the inflammatory response and reduces the sensation of pain at the peripheral sites of injury.

The appropriate dose of Mialdex is determined by the prescribing clinician based on the patient’s condition, age, renal and hepatic function, and other individual factors. Patients should follow the dosage instructions provided by their healthcare professional.

Safety of dexketoprofen trometamol in pregnancy or lactation has not been fully established. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and this decision must be made by a qualified healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Dexketoprofen trometamol is the active enantiomer of ketoprofen, offering rapid onset of analgesia with a potentially lower gastrointestinal risk profile compared with some non‑selective NSAIDs. However, individual response and safety vary, so clinicians choose the most appropriate NSAID based on patient history and therapeutic goals.

Mialdex should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture, and store it away from direct sunlight to maintain its stability and potency.

Mialdex is administered orally. The tablet or oral formulation should be swallowed with a full glass of water, preferably with food or after a meal to minimise gastrointestinal irritation, unless otherwise directed by a healthcare professional.

Serious risks include gastrointestinal bleeding or ulceration, severe allergic reactions such as anaphylaxis, renal impairment, and cardiovascular events like hypertension or thrombotic complications. Patients should be monitored for these events, especially if they have pre‑existing risk factors.

Mialdex should be avoided in individuals with known hypersensitivity to dexketoprofen, other NSAIDs, or any of the excipients. It is also contraindicated in patients with active gastrointestinal ulceration, severe renal or hepatic impairment, and in those receiving anticoagulant therapy without careful medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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