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 non‑steroidal anti‑inflammatory drug (NSAID) presented as an injectable solution for intramuscular and intravenous use. It provides analgesic and anti‑inflammatory effects for mild to moderate pain, post‑operative discomfort, musculoskeletal pain and other inflammatory conditions in adult patients.

GNH India supplies Mialdex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory conformity across EU and global markets, with reliable logistics and comprehensive support for partners.

Manufacturer / TM Owner

Uab Inteli Generics Nord

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Indications & Clinical Uses

Dexketoprofen Trometamol is used to manage pain and inflammation in several clinical settings.

  • Mild to moderate pain: provides rapid analgesia for acute pain episodes, improving patient comfort and functional ability.
  • Post‑operative pain: reduces pain and inflammation after surgical procedures, facilitating early mobilization and recovery.
  • Musculoskeletal pain: alleviates pain associated with strains, sprains and overuse injuries, supporting return to activity.
  • Inflammatory conditions: helps control inflammation in conditions such as bursitis or tendonitis, decreasing swelling and discomfort.

How It Works

  • Dexketoprofen Trometamol exerts its effect by non‑selectively inhibiting cyclooxygenase enzymes COX‑1 and COX‑2, which blocks the conversion of arachidonic acid to prostaglandins. The reduction in prostaglandin synthesis diminishes peripheral sensitisation of nociceptors and decreases inflammatory mediators, resulting in analgesic and anti‑inflammatory actions. The trometamol salt enhances aqueous solubility, allowing rapid intravenous or intramuscular administration and quick plasma concentrations, which contributes to its fast onset of analgesia.

Side Effects

Dexketoprofen Trometamol may cause adverse reactions, which are categorised by frequency and severity.

Common Side Effects

  • Nausea: mild gastrointestinal upset.
  • Headache: transient headache.
  • Dizziness: light‑headed sensation.
  • Injection site pain: discomfort at the site of administration.

Serious or Rare Side Effects

  • Gastrointestinal bleeding: severe ulceration or hemorrhage.
  • Renal impairment: sudden decrease in kidney function.
  • Allergic reactions: rash, pruritus, or anaphylaxis.

Precautions & Warnings

When prescribing Dexketoprofen Trometamol, clinicians should consider several precautions to minimise risk.

  • Assess renal function: avoid use in patients with severe renal impairment.
  • Evaluate gastrointestinal risk: use cautiously in those with history of ulcers or bleeding.
  • Monitor cardiovascular status: NSAIDs may increase risk of thrombotic events.
  • Check for hypersensitivity: discontinue if signs of allergic reaction appear.
  • Use lowest effective dose: limit duration to the shortest necessary period.
  • Store at ambient temperature: keep below 25°C, protect from moisture and light in original packaging.

Avoid Interactions

Dexketoprofen Trometamol can interact with other medicines, affecting efficacy or safety.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): increased bleeding risk.
  • Other NSAIDs or COX‑2 inhibitors: heightened gastrointestinal toxicity.
  • Corticosteroids: additive risk of ulceration.

Moderate Interactions (Monitor Closely)

  • ACE inhibitors or ARBs: may reduce renal function.
  • Diuretics: potential for decreased renal perfusion.
  • Lithium: NSAIDs can raise lithium levels.

Frequently Asked Questions

Mialdex contains dexketoprofen trometamol and is indicated for the relief of mild to moderate pain, post‑operative discomfort, musculoskeletal pain and other inflammatory conditions where an NSAID is appropriate.

The drug blocks both COX‑1 and COX‑2 enzymes, reducing the formation of prostaglandins that mediate pain and inflammation. Lower prostaglandin levels decrease peripheral sensitisation of nerve endings, providing analgesic and anti‑inflammatory effects.

The specific dose and frequency of Mialdex are determined by the prescribing clinician based on the patient’s condition, severity of pain, and clinical response. No fixed regimen is provided here.

Safety data for dexketoprofen trometamol in pregnancy and lactation are limited. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and under medical supervision.

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 S‑enantiomer of ketoprofen, offering a faster onset of analgesia and potentially better tolerability than racemic ketoprofen. Compared with ibuprofen or naproxen, it provides comparable pain relief with a shorter time to peak effect.

Store Mialdex at ambient temperature, preferably below 25 °C. Keep the vials in their original packaging, protect from moisture and light, and ensure the container is sealed when not in use.

Mialdex is supplied for parenteral use and may be given by intramuscular injection or intravenous infusion, according to the prescribing information and clinical setting.

Serious adverse events include gastrointestinal bleeding or ulceration, acute renal impairment, and severe allergic reactions such as anaphylaxis. Patients should be monitored for signs of these conditions, especially if they have pre‑existing risk factors.

Mialdex is contraindicated in patients with known hypersensitivity to dexketoprofen, other NSAIDs, or any component of the formulation, as well as in individuals with active gastrointestinal bleeding, severe renal failure, or those receiving certain anticoagulants without careful monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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