Dexketoprofen is indicated for the symptomatic relief of mild to moderate pain and inflammation, including musculoskeletal pain, menstrual pain, and dental pain.

Dexketoprofen is the S(+)-enantiomer of ketoprofen and is responsible for its analgesic and anti-inflammatory effects. The inactive R(-)-enantiomer does not contribute to the therapeutic activity but increases the metabolic burden. Dexketoprofen is formulated as a trometamol salt, which provides high water solubility and allows rapid absorption through the gastrointestinal tract, resulting in a faster onset of action than ketoprofen. Peak plasma concentrations are reached more quickly than with many commonly used analgesics, with an onset of action of about 30 minutes. After oral administration as tablets, dexketoprofen trometamol reaches maximum plasma concentration (tmax) within 0.25–0.75 hours, whereas the tmax of the S-enantiomer from racemic ketoprofen is between 0.5 and 3 hours. Peak plasma levels of 1.4 mg/L and 3.1 mg/L are achieved after doses of 12.5 mg and 25 mg, respectively. Approximately 70–80% of the dose is excreted in urine within 12 hours, mainly as glucuronide conjugates of the parent drug. No R(-)-ketoprofen is detected in urine after administration of dexketoprofen, confirming the absence of metabolic inversion of the S(+)-enantiomer in humans. The anti-inflammatory effect of dexketoprofen is equivalent to that achieved with twice the dose of ketoprofen.

The dose of Dexketoprofen 25 mg tablets depends on the type, severity, and duration of pain. The recommended dose is generally 1 tablet every 8 hours, with no more than 3 tablets daily. The elderly and patients with renal or hepatic impairment should start treatment with a total daily dose of no more than 2 tablets. Normally it is recommended to take the tablets with food. In the case of acute pain, it is recommended that tablets be taken at least 30 minutes before meals. Dexketoprofen is not recommended for children.

The following medicines should not be used concurrently with dexketoprofen: other non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants, lithium, methotrexate, hydantoins (used for epilepsy), and certain sulphonamide antibiotics (e.g. sulfamethoxazole). It may also interact with medicines used to treat high blood pressure such as ACE inhibitors, diuretics, and beta-blockers, as well as pentoxifylline, zidovudine, cyclosporine, and tacrolimus. In addition, caution is required with oral antidiabetic drugs (sulphonylureas), thrombolytic agents, probenecid, cardiac glycosides, mifepristone, and quinolone antibiotics.

Dexketoprofen tablets are not recommended for patients who are allergic to this medicine, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs). It should be avoided in individuals who have experienced asthma attacks, bronchospasm, acute rhinitis, nasal polyps, urticaria, or angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) after taking aspirin or other NSAIDs. It is also contraindicated in patients with current or previous peptic ulcer or chronic gastrointestinal disorders, a history of gastrointestinal bleeding, bronchial asthma, severe heart failure, moderate to severe renal impairment, or severely impaired liver function. Additionally, it should not be used in patients with bleeding or clotting disorders, those taking anticoagulants, or in pregnant and breastfeeding women.

As with all medicines, dexketoprofen 25 mg tablets may cause unwanted effects in some patients. These are typical of non-steroidal anti-inflammatory drugs (NSAIDs) and are listed below:

• Common (1–10%): nausea, vomiting, diarrhoea, stomach pain, or heartburn.
• Uncommon (0.1–1%): sleep disturbances, nervousness, headache, dizziness, vertigo, palpitations, constipation, dry mouth, flatulence, skin rash, fatigue, hot flushes, shivering, and general malaise.
• Rare (0.01–0.1%): stomach ulcer, gastric bleeding or perforation, tingling sensations, high blood pressure, fluid retention, slowed breathing, increased liver enzymes, and increased sweating.
• Very rare / isolated cases (<0.01%): blurred vision, tinnitus, low blood pressure, blood disorders, liver or kidney damage, skin and photosensitivity reactions, bronchospasm, or anaphylaxis.

In patients with systemic lupus erythematosus or mixed connective tissue disease, anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

Dexketoprofen tablets are not recommended for use during pregnancy or breastfeeding.

Caution should be exercised when using dexketoprofen tablets in patients who are allergic to other NSAIDs, or who have kidney disease, liver disease, heart disease, or fluid retention. It should also be used carefully in patients with blood disorders, systemic lupus erythematosus, or mixed connective tissue disease.

This medicine should not be administered to children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Store below 30°C, protected from light and moisture. Keep out of reach of children.