Dexketoprofen (Dexonal) 25 mg – [10 tablets]

Description

Dexonal Pharmacodynamics
Dexetoprofen trometamol, active substance of Dexonal®, belongs to nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, anti-inflammatory and antipyretic effect. The mechanism of action of dexetoprofen is based on inhibition of prostaglandin synthesis at the level of cyclooxygenases (COX-1 and COX-2).
Analgesic effect occurs 30 min after oral administration of Dexonal® , duration of therapeutic effect reaches 4-6 hours.

Indications
Musculoskeletal pain (mild to moderate), algodysmenorrhea, toothache
The drug is intended for symptomatic treatment, reduction of pain and inflammation at the time of application.

Contraindications
– Hypersensitivity to dexketoprofen, other components of the drug and other NSAIDs;
– complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis and intolerance to acetylsalicylic acid or other NSAIDs (including anamnesis);
– erosive-ulcerative lesions of the gastrointestinal tract in the acute stage;
– gastrointestinal bleeding or perforations in history, including those associated with previous use of NSAIDs;
– gastrointestinal bleeding; other active bleeding (including suspected intracranial hemorrhage);
– inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute stage;
– severe hepatic insufficiency (10-15 points on the Child-Pugh scale);
– progressive kidney disease, confirmed hyperkalemia;
– Chronic kidney disease: stage 3a (glomerular filtration rate (GFR) 45- 59 ml/min/1.73 m2), 3b (GFR 30-44 ml/min/1.73 m2) and 4 (GFR <30 ml/min/1.73 m2);
– period after aortocoronary bypass surgery;
– severe heart failure (NYHA class III-IV);
– hemorrhagic diathesis and other blood clotting disorders;
– Under 18 years of age (due to lack of efficacy and safety data);
– pregnancy and breastfeeding.

Dosage and administration

• Dexonal® is taken orally with meals. Simultaneous intake of food slows down absorption of Dexketoprofen, therefore in case of acute pain it is recommended to use the drug at least 30 minutes before a meal.
• Depending on intensity of pain syndrome the recommended dose for adults is 12.5 mg dexketoprofen (1/2 tablet Dexonal®) every 4-6 hours or 25 mg dexketoprofen (1 tablet Dexonal®) every 8 hours.
• Maximal daily dose is 75 mg.
• The drug is not intended for long-term therapy, the course of drug treatment should not exceed 3-5 days.
• Patients aged 65 years and older.
• Elderly patients should take the drug, starting from the lowest recommended dose. The maximum daily dose is 50 mg. If well tolerated, doses recommended for the general population may be used.
• Patients with hepatic impairment
• Patients with mild to moderate hepatic impairment should take the drug starting with the minimum recommended dose. Maximum daily dose is 50 mg.
• Administration of Dexonal® in patients with severe hepatic insufficiency is contraindicated.
• Patients with renal insufficiency.
  Patients with mild renal insufficiency – chronic kidney disease, stage 2 (GFR 60-89 ml/min/ 1.73 m2) should take the preparation using the lowest recommended dose.
• Maximum daily dose is 50 mg. This medicine is contraindicated in patients with chronic kidney disease stages 3a (FFR 45-59 ml/min/1.73 m2), 3b (FFR 30-44 ml/min/1.73 m2) and 4 (FFR <30 ml/min/1.73 m2).