- active substance: dexketoprofen;
- 1 ml of the drug contains dexketoprofen 25 mg;
- other components: ethanol 96%, sodium chloride, sodium hydroxide, water for injections.
Dosage form. Solution for injection.
Basic physical and chemical properties: transparent colorless solution.
2 ml in ampoules №10 (5'2), №10 (10'1) in a blister in a box.
Indications for use:
Symptomatic treatment of acute pain of moderate to high intensity in cases where oral administration of the drug is inappropriate, for example, with postoperative pain, renal colic and lower back pain.
- Hypersensitivity to dexketoprofen, any other non-steroidal anti-inflammatory drug (NSAID) or to excipients of the drug;
- if substances of similar action, for example, acetylsalicylic acid or other NSAIDs, provoke the development of attacks of bronchial asthma, bronchospasm, acute rhinitis or cause the development of nasal polyps, the appearance of urticaria or angioedema;
- if photoallergic or phototoxic reactions occur during treatment with ketoprofen or fibrate;
- with a history of gastrointestinal bleeding or perforation associated with pretreatment with NSAIDs;
- patients with active peptic ulcer / gastrointestinal bleeding or with a history of gastrointestinal bleeding, ulceration or perforation;
- patients with chronic dyspepsia;
- with another bleeding in the active phase or increased bleeding;
- with Crohn’s disease or with ulcerative colitis;
- with severe heart failure;
- in case of moderate or severe renal dysfunction (creatinine clearance ≤ 59 ml / min);
- with severe liver dysfunction (10-15 points on the Child-Pugh scale);
- with hemorrhagic diathesis and other blood clotting disorders;
- with severe dehydration (as a result of vomiting, diarrhea, or insufficient fluid intake);
- in the third trimester of pregnancy and during lactation;
Due to the ethanol content of the drug, the drug is contraindicated for neuraxial (intrathecal or epidural) administration.
Method of administration and dosage
Adults. The recommended dosage is 50 mg every 8-12 hours. If necessary, repeat the dose after 6 hours. The maximum daily dosage should not be 150 mg. The drug is intended for short-term use, so it should be used during the period of acute pain (no longer than 2 days). Patients should be switched to oral analgesics if possible. Adverse reactions can be reduced by using the lowest effective dose for as short a time as necessary to improve the condition. In case of postoperative pain of moderate or severe severity, the drug can be used according to indications in the same recommended doses in combination with opioid analgesics.
Elderly patients. No dose adjustment is usually required. However, due to a physiological decrease in renal function, a lower dose of the drug is recommended, the maximum daily dose is 50 mg with mild renal impairment.
From the liver. For patients with mild to moderate liver disease, the maximum daily dose should be reduced to 50 mg and liver function should be carefully monitored. In severe liver diseases, the drug is contraindicated (10-15 points on the Child-Pugh scale).
From the side of the kidneys. For patients with mild renal impairment (creatinine clearance 60–89 ml / min), the maximum daily dose should be reduced to 50 mg. In case of moderate or severe renal impairment (creatinine clearance <59 ml / min), the drug is contraindicated.
Children and adolescents. The drug should not be used in children and adolescents due to the lack of data on its effectiveness and safety.
Mode of application
Intramuscular injection. The content of 1 ampoule (2 ml) is slowly injected deep into the muscles.
For intravenous infusion, dilute the content of a 2 ml ampoule in 30-100 ml of 0.9% sodium chloride solution, glucose solution or Ringer’s lactate solution. The solution for infusion should be prepared under aseptic conditions, avoiding exposure to daylight. The prepared solution should be clear. The infusion must be carried out within 10-30 minutes. Avoid exposure to daylight on the prepared solution.
The drug, diluted in 100 ml of 0.9% sodium chloride solution or in glucose solution, can be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine, and theophylline.
Diluted infusion solutions should not be mixed with promethazine and pentazocine.
Intravenous injection (bolus injection).
If necessary, the contents of 1 ampoule (2 ml of injection solution) should be administered intravenously for at least 15 seconds. The drug can be mixed in small volumes (for example, in a syringe) with solutions for injections of heparin, lidocaine, morphine and theophylline.
The drug should not be mixed in small volumes (for example, in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine, and hydrocortisone, as a white precipitate form.
The drug can only be mixed with the drugs indicated above.
When put into action after it has been recruited from the ampoule. The solution for intravenous infusion should be used immediately after its preparation.
During storage of dilute solutions of drugs in plastic bags or devices for the introduction of products from ethyl vinyl acetate, cellulose propionate, low-density polyethylene, and polyvinyl chloride, no changes in the active substance of the sorption additive were observed.
The drug is intended for single-use, so pour out the remnants of the finished solution. Before the introduction of the drug, you must make sure that the solution is clear and colorless. A solution containing solid particles must not be used.
The drug should not be used in children and adolescents due to the lack of data on its effectiveness and safety.
Overdose symptoms are unknown. Similar drugs cause disturbances in the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, dizziness, disorientation, headache). In case of accidental overdose, symptomatic treatment should be started immediately in accordance with the patient’s condition. Dexketoprofen trometamol is removed from the body by dialysis.