COMPOSITION :
Dexfen® Injection 50 mg/2 ml, each ml contains : Dexketoprofen trometamol equivalent with Dexketoprofen 25 mg, alcohol 10%.
DESCRIPTIONS :
Dexfen® contains Dexketoprofen trometamol (equivalent with Dexketoprofen) available in injection.
INDICATIONS :
Treatment of symptoms with the intensity of acute pain, in situations where oral administration is not possible, such as pain after surgery.
DOSAGE AND ADMINISTRATIONS :
Dose :
50 mg every 8 – 12 hours. If needed, administration can be repeated every 6 hours. The total dose per day should not exceed 150 mg. Dexketoprofen trometamol injection is not intended for long-term use and therapy should be limited to acute symptomatic periods. In the case of pain after surgery, Dexketoprofen trometamol injection can be used together with an opioid analgesic to compensate for pain, especially in the period beginning after surgery where the pain feels heavier.
Route of administration :
Dexketoprofen trometamol can be administered IM or IV.
IM : Dexketoprofen trometamol injection must be administered by slow injection in the muscle.
IV infusion : Dexketoprofen trometamol injection must be dissolved in 30 – 100 ml physiological NaCl solution or glucose. The diluted solution must be administered by slow intravenous infusion for 10 – 30 minutes. The solution must be protected from direct sunlight.
IV bolus : If needed, Dexketoprofen trometamol injection can be given bolus intravenously not later than 15 seconds.
When Dexketoprofen trometamol injection is given either IM or IV bolus, the solution must be injected directly after being removed from the chocolate ampoule. In intravenous administration, the solution must be dissolved aseptically and protected from direct sunlight.
CONTRAINDICATIONS :
- Patients with a history of hypersensitivity to Dexketoprofen, other NSAIDs or additional ingredients in the preparation.
- Patients who have an asthma attack, bronchospasm, acute rhinitis or nasal polyp, urticaria or angioneurotic edema triggered by other drugs in a similar way (e.g., Aspirin or other NSAIDs).
- Patients with history or suffer of gastric ulcer (active or just a suspicion) or chronic dyspepsia, gastric bleeding or other active bleeding, Crohn’s disease or ulcerative colitis, history of bronchial asthma, severe heart failure, moderate to severe renal dysfunction (creatinine clearance < 50 ml / minute), severe liver function damage (value of Child Pugh 10 – 15).
- Patients with haemorrhagic diathesis and other coagulation abnormalities or patients treated with anticoagulants.
- Pregnant and lactating women.
- Neuraxial administration (intrathecal or epidural) because the product contain alcohol.
WARNINGS AND PRECAUTIONS :
- Has not been ensured the safety of use in children.
- Be careful of patients with a history of drug allergies and bronchial asthma.
- Patients with gastrointestinal symptoms should be monitored for gastrointestinal disorders, especially gastrointestinal bleeding. If there is bleeding or gastrointestinal ulcers, therapy must be stopped immediately.
- As with other NSAIDs, can inhibit platelet aggregation and prolong bleeding time via inhibition of prostaglandin synthesis. The use together with Dexketoprofen trometamol with preventive dose of low molecular weight heparin in the postoperative period have already been tested and no effect on coagulation parameters have been set. However, patients who receive other therapies that affect haemostasis must be monitored carefully.
- As with other NSAIDs, may increase plasma urea nitrogen and creatinine. As inhibitors of prostaglandin synthesis, adverse reactions may occur in the renal system : Glomerulonephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure.
- As with other NSAIDs, these drugs can increase liver enzymes (temporarily), if an increase in SGPT and SGOT significant, discontinue therapy immediately. Be careful of patients with hematopoietic disorders, systemic lupus erythematosus or mixed type connective tissue disease. Like other NSAIDs, Dexketoprofen can mask the symptoms of infectious diseases.
- Be careful of patients with liver, renal or heart dysfunction and other conditions that will cause fluid retention. In these patients the use of NSAIDs can cause deterioration of renal function and fluid retention. Also be careful of patients who have diuretic therapy or who can experience hypovolemia because it can increase the risk of nephrotoxicity.
- Be careful of elderly patient, more susceptible to adverse reactions : Gastrointestinal bleeding or perforation occurs depending on the dose. During therapy, sometimes it can become more serious and can occur without warning symptoms or previous history. The elderly are more likely to be affected by renal or liver cardiovascular function, so renal and liver function must be monitored.
DRUG INTERACTIONS :
- Ulcers and gastrointestinal bleeding may occur use together with other NSAIDs, because of synergistic effect.
- There can be an increase risk of bleeding and damage to the gastrointestinal mucosa in use together with anticoagulant drugs, Heparin above the parenteral prophylactic dose, as well as Ticlopidine.
- NSAIDs can increase levels of lithium in the blood which can reach toxic levels, so that needs
- When using Methotrexate above 15 mg/week or more, NSAIDs can increase the toxicity of Methotrexate to blood, because decreases of renal clearance.
- There can be an increase in the toxicity of hydantoin and sulfonamides, if used together with NSAIDs.
- There was a decrease antihypertensive effects diuretic drugs and class of β-blockers drugs (make sure there is no dehydration).
- There is an increase risk of bleeding use together with Pentoxifilin and thrombolytic drugs.
- There is an increase red blood cell poisoning (affecting reticulation) in use with Zidovudine.
- There is an increase hypoglycemic effect of sulfonylurea drugs.
- There is an increase nephrotoxicity in the use of Cyclosporine and tacrolimus by NSAIDs. During combination treatment, renal function must be monitored.
- There is an increase level of Dexketoprofen in the blood in use with Probenecid.
- Cardiac glycoside : NSAIDs can increase levels of glycosides in the blood.
- Mifepristone : NSAIDs should not be used within 8 – 12 days after the use of Mifepristone, because theoretically prostaglandin synthesis inhibitors can change the efficacy of Mifepristone.
- Quinolone antibiotics : Data in animals shows high doses of Quinolone with NSAIDs can increase the risk of convulsions.
ADVERSE REACTIONS :
Adverse reactions that have been reported :
- Common : Nausea, vomiting, pain at the injection site.
- Unusual : Anemia, headache, dizziness, insomnia, drowsiness, blurred vision, hypotension, hot flushes, abdominal pain, dyspepsia, diarrhea, constipation, vomiting of blood, dry mouth, dermatitis, pruritus, skin rash, excessive sweating, reaction at injection site, inflammatory bruising or bleeding, fever, weakness, pain, cold.
- Rarely : Hyperglycemia, hypoglycemia, hypertriglyceridamia, paresthesia, tinnitus, extrasystole, tachycardia, hypertension, peripheral edema, thrombophlebitis, superficial, bradypnea, peptic ulcer, gastrointestinal bleeding or perforation, anorexia, increase liver enzymes, liver disorders, jaundice, urticaria, acne, joint stiffness, muscle cramps, polyuria, renal pain, menstrual disorders, prostatic disorders, back pain, syncope, shivering, ketonuria, proteinuria.
- Very rare : Neutropenia, thrombocytopenia, bronchospasm, dyspnoea, pancreatic damage, liver damage, severe skin, mucocutaneous reactions (Steven-Johnson syndrome, Lyell’s syndrome), angioedema, dermatological reactions, photosensitivity reactions, pruritus, renal damage (nephritis or nephrotic syndrome), anaphylaxis, edema of the face.
The following adverse reactions may occur because these adverse reactions appear in the use of other NSAIDs and may be associated with prostaglandin synthesis inhibitors :
- Aseptic Meningitis : Which will mainly occur in patients with SLE (systemic lupus erythematous) or a mixed type of connective tissue disease.
- Hematologic Reactions : Purpura, aplastic and haemolytic anemia, and rarely are agranulocytosis and medullary hypoplasia.
PRESENTATION :
Dexfen® Injection 50 mg/2 ml Box, 5 ampoules @ 2 ml
Reg. No. DKL2002362743A1
STORAGE :
STORE BELOW 30ºC, protect from light
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
