Captofen

Dexketoprofen trometamol.

Each mL contains: Dexketoprofen Trometamol equivalent to Dexketoprofen 25 mg.

Pharmacology: Dexketoprofen Trometamol is a tromethamine salt of S(+)-2-(3-benzoylphenyl) propionic acid, is an analgesic, anti-inflammatory and antipyretic belong to non-steroidal anti-inflammatory drugs (NSAIDs).
Mechanism of action of nonsteroidal anti-inflammatory drugs are associated with a reduction of prostaglandin synthesis by inhibition of cyclooxygenase pathway. Inhibition of the transformation of arachidonic acid into cyclic endeperoxide, PGG₂ and PGH₂, which produce prostaglandins; PGE₁, PGE₂, PGF_2a and PGD₂ and also prostacyclin PGl₂ and thromboxane (TxA₂ and TxB₂) specifically occur. Furthermore, inhibition of prostaglandin synthesis can affect other inflammatory mediators such as kinin, causing indirect action that strengthens direct action.

Treatment of the symptoms with acute pain intensity, where per oral administration is inadequate, such as post operative pain.

Dosage: 50 mg every 8-12 hours. If needed, the administration can be repeated every 6 hours. The total dosage per day may not exceed 150 mg.
CAPTOFEN Injection is not addressed for prolong administration, and the therapy should be limited for acute symptomatic period only.
For post operative pain, CAPTOFEN injection can be used with the opioid analgesic for the pain, particularly severe pain in the initial period after surgery.
Elderly: Adjustment doses usually not required in elderly patients. However, due to decreased physiological kidney function in the elderly patients, lower doses is recommended in the case of mild impairment of kidney functions. The total doses per day is 50 mg.
Hepatic Dysfunction: In patients with mild to moderate hepatic impairment (Child-Pugh Score 5-9), the doses should be lowered to 50 mg total daily dose, and the hepatic function be monitored strictly. CAPTOFEN Injection solution or concentrate solution for infusion should not be given for patient with severe hepatic dysfunction (Child-Pugh score 10-15).
Renal Dysfunction: In patients with reduced mild kidney function condition (creatinine clearance 50-80 mL/minutes), the doses should be lowered to 50 mg total daily dose. CAPTOFEN Injection or concentrate solutions concentrates for infusion should not be given to the patients with moderate to severe renal dysfunction (creatinine clearance 50 mL/minutes).
Children: This drug should not be used in children.
Administration: CAPTOFEN can be administered IM or IV route.
IM: CAPTOFEN Injection should be given with slow injection to the muscle.
IV Infusion: CAPTOFEN Injection should be diluted into 30 to 100 ml NaCl, Glucose or Ringer Lactate solution. Diluted solution should be given with slow intravenous infusion for 10 until 30 minutes. The solution must be protected from direct sunlight.
IV bolus: If needed, CAPTOFEN Injection can be administered as slow bolus intravenous with not more than 15 seconds administration.
When CAPTOFEN Injection is administered as IM or IV bolus, the solution should be directly injected after being removed from amber ampoules. In i.v. infusion administration, the solution should be diluted aseptically and protected from direct sunlight.

Patients with a history of hypersensitivity to Dexketoprofen, other NSAIDs, or excipients contained in the preparation.
Patients who have had an asthma attack, bronchospasm, acute rhinitis, or nasal polyps, urticaria or angioneurotic edema that are triggered by other drugs in similar ways (eg Aspirin, or other NSAIDs).
Patients with a history of suffering from gastric ulcer (active or new suspicion only), 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/minutes), damage severe liver function (Child-Pugh score 10-15).
Patients with haemorrhagic diathesis and other coagulation disorders, or patients treated with anticoagulants.
Pregnancy and breast-feeding.
Neuraxial administration (lntrathecal or epidural) regarding alcohol content in the product.

Cardiovascular risks: NSAIDs can cause an increased risk of serious cardiovascular thrombosis, myocardial infarction and stroke which can be fatal. These risks increase with the duration of use. Patients with cardiovascular disease or who have risk factors for cardiovascular disease. (See Precautions.)
CAPTOFEN is contraindicated for the treatment of perioperative pain in coronary bypass surgery. (See Precautions.)
Gastrointestinal tract risks: NSAIDs cause an increased risk of serious side effects in the gastrointestinal tract, including bleeding, ulceration, and perforation of the stomach or intestine, which can be fatal. These side effects can occur at any time, without warning symptoms. Elderly patients have greater risk for serious side effects in the gastrointestinal tract. (See Precautions.)

Caution in patients with a history of drug allergy and bronchial asthma.
Patients with diseases of the gastrointestinal symptoms should be monitored, specifically the gastrointestinal bleeding. If bleeding or gastrointestinal peptic occur, treatment must be discontinued immediately.
As with other NSAIDs, it could potentially inhibit aggregation of platelets and prolong bleeding time through the inhibition of prostaglandins synthesis. Concomitant use of Dexketoprofen Trometamol with preventive dose of lower molecular weight of Heparin in postoperative shows that there is no effect for the coagulation parameter that already determined. However, the patients who have other therapy that affect hemostasis should be monitored carefully.
Increase of urea nitrogen and plasma creatinine can happen like other NSAIDs. As inhibitors of prostaglandin synthesis, side effects can 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 (temporary), if occur a significant increase in SGPT and SGOT, discontinue therapy immediately. Caution in patients with hematopoietic disorders, systemic lupus erythematosus, or a mixed connective tissue disease. The use of NSAIDs may mask the symptoms of the infection.
Caution in patients with impaired liver function, kidney or heart failure and other conditions that would cause fluid retention. In these patients, NSAID treatment can decrease kidney function and fluid retention. Caution in patients that already have diuretic therapy or hypovolemia incidence that can increase nephrotoxicity risk.
Use in Children: The safety of its use in children has not been established.
Use in the Elderly: Caution in elderly patients, are more susceptible to side effects: gastrointestinal bleeding and/or perforation, depending on the doses. While therapy, sometimes it can be more serious and occurring without warning or previous history. In elderly patients, the risk of kidney, cardiovascular and liver damage is increasing so their function should be monitored.

Nausea, vomiting, pain at the administration site, anemia, headache, dizziness, insomnia, drowsiness, blurred vision, hypotension, hot flushes, abdominal pain, dyspepsia, diarrhea, constipation, vomiting blood, dry mouth, dermatitis, pruritus, skin rashes, excessive sweating, reaction in injection area, inflammatory bruise or bleeding, fever, fatigue, pain, coldness, hyperglycemia, hypoglycemia, hypertriglyceridemia, paresthesia, tinnitus, extrasystole, tachycardia, hypertension, peripheral edema, thrombophlebitis, superficial, bradypnea, peptic ulcers, bleeding or gastroduodenal perforation, anorexia, elevated liver enzyme, liver disorders, jaundice, urticaria, acne, stiff joints, muscular cramp, polyuria, kidney pain, menstrual disorders, prostatic disorder, back pain, syncope, chills, ketonuria, proteinuria, neutropenia, thrombocytopenia, bronchospasm, dyspnea, pancreatic damage, liver damage, severe mucocutaneous skin reaction (Stevens-Johnson syndrome, Lyell syndrome), angioedema, dermatology reaction, photosensitivity reaction, pruritus, kidney damage (nephritis or nephrotic syndrome), anaphylaxis , face edema.
The following adverse reactions may occur because of the side effects appear in other NSAID and may be related to prostaglandin synthesis inhibitors: Aseptic meningitis: will primarily occur in patients with SLE (Systemic Lupus Erythematosus) or mixed connective tissue disease.
Hematological reactions: purpura, hemolytic and aplastic anemia, and rarely, agranulocytosis and medullar hypoplasia.

Ulcers and gastrointestinal bleeding may occur in the concomitant use with other NSAIDs, for their synergistic effect.
There may be an increased risk of bleeding and damage to the gastrointestinal mucosa on the concomitant use with anticoagulant drugs, above Heparin prophylaxis dose parenterally, as well as Ticlopidine.
NSAIDs can increase lithium level in the blood until toxic levels, so it needs to be monitored.
On the use of Methotrexate above 15 mg/week or more, NSAIDs may increase Methotrexate toxicity in blood because of clearance through the kidney decreased.
There may be an increase in the toxicity of hydantoins and sulfonamides, if used concomitantly with NSAIDs.
Reduction of antihypertensive effects of diuretics and [3-blockers group (keep out there is no dehydration).
There is an increased risk of bleeding in concomitant use with Pentoxifylline and thrombolytic drugs.
An increase poisoning of red blood cells (reticulocytes influence) on the concomitant use with Zidovudine.
An increase in hypoglycaemic effect of sulfonylurea class of drugs.An increase of nephrotoxicity in the use of Cyclosporine and Tacrolimus by NSAIDs. During combination therapy, renal function should be monitored.
An increase in hypoglycaemic effect of sulfonylurea class of drugs.
An increase of nephrotoxicity in the use of Cyclosporine and Tacrolimus by NSAIDs. During combination therapy, renal function should be monitored.
An increase in the blood levels of Dexketoprofen on concomitant use with Probenecid.
Cardiac glycosides: NSAIDs may increase blood levels of glycosides.
Mifepristone: NSAIDs should not be used within 8-12 days after Mifepristone use. Because theoretically an inhibitor of prostaglandin synthesis can change the efficacy of Mifepristone.
Quinolone antibiotics: high doses of quinolone and NSAIDs may increase the risk of convulsions.

Store below 30°C, away from light.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE17 - dexketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

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