Sandetofen

Sandetofen

dexketoprofen

Manufacturer:

Sanbe

Marketer:

Sanbe
Concise Prescribing Info
Contents
Dexketoprofen
Indications/Uses
FC tab: Symptomatic treatment of mild to moderate pain eg, acute musculoskeletal, dental & post-op pain, dysmenorrhea. Inj: Symptomatic treatment of acute pain intensity when PO is inadequate eg, post-op pain.
Dosage/Direction for Use
FC tab 12.5 mg every 4-6 hr or 25 mg every 8 hr. Max total dose: 75 mg daily. Mild to moderate hepatic impairment, mild renal impairment (CrCl 50-80 mL/min), Elderly Initially 50 mg daily. IM or IV 50 mg every 8-12 hr. If needed, can be repeated every 6 hr. Max: 150 mg. Mild to moderate hepatic impairment, mild renal impairment (CrCl 50-80 mL/min), Elderly 50 mg daily.
Administration
Should be taken on an empty stomach: Take 30 min before meals, especially for quick relief of acute pain.
Contraindications
History of hypersensitivity to dexketoprofen trometamol, other NSAIDs. Peri-op pain in CABG surgery. Patients who have asthma, urticaria, or other sensitivity reactions that are precipitated by aspirin or other NSAIDs. Patients w/ severe heart failure. Moderate to severe renal dysfunction (CrCl <50 mL/min). Severe liver impairment (Child-Pugh score10-15). Pregnancy & breast-feeding. FC tab: Patients w/ hemorrhagic disorders; active, suspected or history recurrent peptic ulcer/hemorrhage. Inj: Neuraxial administration. Patients who have had bronchospasm, acute rhinitis, or nasal polyps or angioneurotic edema that are triggered by other drugs in similar ways (eg, aspirin, or other NSAIDs). 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. Haemorrhagic diathesis & other coagulation disorders, or patients treated w/ anticoagulants.
Special Precautions
Increased risk of serious CV thrombosis, MI & stroke in patients w/ known or risk factors for CV disease. Patients w/ fluid retention or heart failure. Increased risk of serious side effects in the GI tract, including bleeding, ulceration & perforation of the stomach or intestine. Immediately discontinue if bleeding or GI peptic ulcer occur; significant increase in SGPT & SGOT. May increase plasma urea nitrogen & creatinine; nephrotoxicity eg, glomerulonephritis, interstitial nephritis & nephrotic syndrome; renal papillary necrosis & other renal injury w/ prolonged used. Hematopoietic disorders, SLE, or a mixed connective tissue disease. May mask the usual signs & symptoms of infection or other diseases. Childn. Elderly. FC tab: History of allergic conditions, esophagitis, & gastritis. Can lead to onset of new or worsening of preexisting HTN. Closely monitor BP prior & during the therapy. Patients w/ HTN; prior history of PUD &/or GI bleeding; who may be adversely affected by bleeding time prolongation (eg, patients receiving anticoagulant therapy). Not recommended in patients w/ advanced renal disease; closely monitor renal function in patients w/ severe renal impairment. Inj: History of drug allergy & bronchial asthma. Monitor GI symptoms especially bleeding; patients who have other therapy that affect hemostasis. Impaired liver function, kidney failure.
Adverse Reactions
Nausea, vomiting, anemia, headache, dizziness, insomnia, drowsiness, hypotension, hot flushes, abdominal pain, dyspepsia, diarrhea, constipation, dry mouth, pruritus, skin rashes, excessive sweating, fatigue, pain, paresthesia, tinnitus, tachycardia, HTN, peripheral edema, peptic ulcers, anorexia, urticaria, neutropenia, thrombocytopenia, bronchospasm, dyspnea, liver damage, SJS, angioedema, photosensitivity reaction, anaphylaxis, facial edema, liver disorders, elevated SGPT or SGOT conc. FC tab: GI bleeding or perforation, palpitation, flatulence, pancreatitis, gastritis, anxiety, malaise, asthenia, vertigo, purpura, agranulocytosis, TEN, visual disturbances, aseptic meningitis. Inj: Pain at the administration site, blurred vision, vomiting blood, dermatitis, reaction in inj area, inflammatory bruise or bleeding, fever, coldness, hyperglycemia, hypoglycemia, hypertriglyceridemia, extrasystole, thrombophlebitis, superficial, bradypnea, bleeding or gastroduodenal perforation, jaundice, acne, stiff joint, muscular cramp, polyuria, kidney pain, menstrual disorders, prostatic disorder, back pain, syncope, chills, ketonuria, proteinuria, pancreatic damage, severe mucocutaneous skin reaction, Lyell syndrome, dermatologic reaction, kidney damage (nephritis or nephrotic syndrome).
Drug Interactions
Increased risk of bleeding & damage to GI mucosa w/ anticoagulant & thrombolytic agents. Increased plasma conc of cardiac glycosides. Increased plasma conc w/ probenecid. Elevated & prolonged blood conc of MTX. Increased serum lithium conc. Convulsions w/ high doses of quinolones. Increased risk of hematotoxicity (eg, reticulocytes influence) w/ zidovudine; nephrotoxicity w/ cyclosporine & tacrolimus. Can change the efficacy of mifepristone. Increased hypoglycaemic effect of sulfonylureas. FC tab: Reduced BP response w/ antihypertensive agents eg, ACE inhibitors & AIIA. Increased risk of hyperkalemia w/ ACE inhibitors & some diuretics eg, K-sparing diuretics; developing renal failure secondary to decrease renal blood flow w/ diuretics. Increased risk for serious GI effects w/ aspirin. Increased effects of phenytoin. Inj: Synergistic effect w/ other NSAIDs. Increased toxicity of hydantoins & sulfonamides. Reduction of antihypertensive effects of diuretics & β-blockers. Increased risk of bleeding in concomitant use w/ pentoxifylline & thrombolytic drugs.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE17 - dexketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Sandetofen FC tab 25 mg
Packing/Price
5 × 10's (Rp325,000/boks)
Form
Sandetofen inj 25 mg/mL
Packing/Price
2 mL x 5 × 1's (Rp242,500/boks)
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