Sandetofen

Sandetofen

dexketoprofen

Manufacturer:

Sanbe
Concise Prescribing Info
Contents
Dexketoprofen
Indications/Uses
Symptomatic treatment of acute pain intensity when PO is inadequate eg, post-op pain.
Dosage/Direction for Use
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.
Contraindications
History of hypersensitivity to dexketoprofen, other NSAIDs. Peri-op pain in coronary bypass surgery. Neuraxial administration. 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). 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. Haemorrhagic diathesis & other coagulation disorders, or patients treated w/ anticoagulants. Moderate to severe renal dysfunction (CrCl <50 mL/min). Severe liver impairment (Child-Pugh score10-15). Pregnancy & breast-feeding.
Special Precautions
History of drug allergy & bronchial asthma. Immediately discontinue if bleeding or GI peptic ulcer occur; significant increase in SGPT & SGOT. Can cause an increased risk of serious CV thrombosis, MI & stroke; serious side effects in the GI tract, including bleeding, ulceration & perforation of the stomach or intestine. Monitor GI symptoms especially bleeding; patients who have other therapy that affect hemostasis. May mask symptoms of infection. Hematopoietic disorders, SLE, or a mixed connective tissue disease. Heart failure. Impaired liver function, kidney failure. Childn. Elderly.
Adverse Reactions
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 inj area, inflammatory bruise or bleeding, fever, fatigue, pain, coldness, hyperglycemia, hypoglycemia, hypertriglyceridemia, paresthesia, tinnitus, extrasystole, tachycardia, HTN, peripheral edema, thrombophlebitis, superficial, bradypnea, peptic ulcers, bleeding or gastroduodenal perforation, anorexia, elevated liver enzyme, liver disorders, jaundice, urticaria, acne, stiff joint, 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 (SJS, Lyell syndrome), angioedema, dermatologic reaction, photosensitivity reaction, pruritus, kidney damage (nephritis or nephrotic syndrome), anaphylaxis, facial edema.
Drug Interactions
Synergistic effect w/ other NSAIDs. Increase blood levels of glycosides. Increased risk of bleeding & damage to GI mucosa w/ anticoagulant drugs. Increased lithium levels in the blood; methotrexate; toxicity of hydantoins & sulfonamides. Reduction of antihypertensive effects of diuretics & β-blockers. Increased risk of bleeding in concomitant use w/ pentoxifyline & thrombolytic drugs.  Reticulocytes influence w/ zidovudine. Increase in hypoglycaemic effect of sulfonylureas; nephrotoxicity w/ cyclosporine & tacrolimus; blood levels w/ probenecid; convulsions w/ high doses of quinolones. Can change the efficacy of mifepristone.
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 inj 25 mg/mL
Packing/Price
2 mL x 5 × 1's (Rp230,750/boks)
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