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Remopain 3%

Remopain 3%

ketorolac

Manufacturer:

PT Ferron Par

Distributor:

BJC Healthcare

Marketer:

BJC Healthcare
Concise Prescribing Info
Contents
Ketorolac tromethamine
Indications/Uses
Short-term management of moderate to severe acute post-op pain.
Dosage/Direction for Use
IM/IV Administer as slow IM inj or bolus IV inj given over no <15 sec. Adult ≥65 yr w/ renal impairment &/or <50 kg Single dose: 30 mg IM or 15 mg IV. Multiple-dose: 15 mg IM/IV every 6 hr. Max: 60 mg daily, <65 yr Single dose: 60 mg IM or 30 mg IV. Multiple dose: 30 mg IM/IV every 6 hr. Max: 120 mg daily. Max treatment duration: 2 days.
Contraindications
Hypersensitivity to ketorolac or other NSAIDs; aspirin or other prostaglandin synthesis inhibitors. Patients w/ history of asthma; active or history of GI bleeding or perforation, related to previous NSAIDs therapy; active or history of recurrent peptic ulcer/hemorrhage (≥2 distinct episodes of proven ulceration or bleeding); severe heart, hepatic & renal failure; suspected or confirmed cerebrovascular bleeding, who have had operations w/ high risk of hemorrhage or incomplete hemostasis & those at high risk of bleeding eg, those w/ hemorrhagic diatheses, including coagulation disorders; complete or partial syndrome of nasal polyps, angioedema, or bronchospasm. Neuraxial (epidural or intrathecal) administration. As prophylactic analgesia before surgery & intraoperatively. Patients on anticoagulants, including warfarin & low dose heparin (2,500-5,000 u 12 hrly); currently receiving ASA or other NSAIDs (including COX-2 selective inhibitors). Combination w/ pentoxifylline. Concurrent treatment w/ probenecid or lithium salts. Moderate or severe renal impairment (serum creatinine >160 mcmol/l) or in patients at risk for renal failure due to vol depletion or dehydration. Pregnancy, labor, delivery or lactation.
Special Precautions
Hypersensitivity or anaphylactoid reactions even w/o prior exposure. Discontinue treatment immediately if signs or symptoms of hepatic disease develop or if systemic manifestations occur; at first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Avoid use in heart failure; patients w/ recent MI unless benefits outweigh risk of CV thrombolytic events; severe GI bleeding; history of acute lower GI bleeding. Not to exceed combined therapy duration (oral & parenteral) of 5 days. Not be used for epidural or spinal administration. Closely monitor patients w/ coagulation disorders or who are receiving anticoagulants. Monitor patients on long term NSAIDs therapy for anemia. May decrease platelet adhesion & aggregation, & prolong bleeding time. Increased risk of serious adverse CV thrombolytic events, including MI & stroke; serious GI inflammation, ulceration, bleeding & perforation; aseptic meningitis in patients w/ SLE & mixed connective tissue disorders. May cause potentially fatal serious skin reactions including exfoliative dermatitis, SJS, & TEN; Na & fluid retention. New onset or exacerbation of HTN. Severe hepatic reactions (eg, jaundice, fulminant hepatitis, hepatic necrosis & failure). Patients w/ known CV disease or risk factors & those receiving higher doses; "aspirin triad" (bronchial asthma, aspirin intolerance, rhinitis); HTN; edema; advanced hepatic disease, coagulopathy, smoking, alcohol use; hypovolemia, heart failure. Debilitated patients. History of hepatic disease; PUD &/or GI bleeding; GI ulcers, inflammatory bowel disease. Monitor BP; any abnormal LFT. Use lowest effective dose for shortest duration to reduce risk of CV events. May impair response to ACE inhibitors, thiazide diuretics, or loop diuretics. Concurrent therapy w/ drugs known to increase risk of GI bleeding eg, aspirin, anticoagulants, &/or corticosteroids, SSRIs. Concomitant use of other agents capable of inducing hyperkalemia eg, ACE inhibitors. Hepatic & renal impairment. May impair fertility. Not recommended in women attempting to conceive. Consider w/drawal of treatment in women who have difficulty conceiving or are undergoing investigation of fertility. Not recommended in childn <2 yr. Elderly ≥65 yr (increased risk of hyperkalemia; closely monitor K).
Adverse Reactions
Edema, HTN; dizziness, drowsiness, headache; diaphoresis, pruritus, skin rash; constipation, diarrhea, dyspepsia, flatulence, GI fullness, hemorrhage, pain, perforation & ulcer, heartburn, nausea, stomatitis, vomiting; anemia, prolonged bleeding time, purpura; increased liver enzymes; inj site pain; tinnitus; renal function abnormality. Erythema multiforme, SJS, TEN.
Drug Interactions
Avoid concomitant use w/ acemetacin, systemic aminolevulinic acid, aspirin, dexibuprofen, dexketoprofen, floctafenine, nasal ketorolac, macimorelin, mifamurtide, morniflumate, NSAIDs, omacetaxine, pelubiprofen, pentoxifylline, phenylbutazone, probenecid, talniflumate, tenoxicam, urokinase, zaltoprofen. May increase effects of 5-aminosalicylic acid derivatives, agents w/ antiplatelet properties, aliskiren, aminoglycosides, systemic & topical aminolevulinic acid, anticoagulants, apixaban, aspirin, bemiparin, bisphosphonate derivatives, cephalothin, systemic collagenase, systemic cyclosporine, dabigatran etexilate, deferasirox, deoxycholic acid, desmopressin, dexibuprofen, digoxin, drospirenone, edoxaban, enoxaparin, eplerenone, haloperidol, heparin, ibritumomab, tiuxetan, lithium, metformin, MTX, nondepolarizing neuromuscular-blocking agents, NSAID, obinutuzumab, omacetaxine, pentoxifylline, porfimer, K-sparing diuretics, pralatrexate, quinolones, rivaroxaban, salicylates, systemic tacrolimus, tenofovir products, thrombolytic agents, tolperisone, urokinase, vancomycin, verteporfin, vit K antagonists. Increased effects w/ acalabrutinib, acemetacin, ethyl alcohol, ARBs, ACE inhibitors, systemic corticosteroids, systemic cyclosporine, desatinib, dexketoprofen, fat emulsion (fish oil based), felbinac, floctafenine, glucosamine, herbs w/ anticoagulant/antiplatelet properties, ibrutinib, inotersen, nasal ketorolac, limaprost, loop diuretics, morniflumate, multivit/fluoride (w/ ADE), multivit/minerals (w/ ADEK, folate, Fe, w/ AE, no Fe), naftazone, omega-3 fatty acids, pelubiprofen, pentosan polysulfate Na, phenylbutazone, probenecid, prostacyclin analogues, SSRIs, serotonin/norepinephrine reuptake inhibitors, Na phosphates, talniflumate, tenoxicam, thiazide & thiazide-like diuretics, tipranavir, tolperisone, TCAs (tertiary amine), systemic vit E, zaltoprofen, zanubrutinib. May decrease effects of aliskiren, ARBs, ACE inhibitors, aspirin, β-blockers, eplerenone, hydralazine, loop diuretics, ophth prostaglandins, salicylates, SSRIs, sincalide, thiazide & thiazide-like diuretics. Decreased effects w/ bile acid sequestrants, salicylates.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Remopain 3% soln for inj 30mg/mL
Packing/Price
5 × 1's
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