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Zirolac

Zirolac

ketorolac

Manufacturer:

Myungmoon

Distributor:

Zyre Pharma
Full Prescribing Info
Contents
Ketorolac trometamol.
Description
Each mL contains: Ketorolac trometamol 30 mg.
Action
Non-opioid Analgesic.
Indications/Uses
Indicated for the short term management of moderately severe, acute pain at the opioid level.
Postoperative pain after general, orthopedic, gynecological and dental operation.
Pediatrics (2 years of age and older): Severe postoperative pain that requires analgesia at the opioid level.
Dosage/Direction for Use
Adult: Ketorolac trometamol IV/IM is initiated with 10 mg, maintained with 10-30 mg every 4-6 hours and the minimum effective dose is used. Therapy should not to exceed 2 days. In elderly patients, patients with renal failure and patients below 50 kg of body weight, daily dose should not exceed 60 mg. Ketorolac trometamol is contraindicated for intrathecal or epidural administration. Based on incidence of symptoms or severity of the pain, amount of dosage and intervals are adjusted.
Ketorolac trometamol is used concomitantly with morphine if necessary. Maximum duration of therapy is 5 days.
Children, 2 years of age and older: Single intravenous injection after pediatric operation. Thereafter, IV bolus can be given several times if necessary. In pediatric use, intravenous injection is recommended because of IM injection accompanying pain. Administer 0.5 mg/kg every 6 hours, if necessary, after 0.5-1.0 mg/kg single dose. Therapy should not to exceed 2 days. Based on incidence of symptoms or severity of the pain, amount of dosage and intervals are adjusted. Or as prescribed by the physician.
Contraindications
Ketorolac trometamol is contraindicated in patient with: History of peptic ulcer, ulcer or perforation; History of gastrointestinal bleeding; Hemorrhagic diathesis, or a history of thereof; Suspected or confirmed cerebrovascular bleeding; Bronchial asthma or history of thereof; Moderate or severe renal failure (serum creatinine >160 mol/L); Hypovolemia or dehydration; Hypersensitivity to ketorolac trometamol, aspirin or other NSAIDs; Nasal polyp, vascular edema, or bronchial convulsion; Patients took surgery with incomplete hemostasis or those at high risk of bleeding; Pregnant women and nursing mothers; Patients receiving other NSAIDs; Patients taking anticoagulants, pentoxifylline, probenecid or lithium; Patients taken tonsillotomy; Pediatrics below 2 years of age; Prophylaxis before major surgery.
Special Precautions
Ketorolac trometamol should be administered with care in patients with: Depressed renal function or history of hepatic disease; History of renal disorder; Elderly patients; Hypertension; Cardiac decompensation; Hypovolemia, dehydration or receiving diuretics; Congestive heart failure; Dehydration; History of gastrointestinal disease; Active gastrointestinal; Asthma; Nasal polyps; Hepatic impairment.
Patients who consume more than 3 cups of alcoholic drink every day should not use this medicine or another antipyretic analgesic. They should consult physician before dosing. This drug may cause stomach bleeding in the patients.
When glass ampoule is broken, glass particles can be mixed with drug, and result in side effects. Therefore, ampoules should be cautiously broken to prevent contamination, and particularly caution is required in children's use or, the old and weak person's use.
Treatment should be started as IM or IV then changed to PO only as continuation treatment.
Total therapy should not exceed 5 days.
Dizziness may affect the performance skilled tasks such as driving.
Not given to patients with coagulation haemorrhage disorders.
Adverse Reactions
Body as a whole: Occasionally edema, rarely anaphylaxis, bronchial convulsion, laryngeal edema, tongue edema, hypotension, rubedo, weight gain, fever, infections, asthenia may occur.
GI: Nausea, dyspepsia, gastrointestinal pain, diarrhea, occasionally constipation, flatulence, gastrointestinal fullness, vomiting, stomatitis, rarely peptic ulcer, gastrointestinal bleeding, perforation, hemafecia, rectal bleeding, gastritis, ructus, anorexia, increased appetite, pancreatitis may occur, increase blood in urea & creatinine.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
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
Zirolac soln for inj 30 mg/mL
Packing/Price
1 mL x 10 × 1's
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