Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
KETOROLAC TROMETHAMINE
NOVOPHARM LIMITED
M01AB15
KETOROLAC
10MG
TABLET
KETOROLAC TROMETHAMINE 10MG
ORAL
100/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0121995001; AHFS:
CANCELLED POST MARKET
2015-10-26
PRODUCT MONOGRAPH NOVO–KETOROLAC (ketorolac tromethamine) 10 mg Tablets NSAID Analgesic Agent Novopharm Limited DATE OF REVISION: Toronto, Canada AUGUST 02, 2007 CONTROL NUMBER 112565 PRODUCT MONOGRAPH NOVO–KETOROLAC (ketorolac tromethamine) 10 mg Tablets THERAPEUTIC CLASSIFICATION NSAID Analgesic Agent ACTION AND CLINICAL PHARMACOLOGY NOVO-KETOROLAC (ketorolac tromethamine) is a non-steroidal anti-inflammatory drug (NSAID) that has analgesic activity. It is considered to be a peripherally acting analgesic. It is thought to inhibit the cyclo-oxygenase enzyme system, thereby inhibiting the synthesis of prostaglandins. At analgesic doses it has minimal anti-inflammatory and antipyretic activity. The peak analgesic effect occurs at 2 to 3 hours post-dosing with no evidence of a statistically significant difference over the recommended dosage range. The greatest difference between large and small doses of administered ketorolac is in the duration of analgesia. Following oral administration, ketorolac tromethamine is rapidly and completely absorbed, and pharmacokinetics are linear following single and multiple dosing. Steady state plasma levels are achieved after one day of q.i.d. dosing. - 2 - Peak plasma concentrations of 0.7 to 1.1 µg/mL occurred at 44 minutes following a single oral dose of 10 mg. The terminal plasma elimination half-life ranged between 2.4 and 9 hours in healthy adults, while in the elderly subjects (mean age: 72 years) it ranged between 4.3 and 7.6 hours. A high fat meal decreased the rate but not the extent of absorption of oral ketorolac tromethamine, while antacid had no effect. In renally impaired patients there is a reduction in clearance and an increase in the terminal half- life of ketorolac tromethamine (See Table 1). Table 1 - The Influence of Age, Liver and Kidney Function on the Clearance and Terminal Half- Life of Oral 1 Ketorolac Tromethamine TYPES OF SUBJECTS TOTAL CLEARANCE (in L/h/kg) 2 TERMINAL HALF- LIFE (in hours) Mean (range) Mean (range) Normal Subjects (n =77) 0.025 (0 Đọc toàn bộ tài liệu