NOVO-KETOROLAC - TAB 10MG TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

KETOROLAC TROMETHAMINE

Disponible desde:

NOVOPHARM LIMITED

Código ATC:

M01AB15

Designación común internacional (DCI):

KETOROLAC

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

KETOROLAC TROMETHAMINE 10MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0121995001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2015-10-26

Ficha técnica

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