Xevolac 10 mgml Solution for Injection

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

KETOROLAC TROMETHAMINE

Available from:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (International Name):

KETOROLAC TROMETHAMINE

Units in package:

6ampoule Ampoules; 6ampoule Ampoules

Manufactured by:

PT NOVELL PHARMACEUTICAL LABORATORIES.

Summary of Product characteristics

XEVOLAC SOLUTION FOR INJECTION
KETOROLAC TROMETHAMINE
PRODUCT NAME
XEVOLAC 10 mg/ml SOLUTION FOR INJECTION
XEVOLAC 30mg/ml SOLUTION FOR INJECTION
PRODUCT DESCRIPTION
Solution, clear to pale yellow .
Xevolac Solution for Injection can be diluted in Glucose 5.0%, Sodium
Chloride 0.9%,
Ringer’s solution and Ringer’s Lactate solution.
This product is clear and stable for 120 hours at temperature below
25°C after dilution in
Sodium Chloride 0.9% solution and Ringer’s solution. And this
product is clear and
stable for 72 hours at temperature below 25°C after dilution in
Glucose 5% and Ringer’s
Lactate solution.
COMPOSITION
_XEVOLAC INJECTION 10 mg/ml : _
Each ml of injection contains Ketorolac Tromethamine 10 mg
._ _
_XEVOLAC INJECTION 30 mg/ml: _
Each ml of injection contains Ketorolac Tromethamine 30 mg.
PHARMACODYNAMICS
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug. It
has an activity as
anti-inflammatory, analgesic and antipyretic activity. It may inhibit
the synthesis of
prostaglandins in tissues by inhibiting cyclooxygenase, an enzyme that
catalyzes the
formulation of prostaglandin precursors (endoperoxides) from
arachidonic acid.
PHARMACOKINETICS
Ketorolac tromethamine is absorbed after intramuscular or oral doses.
At physiological
pH ketorolac tromethamine dissociates to form an anionic ketorolac
molecule which is
less hydrophilic than the tromethamine salt. The peak plasma
concentration of ketorolac
is reached within about 30 to 60 minutes; absorption after
intramuscular injection may be
slower than that after oral doses in some individuals. Ketorolac is
over 99% bound to
plasma proteins. It does not readily penetrate the blood-brain
barrier. Ketorolac crosses
the placenta and small amounts of drug are distributed into breast
milk. The terminal
plasma half-life is about 4 to 6 hours, but is about 6 to 7 hours in
the elderly and 9 to 10
hours in patients with renal dysfunction. The major metabolic pathway
is glucuronic acid
conjugation; there is some
_para_
-hydroxylation. About 90%