Page 7 - D'Conner PRODUCT catalogue

FORMULATION:
Each ampule contains 30mg/ml, 1 ml solution for injection. It is a colorless or slightly yellowish
solution in amber glass ampoules.
DESCRIPTION:
It is a potent analgesic agent of NSAID class with anti-inflammatory and anti-pyretic properties.
INDICATION: Marolac is used for short-term management of moderate to severe postoperative
pain.
MECHANISM OF ACTION:
 Ketorolac reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and -2) enzymes, which
results in decreased formation of prostaglandin precursors. It exhibits minimal anti-
inflammatory effect at its analgesic dose.
PHARMACOKINETICS:
Absorption: Rapidly and completely absorbed following IM administration with a
bioavailability between 80-100% after oral administration. It can cross the placenta and enter
the breast milk in small amounts but it poorly penetrates the blood-brain barrier. It undergoes
conjugation w/ glucuronic acid and hydroxylation in the liver to form p-hydroxyketorolac. It is
primarily excreted via urine. Its onset of action is approx. 30 min (IM/IV) after administration
with a duration of 4-6 hours.
DOSAGE AND ADMINISTRATION:
The following regimen should be limited to single administration use only
 It may be used as a single or multiple dose on a regular or "prn" schedule for
the management of moderately severe and acute pain. Administer the
intravenous bolus over no less than 15 seconds. During an intramuscular
administration, it should be given slowly and deeply into the muscle.
 Intramuscular Dosing: Patients <65 years of age: One dose of 60 mg.
 Intravenous Dosing: Patients <65 years of age: One dose of 30 mg.
 Multiple-Dose Treatment (Intravenous or Intramuscular): Patients <65 years of age:
The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. Do
not exceed 120 mg.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
 It may be associated with a high risk of serious gastrointestinal toxicity especially
when used outside the licensed indications and/or for prolonged periods
DRUG INTERACTION:
Do not co-administer with the following:
 NSAIDs/Aspirin, Thromboxane, Anticoagulants, Lithium, Probenecid, Mifepristone,
Oxpentifylline
PREGNANCY CATEGORY: C
CONTRAINDICATION:
 Do not use in labor and delivery due to possible increase in bleeding
 It is contraindicated in mothers who are breast-feeding.

MANUFACTURER: THE ACME LABORATORIES LTD.
IMPORTER: EURO-GENERICS INTERNATIONAL PHIL. INC.