Marolac

Clear yellowish liquid in a sealed amber colored glass ampoule, free from any visible contamination.
Each mL contains: Ketorolac trometamol USP 30 mg.

Pharmacology: Pharmacodynamics: Ketorolac is a potent analgesic agent of the non-steroidal, anti-inflammatory class (NSAID). It is not an opioid and has no known effects on opioid receptors. Its mode of action is to inhibit the cyclo-oxygenase enzyme system and hence prostaglandin synthesis and it demonstrates a minimal anti-inflammatory effect at its analgesic dose.
Pharmacokinetics: Intramuscular: Following intramuscular administration, ketorolac was rapidly and completely absorbed. A mean peak plasma concentration of 2.2 mcg/mL occurred an average of 50 minutes after a single 30 mg dose.
Intravenous: Intravenous administration of a single 10 mg dose of ketorolac resulted in a mean peak plasma concentration of 2.4 mcg/mL at an average of 5.4 minutes after dosing. The terminal plasma elimination half-life was 5.1 hours, average volume of distribution 0.15 L/kg, and total plasma clearance 0.35 mL/min/kg.
The pharmacokinetics of ketorolac in man following single or multiple doses are linear. Steady state plasma levels are achieved after dosing every six hours for one day. No changes in clearance occurred with chronic dosing. The primary route of excretion of ketorolac and its metabolites is renal: 91.4% (mean) of a given dose being found in the urine and 6.1% (mean) in the faeces.
More than 99% of the ketorolac in plasma is protein-bound over a wide concentration range.

Ketorolac trometamol (Marolac) is used for short-term management of moderate to severe postoperative pain.

ADULT AND CHILD over 16 years, by intramuscular injection or by intravenous injection over at least 15 seconds, initially 10 mg, then 10-30 mg every 4-6 hours as required (up to every 2 hours during initial postoperative period); max. 90 mg daily (ELDERLY and patients weighing less than 50 kg max. 60 mg daily); max. duration of treatment 2 days.
When converting from parenteral to oral administration, total combined dose on the day of converting should not exceed 90 mg (60 mg in the elderly and patients weighing less than 50 kg) of which the oral component should not exceed 40 mg.
Some people who do not need more than one injection may receive one dose of 60 mg, injected into a muscle.
Or as directed by the physician.

Overdose: Single overdoses of Ketorolac have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing. Gastrointestinal bleeding may occur. Hypertension, acute renal failure, respiratory depression and coma may occur after the ingestion of NSAIDs but are rare. Headache, epigastric pain, disorientation, excitation, drowsiness, dizziness, tinnitus and fainting have also been observed. Rare cases of diarrhoea and occasional convulsions have been reported. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose.
Treatment: Patients should be managed by symptomatic and supportive care following NSAIDs overdose. There are no specific antidotes. Dialysis does not significantly clear ketorolac from the blood stream. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition.

A history of peptic ulcer or gastrointestinal bleeding.
Suspected or confirmed cerebrovascular bleeding.
Hemorrhagic diatheses, including coagulation disorders.
Patients with hypersensitivity to Ketorolac trometamol and other NSAIDs.
A history of asthma.

Physicians should carefully weigh the potential risks and benefits of its use on a long term basis. Patients should be instructed to watch for signs of serious GI adverse events and they should be monitored more closely than if they were on another NSAID.
Use in Children: Safety and efficacy in children have not been established. Therefore, Ketorolac trometamol (Marolac) is contraindicated for use in children under 16 years of age.

Safety in pregnancy has not been established. It is not recommended during pregnancy, labour or delivery and in mothers who are breastfeeding.

Nausea, dyspepsia, gastro-intestinal pain, dizziness, headache, sweating, dry mouth, bradycardia, purpura, thrombocytopenia, dyspnea, asthma, pruritus, urticaria, anaphylaxis, bronchospasm.

Methotrexate, diuretics, ACE inhibitors, warfarin, lithium, aminoglycosides and other NSAIDs.

Special Precautions for Handling and Disposal: Any unused medicine should be disposed properly. Consult the pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.

Store at temperatures not exceeding 30°C. Protect from light.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

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