ORADOL

Ketorolac Tromethamine

Description:

Ketorolac is a potent non-steroidal anti-inflammatory drug that is indicated for the management of moderately severe acute pain that requires analgesia at the opioid level.

Composition:

Oradol Tablet: Each tablet contains Ketorolac Tromethamine USP 10 mg.

Oradol Injection: Each ml injection contains Ketorolac Tromethamine USP 30 mg.

Pharmacology:

Oradol (Ketorolac tromethamine) is a nonsteroidal anti-inflammatory drug that exhibits analgesic activity. Ketorolac Tromethamine inhibits synthesis of prostaglandins and may be considered a peripherally acting analgesic. Ketorolac Tromethamine possesses no sedative or anxiolytic properties.

Indication:

Oradol is indicated for short term management of moderate to severe acute post operative pain.

Dosage and administration:

By mouth, 10 mg every 4-6 hours (elderly every 6-8 hours); max. 40 mg daily; max. duration of treatment 7 days.

By intravenous/intramuscular injection over not less than 15 seconds, initially 10 mg, then 10-30 mg every 4-6 hours when required (every 2 hours in 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 by either route. 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; patients should be converted to oral route as soon as possible.

Contraindications:

Oradol is contraindicated in patients who are hypersensitive to any component of this product. It is also contraindicated in patients with history of asthma, complete or partial syndrome of nasal polyps, angioedema or bronchospasm, history of peptic ulceration or gastrointestinal bleeding, haemorrhagic diatheses (including coagulation disorders) and operations with high risk of haemorrhage or incomplete haemostasis, confirmed or suspected cerebrovascular bleeding, moderate or severe renal impairment, hypovolaemia or dehydration, pregnancy (including labour and delivery) and breast-feeding.

Drug interactions:

Ketorolac should not be given to patients already receiving anticoagulatants, or to those who will require prophylactic anticoagulant therapy, including low dose heparin. The risk of ketorolac-associated bleeding is increased by other NSAIDs or aspirin and by pentoxifylline and concomitant use should be avoided. Probenecid increases the half-life and plasma concentrations of Ketorolac and the two drugs should not be given together.

Side-effects:

Anaphylaxis, dry mouth, excessive thirst, psychotic reactions, convulsion, myalgia, hyponatraemia, hyperkalaemia, flushing or pallor, bradycardia, hypertension, palpitations, chest pain, purpura, post operative wound haemorrhage, haematoma, epistaxis, pain at injection site.

Precaution:

Ketorolac should be used with caution in heart failure, hepatic impairment and conditions leading to reduction in blood volume or in renal blood flow. The dose of Ketorolac should be reduced in the elderly and in patients weighing less than 50 kg. It is recommended that patients with mild renal impairment should receive a reduced dose of Ketorolac and undergo close monitoring of renal function.

Use in pregnancy and lactation:

Ketorolac is contraindicated in the later stages of pregnancy and should only be used earlier in the pregnancy if there are compelling reasons. Because of the possible of adverse effects of prostaglandin-inhibiting drugs on neonates, use in nursing mothers is contraindicated.

Pediatric use:

Safety and effectiveness have been established in paediatric patients between the ages of 2 and 16 years.

The elderly:

Storage:

Oradol Tablet: Store at room temperature, protected from light and excessive humidity.

Oradol Injection: Store at room temperature, protected from light.

Packing:

Oradol Tablet: Each box contains 2×10's tablets in blister pack.

Oradol Injection: Each box contains 1×5's ampoules.