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Generic Name

Ketorolac Tromethamine

Therapeutic Class: Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics

Indications:
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute postoperative pain.

Presentation:
Ketorolac 30 IM/IV injection: Each 1 ml ampoule contains a concentrated sterile solution of ketorolac Tromethamine USP 30 mg.
Ketorolac 60 IM injection: Each 2 ml ampoule contains a concentrated sterile solution of Ketorolac Tromethamine USP 60 mg.
Ketorolac tablet: Each film-coated tablet contains Ketorolac Tromethamine USP 10 mg.

Description:
Ketorolac Tromethamine is a drug of the pyrrolo-pyrrole group of the nonsteroidal anti-inflammatory drugs (NSAID). Chemically it is known as 5 benzoyl-2,3-dihydro-1H-pyrrolidine-1-carboxylic acid, compound with 2 - amino-2-(hydroxymethyl)-1,3-propanediol (1:1). Ketorolac Tromethamine inhibits the synthesis of prostaglandins and may be considered as a peripherally acting analgesic. The biological activity of Ketorolac Tromethamine is associated with the S-form. The pharmacokinetic property of Ketorolac Tromethamine is linear. It is highly protein-bound and is largely metabolized in the liver. The products of metabolism and some unchanged drugs are excreted in the urine.

Description:
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.

Dosage & Administration:
Tablet-
The recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and is not recommended for chronic use. Doses exceeding 40 mg/day are not recommended.

Injection-

Ketorolac injection may be used as single or multiple doses, on a regular or when the necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):

• Patients <65 years of age: One dose of 60 mg.
• Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg. 

IV Dosing (Adult):

• Patients <65 years of age: One dose of 30 mg.
• Patients >65 years of age, Renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

IV or IM Dosing (2 to 16 years of age):

• IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
• IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

Multiple-Dose Treatment (IV or IM)-

• Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients, and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
• Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adults patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.

Interaction:

• Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
• Anti-coagulants: Enhance anti-coagulant effect.
• Beta-Blocker: Reduce the anti-hypertensive effect.
• ACE Inhibitors: Increase the risk of renal impairment.
• Methotrexate: Enhance the toxicity of methotrexate.

Contraindications:
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as a prophylactic analgesic before surgery.

Side Effects:
Commonly occurring side effects are nausea, vomiting, gastrointestinal bleeding, Melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in females, and pulmonary edema.

Pregnancy & Lactation:
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Precautions & Warnings:
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.

Overdose:
Overdosage of Ketorolac Tromethamine may cause abdominal pain, peptic ulcers which healed after discontinuation of doses. Metabolic acidosis has been reported following intentional overdosage.

Storage:
Keep in a dry place away from light and heat. Keep out of the reach of children.