Xiroket IM/IV

Description

Pharmacology: XIROKET is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAID). It inhibits the cyclo-oxygenase enzyme system and hence prostaglandin synthesis. Thus it gives minimal inflammatory effect at its analgesic effect.

Dose and administration: Adults: The recommended initial dose of XIROKET is 10 mg, followed by 10-30 mg every 4 to 6 hours as required. In the initial postoperative period, XIROKET may be given as often as every 2 hours if needed. The lowest effective dose should be given. The maximum duration of treatment should not exceed 2 days.

Types of patients	Single dosage		Double dosage
	IV	IM	IV	IM
≥2 years	0.5 mg/kg	1 mg/kg	Initially 0.5 mg/kg then 0.5 mg/kg every 6 hour for maximum 2 days	——————
<  65 years	10-30 mg	10-60 mg	10-30 mg every 6 hour. Daily 120 mg for maximum 5 days	10-30 mg every 4 hour. Daily 120 mg for maximum 5 days
≥65 years or renal impairment or under 50 kg	10-15 mg	10-30 mg	10-15 mg every 6 hour. Daily 60 mg for maximum 5 days	10-15 mg every 4-6 hour. Daily 60 mg for maximum 5 days

 

Geriatric Use (≥65 Years of Age): Because ketorolac tromethamine may be cleared more slowly by the elderly who are also more sensitive to the dose-related adverse effects of NSAIDs, extreme caution and reduced dosages and careful clinical monitoring must be used when treating the elderly with ketorolac tromethamine.

Contraindication: Ketorolac Tromethamine is contraindicated in patients with known hypersensitivity to NSAIDs and any of the components of the product. Moreover, the patient with the history of asthma, nasal polyp, angioedema, peptic ulcer and bleeding, bleeding disorders are contraindicated for this drug.

Warning and Precaution: Since ketorolac tromethamine and its metabolites are excreted primarily by the kidney, patients with moderate to severe impairment of renal function should not receive. Asthma & pregnant patients should used with caution.

Side effects:

a) Common: Commonly occurring side-effects are nausea, vomiting, gastro-intestinal bleeding, melaena, peptic ulcer, pancreatitis, anxiety, drowsiness, dizziness, headache, hallucinations, excessive thirst, inability to concentrate, insomnia, malaise, fatigue, pruritus, urticaria, skin photosensitivity, Lyell’s syndrome, Stevens Johnson syndrome, flushing.

b) Rare: Bradycardia, hypertension, palpitations, chest pain, infertility in female, dyspnoea, asthma, pulmonary edema, fever, injection site pain.

Use in pregnancy & lactation: Safety in human pregnancy has not been established. Ketorolac has been detected in human milk at low levels. Ketorolac is therefore contraindicated during pregnancy, labour or delivery, or in mothers who are breast feeding.

Use in children & adolescents: Pediatric Use, Ketorolac tromethamine is not indicated for use in pediatric patients. The safety and effectiveness of ketorolac tromethamine oral in pediatric patients below the age of 17 have not been established.

Drug interaction:

a) With Medicine: Ketorolac tromethamine should not be used with other NSAIDs, aspirin, anti-coagulants Ketorolac, other non-steroidal anti-inflammatory drugs, the anti-hypertensive effect of beta-blockers and ACE inhibitors, particularly in volume depleted patients. Caution is advised when methotrexate is administered concurrently, since some prostaglandin synthesis inhibiting drugs have been reported to reduce the clearance of methotrexate, and thus possibly enhance its toxicity. Probenecid should not be administered

b) With food: No interaction with food.

Overdose: Doses of 360 mg given intramuscularly over and 8 hour interval for 5 consecutive days have caused abdominal pain and peptic ulcers which have healed after discontinuation of dosing.

Storage: XIROKET Ampule should be store below 30 °C in a dry place, protect from light & moisture.

Packing: XIROKET Injection: Each box containing 1X1 ampoule in blister pack.