Ketorolac Tromethamine

Non-narcotic Analgesic · NSAID

Indications

Short-term management of moderate to severe post- operative pain.

Dosage

Adults: 16 yr to <65 yr: Single Dose: 60 mg IM or 30 mg IV. Multiple Dose: 30 mg IV/IM every 6 hr. Max: 120 mg/day for 2 days. >65 yr or <50 kg: Single Dose: 30 mg IM or 15 mg IV. Multiple Dose: 15 mg IV/IM every 6 hr. Max: 60 mg/day for 2 days. Children: Under 16 yr, not recommended. Tab: 20 mg once after IV/IM therapy, then 10 mg q4-6 hr; not to exceed 40 mg/day.

Administration

IM: Administer slowly and deeply into the muscle. Analgesia begins in 30 min & max effect within 2 hours. IV: Administer IV bolus over a minimum of 15 seconds; onset within 30 min; peak analgesia within 2 hours. Compatibility: Stable in D5NS, D5W, LR, NS. Y-site administration: Drug to Drug IV Compatibility: Cisatracurium, dexamethasone, fentanyl, hydromorphone, lorazepam, morphine. Drug to Drug IV Incompatibility: Azithromycin. When admixed: Incompatible with hydroxyzine, meperidine, morphine, promethazine. Stability: Store at room temperature 15°C-30°C. Protect from light.

Adverse Effects

GI disturbances, ulcers, bleeds. Wound haemorrhage. Abnormal liver function tests. Drowsiness, acute renal failure, oedema, bronchospasm, anaphylaxis, pain at injection site, thrombocytopenia, hepatitis, liver failure. CNS, respiratory or cardiovascular disorders, thirst, asthenia, myalgia, fever, chest pain, elevated serum creatinine and urea, electrolyte disturbances, hypersensitivity and skin reactions.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Risk cannot be ruled out. Lactation: Contraindicated or not recommended. Contraindications: Peptic ulcer, GI or cerebrovascular bleeding, haemorrhagic diathesis, aspirin/anti-inflammatory induced allergies, coagulation disorders, asthma, hepatic or renal impairment, hypovolaemia, dehydration, severe heart failure, nasal polyps, angioedema. High risk of surgically-induced haemorrhage. Precautions: Elderly, GI disease, cardiac, renal, hepatic or allergic disease. Haemostasis. Mild to moderate heart failure, ischaemic heart disease, cerebrovascular disease, peripheral arterial disease. Hypertension, other cardiovascular risk factors. SLE, mixed connective tissue disorders. Use lowest effective dose for shortest duration.

Interactions

Anticoagulants, lithium, NSAIDs, methotrexate, probenecid, aspirin, diuretics, pentoxifylline, antihypertensives, SSRIs, corticosteroids, mifepristone, cyclosporin, tacrolimus, digoxin, quinolones, zidovudine.

Advice to Patient

Take oral form with meals. Take medication with a full glass of water and stay upright for atleast 15 minutes after taking medication. Discontinue medication and report immediately abdominal pain, blood in urine or stool. Contact prescriber if there is unrelieved nausea or vomiting, difficulty in breathing, difficulty in speaking, ringing in ears, ulceration, skin rash, itching, easy bruising or bleeding, chest pain, palpitations, unusual swelling of extremities, yellowing of eyes or skin. Avoid alcohol during therapy. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless restricted by the prescriber. Maintain good oral hygiene and use a soft-bristled toothbrush while taking medication. Do not take medication during last trimester of pregnancy. Get dental procedures done before starting therapy.

Pharmacokinetics

Onset of action: Analgesic: Oral: 30-60 mins; IM, IV: Approx. 30 mins. Peak effect: Analgesic: Oral: 2-3 hrs; IM, IV: 2-3 hrs. Duration: Analgesic: 4-6 hrs. Absorption: Oral: Well absorbed (100%); IM: Rapid and complete. Metabolism: Hepatic. Bioavailability: Oral, IM: 100%. Half-life elimination: Infants 6-18 mths of age (n=25): S-enantiomer: 0.83 ± 0.7 hrs; R-enantiomer: 4 ± 0.8 hrs. Children: 1-16 yrs (n=36): Mean: 3 ± 1.1 hrs. 3-18 yrs (n=24): Mean: 3.8 ± 2.6 hrs. 4-8 yrs (n=10): Mean: Approx. 6 hrs; Range: 3.5-10 hrs. Adults: Mean: Approx. 5 hrs; Range: 2-9 hrs [S-enantiomer approx. 2.5 hrs (biologically active); R-enantiomer approx. 5 hrs]; Prolonged 30%-50% in elderly. With renal impairment: SCr 1.9-5 mg/dL: Mean: Approx. 11 hrs; Range: 4-19 hrs. Renal dialysis patients: Mean: Approx. 14 hrs; Range: 8-40 hrs. Time to peak, serum: Oral: Approx. 45 mins; IM: 30-60 mins; IV: 1-3…

Brands with this active ingredient

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