Ketorolac Tromethamine 15.8% Nasal prep

Indications

Ketorolac Tromethamine 15.8% Nasal prep is used for: Allergic rhinitis

Adult Dose

Pain Indicated for short-term (up to 5 days) management of moderate to moderately severe pain <65 years: 31.5 mg (ie, 1 spray in each nostril) q6-8h; not to exceed 126 mg/day <50 kg or >65 years: 15.75 mg (ie, 1 spray in only 1nostril) q6-8h; not to exceed 63 mg/day Hepatic Impairment Use caution; may cause elevation of liver enzymes; discontinued if symptoms of liver toxicity develop

Child Dose

Safety and efficacy not established

Renal Dose

Renal Impairment 1 spray (15.75 mg) in 1 nostril Total dose: 15.75 mg intranasal q6-8hr; not to exceed 4 doses (63 mg/day)

Administration

Contra Indications

Hypersensitivity to aspirin or other NSAIDs, asthma. Nasal polyps, angioedema, bronchospasm.Moderate to severe renal impairment. Pregnancy, lactation.

Precautions

Elderly, patients weighing <50 kg, hepatic dysfunction, heart failure, predisposition to reduced blood volume or renal blood flow. Mild renal impairment; monitor renal function closely. Lactation: Distributed in human breast milk, caution not advised

Pregnancy-Lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus Avoid NSAIDs in pregnant women starting at 30 weeks of gestation Lactation Excreted in human milk Limited data from one published study involving ten nursing mothers 2-6 days postpartum showed low levels of ketorolac in breast milk The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the dru or from the underlying maternal condition

Interactions

May reduce effects of antihypertensives eg ACE inhibitors or angiotensin II receptor antagonists (AIIA). Increased risk of renal toxicity with ACE inhibitors, diuretics. Increased adverse effects with aspirin or other NSAIDs. Hallucinations may occur when used with fluoxetine, thiothixene, alprazolam. Potentially Fatal: Increased risk of GI bleeding with warfarin. May increase toxicity of methotrexate (MTX) and lithium. Increased plasma concentrations with probenecid.

Side Effects

Side effects of Ketorolac Tromethamine 15.8% Nasal prep : >10% Nasal discomfort (15%), Rhinalgia (13%) 1-10% Increased lacrimation (5%), Throat irritation (4%), Oliguria (3%), Rash (3%), Bradycardia (2%), Decreased urine output (2%), Increased ALT and/or AST (2%), Hypertension (2%), Rhinitis (2%)

Mode of Action

Ketorolac inhibits prostaglandin synthesis by decreasing the activity of the cyclooxygenase enzyme.