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.