ketorolac intranasal (Rx)

Brand and Other Names:Sprix
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal

  • 15.75mg per 100 microL spray; 8 sprays/1.7g bottle

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 1 nostril) q6-8h; not to exceed 63 mg/day

Also see Administration

Dosage Modifications

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)

Hepatic Impairment

  • Use caution; may cause elevation of liver enzymes; discontinued if symptoms of liver toxicity develop

Safety and efficacy not established

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Interactions

Interaction Checker

and ketorolac intranasal

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >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%)

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            Warnings

            Black Box Warnings

            Limitations of use

            • Total duration of use of intranasal alone or sequentially with and other ketorolac formulations should not exceed 5 days

            Cardiovascular risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal; risk may increase with duration of use; patients with risk factors for or existing cardiovascular disease may be at greater risk; contraindicated for perioperative pain in the setting of CABG surgery (increased risk of MI and stroke)

            Gastrointestinal risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal; GI adverse events may occur at any time during use and without warning symptoms; elderly patients are at greater risk for serious GI events

            Bleeding risk

            • Inhibits platelet function and is contraindicated with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding

            Renal risk

            • Contraindicated with advanced renal impairment and patients at risk for renal failure due to volume depletion

            Contraindications

            Hypersensitivity to ketorolac, other NSAID, aspirin, ethylenediamine tetraacetic acid (EDTA)

            Active peptic ulcer disease, recent GI bleeding or perforation, or history of peptic ulcer disease or GI bleeding

            History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

            Prophylactic analgesic before any major surgery; during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery; advanced renal disease or patients at risk for renal failure due to volume depletion

            Labor and delivery

            Breastfeeding women

            Suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical

            Coadministration with probenecid or pentoxifylline

            Cautions

            May lead to onset of new hypertension or exacerbate existing hypertension

            NSAIDs may cause serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)

            Common local adverse effects include mild and transient nasal discomfort and irritation

            Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs

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            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

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase isoenzymes, cyclooxygenase-1 (COX-1) and -2 (COX-2)

            May inhibit chemotaxis, may alter lymphocyte activity, decrease proinflammatory cytokine activity, and may inhibit neutrophil aggregation. These effects may contribute to its anti-inflammatory activity

            Pharmacokinetics

            Bioavailability: 60% (compared with 30 mg IM)

            Peak plasma time: 0.75 hr

            Peak plasma concentration: 1805.8 ng/mL

            Protein bound: 99% (5% to albumin)

            Vd: 13 L

            Metabolism: By liver via hydroxylation and conjugation

            Half-life: 5.24 hr; 6-19 hr with renal impairment

            Excretion: 92% urine (~40% as metabolites); 6% feces

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            Administration

            Intranasal Administration

            Is not an inhaled product; do not inhale when administering this product

            Do not use concomitantly with other formulations of ketorolac or other NSAIDs

            Activate pump

            • Activate the pump before using the bottle for the FIRST time, activate the pump
            • To activate the pump, hold the bottle at arm’s length away from the body with index finger and middle finger resting on the top of the finger flange and thumb supporting the base
            • Press down evenly and release the pump 5 times; patient may not see a spray the first few times it is pressed down
            • No need to activate the pump again if more doses are used from the bottle

            Patient instructions

            • Step 1
              • Blow nose gently to clear nostrils
              • Sit up straight or stand; tilt head slightly forward
              • Insert the tip of the container into your right nostril
              • Point the container away from the center of your nose
              • Hold your breath and spray once into your right nostril, pressing down evenly on both sides
              • Immediately after administration, resume breathing through mouth to reduce expelling the product
              • Also pinch the nose to help retain the spray if it starts to drip
              • If only one spray per dose is prescribed, administration is complete; skip to Step 3 below
            • Step 2
              • If a dose of 2 sprays is prescribed, repeat the process in Step 1 for the left nostril
              • Again, be sure to point the spray away from the center of nose
              • Spray once into the left nostril
            • Step 3
              • Replace the clear plastic cover and place the bottle in a cool, dry location out of direct sunlight
              • Keep out of reach of children
              • Discard bottle within 24 hr after first priming, even if bottle still contains medication (will not deliver intended dose after 24 hr)

            Storage

            Protect from light and freezing

            Refrigerate unopened bottle at 2-8°C (36-46°F)

            Store at controlled room temperature during use, between 15-30°C (59-86°F), out of direct sunlight

            Discard within 24 hr of priming

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.