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SPRIX
Nonnarcotic analgesics
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Drug Name:

SPRIX Rx

Generic Name and Formulations:
Ketorolac tromethamine 15.75mg; per 100μL nasal spray; contains EDTA.

Company:
Egalet

Therapeutic Use:

Indications for SPRIX:

For the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. Limitations of use: Max duration of use alone or sequentially with other ketorolac forms: 5 days. Not to be used concomitantly with other ketorolac forms or other NSAIDs.

Adult:

Use lowest effective dose for shortest duration. 18–64yrs: 1 spray in each nostril (total dose: 31.5mg) every 6–8hrs; max daily dose 126mg (4 doses). ≥65yrs, renally-impaired, or <50kg: 1 spray in one nostril (total dose: 15.75mg) every 6–8hrs; max daily dose 63mg (4 doses). Discard used bottle after 24hrs.

Children:

≤17yrs: not established.

Contraindications:

Active peptic ulcer, recent GI bleed or perforation. Cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or for whom hemostasis is critical. Aspirin allergy. Pre-op use. Coronary artery bypass graft surgery. Advanced renal disease or at risk for renal failure due to volume depletion. Concomitant probenecid, pentoxifylline. Labor & delivery.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Inflammatory bowel disease (eg, ulcerative colitis, Crohns disease). Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Avoid spraying into eyes. Elderly. Debilitated. Pregnancy (Cat.C <30 weeks gestation; Cat.D ≥30 weeks gestation: avoid). Nursing mothers.

Interactions:

See Contraindications. Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Possible seizures with phenytoin, carbamazepine. Possible hallucinations with fluoxetine, thiothixene, alprazolam. Caution with nondepolarizing muscle relaxants; monitor for apnea.

Pharmacological Class:

NSAID (pyrrolo-pyrrole).

Adverse Reactions:

Nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash (may be serious), bradycardia, decreased urine output, increased ALT/AST, hypertension, rhinitis; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

How Supplied:

Single-day nasal spray bottle (8 sprays/1.7g bottle)—1, 5

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