酮洛酸氨丁三醇鼻腔喷雾剂
SPRIX Rx
Nonnarcotic analgesics  Only 4 drugs may be compared at once
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Generic Name and Formulations:
Ketorolac tromethamine 15.75mg; per 100μL nasal spray; contains EDTA.
Company:
Regency Therapeutics
 
Select therapeutic use: Nonnarcotic analgesics
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 for use in pediatric patients ≤17yrs or concomitantly with other ketorolac forms or other NSAIDs.

Adult:
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, history of peptic ulcer or GI bleeding. Cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or for whom hemostasis is critical. History of asthma, urticaria, aspirin allergy. Pre-op use. CABG surgery. Advanced renal disease or at risk for renal failure due to volume depletion. EDTA allergy. Concomitant probenecid, pentoxifylline. Labor & delivery.

Warnings/Precautions:
Increased risk of GI, bleeding, cardiovascular, or renal effects; monitor. Inflammatory bowel disease (eg, ulcerative colitis, Crohns disease). Hypertension. CHF. Edema. Coagulation disorders. Post-op use. Preexisting asthma. Discontinue if rash or hypersensitivity develops. May mask signs of infection. Maintain adequate hydration. Impaired heart, renal, or liver function. Avoid spraying into eyes. Use lowest effective dose for shortest duration. Debilitated. Elderly. Pregnancy (Cat.C prior to 30 weeks gestation; Cat.D starting at 30 weeks gestation). Nursing mothers.

Interactions:
See Contraindications. Increased risk of bleeding with concomitant anticoagulants, SSRIs. May diminish effects of furosemide, thiazides, ACE inhibitors, angiotensin II receptor antagonists. Possible seizures with phenytoin, carbamazepine. Possible hallucinations with fluoxetine, thiothixene, alprazolam. Monitor for lithium, methotrexate toxicity. Caution with nondepolarizing muscle relaxants (apnea).

Pharmacological Class:
NSAID (pyrrolo-pyrrole).

Adverse Reactions:
Nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT/AST, hypertension, rhinitis; GI bleed/ulceration/perforation (discontinue if occurs), anaphylactoid reactions, serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis; may be fatal), severe hepatic reactions (eg, jaundice, fulminant hepatitis, liver necrosis, hepatic failure; discontinue if develops), severe renal effects (eg, renal papillary necrosis, interstitial nephritis, nephrotic syndrome; with long-term use). See full labeling re: risk of cardiovascular events.

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