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Pronunciation:

(KOE leen mag NEE zhum trye sa LIS i late)

U.S. Brand Names:

Trilisate® [DSC]

Synonyms:

Tricosal

Generic Available:

Yes

Use:

Management of osteoarthritis, rheumatoid arthritis, and other arthritis; acute painful shoulder

Pregnancy Risk Factor:

C/D (3rd trimester)

Pregnancy Implications:

Animal reproduction studies have not been conducted. Due to the known effects of other salicylates (closure of ductus arteriosus), use during late pregnancy should be avoided.

Lactation:

Enters breast milk/use caution

Contraindications:

Hypersensitivity to salicylates, other nonacetylated salicylates, other NSAIDs, or any component of the formulation; bleeding disorders; pregnancy (3rd trimester)

Warnings/Precautions:

Salicylate salts may not inhibit platelet aggregation and, therefore, should not be substituted for aspirin in the prophylaxis of thrombosis. Use with caution in patients with impaired renal function, dehydration, erosive gastritis, asthma, or peptic ulcer. Discontinue use 1 week prior to surgical procedures. Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. Changes in behavior (along with nausea and vomiting) may be an early sign of Reye's syndrome; patients should be instructed to contact their healthcare provider if these occur.

Elderly are a high-risk population for adverse effects from NSAIDs. As many as 60% of elderly can develop peptic ulceration and/or hemorrhage asymptomatically. Use lowest effective dose for shortest period possible. Tinnitus or impaired hearing may indicate toxicity. Tinnitus may be a difficult and unreliable indication of toxicity due to age-related hearing loss or eighth cranial nerve damage. CNS adverse effects may be observed in the elderly at lower doses than younger adults.

Adverse Reactions:

<20%:

Gastrointestinal: Nausea, vomiting, diarrhea, heartburn, dyspepsia, epigastric pain, constipation

Otic: Tinnitus

<2%:

Central nervous system: Headache, lightheadedness, dizziness, drowsiness, lethargy

Otic: Hearing impairment

<1%: Gastric ulceration, occult bleeding, increased BUN and creatinine, rash, pruritus, anorexia, weight gain, edema, epistaxis, dysgeusia

Postmarketing and/or case reports: Asthma, bruising, confusion, duodenal ulceration, erythema multiforme, esophagitis, hallucinations, hepatic enzymes increased, hearing loss (irreversible)

Overdosage/Toxicology:

Symptoms of overdose include tinnitus, vomiting, acute renal failure, hyperthermia, irritability, seizures, coma, and metabolic acidosis. For acute ingestion, determine serum salicylate levels 6 hours after ingestion. Nomograms, such as the "Done" nomogram, may be helpful for estimating the severity of aspirin poisoning and directing treatment using serum salicylate levels. Treatment is based upon symptomatology.

Drug Interactions:

ACE inhibitors: Effects of ACE inhibitors may be decreased by concurrent therapy with NSAIDs.

Antacids: Concomitant use may lead to decreased salicylate concentration.

Warfarin: Concomitant use may increase the hypoprothrombinemic effect of warfarin.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may enhance gastric mucosal irritation).

Food: May decrease the rate but not the extent of oral absorption.

Herb/Nutraceutical: Avoid cat's claw, dong quai, evening primrose, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, ginseng (all have additional antiplatelet activity). Limit curry powder, paprika, licorice, Benedictine liqueur, prunes, raisins, tea, and gherkins; may cause salicylate accumulation. These foods contain 6 mg salicylate/100 g.

Stability:

Store at controlled room temperature of 15°C to 30°C (59°F to 86°F).

Mechanism of Action:

Inhibits prostaglandin synthesis; acts on the hypothalamus heat-regulating center to reduce fever; blocks the generation of pain impulses

Pharmacodynamics/Kinetics:

Onset of action: Peak effect: ~2 hours

Absorption: Stomach and small intestines

Distribution: Readily into most body fluids and tissues; crosses placenta; enters breast milk

Half-life elimination (dose dependent): Low dose: 2-3 hours; High dose: 30 hours

Time to peak, serum: ~2 hours

Dosage:

Oral (based on total salicylate content):

Children <37 kg: 50 mg/kg/day given in 2 divided doses; 2250 mg/day for heavier children

Adults: 500 mg to 1.5 g 2-3 times/day or 3 g at bedtime; usual maintenance dose: 1-4.5 g/day

Elderly: 750 mg 3 times/day

Dosing adjustment/comments in renal impairment: Avoid use in severe renal impairment

Administration:

Liquid may be mixed with fruit juice just before drinking. Do not administer with antacids. Take with a full glass of water and remain in an upright position for 15-30 minutes after administration.

Monitoring Parameters:

Serum magnesium with high dose therapy or in patients with impaired renal function; serum salicylate levels, renal function, hearing changes or tinnitus, abnormal bruising, weight gain and response (ie, pain)

Reference Range:

Salicylate blood levels for anti-inflammatory effect: 150-300 mcg/mL; analgesia and antipyretic effect: 30-50 mcg/mL

Test Interactions:

False-negative results for glucose oxidase urinary glucose tests (Clinistix®); false-positives using the cupric sulfate method (Clinitest®); also, interferes with Gerhardt test (urinary ketone analysis), VMA determination; 5-HIAA, xylose tolerance test, and T3 and T4; increased PBI

Dietary Considerations:

Take with food or large volume of water or milk to minimize GI upset. Liquid may be mixed with fruit juice just before drinking. Hypermagnesemia resulting from magnesium salicylate; avoid or use with caution in renal insufficiency.

Patient Education:

If self-administered, use exactly as directed; do not increase dose or frequency. Adverse reactions can occur with overuse. Take with food or milk. While using this medication, do not use alcohol, excessive amounts of vitamin C, or salicylate-containing foods (curry powder, prunes, raisins, tea, or licorice), other prescription or OTC medications containing aspirin or salicylate, or other NSAIDs without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. You may experience nausea, vomiting, gastric discomfort (frequent mouth care, small, frequent meals, sucking lozenges, or chewing gum may help). GI bleeding, ulceration, or perforation can occur with or without pain. Stop taking medication and report ringing in ears; persistent stomach pain; unresolved nausea or vomiting; respiratory difficulty or shortness of breath; or unusual bruising or bleeding (mouth, urine, stool); or skin rash. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Anesthesia and Critical Care Concerns/Other Considerations:

Salicylate salts do not inhibit platelet aggregation and, therefore, should not be substituted for aspirin in the prophylaxis of thrombosis.

Dental Health: Effects on Dental Treatment:

NSAID formulations are known to reversibly decrease platelet aggregation via mechanisms different than observed with aspirin. The dentist should be aware of the potential of abnormal coagulation. Caution should also be exercised in the use of NSAIDs in patients already on anticoagulant therapy with drugs such as warfarin (Coumadin®).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause sedation; may rarely cause nervousness or insomnia

Mental Health: Effects on Psychiatric Treatment:

May rarely cause leukopenia; use caution with clozapine and carbamazepine

Dosage Forms:

Liquid: 500 mg/5 mL (240 mL) [choline salicylate 293 mg and magnesium salicylate 362 mg per 5 mL; cherry cordial flavor]

Tablet: 500 mg [choline salicylate 293 mg and magnesium salicylate 362 mg]; 750 mg [choline salicylate 440 mg and magnesium salicylate 544 mg]; 1000 mg [choline salicylate 587 mg and magnesium salicylate 725 mg]

References

Berde C, Ablin A, Glazer J, et al, "American Academy of Pediatrics Report of the Subcommittee on Disease-Related Pain in Childhood Cancer,"Pediatrics, 1990, 86(5 Pt 2):818-25.

Chapman BJ and Proudfoot AT, "Adult Salicylate Poisoning: Deaths and Outcome in Patients With High Plasma Salicylate Concentrations,"Q J Med, 1989, 72(268):699-707.

Department of Health and Human Services, Food and Drug Administration, "Labeling for Oral and Rectal Over-the-Counter Drug Products Containing Aspirin and Nonaspirin Salicylates; Reye's Syndrome Warning; Final Rule, (29 CFR Part 201),"Federal Register, April 17, 2003, 18861-9.

"Drugs for Pain,"Med Lett Drugs Ther, 1998, 40(1033):79-84.

Dugandric RM, Tierney MG, and Dickinson GE, "Evaluation of the Done Nomogram in the Management of Acute Salicylate Intoxication,"Ann Emerg Med, 1989, 18(11):1186-90.

Hawkey CJ, Karrasch JA, Szczepañski L, et al, "Omeprazole Compared With Misoprostrol for Ulcers Associated With Nonsteroidal Anti-inflammatory Drugs,"N Engl J Med, 1998, 338(11):727-34.

Vandenberg SA, Smolinske SC, Spoerke DG, et al, "Nonaspirin Salicylates: Conversion Factors for Estimating Aspirin Equivalency,"Vet Hum Toxicol, 1989, 31(1):49-50.

Verbeeck RK, "Pharmacokinetic Drug Interactions With Nonsteroidal Anti-inflammatory Drugs,"Clin Pharmacokinet, 1990, 19(1):44-66.

Vertrees JE, McWilliams BC, and Kelly HW, "Repeated Oral Administration for Treating Aspirin Overdose in Young Children,"Pediatrics, 1990, 85(4):594-8.

Weissmann G, "Aspirin,"Sci Am, 1991, 264(1):84-90.

Yeomans ND, Tulassay Z, Juhasz L, et al, "A Comparison of Omeprazole With Ranitidine for Ulcers Associated With Nonsteroidal Anti-inflammatory Drugs,"N Engl J Med, 1998, 338(11):719-26.

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