No

Salicylate

Management of osteoarthritis, rheumatoid arthritis, and other arthritis; salicylate salts may not inhibit platelet aggregation and, therefore, should not be substituted for aspirin in the prophylaxis of thrombosis

C (D in 3rd trimester)

Bleeding disorders; hypersensitivity to salicylates or other nonacetylated salicylates or other NSAIDs; tartrazine dye hypersensitivity, asthma

Use with caution in patients with impaired renal function, dehydration, erosive gastritis, or peptic ulcer; avoid use in patients with suspected varicella or influenza (salicylates have been associated with Reye's syndrome in children <16 years of age when used to treat symptoms of chickenpox or the flu). Tinnitus or impaired hearing may indicate toxicity; discontinue use 1 week prior to surgical procedures.

>10%: Gastrointestinal: Nausea, heartburn, stomach pains, dyspepsia, epigastric discomfort

1% to 10%:

Central nervous system: Fatigue

Dermatologic: Rash

Gastrointestinal: Gastrointestinal ulceration

Hematologic: Hemolytic anemia

Neuromuscular & skeletal: Weakness

Respiratory: Dyspnea

Miscellaneous: Anaphylactic shock

<1%: Insomnia, nervousness, jitters, occult bleeding, prolongation of bleeding time, leukopenia, thrombocytopenia, iron deficiency anemia, hepatotoxicity, impaired renal function, bronchospasm, increased uric acid

Symptoms of overdose include tinnitus, vomiting, acute renal failure, hyperthermia, irritability, seizures, coma, metabolic acidosis

For acute ingestions, determine serum salicylate levels 6 hours after ingestion; the "Done" nomogram may be helpful for estimating the severity of aspirin poisoning and directing treatment using serum salicylate levels.

Treatment should also be based upon symptomatology. Toxic symptoms and corresponding treatments are as follows:

• Overdose: Induce emesis with ipecac, and/or lavage with saline, followed with activated charcoal
• Dehydration: I.V. fluids with KCl (no D₅W only)
• Metabolic acidosis (must be treated): Sodium bicarbonate
• Hyperthermia: Cooling blankets or sponge baths
• Coagulopathy/hemorrhage: Vitamin K I.V.
• Hypoglycemia (with coma, seizures, or change in mental status): Dextrose 25 g I.V.
• Seizures: Diazepam 5-10 mg I.V.

Decreased effect: Antacids + Trilisate® decreased salicylate concentration; ACE-inhibitor effects may be decreased by concurrent therapy with NSAIDS

Increased toxicity: Warfarin + Trilisate® possible increased hypoprothrombinemic effect

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

Peak concentrations in ~2 hours after oral dose

Absorption: Absorbed from the stomach and small intestine

Distribution: Readily distributes into most body fluids and tissues; crosses the placenta; appears in breast milk

Half-life: Dose-dependent ranging from 2-3 hours at low doses to 30 hours at high doses

Time to peak serum concentration: ~2 hours

Oral (based on total salicylate content):

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

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

Alcohol: Combination causes GI irritation, possible bleeding; avoid or limit alcohol. Patients at increased risk include those prone to hypoprothrombinemia, vitamin K deficiency, thrombocytopenia, thrombotic thrombocytopenia purpura, severe hepatic impairment, and those receiving anticoagulants.

Food: May decrease the rate but not the extent of oral absorption. Drug may cause GI upset, bleeding, ulceration, perforation. Take with food or or large volume of water or milk to minimize GI upset.

Folic acid: Hyperexcretion of folate; folic acid deficiency may result, leading to macrocytic anemia. Supplement with folic acid if necessary.

Iron: With chronic use and at doses of 3-4 g/day, iron deficiency anemia may result; supplement with iron if necessary

Magnesium: Hypermagnesemia resulting from magnesium salicylate; avoid or use with caution in renal insufficiency

Sodium: Hypernatremia resulting from buffered aspirin solutions or sodium salicylate containing high sodium content. Avoid or use with caution in CHF or any condition where hypernatremia would be detrimental.

Curry powder, paprika, licorice, Benedictine liqueur, prunes, raisins, tea and gherkins: Potential salicylate accumulation. These foods contain 6 mg salicylate/100 g. An ordinary American diet contains 10-200 mg/day of salicylate. Foods containing salicylates may contribute to aspirin hypersensitivity. Patients at greatest risk for aspirin hypersensitivity include those with asthma, nasal polyposis, or chronic urticaria.

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)

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

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

May cause sedation; may rarely cause nervousness or insomnia

May rarely cause leukopenia; use caution with clozapine and carbamazepine

No information available to require special precautions

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®).

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 pain in stomach; unresolved nausea or vomiting; difficulty breathing or shortness of breath; unusual bruising or bleeding (mouth, urine, stool); or skin rash. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Liquid may be mixed with fruit juice just before drinking; do not administer with antacids

Liquid:

Trilisate®: 500 mg/5 mL total salicylate (293 mg/5 mL choline salicylate and 362 mg/5 mL magnesium salicylate)

Tablet:

Trilisate 500®: 500 mg total salicylate (293 mg choline salicylate and 362 mg magnesium salicylate)

Trilisate 750®: 750 mg total salicylate (440 mg choline salicylate and 544 mg magnesium salicylate)

Trilisate 1000®: 1000 mg total salicylate (587 mg choline salicylate and 725 mg magnesium salicylate)

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

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

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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.