Trilisate

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Warnings
Precautions

WARNINGS

Reye Syndrome is a rare but serious disease which may develop in children and teenagers who have chicken pox, influenza, or flu symptoms. While the cause of Reye Syndrome is unknown, some studies suggest a possible association between the development of Reye Syndrome and the use of medicines containing acetylated salicylates or aspirin. TRILISATE (choline magnesium trisalicylate) Tablets and Liquid are a combination of choline salicylate and magnesium salicylate which are nonacetylated salicylates, and there have been no reported cases associating TRILISATE (choline magnesium trisalicylate) with Reye Syndrome. Nevertheless, TRILISATE (choline magnesium trisalicylate) , as a salicylate-containing product, is not recommended for use in children and teenagers with chicken pox, influenza or flu symptoms.

PRECAUTIONS

General

As with other salicylates and non- steroidal anti-inflammatory drugs, TRILISATE (choline magnesium trisalicylate) preparations should be used with caution in patients with acute or chronic renal insufficiency, with acute or chronic hepatic dysfunction, or with gastritis or peptic ulcer disease.

Although reports exist of cross reactivity, including bronchospasm, with the use of non-acetylated salicylate products in aspirin- sensitive patients, TRILISATE (choline magnesium trisalicylate) preparations were found to be well tolerated with regard to pulmonary function and respiratory symptoms when these parameters were monitored in a group of documented aspirin-sensitive asthmatics dosed with TRILISATE (choline magnesium trisalicylate) in both controlled and open label studies.1

Concurrent use of other salicylate-containing products and TRILISATE (choline magnesium trisalicylate) preparations can lead to an increase in plasma salicylate concentration and may result in potentially toxic salicylate levels.

Laboratory Tests

Plasma salicylate levels can be periodically assessed during treatment with TRILISATE (choline magnesium trisalicylate) preparations to determine whether a therapeutically effective anti-inflammatory concentration of 15 to 30 mg/ 100 ml (150-300 µg/ mL) is being maintained. Manifestations of systemic salicylate intoxication are usually not seen until the concentration exceeds 30 mg/100 mL. However, such tests rarely differentiate between the active free and inactive protein bound salicylate components. Since protein binding of salicylate is affected by age, nutritional status, competitive binding of other drugs, and underlying disease (e.g. rheumatoid arthritis), plasma salicylate level determinations may not always accurately reflect efficacious or toxic levels of active free salicylate. Acidification of the urine can significantly diminish the renal clearance of salicylate and increase plasma salicylate concentrations.

Drug/ Laboratory Test Interactions

Free T4 values may be increased in patients on salicylate drug products due to competitive plasma protein binding; a concurrent decrease in total plasma T4 may be observed. Thyroid function is not affected.

Carcinogenesis

No long-term animal studies have been performed with TRILISATE (choline magnesium trisalicylate) to evaluate its carcinogenic potential.

Use in Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with TRILISATE (choline magnesium trisalicylate) preparations. It is also not known whether TRILISATE (choline magnesium trisalicylate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TRILISATE (choline magnesium trisalicylate) should be given to a pregnant woman only if clearly needed. Because of the known effects of other salicylate drug products on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided.

Labor and Delivery

The effects of TRILISATE (choline magnesium trisalicylate) on labor and delivery in pregnant women are unknown. Since prolonged gestation and prolonged labor due to prostaglandin inhibition have been reported with the use of other salicylate products, the use of TRILISATE (choline magnesium trisalicylate) preparations near term is not recommended. Other salicylate products have also been associated with alterations in maternal and neonatal hemostasis mechanisms and with perinatal mortality.

Nursing Mothers

Salicylate is excreted in human milk. Peak milk salicylate levels are delayed, occurring as long as 9 to 12 hours post dose, and the milk: plasma ratio has been reported to be as high as 0.34. Because of the potential for significant salicylate absorption by the nursing infant, caution should be exercised when TRILISATE (choline magnesium trisalicylate) is administered to a nursing woman.

Pediatric Use

In a four-week, open-label pilot study of patients with juvenile rheumatoid arthritis, children from 6 to 16 years of age previously on aspirin received weight-adjusted doses (50-60 mg/ kg) of TRILISATE (choline magnesium trisalicylate) 500 mg tablets on a divided b.i.d. schedule with subsequent dose titration to achieve therapeutic serum salicylate levels. Eighty-three percent (83%) of the patients rated the therapeutic effect of TRILISATE (choline magnesium trisalicylate) as good or excellent. Tinnitus was reported by one patient and elevated SGOT levels at Week 1, which decreased during the trial, were detected in two patients. (See

WARNINGS

section.)

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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