Trilisate

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

Indications
Dosage
How Supplied

INDICATIONS

Osteoarthritis, Rheumatoid Arthritis and Acute Painful Shoulder

Salicylates are considered the base therapy of choice in the arthritides; and TRILISATE (choline magnesium trisalicylate) preparations are indicated for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and other arthritides. TRILISATE (choline magnesium trisalicylate) Tablets or Liquid are indicated in the long-term management of these diseases and especially in the acute flare of rheumatoid arthritis. TRILISATE (choline magnesium trisalicylate) Tablets or Liquid are also indicated for the treatment of acute painful shoulder.

TRILISATE (choline magnesium trisalicylate) preparations are effective and generally well tolerated, and are logical choices whenever salicylate treatment is indicated. They are particularly suitable when a once-a-day or b.i.d. dosage regimen is important to patient compliance; when gastrointestinal intolerance to aspirin is encountered; when gastrointestinal microbleeding or hematologic effects of aspirin are considered a patient hazard; and when interference (or the risk of interference) with normal platelet function by aspirin or by propionic acid derivatives is considered to be clinically undesirable. Use of TRILISATE (choline magnesium trisalicylate) Liquid is appropriate when a liquid dosage form is preferred, as in the elderly patient.

The efficacy of TRILISATE (choline magnesium trisalicylate) preparations has not been studied in those patients who are designated by the American Rheumatism Association as belonging in Functional Class IV (incapacitated, largely or wholly bedridden or confined to a wheelchair, with little or no self-care).

Analgesic and Antipyretic Action

TRILISATE (choline magnesium trisalicylate) Tablets/ Liquid are also indicated for the relief of mild to moderate pain and for antipyresis. In children, TRILISATE (choline magnesium trisalicylate) preparations are indicated for conditions requiring anti- inflammatory or analgesic action such as juvenile rheumatoid arthritis and other appropriate conditions.

DOSAGE AND ADMINISTRATION

ADULTS

In rheumatoid arthritis, osteoarthritis, the more severe arthritides, and acute painful shoulder, the recommended starting dosage is 1500 mg given b.i.d. Some patients may be treated with 3000 mg given once per day (h.s.) In the elderly patient, a daily dosage of 2250 mg given as 750 mg t.i.d. may be efficacious and well tolerated. Dosage should be adjusted in accordance with the patients response. In patients with renal dysfunction, monitor salicylate levels and adjust dose accordingly.

For mild to moderate pain or for antipyresis, the usual dosage is 2000 mg to 3000 mg daily in divided doses (b.i.d.). Based on patient response or salicylate blood levels, dosage may be adjusted to achieve optimum therapeutic effect. Salicylate blood levels should be in the range of 15 to 30 mg/ 100 mL for anti-inflammatory effect and 5 to 15 mg/ 100 mL for analgesia and antipyresis.

Each 500 mg tablet or teaspoonful is equivalent in salicylate content to 10 g of aspirin; each 750 mg tablet, to 15 g of aspirin; and each 1000 mg tablet, to 20 g of aspirin.

If the physician prefers, the recommended daily dosage may be administered on a t.i.d. schedule.

As with other therapeutic agents, individual dosage adjustment is advisable, and a number of patients may require higher or lower dosages than those recommended. Certain patients require 2 to 3 weeks of therapy for optimal effect.

CHILDREN

Usual daily dose for children for anti- inflammatory or analgesic action:

TRILISATE (choline magnesium trisalicylate) 500 mg Tablets/ Liquid and TRILISATE (choline magnesium trisalicylate) 750 mg and 1000 mg Tablets, 50 mg/ kg/ day.

Weight (kg)

Total daily dose

12- 13

500 mg

14- 17

750 mg

18- 22

1000 mg

23- 27

1250 mg

28- 32

1500 mg

33- 37

1750 mg


Total daily doses should be administered in divided doses (b.i.d.). Doses of TRILISATE (choline magnesium trisalicylate) preparations are calculated as the total daily dose of 50 mg/ kg/ day for children of 37 kg body weight or less and 2250 mg/ day for heavier children.

TRILISATE (choline magnesium trisalicylate) Liquid is available for greater convenience in treating younger patients and those adult patients unable to wswallow a solid dosage form.

HOW SUPPLIED

NDC 0034-0500-80: TRILISATE (choline magnesium trisalicylate) 500 mg Tablets (pale pink, scored) supplied in bottles of 100 tablets.

NDC 0034-0500-50: TRILISATE (choline magnesium trisalicylate) 500 mg Tablets (pale pink, scored) supplied in bottles of 500 tablets.

NDC 0034-0500-10: TRILISATE (choline magnesium trisalicylate) 500 mg Tablets (pale pink, scored) supplied in unit dose packaging with 10 tablets per card. Ten cards are packed in each carton; 10 cartons are packed in each shipper.

NDC 0034-0505-80: TRILISATE (choline magnesium trisalicylate) 750 mg Tablets (scored, white, film-coated) in bottles of 100 tablets.

NDC 0034-0505-50: TRILISATE (choline magnesium trisalicylate) 750 mg Tablets (scored, white, film-coated) in bottles of 500 tablets.

NDC 0034-0505-10: TRILISATE (choline magnesium trisalicylate) 750 mg Tablets (scored, white, film-coated) supplied in unit dose packaging with 10 tablets per card. Ten cards are packed in each carton; 10 cartons are packed in each shipper.

NDC 0034-0510-60: TRILISATE (choline magnesium trisalicylate) 1000 mg Tablets (scored, red, film-coated) in bottles of 60 tablets.

NDC 0034-0510-80: TRILISATE (choline magnesium trisalicylate) 1000 mg Tablets (scored, red, film-coated) in bottles of 100 tablets.

NDC 0034-0520-80: TRILISATE (choline magnesium trisalicylate) Liquid in bottles of 8 fl. oz. (237 mL).

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

CAUTION: Federal law prohibits dispensing without a prescription.

REFERENCES

1. Szczeklik, A et al; Choline magnesium trisalicylate in patients with aspirin- induced asthma; Eur Respir J; 3: 535- 539, 1990.

2. Zucker, MB and Rothwell KB; Differential influences of salicylate compounds on platelet aggregation and serotonin release; Current Therapeutic Research; 23(2), Feb 1987.

3. Stuart, JJ and Pisko, EJ; Choline magnesium trisalicylate does not impair platelet aggregation; Pharmatherapeutica; 2(8): 547, 1981.

4. Danesh, BJZ, Saniabadi, AR, Russell, RI et al; Therapeutic potential of choline magnesium trisalicylate as an alternative to aspirin for patients with bleeding tendencies; Scottish Medical Journal; 32: 167- 168, 1987.

5. Danesh, BJZ, McLaren, M, Russell, RI et al; Does non- acetylated salicylate inhibit thromboxane biosynthesis in human platelets? Scottish Medical Journal; 33: 315- 316, 1988.

6. Danesh, BJZ, McLaren, M, Russell, RI etal; Comparison of the effect of aspirin and choline magnesium trisalicylate on thromboxane biosynthesis in human platelets: role of the acetyl moiety; Haemostasis; 19: 169- 173, 1989.

7. Data on file. Medical Department. The Purdue Frederick Company, 1989.

8. Blechman, WJ, and Lechner, BL; Clinical comparative evalua- tion of choline magnesium trisalicylate and acetylsalicylic acid in rheumatoid arthritis; Rheumatology and Rehabilitation; 18: 119- 124, 1979.

9. McLaughlin, G; Choline magnesium trisalicylate vs. naproxen in rheumatoid arthritis; Current Therapeutic Research; 32(4): 579- 585, 1982.

10. Ehrlich, GE; Miller, SB; and Zeiders, RS; Choline magnesium trisalicylate vs. ibuprofen in rheumatoid arthritis; Rheumatol- ogy and Rehabilitation; 19: 30- 41, 1980.

11. Goldenberg, A; Rudnicki, AD, and Koonce, ML; Clinical com- parison of efficacy and safety of choline magnesium trisalicylate and indomethacin in treating osteoarthritis; Current Therapeutic Research; 24(3): 245- 260, 1978.

12. Guerin, BK and Burnstein, SL; Conservative therapy of acute painful shoulder; Orthopedic Review; XI (7) :29- 37, 1982.

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

Indications
Dosage
How Supplied
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