CHOLINE MAGNESIUM TRISALICYLATE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLINE MAGNESIUM TRISALICYLATE (UNII: DJJ95FJP1H) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Lannett Company, Inc.

INN (International Name):

CHOLINE MAGNESIUM TRISALICYLATE

Composition:

SALICYLIC ACID 500 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Osteoarthritis, Rheumatoid Arthritis and Acute Painful Shoulder : Salicylates are considered the base therapy of choice in the arthritides; and choline magnesium trisalicylate preparation is indicated for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and other arthritides. Choline Magnesium Trisalicylate Liquid is indicated in the long-term management of these diseases and especially in the acute flare of rheumatoid arthritis. Choline Magnesium Trisalicylate Liquid is also indicated for the treatment of acute painful shoulder. Choline Magnesium Trisalicylate Liquid is effective and generally well tolerated, and is logical choice whenever salicylate treatment is indicated. It is 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 int

Product summary:

Choline Magnesium Trisalicylate Liquid is supplied in bottles of 240 mL. Store at controlled room temperature 15° to 30°C (59° to 86°F).

Authorization status:

unapproved drug other

Summary of Product characteristics

CHOLINE MAGNESIUM TRISALICYLATE- CHOLINE MAGNESIUM TRISALICYLATE
LIQUID
LANNETT COMPANY, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CHOLINE MAGNESIUM TRISALICYLATE LIQUID
500 MG SALICYLATE CONTENT PER 5ML
DESCRIPTION
Choline Magnesium Trisalicylate Liquid is a nonsteroidal,
anti-inflammatory preparation containing
choline magnesium trisalicylate which is freely soluble in water. The
absolute structure of choline
magnesium trisalicylate is not known at this time. Choline magnesium
trisalicylate has a molecular
formula of C
H O NMg, a molecular weight of 539.8, and it may be represented in the
solid form
as:
Choline Magnesium Trisalicylate Liquid is a cherry-flavored liquid
providing 500 mg salicylate
content per teaspoonful (5 mL) for oral administration.
INACTIVE INGREDIENTS: Each teaspoonful (5 mL) of Choline Magnesium
Trisalicylate Liquid contains:
caramel, carboxymethylcellulose sodium, edetate disodium, FD&C yellow
no. 6, flavor, glycerin,
methylparaben, potassium sorbate, sodium citrate, sorbic acid,
sorbitol, and water.
CLINICAL PHARMACOLOGY
Choline Magnesium Trisalicylate Liquid contains salicylate with
anti-inflammatory, analgesic and
antipyretic action. On ingestion of Choline Magnesium Trisalicylate
Liquid, the salicylate moiety is
absorbed rapidly and reaches peak blood levels within an average of
one to two hours after single dose
of the liquid. The primary route of excretion is renal: the excretion
products are chiefly the glycine and
glucuronide conjugates. At higher serum salicylate concentrations, the
glycine conjugation pathway
becomes rapidly saturated. Thus, the slower glucuronide conjugation
pathway becomes the rate limiting
step for salicylate excretion. In addition, salicylate excreted in the
bile as glucuronide conjugate may be
reabsorbed. These factors account for the prolongation of salicylate
half-life and the nonlinear increase
in