A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tolectin Indications, Dosage, Storage, Stability - Tolmetin
Tolectin Indications, Dosage, Storage, Stability - Tolmetin
INDICATIONS
AND USES
TOLECTIN (tolmetin sodium) is indicated for the relief of signs and symptoms
of rheumatoid arthritis and osteoarthritis. TOLECTIN is indicated in the treatment
of acute flares and the long-term management of the chronic disease.
TOLECTIN is also indicated for treatment of juvenile rheumatoid arthritis.
The safety and effectiveness of TOLECTIN have not been established in children
under 2 years of age (see PRECAUTIONS Pediatric Use and DOSAGE AND ADMINISTRATION
).
DOSAGE AND ADMINISTRATION
In adults with rheumatoid arthritis or osteoarthritis, the recommended starting
dose is 400 mg three times daily (1200 mg daily), preferably including a dose
on arising and a dose at bedtime. To achieve optimal therapeutic effect the
dose should be adjusted according to the patient's response after one to two
weeks. Control is usually achieved at doses of 600-1800 mg daily in divided
doses (generally t.i.d.). Doses larger than 1800 mg/day have not been studied
and are not recommended.
The recommended starting dose for children (2 years and older) is 20 mg/kg/day
in divided doses (t.i.d. or q.i.d.). When control has been achieved, the usual
dose ranges from 15 to 30 mg/kg/day. Doses higher than 30 mg/kg/day have not
been studied and, therefore, are not recommended.
A therapeutic response to TOLECTIN (tolmetin sodium) can be expected in a few
days to a week. Progressive improvement can be anticipated during succeeding
weeks of therapy. If gastrointestinal symptoms occur, TOLECTIN can be administered
with antacids other than sodium bicarbonate. TOLECTIN bioavailability and pharmacokinetics
are not significantly affected by acute or chronic administration of magnesium
and aluminum hydroxides; however, bioavailability is affected by food or milk
(see PRECAUTIONS Drug-Food Interaction ).
HOW SUPPLIED
TOLECTIN® 200 (tolmetin sodium) tablets 200 mg (white, scored, imprinted "TOLECTIN,"
"200" and "McNEIL"), NDC 0045-0412, bottles of 100.
TOLECTIN® DS (tolmetin sodium) capsules 400 mg (colored orange opaque, with
contrasting parallel bands, imprinted "TOLECTIN DS" and "McNEIL"), NDC 0045-0414,
bottles of 100, 500.
TOLECTIN® 600 (tolmetin sodium) tablets 600 mg (colored orange, film coated,
imprinted "TOLECTIN 600" and "McNEIL"), NDC 0045-0416, bottles of 100 and 500.
Dispense in tight, light-resistant container as defined in the official compendium.
Store at controlled room temperature (15°-30°C, 59°-86°F). Protect from light.
McNeil Pharmaceutical, McNEILAB, Inc.
Spring House, PA 19477
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