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
Ultracet Indications, Dosage, Storage, Stability - Tramadol hydrochloride / Acetaminophen
Ultracet Indications, Dosage, Storage, Stability - Tramadol hydrochloride / Acetaminophen
INDICATIONS AND USAGE
ULTRACET is indicated for the short-term (five days or less)
management of acute pain.
DOSAGE AND ADMINISTRATION
For the short-term (five days or less) management of acute
pain, the recommended dose of ULTRACET is 2tablets every 4 to 6 hours as needed
for pain relief up to a maximum of 8 tablets per day.
Individualization of Dose
In patients with creatinine clearances of less than 30 mL/min,
it is recommended that the dosing interval of ULTRACET be increased not to exceed
2 tablets every 12 hours. Dose selection for an elderly patient should be cautious,
in view of the potential for greater sensitivity to adverse events.
HOW SUPPLIED
ULTRACET (37.5 mg tramadol hydrochloride/325 mg acetaminophen)
Tablets (light yellow, film-coated capsule-shaped tablet) debossed "O-M"
on one side and "650" on the other are available as follows: 20’s:
NDC 0045 0650 50 (Bottles of 20 tablets) 100’s: NDC 0045 0650 60 (Bottles of
100 tablets) 500’s: NDC 0045 0650 70 (Bottles of 500 tablets) HUD 100’s: NDC
0045 0650 10 (Packages of 100 unit doses in blister packs, 10 cards of 10 tablets
each) Dispense in a tight container. Store at 25°C (77°F); excursions permitted
to 15 - 30°C (59 - 86°F).
OMP DIVISION ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869 U.S. Patent 5,336,691 635-11-231-1 © OMP 2001 Issued
August 2001 7517200
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