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
Canasa Indications, Dosage, Storage, Stability - Mesalamine
Canasa Indications, Dosage, Storage, Stability - Mesalamine
INDICATIONS AND USAGE
CANASA® 500 mg and 1000 mg Suppositories are indicated for the treatment of active ulcerative proctitis.
DOSAGE AND ADMINISTRATION
The usual dosage of CANASA® (mesalamine, USP) 500 mg Suppositories is one 500 mg rectal suppository 2 times daily with possible increase to 3 times daily if inadequate response at two weeks. The usual dosage of CANASA® (mesalamine, USP) 1000 mg Suppositories is one rectal suppository 1 time daily at bedtime.
The suppository should be retained for one to three hours or longer, if possible, to achieve the maximum benefit. While the effect of CANASA® Suppositories may be seen within three to twenty-one days, the usual course of therapy would be from three to six weeks depending on symptoms and sigmoidoscopic findings. Studies have suggested that CANASA® Suppositories will delay relapse after the six-week short-term treatment.
Patient Instructions
NOTE: CANASA® Suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.
I. Detach one suppository from strip of suppositories.
II. Hold suppository upright and carefully remove the plastic wrapper.
III. Avoid excessive handling of suppository, which is designed to melt at body temperature.
IV. Insert suppository completely into rectum with gentle pressure, pointed end first.
V. A small amount of lubricating gel may be used on the tip of the suppository to assist insertion.
HOW SUPPLIED
CANASA® (Mesalamine, USP) 500 mg Suppositories: CANASA® 500 mg Suppositories for rectal administration are available as bullet shaped, light tan suppositories containing 500 mg mesalamine supplied in boxes of 30 individually plastic wrapped suppositories (NDC 58914-500-56).
CANASA® (Mesalamine, USP) 1000 mg Suppositories: CANASA® 1000 mg
Suppositories for rectal administration are available as bullet shaped, light tan suppositories containing 1000 mg mesalamine supplied in boxes of 30 individually plastic wrapped suppositories (NDC 58914-501-56).
Store below 25°C (77°F), do not freeze. Keep away from direct heat, light or humidity.
Axcan Scandipharm, Inc. Birmingham, AL 35242, Date: September 23, 2004
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