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
Sanctura Indications, Dosage, Storage, Stability - Trospium
Sanctura Indications, Dosage, Storage, Stability - Trospium
INDICATIONS AND USAGE
Sanctura is indicated for the treatment of overactive bladder
with symptoms of urge urinary incontinence, urgency, and urinary frequency.
DOSAGE AND ADMINISTRATION
The recommended dose is 20 mg twice daily. Sanctura should
be dosed at least one hour before meals or given on an empty stomach.
Dosage modification is recommended in the following patient
populations:
For patients with severe renal impairment (CLcr < 30 mL/min),
the recommended dose is 20 mg once daily at bedtime (See PRECAUTIONS:
General).
In geriatric patients >75 years of age, dose may
be titrated down to 20 mg once daily based upon tolerability (See PRECAUTIONS:
Geriatric Use).
HOW SUPPLIED
Sanctura™ tablets 20 mg (brownish yellow,
biconvex, glossy coated tablets printed with black ink) are supplied as follows:
60 count HDPE bottle- NDC 67979-631-01
500 count HDPE bottle- NDC 67979-631-02
14 count blister (PVC/Paper backed foil) - NDC 67979-631-03
14 count blister (PVC-Aclar/Paper backed foil) - NDC 67979-631-04
Store at controlled room temperature 20° to 25°C (68° to 77°F)
(see USP). Rx only
Manufactured for: Odyssey Pharmaceuticals,
Inc. East Hanover, NJ 07936 USA and Indevus Pharmaceuticals, Inc. Lexington,
MA 02421 USA, Manufactured by: Madaus AG Troisdorf, Germany, Address Medical
Inquiries to: www.SANCTURA.com or (877)-427-9068
Updated Jun 17, 2004
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