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
Campral Indications, Dosage, Storage, Stability - Acamprosate Calcium
Campral Indications, Dosage, Storage, Stability - Acamprosate Calcium
INDICATIONS AND USAGE
CAMPRAL is indicated for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at treatment
initiation. Treatment with CAMPRAL should be part of a comprehensive
management program that includes psychosocial support.
The efficacy of CAMPRAL in promoting abstinence has
not been demonstrated in subjects who have not undergone detoxification and
not achieved alcohol abstinence prior to beginning CAMPRAL treatment.
The efficacy of CAMPRAL in promoting abstinence from alcohol in polysubstance
abusers has not been adequately assessed.
DOSAGE AND ADMINISTRATION
The recommended dose of CAMPRAL is two 333 mg tablets
(each dose should total 666 mg) taken three times daily. Although dosing may
be done without regard to meals, dosing with meals was employed during clinical
trials and is suggested as an aid to compliance in those patients who regularly
eat three meals daily. A lower dose may be effective in some patients.
Treatment with CAMPRAL should be initiated as soon as
possible after the period of alcohol withdrawal, when the patient has achieved
abstinence, and should be maintained if the patient relapses. CAMPRAL
should be used as part of a comprehensive psychosocial treatment program.
Dosage in Renal Impairment
For patients with moderate renal impairment (creatinine clearance
of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily
is recommended. Patients with severe renal impairment (creatinine clearance
of <30 mL/min) should not be given CAMPRAL.
HOW SUPPLIED
CAMPRAL 333 mg tablets are enteric-coated, white, round,
biconvex tablets, identified with "333" debossed on one side.
Opaque HDPE bottles of 180-NDC #0456-3330-01 Dose Pak of 180-NDC
#0456-3330-60
Storage
Store at 25ºC (77ºF); excursions permitted to 15º - 30ºC (59º
- 86ºF).
Manufactured by: Merck Santé s.a.s.,
Subsidiary of Merck KGaA, Darmstadt, Germany 37, rue Saint-Romain 69008 LYON
FRANCE., Manufactured for FOREST PHARMACEUTICALS, Inc. Subsidiary of Forest
Laboratories, Inc. St. Louis, MO 63045, 07/04
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