Dietary administration of acamprosate calcium for 2 years to Sprague-Dawley rats at doses of 25, 100 and 400 mg/kg/day (up to 3 times the maximum recommended human daily (MRHD) oral dose on an AUC basis) and CD-1 mice at doses of 400, 1200 and 3600 mg/kg/day (up to 25 times the MRHD on an AUC basis) showed no evidence of increased tumor incidence.
Acamprosate calcium was negative in all genetic toxicology studies conducted. Acamprosate calcium demonstrated no evidence of genotoxicity in an in vitro bacterial reverse point mutation assay (Ames assay) or an in vitro mammalian cell gene mutation test using Chinese Hamster Lung V79 cells. No clastogenicity was observed in an in vitro chromosomal aberration assay in human lymphocytes and no chromosomal damage detected in an in vivo mouse micronucleus assay.
Acamprosate calcium had no effect on fertility after treatment for 70 days prior to mating in male rats and for 14 days prior to mating, throughout mating, gestation and lactation in female rats at doses up to 1000 mg/kg/day (approximately 4 times the MRHD oral dose on a mg/m2 basis). In mice, acamprosate calcium administered orally for 60 days prior to mating and throughout gestation in females at doses up to 2400 mg/kg/day (approximately 5 times the MRHD oral dose on a mg/m2 basis) had no effect on fertility.
The efficacy of Acamprosate Calcium in the maintenance of abstinence was supported by three clinical studies involving a total of 998 patients who were administered at least one dose of Acamprosate Calcium or placebo as an adjunct to psychosocial therapy. Each study was a double-blind, placebo-controlled trial in alcohol-dependent patients who had undergone inpatient detoxification and were abstinent from alcohol on the day of randomization. Study durations ranged from 90 days to 360 days. Acamprosate Calcium proved superior to placebo in maintaining abstinence, as indicated by a greater percentage of subjects being assessed as continuously abstinent throughout treatment.
In a fourth study, the efficacy of Acamprosate Calcium was evaluated in alcoholics, including patients with a history of polysubstance abuse and patients who had not undergone detoxification and were not required to be abstinent at baseline. This study failed to demonstrate superiority of Acamprosate Calcium over placebo.
Opaque HDPE bottles of 180 NDC #0258-4000-60
Storage and Handling
Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).
Physicians are advised to discuss the following issues with patients for whom they prescribe Acamprosate Calcium.
A lower dose is recommended for patients with moderate renal impairment. Acamprosate Calcium is contraindicated in patients with severe renal impairment (creatine clearance of ≤30 mL/min) [see Dosage and Administration (2.1), Contraindications (4.2), Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].
Suicidality and Depression
Families and caregivers of patients being treated with Acamprosate Calcium should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient’s health care provider [see Warnings and Precautions (5.2) ].
Use of Acamprosate Calcium does not eliminate or diminish withdrawal symptoms [see Warnings and Precautions (5.3) ].
Pregnancy and Breast Feeding
- Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy.
- Advise patients to notify their physician if they are breast-feeding.
Relapse to Drinking
- Advise patients to continue Acamprosate Calcium therapy as directed, even in the event of relapse and remind them to discuss any renewed drinking with their physicians.
- Advise patients that Acamprosate Calcium has been shown to help maintain abstinence only when used as a part of a treatment program that includes counseling and support.
Merck Santé s.a.s.
Subsidiary of Merck KGaA, Darmstadt, Germany
37, rue Saint-Romain
69008 LYON FRANCE
Inwood Laboratories, Incorporated
Subsidiary of Forest Laboratories, Inc.
Inwood, NY 11096
Principal Display Panel – 333 mg Bottle Label
Rx only NDC 0258-4000-60
Subsidiary of Forest Laboratories, Inc.
| ACAMPROSATE CALCIUM |
acamprosate calcium tablet, coated
|Labeler — Forest Laboratories, Inc. (001288281)|
Revised: 08/2013 Forest Laboratories, Inc.
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