Acamprosate Calcium (Page 3 of 3)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

14 CLINICAL STUDIES

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

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).

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe Acamprosate Calcium.

Renal Impairment

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) ].

Alcohol Withdrawal

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.

Manufactured by:
Merck Santé s.a.s.
Subsidiary of Merck KGaA, Darmstadt, Germany
37, rue Saint-Romain
69008 LYON FRANCE

Manufactured for:
Inwood Laboratories, Incorporated
Subsidiary of Forest Laboratories, Inc.
Inwood, NY 11096

Principal Display Panel – 333 mg Bottle Label

Rx only NDC 0258-4000-60

ACAMPROSATE CALCIUM

Delayed-Release Tablets

333 mg

180 Tablets

Inwood Laboratories
INCORPORATED

Subsidiary of Forest Laboratories, Inc.

Principal Display Panel – 333 mg Bottle Label
(click image for full-size original)
ACAMPROSATE CALCIUM
acamprosate calcium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0258-4000
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
acamprosate calcium (acamprosate) acamprosate calcium 333 mg
Inactive Ingredients
Ingredient Name Strength
crospovidone
cellulose, microcrystalline
magnesium silicate
sodium starch glycolate type a potato
silicon dioxide
magnesium stearate
talc
propylene glycol
methacrylic acid — ethyl acrylate copolymer (1:1) type a
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code 333
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0258-4000-60 180 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021431 01/11/2005
Labeler — Forest Laboratories, Inc. (001288281)

Revised: 08/2013 Forest Laboratories, Inc.

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