Campral (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 Campral 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 Campral 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. Campral 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 Campral 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 Campral over placebo.

16 HOW SUPPLIED/STORAGE AND HANDLING

Opaque HDPE bottles of 180 NDC #0456-3330-01

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 Campral.

Renal Impairment

A lower dose is recommended for patients with moderate renal impairment. Campral 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 Campral 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 Campral 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 Campral therapy as directed, even in the event of relapse and remind them to discuss any renewed drinking with their physicians.
  • Advise patients that Campral 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:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 333 MG LABEL

Rx Only

NDC 0456-3330-01

CAMPRAL®

(acamprosate calcium)

Delayed-Release Tablets

333 mg

180 Tablets

FOREST PHARMACEUTICALS, INC.

PACKAGE LABEL -- PRINCIPAL DISPLAY PANEL -- 333 MG LABEL
(click image for full-size original)
CAMPRAL
acamprosate calcium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-3330
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:0456-3330-01 180 TABLET, DELAYED RELEASE (180 TABLET) in 1 BOTTLE None
2 NDC:0456-3330-60 180 TABLET, DELAYED RELEASE (180 TABLET) in 1 DOSE PACK None
3 NDC:0456-3330-63 100 TABLET, DELAYED RELEASE (100 TABLET) in 1 BLISTER PACK 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)
Establishment
Name Address ID/FEI Operations
Merck Sante s.a.s. 384668112 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Anderson Packaging, Inc. 053217022 PACK
Establishment
Name Address ID/FEI Operations
Forest Laboratories, Inc. 867188724 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Sharp Corporation 002346625 PACK
Establishment
Name Address ID/FEI Operations
Merck Sante s.a.s. 384953134 MANUFACTURE

Revised: 01/2012 Forest Laboratories, Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.