Acamprosate Calcium (Page 4 of 4)

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

Acamprosate Calcium Delayed-release Tablets, 333 mg are white to off-white, round, biconvex, beveled edge, enteric coated tablets, debossed with ‘569’ on one side and plain on the other side and are supplied as follows:

NDC 68382-569-06 in bottles of 30 tablets with child-resistant closure

NDC 68382-569-16 in bottles of 90 tablets with child-resistant closure

NDC 68382-569-01 in bottles of 100 tablets with child-resistant closure

NDC 68382-569-28 in bottles of 180 tablets with child-resistant closure

NDC 68382-569-05 in bottles of 500 tablets

NDC 68382-569-10 in bottles of 1000 tablets

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container (USP).

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 delayed-release tablets.

Renal Impairment

A lower dose is recommended for patients with moderate renal impairment. Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine 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 delayed-release tablets 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 delayed-release tablets 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 delayed-release tablets 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 delayed-release tablets has been shown to help maintain abstinence only when used as a part of a treatment program that includes counseling and support.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Zydus Lifesciences Ltd.,

Baddi, India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 10/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-569-28 in bottles of 180 tablets

Acamprosate Calcium Delayed-release Tablets

333 mg

Rx only

Zydus

figure
(click image for full-size original)
ACAMPROSATE CALCIUM acamprosate calcium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-569
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
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
METHACRYLIC ACID
POLYETHYLENE GLYCOL 8000
POVIDONE K90
SILICON DIOXIDE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 569
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-569-06 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68382-569-16 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:68382-569-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:68382-569-28 180 TABLET, DELAYED RELEASE in 1 BOTTLE None
5 NDC:68382-569-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE None
6 NDC:68382-569-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205995 06/01/2017
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)

Revised: 11/2023 Zydus Pharmaceuticals (USA) Inc.

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