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.
- 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
ACAMPROSATE CALCIUM acamprosate calcium tablet, delayed release | |||||||||||||||||||||||||||||||||
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Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945) |
Revised: 11/2023 Zydus Pharmaceuticals (USA) Inc.
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