Acamprosate - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Acamprosate. This is the same information dispensing pharmacists read.
5 WARNINGS AND PRECAUTIONS Dose reduction is required for patients with moderate renal impairment .
Monitor patients for depression or suicidal ideation and prompt patients, families, and caregivers to report such symptoms to the health care provider .
5.1 Renal Impairment Treatment with acamprosate calcium in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min) requires a dose reduction [ see Dosage and Administration ].
Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [ see Dosage and Administration , Contraindications , Use in Specific Populations , and Clinical Pharmacology ].
5.2 Suicidality and Depression In controlled clinical trials of acamprosate calcium, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in acamprosate calcium-treated patients than in patients treated with placebo (1.4% vs.
0.5% in studies of 6 months or less; 2.4% vs.
0.8% in year-long studies).
Completed suicides occurred in 3 of 2272 (0.13%) patients in the pooled acamprosate group from all controlled studies and 2 of 1962 patients (0.10%) in the placebo group.
Adverse events coded as "depression" were reported at similar rates in acamprosate calcium-treated and placebo-treated patients.
Although many of these events occurred in the context of alcohol relapse, and the interrelationship between alcohol dependence, depression and suicidality is well-recognized and complex, no consistent pattern of relationship between the clinical course of recovery from alcoholism and the emergence of suicidality was identified.
Alcohol-dependent patients, including those patients being treated with acamprosate calcium, should be monitored for the development of symptoms of depression or suicidal thinking.
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.
5.3 Alcohol Withdrawal Use of acamprosate calcium does not eliminate or diminish withdrawal symptoms.
Applies to YOU?
Some warnings apply only to specific age groups, health conditions, or other medicines. Ask GoDavaii AI to filter which of these 13+ warnings apply to your profile.
Ask Health AI \u2192