Trade Names:Campral- Tablets, delayed-release 333 mg acamprosate calcium (equiv. to 300 mg acamprosate)
Chronic alcohol exposure may alter normal balance between neuronal and excitation and inhibition. In vitro and in vivo animal data suggest acamprosate interacts with glutamate and GABA neurotransmitter systems, restoring this balance.
Bioavailability about 11%. Steady state reached within 5 days. Steady-state concentrations average 350 ng/mL and occur 3 to 8 h postdose. C max and AUC approximately 42% and 23%, respectively.
Vd estimated to be 72 to 109 L (1 L/kg). Protein binding is negligible.
Does not undergo metabolism.
Terminal t ½ ranges from about 20 to 33 h. Major route of excretion is via kidneys.
C max in patients with moderate or severe renal function impairment were 2- and 4-fold higher, respectively. Elimination t ½ were 1.8- and 2.6-fold longer, respectively.
Maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
Severe renal function impairment (Ccr 30 mL/min or less); hypersensitivity to any component of product.
PO Two 333 mg tablets 3 times daily.Renal Function ImpairmentAdults
PO Start with 333 mg 3 times daily in patients with moderate renal function impairment (Ccr 30 to 50 mL/min). Do not administer to patients with severe renal function impairment (Ccr 30 mL/min or less).
Store tablets at controlled room temperature (59° to 86°F).
Weight gain and loss reported more frequently compared with either agent alone.Naltrexone
Acamprosate levels may be increased; however, no dosage adjustment is recommended.
None well documented.
Palpitation, syncope (at least 1%).
Insomnia (7%); asthenia, anxiety (6%); depression (5%); dizziness (3%); dry mouth, paresthesia (2%); headache, somnolence, decreased libido, amnesia, abnormal thinking, tremor, vasodilatation, hypertension (at least 1%).
Pruritus (4%); sweating (2%); rash (at least 1%).
Pharyngitis, abnormal vision, taste perversion (at least 1%).
Diarrhea (16%); nausea (4%); anorexia, flatulence (3%); vomiting, dyspepsia, constipation, increased appetite (at least 1%).
Impotence (at least 1%); acute kidney failure (postmarketing).
Peripheral edema, weight gain (at least 1%).
Back pain, myalgia, arthralgia (at least 1%).
Rhinitis, increased cough, dyspnea, bronchitis (at least 1%).
Accidental injury, pain (3%); abdominal pain, infection, flu syndrome, chest pain, chills, suicide attempt (at least 1%).
Category C .
Safety and efficacy not established.
Because elderly are more likely to have decreased renal function, select dose with care and monitor renal function.
Reduce dose in patients with moderate renal function impairment. Do not administer to patients with severe renal function impairment (Ccr less than 30 mL/min).
Do not administer to patient who has not undergone detoxification or has not achieved alcohol abstinence.
While infrequent, suicide is more common than in patients receiving placebo.
Alcohol withdrawal symptoms are not eliminated or diminished by acamprosate administration.
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