Alcohol use disorder, moderate to severe:
Note: Alternative agent in patients who are using opioids or with acute hepatitis, liver enzymes ≥3 to 5 times normal, or liver failure (Ref). Initiate treatment after alcohol detoxification is complete and when the patient has achieved abstinence. Maintain treatment if the patient relapses (Ref).
Oral: 666 mg 3 times daily; lower doses (eg, 666 mg 2 times daily) may be considered in patients weighing <60 kg (Ref). Some experts consider alternative therapy if goals are not met within 6 months of treatment (Ref).
CrCl 30 to 50 mL/minute: Initial dose: 333 mg 3 times daily. Note: The American Psychiatric Association alcohol use disorder guidelines recommend that acamprosate should not be used first-line for patients with mild to moderate renal impairment (Ref).
CrCl ≤30 mL/minute: Use is contraindicated.
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Gastrointestinal: Diarrhea (17%)
1% to 10%:
Cardiovascular: Chest pain (≥1%), hypertension (≥1%), palpitations (≥1%), peripheral edema (≥1%), syncope (≥1%), vasodilation (≥1%)
Dermatologic: Diaphoresis (3%), pruritus (4%), skin rash (≥1%)
Endocrine & metabolic: Decreased libido (≥1%), weight gain (≥1%)
Gastrointestinal: Abdominal pain (≥1%), anorexia (5%), constipation (≥1%), dysgeusia (≥1%), dyspepsia (≥1%), flatulence (4%), increased appetite (≥1%), nausea (4%), vomiting (≥1%), xerostomia (3%),
Genitourinary: Impotence (≥1%)
Infection: Infection (≥1%)
Nervous system: Abnormality in thinking (≥1%), amnesia (≥1%), anxiety (8%), asthenia (7%), chills (≥1%), depression (8%), dizziness (4%), drowsiness (≥1%), headache (≥1%), insomnia (9%), pain (4%), paresthesia (3%), suicidal ideation (≤2%), suicidal tendencies (≤2%), tremor (≥1%)
Neuromuscular & skeletal: Arthralgia (≥1%), back pain (≥1%), myalgia (≥1%)
Ophthalmic: Visual disturbance (≥1%)
Respiratory: Bronchitis (≥1%), dyspnea (≥1%), flu-like symptoms (≥1%), increased cough (≥1%), pharyngitis (≥1%), rhinitis (≥1%)
<1%:
Cardiovascular: Acute myocardial infarction, angina pectoris, cardiomyopathy, deep vein thrombophlebitis, heart failure, hypotension, mesenteric artery occlusion, orthostatic hypotension, phlebitis, pulmonary embolism, shock, tachycardia, varicose veins
Dermatologic: Acne vulgaris, alopecia, ecchymoses, eczema, exfoliative dermatitis, maculopapular rash, psoriasis, skin photosensitivity, urticaria, vesiculobullous dermatitis, xeroderma
Endocrine & metabolic: Diabetes mellitus, goiter, heavy menstrual bleeding, hyperglycemia, hyperuricemia, hyponatremia, hypothyroidism, increased lactate dehydrogenase, increased libido, increased thirst, vitamin deficiency, weight loss
Gastrointestinal: Abdominal distension, cholecystitis, colitis, duodenal ulcer, dysphagia, eructation, esophagitis, gastric ulcer, gastritis, gastroenteritis, gastrointestinal hemorrhage, hematemesis, hernia of abdominal cavity, melena, oral mucosa ulcer, pancreatitis, rectal hemorrhage, sialorrhea
Genitourinary: Abnormal uterine bleeding, ejaculatory disorder, hematuria, nocturia, sexual disorder, urinary frequency, urinary incontinence, urinary tract infection, urinary urgency, vulvovaginitis
Hematologic & oncologic: Anemia, eosinophilia, hemorrhage, leukopenia, lymphadenopathy, lymphocytosis, monocytosis, thrombocytopenia
Hepatic: Ascites, hepatic carcinoma, hepatic cirrhosis, hepatitis, hyperbilirubinemia, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase
Hypersensitivity: Facial edema, hypersensitivity reaction
Infection: Abscess
Nervous system: Abnormal dreams, agitation, apathy, confusion, depersonalization, encephalopathy, hallucination, hostility, hypoesthesia, malaise, manic reaction, migraine, neuralgia, neurosis, paranoid ideation, psychosis, seizure, twitching, vertigo, withdrawal syndrome
Neuromuscular & skeletal: Gout, hyperkinetic muscle activity, lower limb cramp, myopathy, neck pain, rheumatoid arthritis, torticollis
Ophthalmic: Amblyopia, diplopia, ophthalmic inflammation, photophobia
Otic: Deafness, tinnitus
Renal: Increased serum creatinine, nephrolithiasis, polyuria
Respiratory: Asthma, epistaxis, laryngismus, pneumonia
Miscellaneous: Fever
Postmarketing:
Hypersensitivity: Angioedema (Patnaik 2019)
Nervous system: Myoclonus (Soni 2021)
Renal: Acute kidney injury
Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (CrCl ≤30 mL/minute)
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).
• Suicidal thinking/behavior: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns:
• Alcohol use disorder: Appropriate use: Should be used as part of a comprehensive program to treat alcohol use disorder. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal.
• Renal impairment: Use with caution and reduce dose in patients with moderate renal impairment (CrCl 30 to 50 mL/minute). Use is contraindicated in patients with severe renal impairment (CrCl ≤30 mL/minute). The American Psychiatric Association alcohol use disorder guidelines recommend that acamprosate should not be used first-line for patients with mild to moderate renal impairment. (APA [Reus 2018]).
Dosage form specific issues:
• Sulfites: Traces of sulfites may be present in the formulation.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Delayed Release, Oral, as calcium:
Generic: 333 mg
Yes
Tablet, EC (Acamprosate Calcium Oral)
333 mg (per each): $1.39 - $2.71
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Delayed Release, Oral, as calcium:
Campral: 333 mg
Oral: May be administered without regard to meals (administered with meals during clinical trials to possibly increase compliance). Tablet should be swallowed whole; do not crush or chew.
Bariatric surgery: Tablet, delayed release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. No IR formulation available.
Alcohol use disorder, moderate to severe: Maintenance of abstinence from alcohol in patients with alcohol use disorder who are abstinent at treatment initiation, as part of a comprehensive management program.
Limitations of use: Efficacy has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning treatment. Efficacy in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.
None known.
There are no known significant interactions.
Food decreases absorption of acamprosate (not clinically significant). Management: Administer without regard to meals.
Adverse events were observed in animal reproduction studies.
Pharmacological agents should not be used for the treatment of alcohol use disorder in pregnant women unless needed for the treatment of acute alcohol withdrawal or a coexisting disorder; agents other than acamprosate are recommended for acute alcohol withdrawal (APA [Reus 2018]).
It is not known if acamprosate is present in breast milk. The manufacturer recommends that caution be exercised when administering acamprosate to breastfeeding women. Pharmacological agents should not be used for the treatment of alcohol use disorder in breastfeeding women unless needed for the treatment of acute alcohol withdrawal or a coexisting disorder; agents other than acamprosate are recommended for acute alcohol withdrawal (APA [Reus 2018]).
Abstinence is required for initiation of treatment; however, treatment should be continued in the event of a relapse.
Renal function (baseline; as clinically indicated); weight (baseline; as clinically indicated); suicidal ideation.
Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol use disorder. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion. Insignificant CNS activity, outside its effect on alcohol use disorder, was observed including no anxiolytic, antiseizure, or antidepressant activity.
Distribution: Vd: ~1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: ~11%
Half-life elimination: 20 to 33 hours; 1.8- and 2.6-fold longer in patients with moderate or severe renal impairment
Time to peak, plasma: 3 to 8 hours
Excretion: Urine (as unchanged drug)
Altered kidney function: Cmax in patients with moderate or severe renal impairment were 2- and 4-fold higher, respectively.
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