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Drug overview for ACAMPROSATE CALCIUM (acamprosate calcium):
Generic name: ACAMPROSATE CALCIUM (a-KAM-proe-sate KAL-see-um)
Drug class: Drugs to Treat Alcoholism
Therapeutic class: Chemical Dependency, Agents to Treat
Acamprosate calcium, a homotaurine analog, interacts with glutamate and gamma-aminobutyric acid (GABA) neurotransmitter systems in the CNS.
No enhanced Uses information available for this drug.
Generic name: ACAMPROSATE CALCIUM (a-KAM-proe-sate KAL-see-um)
Drug class: Drugs to Treat Alcoholism
Therapeutic class: Chemical Dependency, Agents to Treat
Acamprosate calcium, a homotaurine analog, interacts with glutamate and gamma-aminobutyric acid (GABA) neurotransmitter systems in the CNS.
No enhanced Uses information available for this drug.
DRUG IMAGES
ACAMPROSATE CALC DR 333 MG TAB
The following indications for ACAMPROSATE CALCIUM (acamprosate calcium) have been approved by the FDA:
Indications:
Alcohol use disorder
Professional Synonyms:
Alcohol addiction
Alcohol dependence
Alcoholism
Indications:
Alcohol use disorder
Professional Synonyms:
Alcohol addiction
Alcohol dependence
Alcoholism
The following dosing information is available for ACAMPROSATE CALCIUM (acamprosate calcium):
The recommended dosage of acamprosate calcium for maintenance of abstinence from alcohol ingestion in adults with normal renal function (creatinine clearance exceeding 50 mL/minute) is 666 mg 3 times daily. A lower dosage (1.3 g daily given in 3 unequally divided doses of 666, 333, and 333 mg each) also was evaluated in clinical studies and may be effective in some patients.
Therapy with acamprosate should be initiated as soon as possible after alcohol withdrawal, when the patient has achieved abstinence from alcohol ingestion. Therapy with acamprosate can be continued even if the patient relapses.
Therapy with acamprosate should be initiated as soon as possible after alcohol withdrawal, when the patient has achieved abstinence from alcohol ingestion. Therapy with acamprosate can be continued even if the patient relapses.
Acamprosate calcium can be administered orally without regard to meals. However, for patients who regularly eat 3 meals a day, administration of the drug with meals may improve compliance.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ACAMPROSATE CALC DR 333 MG TAB | Maintenance | Adults take 2 tablets (666 mg) by oral route 3 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ACAMPROSATE CALC DR 333 MG TAB | Maintenance | Adults take 2 tablets (666 mg) by oral route 3 times per day |
The following drug interaction information is available for ACAMPROSATE CALCIUM (acamprosate calcium):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ACAMPROSATE CALCIUM (acamprosate calcium):
Drug contraindication overview.
Known hypersensitivity to acamprosate or any ingredient in the formulation. Severe renal impairment (creatinine clearance less than 30 mL/minute).
Known hypersensitivity to acamprosate or any ingredient in the formulation. Severe renal impairment (creatinine clearance less than 30 mL/minute).
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Suicidal ideation |
The following adverse reaction information is available for ACAMPROSATE CALCIUM (acamprosate calcium):
Adverse reaction overview.
Adverse effects reported in 5% or more of patients receiving acamprosate and more frequently than placebo include diarrhea and asthenia.
Adverse effects reported in 5% or more of patients receiving acamprosate and more frequently than placebo include diarrhea and asthenia.
There are 82 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Depression |
Chest pain Dyspnea Infection Memory impairment Peripheral edema Suicidal ideation Tinnitus Urticaria Vasodilation of blood vessels |
| Rare/Very Rare |
|---|
|
Abdominal herniation Abnormal hepatic function tests Abscess Acute cognitive impairment Acute myocardial infarction Acute pancreatitis Acute renal failure Anemia Angina Asthma Bloody vomit Cardiomyopathy Cholecystitis Chronic heart failure Colitis Diabetes mellitus Drug-induced psychosis Duodenal ulcer Dysphagia Ecchymosis Encephalopathy Eosinophilia Esophagitis Exfoliative dermatitis Facial edema Fever Gastric ulcer Gastritis Gastroenteritis Gastrointestinal hemorrhage Goiter Gout Hallucinations Hearing loss Hematuria Hemorrhage Hepatitis Hostility Hyperbilirubinemia Hyperglycemia Hyperkinesis Hyperuricemia Hyponatremia Hypotension Hypothyroidism Kidney stone Laryngismus Leukopenia Lymphadenopathy Lymphocytosis Maculopapular rash Malignant neoplasm of liver Manic disorder Orthostatic hypotension Paranoid disorder Phlebitis Pneumonia Polyuria Psoriasis Pulmonary thromboembolism Rectal bleeding Rheumatoid arthritis Shock Suicidal Tachycardia Thrombocytopenic disorder Thrombophlebitis Tonic clonic seizure Urinary incontinence Urinary tract infection Urinary urgency Vertigo |
There are 76 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Accidental injury Diarrhea Dizziness Flatulence Hyperhidrosis Insomnia Nausea Paresthesia Pruritus of skin Symptoms of anxiety Xerostomia |
Acute abdominal pain Anorexia Arthralgia Back pain Bronchitis Chills Constipation Cough Drowsy Dysgeusia Dyspepsia Erectile dysfunction Flu-like symptoms General weakness Headache disorder Hypertension Increased appetite Libido changes Myalgia Pain Palpitations Pharyngitis Rhinitis Skin rash Syncope Tremor Visual changes Vomiting Weight gain |
| Rare/Very Rare |
|---|
|
Abnormal sexual function Abnormal vaginal bleeding Acne vulgaris Agitation Alopecia Aphthous stomatitis Black tarry stools Bullous dermatitis Cramps in legs Depersonalization Diplopia Disorder of ejaculation Dream disorder Dry skin Epistaxis Eructation Hypoesthesia Increased urinary frequency Malaise Menorrhagia Migraine Muscle fasciculation Myopathy Neck pain Neuralgia Nocturia Photophobia Polydipsia Sialorrhea Skin photosensitivity Spasmodic torticollis Toxic amblyopia Vaginitis Varicose veins Vitamin deficiency Weight loss |
The following precautions are available for ACAMPROSATE CALCIUM (acamprosate calcium):
Safety and efficacy not established in children younger than 18 years of age. Acamprosate has been evaluated in a limited number of adolescents 16-19 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
Acamprosate is distributed into milk in rats; caution if used in nursing women.
Experience in those 65 years of age or older insufficient to determine whether they respond differently than younger adults. Pharmacokinetics not evaluated in geriatric individuals. Because geriatric patients frequently have decreased renal function, plasma concentrations of acamprosate are expected to be higher in geriatric individuals than in younger adults.
Select drug dosage carefully. Consider monitoring renal function.
Select drug dosage carefully. Consider monitoring renal function.
The following prioritized warning is available for ACAMPROSATE CALCIUM (acamprosate calcium):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ACAMPROSATE CALCIUM (acamprosate calcium)'s list of indications:
| Alcohol use disorder | |
| F10.1 | Alcohol abuse |
| F10.10 | Alcohol abuse, uncomplicated |
| F10.12 | Alcohol abuse with intoxication |
| F10.120 | Alcohol abuse with intoxication, uncomplicated |
| F10.121 | Alcohol abuse with intoxication delirium |
| F10.129 | Alcohol abuse with intoxication, unspecified |
| F10.13 | Alcohol abuse, with withdrawal |
| F10.130 | Alcohol abuse with withdrawal, uncomplicated |
| F10.131 | Alcohol abuse with withdrawal delirium |
| F10.132 | Alcohol abuse with withdrawal with perceptual disturbance |
| F10.139 | Alcohol abuse with withdrawal, unspecified |
| F10.14 | Alcohol abuse with alcohol-induced mood disorder |
| F10.15 | Alcohol abuse with alcohol-induced psychotic disorder |
| F10.150 | Alcohol abuse with alcohol-induced psychotic disorder with delusions |
| F10.151 | Alcohol abuse with alcohol-induced psychotic disorder with hallucinations |
| F10.159 | Alcohol abuse with alcohol-induced psychotic disorder, unspecified |
| F10.18 | Alcohol abuse with other alcohol-induced disorders |
| F10.180 | Alcohol abuse with alcohol-induced anxiety disorder |
| F10.181 | Alcohol abuse with alcohol-induced sexual dysfunction |
| F10.182 | Alcohol abuse with alcohol-induced sleep disorder |
| F10.188 | Alcohol abuse with other alcohol-induced disorder |
| F10.19 | Alcohol abuse with unspecified alcohol-induced disorder |
| F10.2 | Alcohol dependence |
| F10.20 | Alcohol dependence, uncomplicated |
| F10.22 | Alcohol dependence with intoxication |
| F10.220 | Alcohol dependence with intoxication, uncomplicated |
| F10.221 | Alcohol dependence with intoxication delirium |
| F10.229 | Alcohol dependence with intoxication, unspecified |
| F10.23 | Alcohol dependence with withdrawal |
| F10.230 | Alcohol dependence with withdrawal, uncomplicated |
| F10.231 | Alcohol dependence with withdrawal delirium |
| F10.232 | Alcohol dependence with withdrawal with perceptual disturbance |
| F10.239 | Alcohol dependence with withdrawal, unspecified |
| F10.24 | Alcohol dependence with alcohol-induced mood disorder |
| F10.25 | Alcohol dependence with alcohol-induced psychotic disorder |
| F10.250 | Alcohol dependence with alcohol-induced psychotic disorder with delusions |
| F10.251 | Alcohol dependence with alcohol-induced psychotic disorder with hallucinations |
| F10.259 | Alcohol dependence with alcohol-induced psychotic disorder, unspecified |
| F10.26 | Alcohol dependence with alcohol-induced persisting amnestic disorder |
| F10.27 | Alcohol dependence with alcohol-induced persisting dementia |
| F10.28 | Alcohol dependence with other alcohol-induced disorders |
| F10.280 | Alcohol dependence with alcohol-induced anxiety disorder |
| F10.281 | Alcohol dependence with alcohol-induced sexual dysfunction |
| F10.282 | Alcohol dependence with alcohol-induced sleep disorder |
| F10.288 | Alcohol dependence with other alcohol-induced disorder |
| F10.29 | Alcohol dependence with unspecified alcohol-induced disorder |
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