Acamprosate Calcium (acamprosate calcium)
Drugs to Treat Alcoholism Oral Tablet, Delayed Release (ENTERIC COATED)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Acamprosate calcium, a homotaurine analog, interacts with glutamate and gamma-aminobutyric acid (GABA) neurotransmitter systems in the CNS.
Acamprosate calcium is a synthetic homotaurine derivative and is structurally related to gamma-aminobutyric acid (GABA).
While the precise mechanism of action of acamprosate in the maintenance of abstinence from alcohol ingestion remains to be determined, the drug decreases glutamatergic transmission and modulates neuronal hyperexcitability during withdrawal from alcohol. Acamprosate reduces voluntary intake of alcohol in alcohol-dependent animals. Acamprosate did not exhibit anticonvulsant, antidepressant, or anxiolytic activity in animal studies.
Administration of acamprosate was not associated with the development of tolerance or dependence in animal studies. Acamprosate is not known to cause alcohol aversion. Ingestion of alcohol by individuals receiving acamprosate therapy does not result in a disulfiram-like reaction.
Acamprosate is eliminated principally in urine as unchanged drug. The drug is not metabolized in the liver. Acamprosate does not induce cytochrome P-450 (CYP) isoenzymes 1A2 or 3A4, nor does it inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4.
USES: This medication is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Acamprosate works by restoring the natural balance of chemicals in the brain (neurotransmitters). Before starting this medication, you should no longer be drinking alcohol.
Acamprosate has not been shown to work well if you are still drinking alcohol when you start taking it.
Generic name: acamprosate calcium
Pronunciation: (a-KAM-proe-sate KAL-see-um)
Drug class: Drugs to Treat Alcoholism
Therapeutic class: Chemical Dependency, Agents to Treat
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Acamprosate Calcium
Indications
The following indications are listed for Acamprosate Calcium:
- Alcohol Use Disorder
Also known as: Alcohol Addiction, Alcohol Dependence, Alcoholism.
Dosing
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.
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 | Instructions |
|---|---|---|
| Acamprosate Calc Dr 333 Mg Tab | Maintenance | Take 2 tablets (666 mg) by oral route 3 times per day. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Acamprosate Calc Dr 333 Mg Tab | Maintenance | Take 2 tablets (666 mg) by oral route 3 times per day. |
Drug interactions
Safety profile in patients receiving acamprosate in conjunction with anxiolytics, hypnotics and sedatives (including benzodiazepines), or nonopiate analgesics in clinical studies was similar to that in patients receiving these drugs with placebo.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Known hypersensitivity to acamprosate or any ingredient in the formulation.
Severe renal impairment (creatinine clearance less than 30 mL/minute).
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
- Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
- Suicidal ideation
Adverse reactions
Adverse effects reported in 5% or more of patients receiving acamprosate and more frequently than placebo include diarrhea and asthenia.
More Frequent
- Depression
Less Frequent
- Chest pain
- Dyspnea
- Infection
- Memory impairment
- Peripheral edema
- Suicidal ideation
- Tinnitus
- Urticaria
- Vasodilation of blood vessels
Rare or 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
More Frequent
- Accidental injury
- Diarrhea
- Dizziness
- Flatulence
- Hyperhidrosis
- Insomnia
- Nausea
- Paresthesia
- Pruritus of skin
- Symptoms of anxiety
- Xerostomia
Less Frequent
- 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 or 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
Precautions
No enhanced messaging available.
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.
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.
ICD codes
| Code | Type | Description |
|---|---|---|
| Alcohol use disorder | ||
| F10.1 | ICD10CM | Alcohol abuse |
| F10.10 | ICD10CM | Alcohol abuse, uncomplicated |
| F10.12 | ICD10CM | Alcohol abuse with intoxication |
| F10.120 | ICD10CM | Alcohol abuse with intoxication, uncomplicated |
| F10.121 | ICD10CM | Alcohol abuse with intoxication delirium |
| F10.129 | ICD10CM | Alcohol abuse with intoxication, unspecified |
| F10.13 | ICD10CM | Alcohol abuse, with withdrawal |
| F10.130 | ICD10CM | Alcohol abuse with withdrawal, uncomplicated |
| F10.131 | ICD10CM | Alcohol abuse with withdrawal delirium |
| F10.132 | ICD10CM | Alcohol abuse with withdrawal with perceptual disturbance |
| F10.139 | ICD10CM | Alcohol abuse with withdrawal, unspecified |
| F10.14 | ICD10CM | Alcohol abuse with alcohol-induced mood disorder |
| F10.15 | ICD10CM | Alcohol abuse with alcohol-induced psychotic disorder |
| F10.150 | ICD10CM | Alcohol abuse with alcohol-induced psychotic disorder with delusions |
| F10.151 | ICD10CM | Alcohol abuse with alcohol-induced psychotic disorder with hallucinations |
| F10.159 | ICD10CM | Alcohol abuse with alcohol-induced psychotic disorder, unspecified |
| F10.18 | ICD10CM | Alcohol abuse with other alcohol-induced disorders |
| F10.180 | ICD10CM | Alcohol abuse with alcohol-induced anxiety disorder |
| F10.181 | ICD10CM | Alcohol abuse with alcohol-induced sexual dysfunction |
| F10.182 | ICD10CM | Alcohol abuse with alcohol-induced sleep disorder |
| F10.188 | ICD10CM | Alcohol abuse with other alcohol-induced disorder |
| F10.19 | ICD10CM | Alcohol abuse with unspecified alcohol-induced disorder |
| F10.2 | ICD10CM | Alcohol dependence |
| F10.20 | ICD10CM | Alcohol dependence, uncomplicated |
| F10.22 | ICD10CM | Alcohol dependence with intoxication |
| F10.220 | ICD10CM | Alcohol dependence with intoxication, uncomplicated |
| F10.221 | ICD10CM | Alcohol dependence with intoxication delirium |
| F10.229 | ICD10CM | Alcohol dependence with intoxication, unspecified |
| F10.23 | ICD10CM | Alcohol dependence with withdrawal |
| F10.230 | ICD10CM | Alcohol dependence with withdrawal, uncomplicated |
| F10.231 | ICD10CM | Alcohol dependence with withdrawal delirium |
| F10.232 | ICD10CM | Alcohol dependence with withdrawal with perceptual disturbance |
| F10.239 | ICD10CM | Alcohol dependence with withdrawal, unspecified |
| F10.24 | ICD10CM | Alcohol dependence with alcohol-induced mood disorder |
| F10.25 | ICD10CM | Alcohol dependence with alcohol-induced psychotic disorder |
| F10.250 | ICD10CM | Alcohol dependence with alcohol-induced psychotic disorder with delusions |
| F10.251 | ICD10CM | Alcohol dependence with alcohol-induced psychotic disorder with hallucinations |
| F10.259 | ICD10CM | Alcohol dependence with alcohol-induced psychotic disorder, unspecified |
| F10.26 | ICD10CM | Alcohol dependence with alcohol-induced persisting amnestic disorder |
| F10.27 | ICD10CM | Alcohol dependence with alcohol-induced persisting dementia |
| F10.28 | ICD10CM | Alcohol dependence with other alcohol-induced disorders |
| F10.280 | ICD10CM | Alcohol dependence with alcohol-induced anxiety disorder |
| F10.281 | ICD10CM | Alcohol dependence with alcohol-induced sexual dysfunction |
| F10.282 | ICD10CM | Alcohol dependence with alcohol-induced sleep disorder |
| F10.288 | ICD10CM | Alcohol dependence with other alcohol-induced disorder |
| F10.29 | ICD10CM | Alcohol dependence with unspecified alcohol-induced disorder |
ICD code information from First Databank (FDB).
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Last reviewed · Source: First Databank (FDB) drug data
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