Acamprosate

Name: Acamprosate

What is the most important information I should know about acamprosate?

You should not use acamprosate if you have severe kidney disease.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Uses of Acamprosate

  • It is used to help keep you alcohol-free.

What do I need to tell my doctor BEFORE I take Acamprosate?

  • If you have an allergy to acamprosate or any other part of acamprosate.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have kidney disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take acamprosate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Acamprosate?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid drinking alcohol while taking acamprosate.
  • If you have a drink of alcohol, talk with your doctor.
  • This medicine will not lower or get rid of withdrawal signs. Talk with your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Warnings and Precautions

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 (2.1)]. Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Dosage and Administration (2.1), Contraindications (4.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

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.

Alcohol Withdrawal

Use of Acamprosate calcium does not eliminate or diminish withdrawal symptoms.

Acamprosate Description

Acamprosate calcium is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name is calcium acetylaminopropane sulfonate. Its chemical formula is C10H20N2O8S2Ca and molecular weight is 400.5. Its structural formula is:

Acamprosate calcium is a white or almost white powder. It is freely soluble in water, practically insoluble in alcohol and in methylene chloride.

Each Acamprosate calcium delayed-release tablet intended for oral administration contains 333 mg of Acamprosate calcium equivalent to 300 mg of Acamprosate. In addition, each tablet contains the following inactive ingredients: colloidal anhydrous silica, methacrylic acid copolymer type c, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium bicarbonate, sodium lauryl sulfate,  sodium starch glycolate and talc. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product.

Index Terms

  • Acamprosate Calcium
  • Calcium Acetylhomotaurinate
  • Campral

Brand Names U.S.

  • Campral [DSC]

Dosing Hepatic Impairment

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.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, loss of strength or energy, lack of appetite, or insomnia. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), behavioral changes, agitation, irritability, panic attacks, or mood changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Uses of Acamprosate

Acamprosate is a prescription medication used for the maintenance of abstinence from alcohol. It is used along with behavior modification and counseling in people who have recently quit drinking alcohol. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Acamprosate Drug Class

Acamprosate is part of the drug class:

  • Drugs used in alcohol dependence

Acamprosate Precautions

Serious side effects have been reported with acamprosate including the following:

Suicidal thoughts/actions and depression:

People who drink large amounts of alcohol often become depressed and sometimes try to harm or kill themselves. Taking acamprosate does not decrease and may increase the risk that you will try to harm yourself. You may develop depression while you are taking acamprosate even if you do not go back to drinking.

You or your family should call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

  • feelings of sadness
  • anxiousness
  • hopelessness
  • guilt
  • worthlessness or helplessness
  • loss of interest or pleasure in activities you once enjoyed
  • lack of energy
  • difficulty concentrating
  • making decisions
  • remembering
  • irritability
  • sleep problems
  • changes in appetite or weight
  • restlessness
  • thinking about harming or killing yourself or planning or trying to do so

Be sure that your family knows which symptoms may be serious so they can call the doctor right away if you are unable to seek treatment on your own.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Acamprosate may affect your thinking, ability to make decisions, and coordination. Do not drive a car or operate machinery until you know how this medication affects you.

Patients with moderate renal impairment will need a lower dose of acamprosate.

Do not take acamprosate if you:

  • are allergic to acamprosate or to any of its ingredients
  • have severe renal impairment

Acamprosate Overdose

If you take too much acamprosate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

For the Consumer

Applies to acamprosate: oral tablet delayed release, oral tablet enteric coated

Along with its needed effects, acamprosate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acamprosate:

More common
  • Extreme feeling of sadness or emptiness
  • fear
  • severe depression
Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur while taking acamprosate:

  • Abdominal pain
  • confusion
  • constipation
  • diarrhea
  • dry mouth
  • headache
  • incoherent speech
  • increased urination
  • metallic taste
  • muscle weakness
  • nausea
  • thirst
  • unusual tiredness
  • vomiting
  • weight loss

Some side effects of acamprosate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common
  • Discouragement
  • feeling sad
  • irritability
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • nervousness
  • sleeplessness
  • tiredness
  • trouble concentrating
  • trouble sleeping
Less common
  • Accidental injury
  • bloated or full feeling
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dizziness
  • dry mouth
  • excess air or gas in stomach or intestines
  • itching skin
  • pain
  • passing gas
  • sweating

For Healthcare Professionals

Applies to acamprosate: oral delayed release tablet

Gastrointestinal

Gastrointestinal side effects have frequently included anorexia (3%), diarrhea (16%), flatulence (3%), nausea (4%), dry mouth (2%), vomiting, dyspepsia, constipation, taste perversion, abdominal pain and increased appetite. Gastroenteritis, gastritis, dysphagia, eructation, gastrointestinal hemorrhage, pancreatitis, rectal hemorrhage, esophagitis and hematemesis have also been reported. Melena, stomach ulcer, cholecystitis, colitis, increased salivation, duodenal ulcer, enlarged abdomen, and mouth ulceration have been reported rarely.[Ref]

Diarrhea was the only side effect associated with a drop out rate of greater than 1%, when compared to placebo, in clinical studies.[Ref]

Nervous system

Nervous system side effects have frequently included anxiety/nervousness (6%), dizziness (3%), insomnia (7%), paresthesia (2%), somnolence, decreased libido, amnesia, abnormal thinking and tremor. Convulsions, migraine, confusion, increased libido, vertigo, withdrawal syndrome, apathy, neuralgia and hypesthesia have also been reported. Alcohol craving, hyperkinesia, twitching, torticollis and encephalopathy have been reported rarely.[Ref]

Cardiovascular

Cardiovascular side effects have frequently included palpitations, vasodilation, hypertension and syncope. Hypotension, tachycardia, hemorrhage, angina pectoris, varicose veins, myocardial infarct, phlebitis and postural hypotension have also been reported. Heart failure, mesenteric arterial occlusion, cardiomyopathy, deep thrombophlebitis and shock have been reported rarely.[Ref]

Other

Other side effects have frequently included accidental injury/fractures (3%), asthenia (6%), pain (3%), headache, back pain, chest pain and suicide attempt. Tinnitus, deafness, fever, intentional overdose, malaise, abscess, neck pain, hernia and intentional injury have also been reported. Ascites, face edema, photosensitivity reaction and sudden death have been reported rarely.[Ref]

Hematologic

Hematologic side effects have included anemia, ecchymosis, eosinophilia, lymphocytosis and thrombocytopenia. Leukopenia, lymphadenopathy and monocytosis have been reported rarely.[Ref]

Genitourinary

Genitourinary side effects have frequently included impotence. Metrorrhagia, urinary frequency, urinary tract infection, sexual function abnormality, urinary incontinence and vaginitis have also been reported. Kidney calculus, abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria and urinary urgency have been reported rarely.[Ref]

Metabolic

Metabolic side effects have frequently included peripheral edema and weight gain. Weight loss, hyperglycemia, gout, thirst, hyperuricemia, diabetes mellitus, avitaminosis, bilirubinemia have also been reported. Increased creatinine, hyponatremia and increased lactic dehydrogenase have been reported rarely. Hypercalcemia has been reported in cases of chronic overdose.[Ref]

Musculoskeletal

Musculoskeletal side effects have frequently included myalgia and arthralgia. Leg cramps have also been reported. Rheumatoid arthritis and myopathy have been reported rarely.[Ref]

Dermatologic

Dermatologic side effects have frequently included pruritus (4%), sweating (2%) and rash. Acne, eczema, alopecia, maculopapular rash, dry skin, urticaria, exfoliative dermatitis and vesiculobullous rash have also been reported. Psoriasis has been reported rarely. There is a single case report of a possible association of erythema multiforme with acamprosate.[Ref]

A 40-year-old woman with cirrhosis of the liver presented with a possible case of erythema multiforme after 10 days of therapy. While it may be probable that acamprosate was the cause, it is also possible that this outbreak could have been caused by the herpes simplex virus.[Ref]

Endocrine

Endocrine side effects have rarely included goiter and hypothyroidism.[Ref]

Hepatic

Hepatic side effects have frequently included increased SGOT and increased SGPT. Abnormal liver function tests, liver cirrhosis, and hepatitis have also been reported. Increases in alkaline phosphatase have been reported rarely.[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic reaction.[Ref]

Immunologic

Immunologic side effects have frequently included infection, flu syndrome and chills.[Ref]

Ocular

Ocular side effects have frequently included abnormal vision. Ophthalmitis, diplopia and photophobia have been reported rarely.[Ref]

Renal

Renal side effects have rarely included acute kidney failure.[Ref]

Acute kidney failure has been reported in at least 3 patients. While there has been no causal relationship found between these incidents and acamprosate therapy, a temporal association has been reported by the manufacturer.[Ref]

Respiratory

Respiratory side effects have frequently included rhinitis, increased cough, dyspnea, pharyngitis and bronchitis. Asthma, epistaxis and pneumonia have also been reported.

Laryngismus and pulmonary embolus have been reported rarely.[Ref]

Psychiatric

Psychiatric side effects have included depression (5%), suicidal ideation, hostility, agitation, neurosis, abnormal dreams and hallucinations. Psychosis, depersonalization, paranoid reaction, and manic reaction have been reported rarely.[Ref]

Oncologic

Oncologic side effects have rarely included hepatic carcinoma.[Ref]

Some side effects of acamprosate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Renal Dose Adjustments

In patients with moderate renal dysfunction (creatinine clearance 30 to 50 mL/min) an initial dose of 333 mg three times daily is recommended by the manufacturer.

Acamprosate is contraindicated in patients with severe renal dysfunction (creatinine clearance equal to or less than 30 mL/min).

Acamprosate Breastfeeding Warnings

There are no data on the excretion of acamprosate into human milk. The manufacturer recommends the use of caution when administering acamprosate to nursing women.

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