Acamprol delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Acamprol delayed-release tablets should be part of a comprehensive management program that includes psychosocial support.

The efficacy of Acamprol in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Acamprol delayed-release tablets treatment. The efficacy of Acamprol in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

Acamprol (Acamprol) affects chemicals in the brain that may be unbalanced in a person who is addicted to alcohol. Acamprol works by restoring this chemical balance in the brain in an alcohol-dependent person who has recently quit drinking.

Acamprol is used together with behavior modification and counseling support to help a person who has recently quit drinking alcohol continue to choose not to drink.

Acamprol is not likely to be helpful if you have not already quit drinking or undergone detoxification. It may not help you if you are also addicted to other substances besides alcohol.

Acamprol may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Alcohol Dependence

666 mg orally three times a day

Usual Geriatric Dose for Alcohol Dependence

666 mg orally three times a day

Since geriatric patients may be more prone to a decrease in renal function, the manufacturer advises greater care in dose selection and close monitoring of renal function during therapy in this population.

Usual Pediatric Dose for Alcohol Dependence

There are no data on the safety and efficacy of Acamprol in this population.

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.

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

Liver Dose Adjustments

Acamprol is not metabolized by the liver and the pharmacokinetics of Acamprol are not altered in patients with mild to moderate hepatic impairment (groups A and B of the Child-Pugh classification). No adjustment of dosage is recommended in such patients.

Acamprol is contraindicated in patients with severe hepatic impairment (Child-Pugh C).

Precautions

Acamprol is contraindicated in patients with a creatinine clearance equal to or less than 30 mL/min.

Acamprol therapy has not been reported to eliminate or diminish alcohol withdrawal symptoms.

Acamprol has not been reported to cause a disulfiram type reaction as a result of ethanol ingestion.

There are no data on Acamprol causing alcohol aversion.

Acamprol may impair the mental abilities necessary for potentially hazardous tasks such as driving or operating machinery.

Acamprol should only be used in conjunction with a treatment program that includes counseling and support.

Patients undergoing treatment for alcohol dependence, whether they are taking Acamprol or not, should be monitored for the emergence of symptoms of depression and/or suicidal behavior. Families and caregivers of patients being treated with Acamprol 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 physician.

The concomitant intake of alcohol and Acamprol does not affect the pharmacokinetics of either alcohol or Acamprol.

Safety and efficacy have not been established in pediatric patients (less than 18 years of age).

Dialysis

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

See also:
What is the most important information I should know about Acamprol?

You should not use this medication if you are allergic to Acamprol, or if you have severe kidney disease.

Acamprol will not treat or prevent alcohol withdrawal symptoms.

Before you take Acamprol, tell your doctor if you have any type of kidney problem. You may need a dose adjustment or special tests to safely use this medication.

You may have thoughts about suicide while you are taking Acamprol. Tell your doctor if you feel depressed or have any suicidal thoughts or actions during treatment.

Your family or other caregivers should also be alert to changes in your mood or behavior. Make sure your caregivers know how to contact your doctor in case you have mood changes or suicidal thoughts or actions.

Acamprol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Take this medication for the full prescribed length of time, even if you relapse and drink alcohol. While you are taking Acamprol, tell your doctor about any alcoholic drinks you consume, no matter how many.

Use Acamprol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Acamprol may be taken with or without food.
• Swallow whole. Do not break, crush, or chew before swallowing.
• Continue to take Acamprol even if you feel well. Do not miss any doses.
• If you miss a dose of Acamprol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acamprol.

This medication is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Acamprol works by restoring the natural balance of chemicals in the brain (neurotransmitters).

Before starting this medication, you should no longer be drinking alcohol. Acamprol has not been shown to work well if you are still drinking alcohol when you start taking it.

How to use Acamprol

Read the Patient Information Leaflet if available from your pharmacist before you start taking Acamprol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually three times a day. Swallow the tablets whole. Do not crush or chew the tablets.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

If you begin drinking alcohol again, continue to take this medication and tell your doctor promptly.

See also:
What other drugs will affect Acamprol?

The concomitant intake of alcohol and Acamprol does not affect the pharmacokinetics of either alcohol or Acamprol.

Pharmacokinetic studies indicate that administration of disulfiram or diazepam does not affect the pharmacokinetics of Acamprol. Co-administration of naltrexone with Acamprol produced a 25% increase in AUC and a 33% increase in the Cmax of Acamprol. No adjustment of dosage is recommended in such patients.

The pharmacokinetics of naltrexone and its major metabolite 6-beta-naltrexol were unaffected following co-administration with Acamprol.

Other concomitant therapies: In clinical trials, the safety profile in subjects treated with Acamprol concomitantly with anxiolytics, hypnotics and sedatives (including benzodiazepines), or non-opioid analgesics was similar to that of subjects taking placebo with these concomitant medications. Patients taking Acamprol concomitantly with antidepressants more commonly reported both weight gain and weight loss, compared with patients taking either medication alone.

See also:
What are the possible side effects of Acamprol?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinically significant serious adverse reactions associated with Acamprol described elsewhere in labeling include suicidality and depression and acute kidney failure

The adverse event data described below reflect the safety experience in over 7000 patients exposed to Acamprol for up to one year, including over 2000 Acamprol-exposed patients who participated in placebocontrolled trials.

Adverse Events Leading To Discontinuation

In placebo-controlled trials of 6 months or less, 8% of Acamprol-treated patients discontinued treatment due to an adverse event, as compared to 6% of patients treated with placebo. In studies longer than 6 months, the discontinuation rate due to adverse events was 7% in both the placebo-treated and the Acamprol-treated patients. Only diarrhea was associated with the discontinuation of more than 1% of patients (2% of Acamprol-treated vs. 0.7% of placebo-treated patients). Other events, including nausea, depression, and anxiety, while accounting for discontinuation in less than 1% of patients, were nevertheless more commonly cited in association with discontinuation in Acamprol-treated patients than in placebo-treated patients.

Common Adverse Events Reported In Controlled Trials

Common adverse events were collected spontaneously in some controlled studies and using a checklist in other studies. The overall profile of adverse events was similar using either method. shows those events that occurred in any Acamprol treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events. The reported frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed, without regard to the causal relationship of the events to the drug.

Table 1: Events Occurring at a Rate of at Least 3% and Greater than Placebo in any Acamprol Treatment Group in Controlled Clinical Trials with Spontaneously Reported Adverse Events

Concomitant Therapies

In clinical trials, the safety profile in subjects treated with Acamprol concomitantly with anxiolytics, hypnotics and sedatives (including benzodiazepines), or non-opioid analgesics was similar to that of subjects taking placebo with these concomitant medications. Patients taking Acamprol concomitantly with antidepressants more commonly reported both weight gain and weight loss, compared with patients taking either medication alone.

Other Events Observed During The Premarketing Evaluation Of Acamprol

Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with Acamprol in 20 clinical trials (4461 patients treated with Acamprol, 3526 of whom received the maximum recommended dose of 1998 mg/day for up to one year in duration). This listing does not include those events already listed above; events for which a drug cause was considered remote; event terms which were so general as to be uninformative; and events reported only once which were not likely to be acutely life-threatening.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the summary of adverse events in controlled trials appear in this listing); Infrequent adverse events are those occurring in 1/100 to 1/1000 patients; Rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole -Frequent: headache, abdominal pain, back pain, infection, flu syndrome, chest pain, chills, suicide attempt; Infrequent: fever, intentional overdose, malaise, allergic reaction, abscess, neck pain, hernia, intentional injury; Rare: ascites, face edema, photosensitivity reaction, abdomen enlarged, sudden death.

Cardiovascular System -Frequent: palpitation, syncope; Infrequent: hypotension, tachycardia, hemorrhage, angina pectoris, migraine, varicose vein, myocardial infarct, phlebitis, postural hypotension; Rare: heart failure, mesenteric arterial occlusion, cardiomyopathy, deep thrombophlebitis, shock.

Digestive System - Frequent : vomiting, dyspepsia, constipation, increased appetite; Infrequent: liver function tests abnormal, gastroenteritis, gastritis, dysphagia, eructation, gastrointestinal hemorrhage, pancreatitis, rectal hemorrhage, liver cirrhosis, esophagitis, hematemesis, nausea and vomiting, hepatitis; Rare: melena, stomach ulcer, cholecystitis, colitis, duodenal ulcer, mouth ulceration, carcinoma of liver.

Endocrine System -Rare: goiter, hypothyroidism.

Hemic and Lymphatic System -Infrequent: anemia, ecchymosis, eosinophilia, lymphocytosis, thrombocytopenia; Rare: leukopenia, lymphadenopathy, monocytosis.

Metabolic and Nutritional Disorders -Frequent - peripheral edema, weight gain; Infrequent: weight loss, hyperglycemia, SGOT increased, SGPT increased, gout, thirst, hyperuricemia, diabetes mellitus, avitaminosis, bilirubinemia; Rare:alkaline phosphatase increased, creatinine increased, hyponatremia, lactic dehydrogenase increased.

Musculoskeletal System -Frequent - myalgia, arthralgia; Infrequent: leg cramps; Rare: rheumatoid arthritis, myopathy.

Nervous System -Frequent -somnolence, libido decreased, amnesia, thinking abnormal, tremor, vasodilatation, hypertension; Infrequent: convulsion, confusion, libido increased, vertigo, withdrawal syndrome, apathy, suicidal ideation, neuralgia, hostility, agitation, neurosis, abnormal dreams, hallucinations, hypesthesia; Rare: alcohol craving, psychosis, hyperkinesia, twitching, depersonalization, increased salivation, paranoid reaction, torticollis, encephalopathy, manic reaction.

Respiratory System -Frequent: rhinitis, cough increased, dyspnea, pharyngitis, bronchitis; Infrequent: asthma, epistaxis, pneumonia; Rare: laryngismus, pulmonary embolus.

Skin and Appendages -Frequent: rash; Infrequent: acne, eczema, alopecia, maculopapular rash, dry skin, urticaria, exfoliative dermatitis, vesiculobullous rash; Rare: psoriasis.

Special Senses -Frequent : abnormal vision, taste perversion; Infrequent: tinnitus, amblyopia, deafness; Rare: ophthalmitis, diplopia, photophobia.

Urogenital System -Frequent : impotence; Infrequent - metrorrhagia, urinary frequency, urinary tract infection, sexual function abnormal, urinary incontinence, vaginitis; Rare: kidney calculus, abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria, urinary urgency.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Acamprol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serious Adverse Events Observed During the Non-US Postmarketing Evaluation Of Acamprol (acampros ate calcium)

The serious adverse event of acute kidney failure has been reported to be temporally associated with Acamprol treatment in at least 3 patients and is not described elsewhere in the labeling.

Acamprol, also known by the brand name Acamprol™, is a drug used for treating alcohol dependence. Acamprol is thought to stabilize the chemical balance in the brain that would otherwise be disrupted by alcoholism, possibly by blocking glutaminergic N-methyl-D-aspartate receptors, while gamma-aminobutyric acid type A receptors are activated. Reports indicate that Acamprol only works with a combination of attending support groups and abstinence from alcohol. Certain serious side effects include allergic reactions, irregular heartbeats, and low or high blood pressure, while less serious side effects include headaches, insomnia, and impotence. Acamprol should not be taken by people with kidney problems or allergies to the drug.