Acamprosate

Name: Acamprosate

What is acamprosate?

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

Acamprosate 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.

Acamprosate 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.

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

Commonly used brand name(s)

In the U.S.

  • Campral

Available Dosage Forms:

  • Tablet, Delayed Release
  • Tablet, Enteric Coated

Therapeutic Class: Ethanol Dependency

acamprosate Side Effects

Along with its needed effects, a medicine 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:

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:

  • 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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should this medicine be used?

Acamprosate comes as a delayed-release (releases the medication in the intestine) tablet to take by mouth. It is usually taken with or without food three times a day. To help you remember to take acamprosate, take it around the same times every day. Taking acamprosate with breakfast, lunch, and dinner may help you to remember all three doses. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acamprosate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Acamprosate helps to prevent you from drinking alcohol only as long as you are taking it. Continue to take acamprosate even if you do not think you are likely to start drinking alcohol again. Do not stop taking acamprosate without talking to your doctor.

If you drink alcohol while you are taking acamprosate, continue to take the medication and call your doctor. Acamprosate will not cause you to have an unpleasant reaction if you drink alcohol during treatment.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Patients who take acamprosate may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.

Contraindications

Hypersensitivity to Acamprosate Calcium

Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to Acamprosate calcium or any of its components.

Severe Renal Impairment

Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

Acamprosate - Clinical Pharmacology

Mechanism of Action

The mechanism of action of Acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. In vitro and in vivo studies in animals

have provided evidence to suggest Acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis that Acamprosate restores this balance.

Pharmacodynamics

Pharmacodynamic studies have shown that Acamprosate calcium reduces alcohol intake in alcohol-dependent animals in a dose-dependent manner and that this effect appears to be specific to alcohol and the mechanisms of alcohol dependence.

Acamprosate calcium has negligible observable central nervous system (CNS) activity in animals outside of its effects on alcohol dependence, exhibiting no anticonvulsant, antidepressant, or anxiolytic activity.

The administration of Acamprosate calcium is not associated with the development of tolerance or dependence in animal studies. Acamprosate calcium did not produce any evidence of withdrawal symptoms in patients in clinical trials at therapeutic doses. Post marketing data, collected retrospectively outside the U.S. have provided no evidence of Acamprosate calcium abuse or dependence.

Acamprosate calcium is not known to cause alcohol aversion and does not cause a disulfiram-like reaction as a result of ethanol ingestion.

Pharmacokinetics

Absorption

The absolute bioavailability of Acamprosate calcium after oral administration is about 11%. Steady-state plasma concentrations of Acamprosate are reached within 5 days of dosing. Steady-state peak plasma concentrations after Acamprosate calcium doses of 2 x 333 mg tablets three times daily average 350 ng/mL and occur at 3-8 hours post-dose. Coadministration of Acamprosate calcium with food decreases bioavailability as measured by Cmax and AUC, by approximately 42% and 23%, respectively. The food effect on absorption is not clinically significant and no adjustment of dose is necessary.

Distribution

The volume of distribution for Acamprosate following intravenous administration is estimated to be 72-109 liters (approximately 1 L/kg). Plasma protein binding of Acamprosate is negligible.

Metabolism

Acamprosate does not undergo metabolism.

Elimination

After oral dosing of 2 x 333 mg of Acamprosate calcium, the terminal half-life ranges from approximately 20-33 hours. Following oral administration of Acamprosate calcium, the major route of excretion is via the kidneys as Acamprosate.

Special Populations

Gender: Acamprosate calcium does not exhibit any significant pharmacokinetic differences between male and female subjects.

Age: The pharmacokinetics of Acamprosate calcium have not been evaluated in a geriatric population. However, since renal function diminishes in elderly patients and Acamprosate is excreted unchanged in urine, Acamprosate plasma concentrations are likely to be higher in the elderly population compared to younger adults.

Pediatrics: The pharmacokinetics of Acamprosate calcium have not been evaluated in a pediatric population.

Renal Impairment: Peak plasma concentrations after administration of a single dose of 2 x 333 mg Acamprosate calcium delayed-release tablets to patients with moderate or severe renal impairment were about 2-fold and 4-fold higher, respectively, compared to healthy subjects. Similarly, elimination half-life was about 1.8-fold and 2.6-fold longer, respectively, compared to healthy subjects. There is a linear relationship between creatinine clearance values and total apparent plasma clearance, renal clearance and plasma half-life of Acamprosate. A dose of 1 x 333 mg Acamprosate calcium delayed-release tablets, three times daily, is recommended in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min, [see Use in Specific Populations (8.6)].

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), Warnings and Precautions (5.1), and Use in Specific Populations (8.6)].

Hepatic Impairment: Acamprosate is not metabolized by the liver and the pharmacokinetics of Acamprosate calcium 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.

Alcohol-dependent subjects: A cross-study comparison of Acamprosate calcium at doses of 2 x 333 mg three times daily indicated similar pharmacokinetics between alcohol-dependent subjects and healthy subjects.

Drug-Drug Interactions

Acamprosate had no inducing potential on the cytochrome CYP1A2 and 3A4 systems, and in vitro inhibition studies suggest that Acamprosate does not inhibit in vivo metabolism mediated by cytochrome CYP1A2, 2C9, 2C19, 2D6, 2E1, or 3A4. The pharmacokinetics of Acamprosate calcium were unaffected when co-administered with alcohol, disulfiram or diazepam. Similarly, the pharmacokinetics of ethanol, diazepam and nordiazepam, imipramine and desipramine, naltrexone and 6-beta naltrexol were unaffected following co-administration with Acamprosate calcium. However, co-administration of Acamprosate calcium with naltrexone led to a 33% increase in the Cmax and a 25% increase in the AUC of Acamprosate. No adjustment of dosage is recommended in such patients.

How Supplied/Storage and Handling

Acamprosate Calcium Delayed-release Tablets, 333 mg are white to off-white, round, biconvex, beveled edge, enteric coated tablets, debossed with '569' on one side and plain on the other side and are supplied as follows:

NDC 68382-569-06 in bottles of 30 tablets

NDC 68382-569-16 in bottles of 90 tablets

NDC 68382-569-01 in bottles of 100 tablets

NDC 68382-569-28 in bottles of 180 tablets

NDC 68382-569-05 in bottles of 500 tablets

NDC 68382-569-10 in bottles of 1000 tablets

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container (USP).

Patient Counseling Information

Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe Acamprosate calcium delayed-release tablets.

Renal Impairment

A lower dose is recommended for patients with moderate renal impairment. Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Dosage and Administration (2.1), Contraindications (4.2), Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

Suicidality and Depression

Families and caregivers of patients being treated with Acamprosate calcium delayed-release tablets 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 [see Warnings and Precautions (5.2)].

Alcohol Withdrawal

Use of Acamprosate calcium delayed-release tablets does not eliminate or diminish withdrawal symptoms [see Warnings and Precautions (5.3)].

Pregnancy and Breast Feeding

  • Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy.
  • Advise patients to notify their physician if they are breast-feeding.

Relapse to Drinking

  • Advise patients to continue Acamprosate calcium delayed-release tablets therapy as directed, even in the event of relapse and remind them to discuss any renewed drinking with their physicians.
  • Advise patients that Acamprosate calcium delayed-release tablets has been shown to help maintain abstinence only when used as a part of a treatment program that includes counseling and support.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Manufactured by:

Cadila Healthcare Ltd.

Baddi, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Revision Date: 01/06/16

Rev.: 06/16

Package label.principal display panel

NDC 68382-569-28 in bottles of 180 tablets

Acamprosate Calcium Delayed-release Tablets

333 mg

Rx only

Zydus

Acamprosate CALCIUM 
Acamprosate calcium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68382-569
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acamprosate CALCIUM (Acamprosate) Acamprosate CALCIUM 333 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
MAGNESIUM STEARATE  
METHACRYLIC ACID  
POLYETHYLENE GLYCOL 8000  
POVIDONE K90  
SILICON DIOXIDE  
SODIUM BICARBONATE  
SODIUM LAURYL SULFATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TALC  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 569
Contains     
Packaging
# Item Code Package Description
1 NDC:68382-569-06 30 TABLET, DELAYED RELEASE in 1 BOTTLE
2 NDC:68382-569-16 90 TABLET, DELAYED RELEASE in 1 BOTTLE
3 NDC:68382-569-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE
4 NDC:68382-569-28 180 TABLET, DELAYED RELEASE in 1 BOTTLE
5 NDC:68382-569-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE
6 NDC:68382-569-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205995 06/01/2017
Labeler - Zydus Pharmaceuticals (USA) Inc. (156861945)
Revised: 05/2017   Zydus Pharmaceuticals (USA) Inc.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet Delayed Release, Oral, as calcium:

Campral: 333 mg [DSC]

Generic: 333 mg

Use Labeled Indications

Alcohol abstinence: Maintenance of abstinence from alcohol in patients with alcohol dependence 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.

Dosing Adult

Alcohol abstinence: Oral: 666 mg 3 times daily (a lower dose may be effective in some patients). Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal when the patient has achieved abstinence and should be maintained if patient relapses.

Drug Interactions

There are no known significant interactions.

Warnings/Precautions

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 dependence: Appropriate use: Should be used as part of a comprehensive program to treat alcohol dependence. 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). Contraindicated in patients with severe renal impairment (CrCl ≤30 mL/minute).

Dosage form specific issues:

• Sulfites: Traces of sulfites may be present in the formulation.

Side Effects of Acamprosate

Common side effects include:

  • diarrhea
  • gas
  • upset stomach
  • loss of appetite
  • dry mouth
  • dizziness
  • itching
  • weakness

This is not a complete list of acamprosate side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Acamprosate Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • antidepressants such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), vilazodone (Viibryd), paroxetine (Paxil), fluoxetine (Prozac, Sarafem, Symbyax), and fluvoxamine (Luvox), trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)

This is not a complete list of acamprosate drug interactions. Ask your doctor or pharmacist for more information.

Acamprosate Usage

Take acamprosate exactly as prescribed.

Acamprosate comes as a delayed-release tablet and is taken three times every day, with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of acamprosate at the same time.

Patient Handout

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