Acamprosate

What is Acamprosate?

• Acamprosate (Campral) is a synthetic amino acid and a neurotransmitter analogue that is used as an alcohol deterrent in management of alcohol dependence and abuse.

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Acamprosate

What are the uses of this medicine?

• Acamprosate (Campral) is used along with counseling and social support to help people who have stopped drinking large amounts of alcohol (alcoholism) to avoid drinking alcohol again.

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Acamprosate molecule ball

How does this medicine work?

• Acamprosate (a kam' proe sate) is N-acetylhomotaurine, a synthetic amino acid analogue similar to gamma aminobutyric acid (GABA) and taurine that has been shown to decrease alcohol craving in animal models.
• Acamprosate appears to function as a neurotransmitter with GABA agonist and partial glutamate (N-methyl-D-aspartate [NMDA]) antagonist activity, but its precise mechanism of action in decreasing alcohol craving is unknown.
• When used in a comprehensive alcohol treatment program, acamprosate has been shown to decrease relapse to alcohol use, at least over the short term.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• previously have exhibited hypersensitivity to acamprosate calcium or any of its components.
• severe renal impairment

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention if you are taking any of the following:

• antidepressants ('mood elevators')

Is this medicine FDA approved?

• Acamprosate was approved for use in the therapy of alcohol dependence and abuse in the United States in 2004.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Campral is two 333 mg tablets (each dose should total 666 mg) taken three times daily.

Dosage in Renal Impairment:

• For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended.
• Campral is contraindicated in patients with severe renal impairment.

Administration:

• 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.
• 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.
• 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Enteric-coated tablets, 333 mg

This medicine is available in fallowing brand namesː

• Campral

What side effects can this medication cause?

The most common side effects of this medicine include:

• accidental injury
• asthenia
• pain
• anorexia
• diarrhea
• flatulence
• nausea
• anxiety
• depression
• dizziness
• dry mouth
• insomnia
• paresthesia
• pruritus
• sweating

What special precautions should I follow?

• Treatment with Campral in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) requires a dose reduction. Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min).
• Families and caregivers of patients being treated with Campral 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.
• Use of Campral does not eliminate or diminish withdrawal symptoms.
• 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.
• Advise patients to continue Campral therapy as directed, even in the event of relapse and remind them to discuss any renewed drinking with their physicians.
• Advise patients that Campral has been shown to help maintain abstinence only when used as a part of a treatment program that includes counseling and support.
• Acamprosate has not been linked to serum enzyme elevations during therapy and has not been linked to cases of clinically apparent liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• diarrhea
• Hypercalcemia

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well controlled studies in pregnant women.
• Campral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and efficacy of Campral have not been established in the pediatric population.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• acamprosate calcium

Inactive ingredient:

• CROSPOVIDON
• CELLULOSE, MICROCRYSTALLINE
• MAGNESIUM SILICATE
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• SILICON DIOXIDE
• MAGNESIUM STEARATE
• TALC
• PROPYLENE GLYCOL
• METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

Who manufactures and distributes this medicine?

Manufactured by:

• Merck Santé s.a.s. Subsidiary of Merck KGaA, Darmstadt, Germany 37, rue Saint-Romain LYON FRANCE

Manufactured for:

• Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO

What should I know about storage and disposal of this medication?

• Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).

Substance abuse treatment agents

• Acamprosate, Buprenorphine, Disulfiram, Methadone, Nalmefene, Naloxegol, Naloxone, Naltrexone, Nicotine, Varenicline.

• Dailymed label info on Acamprosate
• FDA Acamprosate

Acamprosate Resources
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