acamprosate (Rx)

Brand and Other Names:Campral
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 333mg

Alcoholism

Indicated for maintenance of alcohol abstinence in patients who are abstinent at treatment initiation

666 mg PO TID

Renal Impairment

CrCl 30-50 mL/min: 333 mg PO TID

CrCl <30 mL/min: Do not administer

Fragile X Syndrome (Orphan)

Orphan designation for treatment of fragile X syndrome

Orphan sponsor

  • Confluence Pharmaceuticals, LLC; Box 528, 351 West 10th Street; Indianapolis, IN 46202

Safety and efficacy have not been established

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Interactions

Interaction Checker

and acamprosate

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • naltrexone

                  naltrexone increases levels of acamprosate by unspecified interaction mechanism. Use Caution/Monitor. No dosage adjustment is needed.

                Minor (0)

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                  Adverse Effects

                  >10%

                  Diarrhea (16%)

                  1-10%

                  Accidental injury (3%)

                  Anorexia (3%)

                  Anxiety (6%)

                  Asthenia (6%)

                  Depression (5%)

                  Dizziness (3%)

                  Dry mouth (2%)

                  Flatulence (3%)

                  Insomnia (7%)

                  Nausea (4%)

                  Pain (3%)

                  Paresthesia (2%)

                  Pruritus (4%)

                  Sweating (2%)

                  Frequency Not Defined

                  Hypertension

                  Chest-pain

                  Edema

                  Syncope

                  Vasodilation

                  Abnormal vision

                  Cough

                  Pharyngitis

                  Dyspnea

                  Rhinitis

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                  Warnings

                  Contraindications

                  Hypersensitivity

                  Severe renal impairment

                  Cautions

                  Does not diminish withdrawal symptoms

                  May impair ability to operate heavy machinery or drive

                  Efficacy not established in promoting abstinence in non-abstinent patients

                  Check for suicidal tendencies

                  Use as part of a conprehensive to treat alcohol dependence

                  Possibility of acute renal failure (ARF)

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                  Pregnancy & Lactation

                  Pregnancy Category: C

                  Lactation: Excretion in milk unknown; use with caution

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Not fully understood; may act by interacting with glutamate & GABA neurotransmitter systems

                  Does not cause alcohol aversion or a disulfiram-like reaction on ethanol ingestion

                  Pharmacokinetics

                  Protein Bound: Negligible

                  Vd: 1 L/kg

                  Peak PlasmaTime: 3-8 hr

                  Concentration: 350 ng/mL for a dose of 666 mg TID

                  Bioavailability: 11%, decreased by food

                  Metabolism: None

                  Excretion: Urine

                  Half-life: 20-33 hr

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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  acamprosate oral
                  -
                  333 mg tablet
                  acamprosate oral
                  -
                  333 mg tablet
                  acamprosate oral
                  -
                  333 mg tablet
                  acamprosate oral
                  -
                  333 mg tablet

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  acamprosate oral

                  ACAMPROSATE CALCIUM DELAYED-RELEASE - ORAL

                  (a-KAM-proe-sate KAL-see-um)

                  COMMON BRAND NAME(S): Campral

                  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.

                  HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking acamprosate 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.

                  SIDE EFFECTS: Diarrhea, nausea, vomiting, gas, stomach pain, loss of appetite, headache, drowsiness, dizziness, constipation, fatigue, weight gain/loss, muscle/joint pain, change in sexual desire or decreased sexual ability may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (including severe depression, thoughts of suicide), signs of kidney problems (such as change in the amount of urine), fainting, fast or pounding heartbeat, vision or hearing changes, increased thirst.Get medical help right away if you have any very serious side effects, including: stomach/abdominal pain that doesn't go away, black stools, vomit that looks like coffee grounds, seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Before taking acamprosate, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                  DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                  OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe diarrhea that doesn't stop.

                  NOTES: Do not share this medication with others.Lab tests (such as kidney function tests) should be done while you are taking this medication. Keep all medical and lab appointments. Go to all of your counseling and support group meetings. Consult your doctor for more details.

                  MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                  STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                  Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.