Campral

DRUG DESCRIPTION

Campral (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 ?-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name is calcium acetylaminopropane sulfonate. Its chemical formula is C10H20N2O8S2Ca and molecular weight is 400.48. Its structural formula is:

CAMPRAL®  (acamprosate calcium) Structural Formula Illustration

Acamprosate calcium is a white, odorless or nearly odorless powder. It is freely soluble in water, and practically insoluble in absolute ethanol and dichloromethane.

Each Campral tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in Campral tablets include: crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, talc, propylene glycol and Eudragit® L 30 D or equivalent. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product.

What are the possible side effects of acamprosate (Campral)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effects such as:

  • mood or behavior changes;
  • thoughts about hurting yourself;
  • severe anxiety or depression;
  • feeling like you might pass out;
  • fast or pounding heartbeats;
  • swelling, weight gain, feeling short of breath;
  • confusion, increased thirst;...

Read All Potential Side Effects and See Pictures of Campral »

What are the precautions when taking acamprosate calcium (Campral)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other kidney disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication...

Read All Potential Precautions of Campral »


Campral Consumer (continued)

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 persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (including severe depression, thoughts of suicide), fainting, fast or pounding heartbeat, vision or hearing changes, increased thirst.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, seizures, persistent stomach pain, black/tarry stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other kidney disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Remember that drinking large amounts of alcohol during pregnancy can cause long-lasting problems in your baby, such as birth defects, growth retardation, and learning disabilities. This set of problems is often called fetal alcohol syndrome.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Campral Patient Information Including Side Effects

Brand Names: Campral

Generic Name: acamprosate (Pronunciation: a KAM proe sate)

  • What is acamprosate (Campral)?
  • What are the possible side effects of acamprosate (Campral)?
  • What is the most important information I should know about acamprosate (Campral)?
  • What should I discuss with my healthcare provider before taking acamprosate (Campral)?
  • How should I take acamprosate (Campral)?
  • What happens if I miss a dose (Campral)?
  • What happens if I overdose (Campral)?
  • What should I avoid while taking acamprosate (Campral)?
  • What other drugs will affect acamprosate (Campral)?
  • Where can I get more information?

What is acamprosate (Campral)?

Acamprosate affects chemicals in the brain that may become 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 to help a person who has recently quit drinking alcohol continue to choose not to drink (remain abstinent from alcohol). It is used together with behavior modification and counseling support to help you stop drinking.

Acamprosate is not likely to be helpful to a person who has not already quit drinking or undergone detoxification. It may not be helpful to a person who is also addicted to other substances besides alcohol.

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

What are the possible side effects of acamprosate (Campral)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effects such as:

  • mood or behavior changes;
  • thoughts about hurting yourself;
  • severe anxiety or depression;
  • feeling like you might pass out;
  • fast or pounding heartbeats;
  • swelling, weight gain, feeling short of breath;
  • confusion, increased thirst; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;
  • constipation, diarrhea;
  • headache, dizziness, drowsiness;
  • vision problems;
  • problems with memory or thinking;
  • weakness, cold or flu-like symptoms;
  • back pain, joint or muscle pain;
  • dry mouth, decreased or distorted sense of taste;
  • sleep problems (insomnia);
  • impotence, loss of interest in sex;
  • sweating, mild skin rash; or
  • numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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

Acamprosate will not treat or prevent alcohol withdrawal symptoms.

Before you take acamprosate, 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 acamprosate. 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.

Acamprosate 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 acamprosate, tell your doctor about any alcoholic drinks you consume, no matter how many.

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