Generic name: Acamprosate calcium

Campral (acamprosate calcium) is a medication that is used to treat alcohol dependence. It works by reducing cravings for alcohol and helping to prevent relapse. Campral is typically used in combination with other treatments, such as counseling and behavioral therapy.

If you are considering Campral as a treatment for alcohol dependence, it is important to talk to your doctor about the potential risks and benefits. This medication can cause serious side effects, so it is important to be sure that it is the right choice for you.

Pharmacokinetics

Campral (acamprosate calcium) is rapidly absorbed from the gastrointestinal tract and reaches peak concentrations in about 2 hours. The mean apparent elimination half-life is 48 hours. Campral (acamprosate calcium) is eliminated primarily by renal excretion as unchanged drug; less than 5% of the dose is recovered in the urine as acamprosinic acid, a metabolite. Acamprosate does not bind to plasma proteins and is not metabolized by cytochrome P450 enzymes.

Campral (acamprosate calcium) is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.

The efficacy of Campral (acamprosate calcium) in maintaining abstinence from alcohol has been demonstrated in two placebo-controlled clinical trials of up to 12 months duration in patients who were abstinent at treatment initiation. In both studies, Campral (acamprosate calcium) was superior to placebo in maintaining abstinence from alcohol as measured by the percent days of abstinence and self-reported number of drinking days.

The safety and efficacy of Campral (acamprosate calcium) have not been established in children or adolescents less than 18 years of age.Campral (acamprosate calcium) is contraindicated in pregnant women and women of childbearing potential not using effective contraception. There are no adequate and well-controlled studies of Campral (acamprosate calcium) use in pregnant women.

There are no adequate and well-controlled studies of Campral (acamprosate calcium) in nursing mothers. Because many drugs are excreted in human milk, caution should be exercised when Campral (acamprosate calcium) is administered to a nursing woman.

Side Effects

Some of the possible side effects of Campral include:

  • Dizziness
  • Headache
  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Stomach pain or discomfort
  • Skin rash
  • Weight gain or loss

Campral can also cause more serious side effects, such as:

  • Depression
  • Anxiety
  • Insomnia
  • Agitation
  • Tremors
  • Hallucinations

If you experience any of these side effects, it is important to contact your doctor right away. These side effects may indicate that Campral is not the right medication for you.

Before taking Campral, it is important to tell your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements. Campral can interact with other medications, so it is important that your doctor is aware of everything you are taking.

It is also important to tell your doctor if you have any medical conditions, such as kidney disease or liver disease. Campral may not be safe for people with certain medical conditions.

Dosage and Administration

The recommended dose of Campral (acamprosate calcium) is two 333 mg tablets taken three times daily. The first dose should be taken within the first week after the last drink.

Campral (acamprosate calcium) can be taken with or without food.

If a patient vomits within 30 minutes after taking a dose of Campral (acamprosate calcium), the patient should repeat that dose. If a patient vomits more than 30 minutes after taking a dose, the patient should not repeat the dose but continue with the next scheduled dose.

Patients should be advised to take Campral (acamprosate calcium) for at least 3 to 6 months following abstinence from alcohol to increase the likelihood of maintaining abstinence.

For patients who are unable to take solid oral dosage forms, an aqueous solution of Campral (acamprosate calcium) is available. One milliliter of the solution contains 167 mg of acamprosate monohydrate equivalent to 150 mg of acamprosate calcium. The recommended dose is 20 mL (3 teaspoonsful) taken three times daily after meals.

Overdose

There have been no reports of overdose with Campral (acamprosate calcium). In the event of an overdose, standard supportive measures should be instituted as required. There is no specific antidote for Campral (acamprosate calcium) overdose.

Storage

Campral (acamprosate calcium) tablets should be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° and 30°C (59° and 86°F).

Campral (acamprosate calcium) aqueous solution should be refrigerated at 2° to 8°C (36° to 46°F). Once mixed, the solution can be stored for up to 4 weeks at 2° to 8°C (36° to 46°F) or at room temperature up to 25°C (77°F).