Acamprosate

Name: Acamprosate

Uses For acamprosate

Acamprosate is used to help overcome your drinking problem. It is not a cure for alcoholism, but rather will help you maintain abstinence.

acamprosate is available only with your doctor's prescription.

Before Using acamprosate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For acamprosate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to acamprosate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Safety and efficacy in pediatric patients have not been established.

Geriatric

acamprosate has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients are more likely to have age-related kidney disease, which may require adjustment of dosage in patients receiving acamprosate .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of acamprosate. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease (severe)—Acamprosate is not recommended; serious side effects could occur.
  • Depression or
  • Suicidal thinking—Acamprosate may make the condition worse.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Acamprosate?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Dosage Forms and Strengths

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.

Drug Interactions

Acamprosate does not affect the pharmacokinetics of alcohol. The pharmacokinetics of Acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and Acamprosate were not observed [see Clinical Pharmacology (12.3)].

Pharmacology

Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion. Insignificant CNS activity, outside its effect on alcohol dependence, was observed including no anxiolytic, anticonvulsant, or antidepressant activity.

Distribution

Vd: ~1 L/kg

Metabolism

Not metabolized

Excretion

Urine (as unchanged drug)

Time to Peak

Plasma: 3 to 8 hours

Half-Life Elimination

20 to 33 hours

Protein Binding

Negligible

Dosing Renal Impairment

CrCl 30 to 50 mL/minute: Initial dose: 333 mg 3 times daily

CrCl ≤30 mL/minute: Use is contraindicated.

Administration

Oral: May be administered without regard to meals (administered with meals during clinical trials to possibly increase compliance). Tablet should be swallowed whole; do not crush or chew.

Dietary Considerations

Abstinence is required for initiation of treatment; however, treatment should be continued in the event of a relapse.

Monitoring Parameters

Alcohol abstinence; symptoms of depression or suicidal thinking; renal function.

Acamprosate and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Acamprosate falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Usual Adult Dose for Alcohol Dependence

666 mg orally three times a day

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