Acamprosate

Name: Acamprosate

Acamprosate Interactions

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with acamprosate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Acamprosate Dosage

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Start taking acamprosate as soon as possible after you have quit drinking.

You may take acamprosate with or without food.

Do not crush, chew, or break a delayed-release tablet. Swallow it whole.

Take this medicine 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.

Use acamprosate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Acamprosate is only part of a complete program of treatment that also includes counseling support and continued abstinence from alcohol.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking acamprosate?

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

Acamprosate will not treat or prevent alcohol withdrawal symptoms.

To make sure acamprosate is safe for you, tell your doctor if you have any type of kidney problem.

You may have thoughts about suicide while taking acamprosate. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether acamprosate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether acamprosate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take acamprosate?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Start taking acamprosate as soon as possible after you have quit drinking.

You may take acamprosate with or without food.

Do not crush, chew, or break a delayed-release tablet. Swallow it whole.

Take this medicine 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.

Use acamprosate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Acamprosate is only part of a complete program of treatment that also includes counseling support and continued abstinence from alcohol.

Store at room temperature away from moisture and heat.

What should I avoid while taking acamprosate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Proper Use of acamprosate

Beginning treatment as soon as possible after the period of alcohol withdrawal, and after you have achieved abstinence.

Using acamprosate as part of a treatment program that includes counseling and support.

Continuing acamprosate therapy, even in the event of a relapse.

In addition to beverages, alcohol is found in many other products. Reading the list of ingredients on foods and other products before using them will help you to avoid alcohol. Do not use alcohol-containing foods such as sauces and vinegars.

You may take acamprosate with or without food .

Dosing

The dose of acamprosate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of acamprosate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • To help overcome drinking problems:
      • Adults—Two tablets (666 mg per dose) taken three times daily.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of acamprosate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Why is this medication prescribed?

Acamprosate 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. Drinking alcohol for a long time changes the way the brain works. Acamprosate works by helping the brains of people who have drunk large amounts of alcohol to work normally again. Acamprosate does not prevent the withdrawal symptoms that people may experience when they stop drinking alcohol. Acamprosate has not been shown to work in people who have not stopped drinking alcohol or in people who drink large amounts of alcohol and also overuse or abuse other substances such as street drugs or prescription medications.

What are some other side effects of Acamprosate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Feeling tired or weak.
  • Not hungry.
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take acamprosate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to acamprosate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Acamprosate Dosage and Administration

The recommended dose of Acamprosate calcium delayed-release tablets is two 333 mg tablets (each dose should total 666 mg) taken three times daily. A lower dose may be effective in some patients.

Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested in those patients who regularly eat three meals daily.

Treatment with Acamprosate calcium delayed-release tablets should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. Acamprosate calcium delayed-release tablets should be used as part of a comprehensive psychosocial treatment program.

Dosage in Renal Impairment

For patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Contraindications (4.2), Warnings and Precautions (5.1), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinically significant serious adverse reactions associated with Acamprosate calcium described elsewhere in labeling include suicidality and depression and acute kidney failure [see Warnings and Precautions (5.2),and Adverse Reactions (6.2)].

The adverse event data described below reflect the safety experience in over 7000 patients exposed to Acamprosate calcium for up to one year, including over 2000 Acamprosate calcium-exposed patients who participated in placebo-controlled trials.

Adverse Events Leading to Discontinuation

In placebo-controlled trials of 6 months or less, 8% of Acamprosate calcium-treated patients discontinued treatment due to an adverse event, as compared to 6% of patients treated with placebo. In studies longer than 6 months, the discontinuation rate due to adverse events was 7% in both the placebo-treated and the Acamprosate calcium-treated patients. Only diarrhea was associated with the discontinuation of more than 1% of patients (2% of Acamprosate calcium-treated vs. 0.7% of placebo-treated patients). Other events, including nausea, depression, and anxiety, while accounting for discontinuation in less than 1% of patients, were nevertheless more commonly cited in association with discontinuation in Acamprosate calcium-treated patients than in placebo-treated patients.

Common Adverse Events Reported in Controlled Trials

Common adverse events were collected spontaneously in some controlled studies and using a checklist in other studies. The overall profile of adverse events was similar using either method. Table 1 shows those events that occurred in any Acamprosate calcium treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events. The reported frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed, without regard to the causal relationship of the events to the drug.

Table 1. Events Occurring at a Rate of at Least 3% and Greater than Placebo in any Acamprosate Calcium Treatment Group in Controlled Clinical Trials with Spontaneously Reported Adverse Events.
* includes 258 patients treated with Acamprosate calcium 2000 mg/day, using a different dosage strength and regimen. † includes all patients in the first two columns as well as 83 patients treated with Acamprosate calcium 3000 mg/day, using a different dosage strength and regimen. ‡ includes events coded as “fracture” by sponsor; § includes events coded as “nervousness” by sponsor
Body System/ Preferred Term

Number of Patients (%) with Events

Acamprosate Calcium
1332 mg/day
Acamprosate Calcium
1998 mg/day*
Acamprosate Calcium
Pooled†
Placebo
Number of patients in
Treatment Group
397
1539
2019
1706
Number (%) of patients with an AE
248 (62%)
910 (59%)
1231 (61%)
955 (56%)
Body as a Whole
121 (30%)
513 (33%)
685 (34%)
517 (30%)
Accidental Injury‡
17 (4%)
44 (3%)
70 (3%)
52 (3%)
Asthenia
29 (7%)
79 (5%)
114 (6%)
93 (5%)
Pain
6 (2%)
56 (4%)
65 (3%)
55 (3%)
Digestive System
85 (21%)
440 (29%)
574 (28%)
344 (20%)
Anorexia
20 (5%)
35 (2%)
57 (3%)
44 (3%)
Diarrhea
39 (10%)
257 (17%)
329 (16%)
166 (10%)
Flatulence
4 (1%)
55 (4%)
63 (3%)
28 (2%)
Nausea
11 (3%)
69 (4%)
87 (4%)
58 (3%)
Nervous System
150 (38%)
417 (27%)
598 (30%)
500 (29%)
Anxiety§
32 (8%)
80 (5%)
118 (6%)
98 (6%)
Depression
33 (8%)
63 (4%)
102 (5%)
87 (5%)
Dizziness
15 (4%)
49 (3%)
67 (3%)
44 (3%)
Dry mouth
13 (3%)
23 (1%)
36 (2%)
28 (2%)
Insomnia
34 (9%)
94 (6%)
137 (7%)
121 (7%)
Paresthesia
11 (3%)
29 (2%)
40 (2%)
34 (2%)
Skin and Appendages
26 (7%)
150 (10%)
187 (9%)
169 (10%)
Pruritus
12 (3%)
68 (4%)
82 (4%)
58 (3%)
Sweating
11 (3%)
27 (2%)
40 (2%)
39 (2%)
Concomitant Therapies

In clinical trials, the safety profile in subjects treated with Acamprosate calcium concomitantly with anxiolytics, hypnotics and sedatives (including benzodiazepines), or non-opioid analgesics was similar to that of subjects taking placebo with these concomitant medications. Patients taking Acamprosate calcium concomitantly with antidepressants more commonly reported both weight gain and weight loss, compared with patients taking either medication alone.

Other Events Observed During the Premarketing Evaluation of Acamprosate Calcium

Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with Acamprosate calcium in 20 clinical trials (4461 patients treated with Acamprosate calcium, 3526 of whom received the maximum recommended dose of 1998 mg/day for up to one year in duration). This listing does not include those events already listed above; events for which a drug cause was considered remote; event terms which were so general as to be uninformative; and events reported only once which were not likely to be acutely life-threatening.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the summary of adverse events in controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole – Frequent: headache, abdominal pain, back pain, infection, flu syndrome, chest pain, chills, suicide attempt; Infrequent: fever, intentional overdose, malaise, allergic reaction, abscess, neck pain, hernia, intentional injury; Rare: ascites, face edema, photosensitivity reaction, abdomen enlarged, sudden death.

Cardiovascular System – Frequent: palpitation, syncope; Infrequent: hypotension, tachycardia, hemorrhage, angina pectoris, migraine, varicose vein, myocardial infarct, phlebitis, postural hypotension; Rare: heart failure, mesenteric arterial occlusion, cardiomyopathy, deep thrombophlebitis, shock.

Digestive System – Frequent: vomiting, dyspepsia, constipation, increased appetite; Infrequent: liver function tests abnormal, gastroenteritis, gastritis, dysphagia, eructation, gastrointestinal hemorrhage, pancreatitis, rectal hemorrhage, liver cirrhosis, esophagitis, hematemesis, nausea and vomiting, hepatitis; Rare: melena, stomach ulcer, cholecystitis, colitis, duodenal ulcer, mouth ulceration, carcinoma of liver.

Endocrine System – Rare: goiter, hypothyroidism.

Hemic and Lymphatic System – Infrequent: anemia, ecchymosis, eosinophilia, lymphocytosis, thrombocytopenia; Rare: leukopenia, lymphadenopathy, monocytosis.

Metabolic and Nutritional Disorders – Frequent – peripheral edema, weight gain; Infrequent: weight loss, hyperglycemia, SGOT increased, SGPT increased, gout, thirst, hyperuricemia, diabetes mellitus, avitaminosis, bilirubinemia; Rare: alkaline phosphatase increased, creatinine increased, hyponatremia, lactic dehydrogenase increased.

Musculoskeletal System – Frequent – myalgia, arthralgia; Infrequent: leg cramps; Rare: rheumatoid arthritis, myopathy.

Nervous System – Frequent –somnolence, libido decreased, amnesia, thinking abnormal, tremor, vasodilatation, hypertension; Infrequent: convulsion, confusion, libido increased, vertigo, withdrawal syndrome, apathy, suicidal ideation, neuralgia, hostility, agitation, neurosis, abnormal dreams, hallucinations, hypesthesia; Rare: alcohol craving, psychosis, hyperkinesia, twitching, depersonalization, increased salivation, paranoid reaction, torticollis, encephalopathy, manic reaction.

Respiratory System – Frequent: rhinitis, cough increased, dyspnea, pharyngitis, bronchitis; Infrequent: asthma, epistaxis, pneumonia; Rare: laryngismus, pulmonary embolus.

Skin and Appendages – Frequent: rash; Infrequent: acne, eczema, alopecia, maculopapular rash, dry skin, urticaria, exfoliative dermatitis, vesiculobullous rash; Rare: psoriasis.

Special Senses – Frequent: abnormal vision, taste perversion; Infrequent: tinnitus, amblyopia, deafness; Rare: ophthalmitis, diplopia, photophobia.

Urogenital System – Frequent: impotence; Infrequent – metrorrhagia, urinary frequency, urinary tract infection, sexual function abnormal, urinary incontinence, vaginitis; Rare: kidney calculus, abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria, urinary urgency.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Acamprosate calcium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serious Adverse Events Observed During the Non-US Postmarketing Evaluation of Acamprosate Calcium

The serious adverse event of acute kidney failure has been reported to be temporally associated with Acamprosate calcium treatment in at least 3 patients and is not described elsewhere in the labeling.

Pronunciation

(a kam PROE sate)

Special Populations Renal Function Impairment

Cmax in patients with moderate or severe renal impairment were 2- and 4-fold higher, respectively.

Adverse Reactions

Many adverse effects associated with treatment may be related to alcohol abstinence; reported frequency range may overlap with placebo.

>10%: Gastrointestinal: Diarrhea (10% to 17%)

1% to 10%:

Cardiovascular: Chest pain, hypertension, palpitations, peripheral edema, syncope, vasodilatation

Central nervous system: Insomnia (6% to 9%), anxiety (5% to 8%), depression (4% to 8%), dizziness (3% to 4%), pain (2% to 4%), paresthesia (2% to 3%), abnormality in thinking, amnesia, attempted suicide, chills, drowsiness, headache

Dermatologic: Pruritus (3% to 4%), diaphoresis (2% to 3%), skin rash

Endocrine & metabolic: Decreased libido, weight gain

Gastrointestinal: Anorexia (2% to 5%), nausea (3% to 4%), flatulence (1% to 4%), xerostomia (1% to 3%), abdominal pain, constipation, dysgeusia, dyspepsia, increased appetite, vomiting

Genitourinary: Impotence

Infection: Infection

Neuromuscular & skeletal: Weakness (5% to 7%), arthralgia, back pain, myalgia, tremor

Ophthalmic: Visual disturbance

Respiratory: Bronchitis, dyspnea, flu-like symptoms, increased cough, pharyngitis, rhinitis

<1% (Limited to important or life-threatening): Abnormal hepatic function tests, agitation, alopecia, anemia, angina pectoris, asthma, brain disease, colitis, confusion, deafness, diabetes mellitus, duodenal ulcer, eosinophilia, epistaxis, exfoliative dermatitis, fever, gastrointestinal hemorrhage, gout, hallucination, hemorrhage, hepatic cirrhosis, hepatitis, hostility, hyperbilirubinemia, hyperesthesia, hyperglycemia, hypersensitivity reaction, hyperuricemia, hyponatremia, hypotension, hypothyroidism, increased serum creatinine, increased serum transaminases, leukopenia, lymphadenopathy, lymphocytosis, myocardial infarction, nephrolithiasis, neuralgia, ophthalmic inflammation, orthostatic hypotension, pancreatitis, pneumonia, psychoneurosis, psychosis, pulmonary embolism, rectal hemorrhage, renal failure, seizure, skin photosensitivity, suicidal ideation, tachycardia, thrombocytopenia, urticaria, withdrawal syndrome

Pregnancy Risk Factor C Pregnancy Considerations

Adverse events were observed in animal reproduction studies.

Acamprosate Overview

Acamprosate is a prescription medication used to help maintain abstinence from alcohol. It is used along with behavior modification and counseling in people who have recently quit drinking alcohol. While the exact way it works is unknown, it is believed to work by restoring the balance of certain brain chemicals in long-term alcohol abusers.

Acamprosate comes as a delayed-release tablet. It is usually taken 3 times daily, with or without food.

Common side effects include diarrhea, gas, and upset stomach.

Acamprosate may affect your thinking, ability to make decisions, and coordination. Do not drive a car or operate machinery until you know how this medication affects you.

Other Requirements

  • Store acamprosate at 25ºC (77ºF).
  • Keep this and all medicines out of the reach of children.

Usual Pediatric Dose for Alcohol Dependence

There are no data on the safety and efficacy of acamprosate in this population.

Dialysis

Acamprosate is contraindicated in patients with severe renal dysfunction (creatinine clearance equal to or less than 30 mL/min).

Acamprosate Pregnancy Warnings

Studies have shown acamprosate to be teratogenic in rats when administered in doses equivalent to human doses, and in rabbits when administered in doses equivalent to three times the human dose.

Acamprosate has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of genotoxicity, but have revealed possible cases of teratogenicity. However, it is difficult to ascertain if these cases were a result of acamprosate therapy or ethyl alcohol ingestion. Animal studies have also shown an increased incidence of still-born fetuses. There are no controlled data in human pregnancy. The manufacturer recommends acamprosate be used during pregnancy only when the potential benefits outweigh the potential risks to the fetus.

(web3)