Data from FDA - Curated by EPG Health - Last updated 30 August 2017

Indication(s)

1 INDICATIONS AND USAGE Campral® is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Campral should be part of a comprehensive management program that includes psychosocial support. The efficacy of Campral in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Campral treatment. The efficacy of Campral in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. Campral® is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( , ). 1 14 Treatment with Campral should be part of a comprehensive management program that includes psychosocial support ( ). 1

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Advisory information

contraindications
4 CONTRAINDICATIONS Campral is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components ( ). 4.1 Campral is contraindicated in patients with severe renal impairment ( ). 4.2 4.1 Hypersensitivity to Acamprosate Calcium Campral is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components. 4.2 Severe Renal Impairment Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [ and ]. see Dosage and Administration ( ), Warnings and Precautions ( ), Use in Specific Populations ( ), 2.1 5.1 8.6 Clinical Pharmacology ( ) 12.3
Adverse reactions
6 ADVERSE REACTIONS Common adverse events that occurred in any Campral treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events are: accidental injury, asthenia, pain, anorexia, diarrhea, flatulence, nausea, anxiety, depression, dizziness, dry mouth, insomnia, paresthesia, pruritus and sweating ( ). 6.1 . To report SUSPECTED ADVERSE REACTIONS, contact Forest Laboratories, Inc. at 1-800-678-1605, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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 Campral described elsewhere in labeling include suicidality and depression and acute kidney failure [s , and ]. ee Warnings and Precautions ( ) 5.2 Adverse Reactions ( ) 6.2 The adverse event data described below reflect the safety experience in over 7000 patients exposed to Campral for up to one year, including over 2000 Campral-exposed patients who participated in placebo-controlled trials. Adverse Events Leading to Discontinuation In placebo-controlled trials of 6 months or less, 8% of Campral-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 Campral-treated patients. Only diarrhea was associated with the discontinuation of more than 1% of patients (2% of Campral-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 Campral-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. shows those events that occurred in any Campral 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 Table 1. Events Occurring at a Rate of at Least 3% and Greater than Placebo in any Campral Treatment Group in Controlled Clinical Trials with Spontaneously Reported Adverse Events. Body System/Preferred Term Number of Patients (%) with Events Campral 1332 mg/day Campral 1998 mg/day 1 Campral Pooled 2 Placebo †*includes events coded as “fracture” by sponsor; ††**includes events coded as “nervousness” by sponsor includes 258 patients treated with acamprosate calcium 2000 mg/day, using a different dosage strength and regimen. 1 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. 2 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 Campral 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 Campral 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 Campral Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with Campral in 20 clinical trials (4461 patients treated with Campral, 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. : headache, abdominal pain, back pain, infection, flu syndrome, chest pain, chills, suicide attempt; : fever, intentional overdose, malaise, allergic reaction, abscess, neck pain, hernia, intentional injury; : ascites, face edema, photosensitivity reaction, abdomen enlarged, sudden death. Body as a Whole – Frequent Infrequent Rare : palpitation, syncope; : hypotension, tachycardia, hemorrhage, angina pectoris, migraine, varicose vein, myocardial infarct, phlebitis, postural hypotension; : heart failure, mesenteric arterial occlusion, cardiomyopathy, deep thrombophlebitis, shock. Cardiovascular System – Frequent Infrequent Rare : vomiting, dyspepsia, constipation, increased appetite; : liver function tests abnormal, gastroenteritis, gastritis, dysphagia, eructation, gastrointestinal hemorrhage, pancreatitis, rectal hemorrhage, liver cirrhosis, esophagitis, hematemesis, nausea and vomiting, hepatitis; melena, stomach ulcer, cholecystitis, colitis, duodenal ulcer, mouth ulceration, carcinoma of liver. Digestive System – Frequent Infrequent Rare: goiter, hypothyroidism. Endocrine System – Rare: : anemia, ecchymosis, eosinophilia, lymphocytosis, thrombocytopenia; leukopenia, lymphadenopathy, monocytosis. Hemic and Lymphatic System – Infrequent Rare: – peripheral edema, weight gain; : weight loss, hyperglycemia, SGOT increased, SGPT increased, gout, thirst, hyperuricemia, diabetes mellitus, avitaminosis, bilirubinemia; alkaline phosphatase increased, creatinine increased, hyponatremia, lactic dehydrogenase increased. Metabolic and Nutritional Disorders – Frequent Infrequent Rare: – myalgia, arthralgia; : leg cramps; rheumatoid arthritis, myopathy. Musculoskeletal System – Frequent Infrequent Rare: –somnolence, libido decreased, amnesia, thinking abnormal, tremor, vasodilatation, hypertension; : convulsion, confusion, libido increased, vertigo, withdrawal syndrome, apathy, suicidal ideation, neuralgia, hostility, agitation, neurosis, abnormal dreams, hallucinations, hypesthesia; : alcohol craving, psychosis, hyperkinesia, twitching, depersonalization, increased salivation, paranoid reaction, torticollis, encephalopathy, manic reaction. Nervous System – Frequent Infrequent Rare : rhinitis, cough increased, dyspnea, pharyngitis, bronchitis; : asthma, epistaxis, pneumonia; laryngismus, pulmonary embolus. Respiratory System – Frequent Infrequent Rare: : rash; : acne, eczema, alopecia, maculopapular rash, dry skin, urticaria, exfoliative dermatitis, vesiculobullous rash; psoriasis. Skin and Appendages – Frequent Infrequent Rare: : abnormal vision, taste perversion; : tinnitus, amblyopia, deafness; ophthalmitis, diplopia, photophobia. Special Senses – Frequent Infrequent Rare: : impotence; – metrorrhagia, urinary frequency, urinary tract infection, sexual function abnormal, urinary incontinence, vaginitis; kidney calculus, abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria, urinary urgency. Urogenital System – Frequent Infrequent Rare: 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of Campral. 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 Campral (acamprosate calcium) The serious adverse event of acute kidney failure has been reported to be temporally associated with Campral treatment in at least 3 patients and is not described elsewhere in the labeling.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended dose of Campral 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 Campral 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. Campral should be used as part of a comprehensive psychosocial treatment program. Recommended dose: 666 mg (two 333 mg tablets) taken three times daily ( ). 2 Dose reduction to one 333 mg tablet taken three times daily for patients with moderate renal impairment (creatinine clearance 30-50 mL/min) ( ). 2.1 Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) ( , , , , ). 2.1 4.2 5.1 8.6 12.3 2.1 Dosage in Renal Impairment For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [ and ]. see Contraindications ( ), Warnings and Precautions ( ), Use in Specific Populations ( ), 4.2 5.1 8.6 Clinical Pharmacology ( ) 12.3
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pregnancy: Campral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus ( ). 8.1 Nursing Mothers: Caution should be exercised when Campral is administered to a nursing woman ( ). 8.3 Renal Impairment: Dose reduction required for moderate renal impairment; contraindicated in severe renal impairment ( , , , , ) 2.1 4.2 5.1 8.6 12.3 8.1 Pregnancy Pregnancy Category C Acamprosate calcium has been shown to be teratogenic in rats when given in doses that are approximately equal to the human dose (on a mg/m basis) and in rabbits when given in doses that are approximately 3 times the human dose (on a mg/m basis). Acamprosate calcium produced a dose-related increase in the number of fetuses with malformations in rats at oral doses of 300 mg/kg/day or greater (approximately equal to the maximum recommended human daily (MRHD) oral dose on a mg/m basis). The malformations included hydronephrosis, malformed iris, retinal dysplasia, and retroesophageal subclavian artery. No findings were observed at an oral dose of 50 mg/kg/day (approximately one-fifth the MRHD oral dose on a mg/m basis). An increased incidence of hydronephrosis was also noted in Burgundy Tawny rabbits at oral doses of 400 mg/kg/day or greater (approximately 3 times the MRHD oral dose on a mg/m basis). No developmental effects were observed in New Zealand white rabbits at oral doses up to 1000 mg/kg/day (approximately 8 times the MRHD oral dose on a mg/m basis). The findings in animals should be considered in relation to known adverse developmental effects of ethyl alcohol, which include the characteristics of fetal alcohol syndrome (craniofacial dysmorphism, intrauterine and postnatal growth retardation, retarded psychomotor and intellectual development) and milder forms of neurological and behavioral disorders in humans. There are no adequate and well controlled studies in pregnant women. Campral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Teratogenic effects: 2 2 2 2 2 2 A study conducted in pregnant mice that were administered acamprosate calcium by the oral route starting on Day 15 of gestation through the end of lactation on postnatal day 28 demonstrated an increased incidence of still-born fetuses at doses of 960 mg/kg/day or greater (approximately 2 times the MRHD oral dose on a mg/m basis). No effects were observed at a dose of 320 mg/kg/day (approximately one-half the MRHD dose on a mg/m basis). Nonteratogenic effects: 2 2 8.2 Labor and Delivery The potential for Campral to affect the duration of labor and delivery is unknown. 8.3 Nursing Mothers In animal studies, acamprosate was excreted in the milk of lactating rats dosed orally with acamprosate calcium. The concentration of acamprosate in milk compared to blood was 1.3:1. It is not known whether acamprosate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Campral is administered to a nursing woman. 8.4 Pediatric Use The safety and efficacy of Campral have not been established in the pediatric population. 8.5 Geriatric Use Forty-one of the 4234 patients in double-blind, placebo-controlled, clinical trials of Campral were 65 years of age or older, while none were 75 years of age or over. There were too few patients in the ≥65 age group to evaluate any differences in safety or effectiveness for geriatric patients compared to younger patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function and ]. [see Clinical Pharmacology ( ), Adverse Reactions ( ), 12.3 6.1 Dosage and Administration ( ) 2.1 8.6 Renal Impairment Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [s and ]. ee Dosage and Administration ( ), Contraindications ( ), Warnings and Precautions ( ), 2.1 4.2 5.1 Clinical Pharmacology ( ) 12.3
Pregnancy and lactation
8.3 Nursing Mothers In animal studies, acamprosate was excreted in the milk of lactating rats dosed orally with acamprosate calcium. The concentration of acamprosate in milk compared to blood was 1.3:1. It is not known whether acamprosate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Campral is administered to a nursing woman.

Interactions

7 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

More information

Category Value
Authorisation number NDA021431
Agency product number 59375N1D0U
Orphan designation No
Product NDC 68151-4760
Date Last Revised 06-08-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 835726
Storage and handling Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).
Marketing authorisation holder Carilion Materials Management