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acamprosate calcium

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acamprosate calcium

Campral

Pharmacologic class: Gamma-aminobutyric acid (GABA) analogue

Therapeutic class: Detoxification agent

Pregnancy risk category C

Action

Unclear. May interact with glutamate and GABA neurotransmitter systems centrally, restoring balance between neuronal excitation and inhibition (which is altered by chronic alcoholism).

Availability

Tablets (enteric-coated): 333 mg

Indications and dosages

To maintain abstinence from alcohol in patients with alcohol dependence who are abstinent when treatment begins

Adults: 2 tablets P.O. t.i.d.

Dosage adjustment

• Moderate renal impairment

Contraindications

• Hypersensitivity to drug
• Severe renal impairment

Precautions

Use cautiously in:
• mild to moderate renal impairment
• suicidal ideation or behavior
• elderly patients
• breastfeeding patients
• children.

Administration

• Give without regard to meals.
• Don't crush or break enteric-coated tablet.
• Know that drug helps maintain alcohol abstinence only when used as part of treatment program that includes counseling and support.

RouteOnsetPeakDuration
P.O.Unknown3-8 hrUnknown

Adverse reactions

CNS: apathy, confusion, agitation, neurosis, malaise, somnolence, abnormal thinking, vertigo, asthenia, anxiety, depression, dizziness, insomnia, paresthesia, tremor, withdrawal syndrome headache, migraine, abnormal dreams, hallucinations, seizures, suicidal ideation or suicide attempt

CV: chest pain, palpitations, syncope, hypotension, angina pectoris, varicose veins, phlebitis, peripheral edema, orthostatic hypotension, vasodilation, tachycardia, hypertension, myocardial infarction

EENT: abnormal vision, amblyopia, hearing loss, tinnitus, rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, belching, gastroenteritis, gastritis, esophagitis, hematemesis, dry mouth, anorexia, pancreatitis, rectal hemorrhage, GI hemorrhage

GU: urinary frequency, urinary tract infection, urinary incontinence, erectile dysfunction, increased or decreased libido, metrorrhagia, vaginitis

Hematologic: anemia, ecchymosis, eosinophilia, lymphocytosis, thrombocytopenia

Hepatic: hepatic cirrhosis

Metabolic: hyperglycemia, diabetes mellitus, hyperuricemia, gout, avitaminosis

Musculoskeletal: joint, muscle, neck, or back pain

Respiratory: cough, dyspnea, bronchitis, epistaxis, pneumonia, asthma

Skin: pruritus, sweating

Other: abnormal taste, increased thirst, increased appetite, weight gain or loss, pain, infection, flulike symptoms, chills, abscess, hernia, allergic reaction, accidental or intentional injury, intentional overdose

Interactions

Drug-drug. Naltrexone: increased acamprosate blood level

Drug-diagnostic tests. Bilirubin, eosinophils, lymphocytes: increased levels

Liver function tests: abnormal results

Red blood cells: decreased count

Patient monitoring

Monitor patient for depression or expressed suicidal ideation.
• Monitor creatinine clearance during therapy.

Patient teaching

• Instruct patient to swallow tablet whole, with or without food.
• Advise patient to keep taking drug exactly as prescribed, even if he has a relapse. Encourage him to discuss any renewed alcohol consumption with prescriber.
Instruct patient to contact prescriber immediately if he experiences seizure, chest pain, suicidal thoughts, or symptoms of liver problems (such as unusual tiredness or yellowing of skin or eyes).
• Caution patient to move slowly to a sitting or standing position, to avoid dizziness or light-headedness from a sudden blood pressure decrease.
• Advise patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, vision, coordination, and physical dexterity.
• Instruct female patient to notify prescriber if she becomes or intends to become pregnant or to breastfeed during therapy.
• Inform patient that drug helps maintain abstinence from alcohol only when used as part of treatment program that includes counseling and support.
• Emphasize that drug doesn't eliminate or diminish alcohol withdrawal symptoms.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.



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The 2004 approval and 2005 market introduction of acamprosate calcium (Forest Laboratories Campral) for treatment of alcohol dependence and the 2002 introduction of buprenorphine and buprenorphone/naloxone (Reckitt Benckisers Subutex and Suboxone, respectively) for treatment of opioid dependence are representative of changes occurring in the market for drug and alcohol addiction.
The 2004 approval and 2005 market introduction of acamprosate calcium (Forest Laboratories Campral) for treatment of alcohol dependence and the 2002 introduction of buprenorphine and buprenorphone/naloxone (Reckitt Benckisers Subutex and Suboxone, respectively) for treatment of opioid dependence are representative of changes occurring in the market for drug and alcohol addiction.
The company is also developing a new formulation of acamprosate calcium for the treatment of movement disorders.
 
 
 
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