acamprosate calcium

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.

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.

acamprosate calcium

(a-cam-pro-sate) ,

Campral

(trade name)

Classification

Therapeutic: alcohol abuse therapy adjuncts
Pharmacologic: gamma aminobutyric acid gaba analogues
Pregnancy Category: C

Indications

Maintenance of alcohol abstinence; part of a comprehensive alcohol abstinence program.

Action

Interacts with and restores balance to CNS glutamate and GABA neurotransmitter systems.

Therapeutic effects

Continued alcohol abstinence.

Pharmacokinetics

Absorption: 11% absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: Not metabolized, excreted mainly unchanged in urine.
Half-life: 20–33 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POunknown3–8 hrunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; CCr ≤30 mL/min.
Use Cautiously in: CCr 30–50 mL/min (dose ↓ necessary); History of depression or suicide attempt; Obstetric: Use only if potential maternal benefit outweighs fetal risk; Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • abnormal thinking
  • anxiety
  • depression
  • drowsiness
  • headache

Ear, Eye, Nose, Throat

  • abnormal vision

Respiratory

  • cough
  • dyspnea
  • pharyngitis
  • rhinitis

Cardiovascular

  • palpitations
  • peripheral edema
  • syncope
  • vasodilation

Gastrointestinal

  • abdominal pain
  • anorexia
  • constipation
  • diarrhea
  • flatulence
  • ↑ appetite
  • nausea
  • taste perversion
  • vomiting

Genitourinary

  • ↓ libido
  • erectile dysfunction

Dermatologic

  • rash

Metabolic

  • weight gain

Musculoskeletal

  • arthralgia
  • back pain
  • mylagia

Neurologic

  • tremor

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Oral (Adults) Two 333-mg tablets (666 mg/dose) 3 times daily. Lower doses may be effective in some patients.

Renal Impairment

Oral (Adults) CCr 30–50 mL/min—One 333-mg tablet 3 times daily.

Availability (generic available)

Tablets: 333 mg

Nursing implications

Nursing assessment

  • Assess for signs of alcohol withdrawal at initiation of therapy. Acamprosate does not eliminate or diminish withdrawal symptoms.
  • Lab Test Considerations: May cause anemia, lymphocytosis, thrombocytopenia, hyperglycemia, abnormal liver function tests, ↑ AST, ↑ ALT, hyperuricemia, and bilirubinemia.

Potential Nursing Diagnoses

Ineffective coping (Indications)

Implementation

  • Treatment with acamprosate should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be continued if the patient relapses.
  • Oral: Administer without regard to meals. May be given with meals to increase adherence.

Patient/Family Teaching

  • Instruct patient to take medication as directed, even if relapse occurs. Advise patient to discuss any renewed drinking with health care professional.
  • May cause dizziness and changes in vision. Caution patients to avoid driving and other activities requiring alertness until response to medication is known.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding...
  • Encourage patient to continue active counseling and support. Acamprosate helps maintain abstinence only when used as part of a comprehensive psychosocial treatment program.

Evaluation/Desired Outcomes

  • Continued abstinence from alcohol.
Mentioned in ?
References in periodicals archive ?
Drug Profiles mentioned in this report are acamprosate calcium, AM-102, AUT-00063, AUT-3, Drug to Activate KCNQ for Tinnitus, esketamine hydrochloride, gacyclidine SR, latanoprost, neramexane mesylate, SF-0034, Small Molecules for Tinnitus, Small Molecules to Activate Kv7 for Neuropathic Pain, Epilepsy and Tinnitus, Small Molecules To Inhibit TNF-Alpha for Tinnitus, SPI-1005 and SPI-3005.
Acamprosate calcium and nalmefene work by reducing cravings for alcohol.
This funding supports the continued development of SNC-102, a new formulation of acamprosate calcium currently being studied in a Phase 2 trial to treat moderate-to-severe tardive dyskinesia (TD).
FDA) has granted final abbreviated new drug approval (ANDA) to Glenmark Generics Inc, USA for Acamprosate Calcium Delayed Release Tablets, the company's generic version of Forest Laboratories' CampralA Delayed Release Tablets.
The use of acamprosate calcium in the treatment of tardive dyskinesia (TD) was pioneered by Synchroneuron co-founder and inventor, Barry Fogel, MD, a neuropsychiatrist and behavioral neurologist at the Brigham and Women's Hospital and Clinical Professor of Psychiatry at Harvard Medical School.
The first drug, Acamprosate Calcium, accounted for almost 95,000 prescriptions.
Acamprosate calcium has been shown to inhibit glutamate release and is used clinically for the treatment of alcohol relapse, but the current formulation of acamprosate has low oral bioavailability and can cause gastrointestinal (GI) disturbances (emesis and nausea) following administration.
which is the US subsidiary of Glenmark Generics Limited (GGL), has won final abbreviated new drug approval (ANDA) from the US Food and Drug Administration (FDA) for acamprosate calcium delayed release tablets.
Disclosed the discovery of a prodrug of acamprosate that has the potential to decrease gastrointestinal disturbance, reduce dosing frequency and provide more consistent (and potentially higher) blood levels of acamprosate compared with the currently approved formulation of acamprosate calcium.
A recently published open-label study of acamprosate calcium in three adult Fragile X syndrome patients with co-occurring autism spectrum disorder was conducted by Craig A.
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.