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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 27.04.2022
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Campral 333mg calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Campral 333mg calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support.
The efficacy of Campral 333mg calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Campral 333mg calcium delayed-release tablets treatment. The efficacy of Campral 333mg calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.
Campral 333mg (Campral 333mg) affects chemicals in the brain that may be unbalanced in a person who is addicted to alcohol. Campral 333mg works by restoring this chemical balance in the brain in an alcohol-dependent person who has recently quit drinking.
Campral 333mg is used together with behavior modification and counseling support to help a person who has recently quit drinking alcohol continue to choose not to drink.
Campral 333mg is not likely to be helpful if you have not already quit drinking or undergone detoxification. It may not help you if you are also addicted to other substances besides alcohol.
Campral 333mg may also be used for purposes not listed in this medication guide.
Usual Adult Dose for Alcohol Dependence
666 mg orally three times a day
Usual Geriatric Dose for Alcohol Dependence
666 mg orally three times a day
Since geriatric patients may be more prone to a decrease in renal function, the manufacturer advises greater care in dose selection and close monitoring of renal function during therapy in this population.
Usual Pediatric Dose for Alcohol Dependence
There are no data on the safety and efficacy of Campral 333mg in this population.
Renal Dose Adjustments
In patients with moderate renal dysfunction (creatinine clearance 30 to 50 mL/min) an initial dose of 333 mg three times daily is recommended by the manufacturer.
Campral 333mg is contraindicated in patients with severe renal dysfunction (creatinine clearance equal to or less than 30 mL/min).
Liver Dose Adjustments
Campral 333mg is not metabolized by the liver and the pharmacokinetics of Campral 333mg are not altered in patients with mild to moderate hepatic impairment (groups A and B of the Child-Pugh classification). No adjustment of dosage is recommended in such patients.
Campral 333mg is contraindicated in patients with severe hepatic impairment (Child-Pugh C).
Precautions
Campral 333mg is contraindicated in patients with a creatinine clearance equal to or less than 30 mL/min.
Campral 333mg therapy has not been reported to eliminate or diminish alcohol withdrawal symptoms.
Campral 333mg has not been reported to cause a disulfiram type reaction as a result of ethanol ingestion.
There are no data on Campral 333mg causing alcohol aversion.
Campral 333mg may impair the mental abilities necessary for potentially hazardous tasks such as driving or operating machinery.
Campral 333mg should only be used in conjunction with a treatment program that includes counseling and support.
Patients undergoing treatment for alcohol dependence, whether they are taking Campral 333mg or not, should be monitored for the emergence of symptoms of depression and/or suicidal behavior. Families and caregivers of patients being treated with Campral 333mg should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient's physician.
The concomitant intake of alcohol and Campral 333mg does not affect the pharmacokinetics of either alcohol or Campral 333mg.
Safety and efficacy have not been established in pediatric patients (less than 18 years of age).
Dialysis
Campral 333mg is contraindicated in patients with severe renal dysfunction (creatinine clearance equal to or less than 30 mL/min).
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What is the most important information I should know about Campral 333mg?
You should not use this medication if you are allergic to Campral 333mg, or if you have severe kidney disease.
Campral 333mg will not treat or prevent alcohol withdrawal symptoms.
Before you take Campral 333mg, tell your doctor if you have any type of kidney problem. You may need a dose adjustment or special tests to safely use this medication.
You may have thoughts about suicide while you are taking Campral 333mg. Tell your doctor if you feel depressed or have any suicidal thoughts or actions during treatment.
Your family or other caregivers should also be alert to changes in your mood or behavior. Make sure your caregivers know how to contact your doctor in case you have mood changes or suicidal thoughts or actions.
Campral 333mg can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Take this medication for the full prescribed length of time, even if you relapse and drink alcohol. While you are taking Campral 333mg, tell your doctor about any alcoholic drinks you consume, no matter how many.
Use Campral 333mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Campral 333mg may be taken with or without food.
- Swallow whole. Do not break, crush, or chew before swallowing.
- Continue to take Campral 333mg even if you feel well. Do not miss any doses.
- If you miss a dose of Campral 333mg, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Campral 333mg.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This medication is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Campral 333mg works by restoring the natural balance of chemicals in the brain (neurotransmitters).
Before starting this medication, you should no longer be drinking alcohol. Campral 333mg has not been shown to work well if you are still drinking alcohol when you start taking it.
How to use Campral 333mg
Read the Patient Information Leaflet if available from your pharmacist before you start taking Campral 333mg and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually three times a day. Swallow the tablets whole. Do not crush or chew the tablets.
The dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
If you begin drinking alcohol again, continue to take this medication and tell your doctor promptly.
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What other drugs will affect Campral 333mg?
The concomitant intake of alcohol and Campral 333mg does not affect the pharmacokinetics of either alcohol or Campral 333mg.
Pharmacokinetic studies indicate that administration of disulfiram or diazepam does not affect the pharmacokinetics of Campral 333mg. Co-administration of naltrexone with Campral 333mg produced a 25% increase in AUC and a 33% increase in the Cmax of Campral 333mg. No adjustment of dosage is recommended in such patients.
The pharmacokinetics of naltrexone and its major metabolite 6-beta-naltrexol were unaffected following co-administration with Campral 333mg.
Other concomitant therapies: In clinical trials, the safety profile in subjects treated with Campral 333mg 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 333mg concomitantly with antidepressants more commonly reported both weight gain and weight loss, compared with patients taking either medication alone.
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What are the possible side effects of Campral 333mg?
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 333mg described elsewhere in labeling include suicidality and depression and acute kidney failure
The adverse event data described below reflect the safety experience in over 7000 patients exposed to Campral 333mg for up to one year, including over 2000 Campral 333mg-exposed patients who participated in placebocontrolled trials.
Adverse Events Leading To Discontinuation
In placebo-controlled trials of 6 months or less, 8% of Campral 333mg-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 333mg-treated patients. Only diarrhea was associated with the discontinuation of more than 1% of patients (2% of Campral 333mg-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 333mg-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 333mg 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 Campral 333mg Treatment Group in Controlled Clinical Trials with Spontaneously Reported Adverse Events
Body System/ Preferred Term | Number of Patients (%) with Events | |
Campral 333mg 1332 mg/day | Campral 333mg 1998 mg/day |
Concomitant Therapies
In clinical trials, the safety profile in subjects treated with Campral 333mg 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 333mg 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 333mg
Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with Campral 333mg in 20 clinical trials (4461 patients treated with Campral 333mg, 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 Campral 333mg. 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 333mg (acampros ate calcium)
The serious adverse event of acute kidney failure has been reported to be temporally associated with Campral 333mg treatment in at least 3 patients and is not described elsewhere in the labeling.
Campral 333mg, also known by the brand name Campral 333mg™, is a drug used for treating alcohol dependence. Campral 333mg is thought to stabilize the chemical balance in the brain that would otherwise be disrupted by alcoholism, possibly by blocking glutaminergic N-methyl-D-aspartate receptors, while gamma-aminobutyric acid type A receptors are activated. Reports indicate that Campral 333mg only works with a combination of attending support groups and abstinence from alcohol. Certain serious side effects include allergic reactions, irregular heartbeats, and low or high blood pressure, while less serious side effects include headaches, insomnia, and impotence. Campral 333mg should not be taken by people with kidney problems or allergies to the drug.
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