U.S. BRAND NAMES — Campral®
PHARMACOLOGIC CATEGORY
GABA Agonist/Glutamate Antagonist
DOSING: ADULTS — Alcohol abstinence: Oral: 666 mg 3 times/day (a lower dose may be effective in some patients).
Adjustment in patients with low body weight (unlabeled): A lower dose (4 tablets/day) may be considered in patients with low body weight (eg, <60 kg).
Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT
Clcr 30-50 mL/minute: Initial dose should be reduced to 333 mg 3 times/day.
Clcr <30 mL/minute: Contraindicated in severe renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, enteric coated, delayed release, as calcium:
Campral®: 333 mg [contains calcium 33 mg and sulfites]
DOSAGE FORMS: CONCISE
Tablet, enteric coated, delayed release:
Campral®: 333 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — May be administered without regard to meals. Tablet should be swallowed whole; do not crush or chew.
USE — Maintenance of alcohol abstinence
ADVERSE REACTIONS SIGNIFICANT — Note: 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: Syncope, palpitation, edema (peripheral)
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%), headache, somnolence, amnesia, tremor, chills
Dermatologic: Pruritus (3% to 4%), rash
Endocrine & metabolic: Weight gain, libido decreased
Gastrointestinal: Anorexia (2% to 5%), flatulence (1% to 3%), nausea (3% to 4%), abdominal pain, dry mouth (1% to 3%), vomiting, dyspepsia, constipation, appetite increased, taste perversion
Genitourinary: Impotence
Neuromuscular & skeletal: Weakness (5% to 7%), back pain, myalgia, arthralgia
Ocular: Abnormal vision
Respiratory: Rhinitis, dyspnea, pharyngitis, bronchitis
Miscellaneous: Diaphoresis (2% to 3%), suicide attempt
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Angina, asthma, exfoliative dermatitis, gastrointestinal hemorrhage, hallucinations, hypothyroidism, MI, ophthalmitis, pancreatitis, photosensitivity, psychosis, pulmonary embolus, renal calculus, renal failure, seizure, suicidal ideation, suicide attempts, suicide completion
CONTRAINDICATIONS — Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (Clcr <30 mL/minute)
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Suicidal ideation/attempt: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns: Alcohol dependence: Appropriate use: Should be used as part of a comprehensive program to treat alcohol dependence. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal. Renal impairment: Use with caution in patients with moderate renal impairment (Clcr 30-50 mL/minute).
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Dosage form specific issues: Sulfites: Traces of sulfites may be present in the formulation.
DRUG INTERACTIONS — There are no known significant interactions.
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Abstinence is required during treatment. Ethanol does not affect the pharmacokinetics of acamprosate; however, the continued use of ethanol will decrease desired efficacy of acamprosate.
Food: Food decreases absorption of acamprosate (not clinically significant).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic in animal studies. No adequate or well-controlled studies in pregnant women; use only if potential benefit outweighs possible risk to the fetus.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — May be taken without regard to meals. Each 333 mg tablet contains 33 mg of elemental calcium.
PRICING — (data from drugstore.com)
Tablet, EC (Campral)
333 mg (180): $148.39
Tablet, EC (Campral Dose Pak)
333 mg (180): $159.10
CANADIAN BRAND NAMES — Campral®
INTERNATIONAL BRAND NAMES — Acampral (KP); Aotal (FR); Campral (AR, AT, AU, BE, BG, BR, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HN, IE, IT, MX, NL, NO, PL, PT, RU, SE, TR)
MECHANISM OF ACTION — Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion.
PHARMACODYNAMICS / KINETICS
Distribution: Vd: 1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: 11%
Half-life elimination: 20-33 hours
Excretion: Urine (as unchanged drug)
Showing posts with label Acamprosate. Show all posts
Showing posts with label Acamprosate. Show all posts
Sunday, May 16, 2010
Acamprosate
U.S. BRAND NAMES — Campral®
PHARMACOLOGIC CATEGORY
GABA Agonist/Glutamate Antagonist
DOSING: ADULTS — Alcohol abstinence: Oral: 666 mg 3 times/day (a lower dose may be effective in some patients).
Adjustment in patients with low body weight (unlabeled): A lower dose (4 tablets/day) may be considered in patients with low body weight (eg, <60 kg).
Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT
Clcr 30-50 mL/minute: Initial dose should be reduced to 333 mg 3 times/day.
Clcr <30 mL/minute: Contraindicated in severe renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, enteric coated, delayed release, as calcium:
Campral®: 333 mg [contains calcium 33 mg and sulfites]
DOSAGE FORMS: CONCISE
Tablet, enteric coated, delayed release:
Campral®: 333 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — May be administered without regard to meals. Tablet should be swallowed whole; do not crush or chew.
USE — Maintenance of alcohol abstinence
ADVERSE REACTIONS SIGNIFICANT — Note: 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: Syncope, palpitation, edema (peripheral)
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%), headache, somnolence, amnesia, tremor, chills
Dermatologic: Pruritus (3% to 4%), rash
Endocrine & metabolic: Weight gain, libido decreased
Gastrointestinal: Anorexia (2% to 5%), flatulence (1% to 3%), nausea (3% to 4%), abdominal pain, dry mouth (1% to 3%), vomiting, dyspepsia, constipation, appetite increased, taste perversion
Genitourinary: Impotence
Neuromuscular & skeletal: Weakness (5% to 7%), back pain, myalgia, arthralgia
Ocular: Abnormal vision
Respiratory: Rhinitis, dyspnea, pharyngitis, bronchitis
Miscellaneous: Diaphoresis (2% to 3%), suicide attempt
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Angina, asthma, exfoliative dermatitis, gastrointestinal hemorrhage, hallucinations, hypothyroidism, MI, ophthalmitis, pancreatitis, photosensitivity, psychosis, pulmonary embolus, renal calculus, renal failure, seizure, suicidal ideation, suicide attempts, suicide completion
CONTRAINDICATIONS — Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (Clcr <30 mL/minute)
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Suicidal ideation/attempt: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns: Alcohol dependence: Appropriate use: Should be used as part of a comprehensive program to treat alcohol dependence. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal. Renal impairment: Use with caution in patients with moderate renal impairment (Clcr 30-50 mL/minute).
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Dosage form specific issues: Sulfites: Traces of sulfites may be present in the formulation.
DRUG INTERACTIONS — There are no known significant interactions.
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Abstinence is required during treatment. Ethanol does not affect the pharmacokinetics of acamprosate; however, the continued use of ethanol will decrease desired efficacy of acamprosate.
Food: Food decreases absorption of acamprosate (not clinically significant).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic in animal studies. No adequate or well-controlled studies in pregnant women; use only if potential benefit outweighs possible risk to the fetus.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — May be taken without regard to meals. Each 333 mg tablet contains 33 mg of elemental calcium.
PRICING — (data from drugstore.com)
Tablet, EC (Campral)
333 mg (180): $148.39
Tablet, EC (Campral Dose Pak)
333 mg (180): $159.10
CANADIAN BRAND NAMES — Campral®
INTERNATIONAL BRAND NAMES — Acampral (KP); Aotal (FR); Campral (AR, AT, AU, BE, BG, BR, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HN, IE, IT, MX, NL, NO, PL, PT, RU, SE, TR)
MECHANISM OF ACTION — Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion.
PHARMACODYNAMICS / KINETICS
Distribution: Vd: 1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: 11%
Half-life elimination: 20-33 hours
Excretion: Urine (as unchanged drug)
PHARMACOLOGIC CATEGORY
GABA Agonist/Glutamate Antagonist
DOSING: ADULTS — Alcohol abstinence: Oral: 666 mg 3 times/day (a lower dose may be effective in some patients).
Adjustment in patients with low body weight (unlabeled): A lower dose (4 tablets/day) may be considered in patients with low body weight (eg, <60 kg).
Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT
Clcr 30-50 mL/minute: Initial dose should be reduced to 333 mg 3 times/day.
Clcr <30 mL/minute: Contraindicated in severe renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, enteric coated, delayed release, as calcium:
Campral®: 333 mg [contains calcium 33 mg and sulfites]
DOSAGE FORMS: CONCISE
Tablet, enteric coated, delayed release:
Campral®: 333 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — May be administered without regard to meals. Tablet should be swallowed whole; do not crush or chew.
USE — Maintenance of alcohol abstinence
ADVERSE REACTIONS SIGNIFICANT — Note: 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: Syncope, palpitation, edema (peripheral)
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%), headache, somnolence, amnesia, tremor, chills
Dermatologic: Pruritus (3% to 4%), rash
Endocrine & metabolic: Weight gain, libido decreased
Gastrointestinal: Anorexia (2% to 5%), flatulence (1% to 3%), nausea (3% to 4%), abdominal pain, dry mouth (1% to 3%), vomiting, dyspepsia, constipation, appetite increased, taste perversion
Genitourinary: Impotence
Neuromuscular & skeletal: Weakness (5% to 7%), back pain, myalgia, arthralgia
Ocular: Abnormal vision
Respiratory: Rhinitis, dyspnea, pharyngitis, bronchitis
Miscellaneous: Diaphoresis (2% to 3%), suicide attempt
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Angina, asthma, exfoliative dermatitis, gastrointestinal hemorrhage, hallucinations, hypothyroidism, MI, ophthalmitis, pancreatitis, photosensitivity, psychosis, pulmonary embolus, renal calculus, renal failure, seizure, suicidal ideation, suicide attempts, suicide completion
CONTRAINDICATIONS — Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (Clcr <30 mL/minute)
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Suicidal ideation/attempt: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns: Alcohol dependence: Appropriate use: Should be used as part of a comprehensive program to treat alcohol dependence. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal. Renal impairment: Use with caution in patients with moderate renal impairment (Clcr 30-50 mL/minute).
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Dosage form specific issues: Sulfites: Traces of sulfites may be present in the formulation.
DRUG INTERACTIONS — There are no known significant interactions.
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Abstinence is required during treatment. Ethanol does not affect the pharmacokinetics of acamprosate; however, the continued use of ethanol will decrease desired efficacy of acamprosate.
Food: Food decreases absorption of acamprosate (not clinically significant).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic in animal studies. No adequate or well-controlled studies in pregnant women; use only if potential benefit outweighs possible risk to the fetus.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — May be taken without regard to meals. Each 333 mg tablet contains 33 mg of elemental calcium.
PRICING — (data from drugstore.com)
Tablet, EC (Campral)
333 mg (180): $148.39
Tablet, EC (Campral Dose Pak)
333 mg (180): $159.10
CANADIAN BRAND NAMES — Campral®
INTERNATIONAL BRAND NAMES — Acampral (KP); Aotal (FR); Campral (AR, AT, AU, BE, BG, BR, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HN, IE, IT, MX, NL, NO, PL, PT, RU, SE, TR)
MECHANISM OF ACTION — Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion.
PHARMACODYNAMICS / KINETICS
Distribution: Vd: 1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: 11%
Half-life elimination: 20-33 hours
Excretion: Urine (as unchanged drug)
Friday, February 1, 2008
Acamprosate
U.S. BRAND NAMES — Campral®
PHARMACOLOGIC CATEGORY GABA Agonist/Glutamate Antagonist
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to acamprosate or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you have kidney disease. If you are addicted to drugs or are going through withdrawal.
What is this medicine used for? This medicine is used to maintain an alcohol-free state.
How does it work? Acamprosate blocks the craving for alcohol.
How is it best taken? Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Check medicines with healthcare provider. This medicine may not mix well with other medicines. You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. Tell healthcare provider if you are pregnant or plan on getting pregnant. Tell healthcare provider if you are breast-feeding.
What are some possible side effects of this medicine? Feeling lightheaded, sleepy, having blurred vision, or a change in thinking clearly. Avoid driving, doing other tasks or activities that require you to be alert or have clear vision until you see how this medicine affects you. Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Belly pain. Diarrhea. Nervous and excitable.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Take good care of your teeth. See a dentist regularly. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Signs or symptoms of depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life. Significant change in thinking clearly and logically. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect from moisture. Do not store in a bathroom or kitchen.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
PHARMACOLOGIC CATEGORY GABA Agonist/Glutamate Antagonist
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to acamprosate or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you have kidney disease. If you are addicted to drugs or are going through withdrawal.
What is this medicine used for? This medicine is used to maintain an alcohol-free state.
How does it work? Acamprosate blocks the craving for alcohol.
How is it best taken? Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Check medicines with healthcare provider. This medicine may not mix well with other medicines. You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. Tell healthcare provider if you are pregnant or plan on getting pregnant. Tell healthcare provider if you are breast-feeding.
What are some possible side effects of this medicine? Feeling lightheaded, sleepy, having blurred vision, or a change in thinking clearly. Avoid driving, doing other tasks or activities that require you to be alert or have clear vision until you see how this medicine affects you. Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Belly pain. Diarrhea. Nervous and excitable.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Take good care of your teeth. See a dentist regularly. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Signs or symptoms of depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life. Significant change in thinking clearly and logically. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect from moisture. Do not store in a bathroom or kitchen.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
Acamprosate
U.S. BRAND NAMES — Campral®
PHARMACOLOGIC CATEGORY GABA Agonist/Glutamate Antagonist
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to acamprosate or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you have kidney disease. If you are addicted to drugs or are going through withdrawal.
What is this medicine used for? This medicine is used to maintain an alcohol-free state.
How does it work? Acamprosate blocks the craving for alcohol.
How is it best taken? Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Check medicines with healthcare provider. This medicine may not mix well with other medicines. You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. Tell healthcare provider if you are pregnant or plan on getting pregnant. Tell healthcare provider if you are breast-feeding.
What are some possible side effects of this medicine? Feeling lightheaded, sleepy, having blurred vision, or a change in thinking clearly. Avoid driving, doing other tasks or activities that require you to be alert or have clear vision until you see how this medicine affects you. Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Belly pain. Diarrhea. Nervous and excitable.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Take good care of your teeth. See a dentist regularly. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Signs or symptoms of depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life. Significant change in thinking clearly and logically. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect from moisture. Do not store in a bathroom or kitchen.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
PHARMACOLOGIC CATEGORY GABA Agonist/Glutamate Antagonist
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to acamprosate or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you have kidney disease. If you are addicted to drugs or are going through withdrawal.
What is this medicine used for? This medicine is used to maintain an alcohol-free state.
How does it work? Acamprosate blocks the craving for alcohol.
How is it best taken? Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Check medicines with healthcare provider. This medicine may not mix well with other medicines. You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. Tell healthcare provider if you are pregnant or plan on getting pregnant. Tell healthcare provider if you are breast-feeding.
What are some possible side effects of this medicine? Feeling lightheaded, sleepy, having blurred vision, or a change in thinking clearly. Avoid driving, doing other tasks or activities that require you to be alert or have clear vision until you see how this medicine affects you. Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Belly pain. Diarrhea. Nervous and excitable.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Take good care of your teeth. See a dentist regularly. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Signs or symptoms of depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life. Significant change in thinking clearly and logically. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect from moisture. Do not store in a bathroom or kitchen.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
Wednesday, January 16, 2008
Acamprosate: Drug information
(For additional information see "Acamprosate: Patient drug information")
U.S. BRAND NAMES — Campral®
PHARMACOLOGIC CATEGORY GABA Agonist/Glutamate Antagonist
DOSING: ADULTS — Alcohol abstinence: Oral: 666 mg 3 times/day (a lower dose may be effective in some patients). Adjustment in patients with low body weight (unlabeled): A lower dose (4 tablets/day) may be considered in patients with low body weight (eg, <60 kg).
Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT Clcr 30-50 mL/minute: Initial dose should be reduced to 333 mg 3 times/day.
Clcr <30 mL/minute: Contraindicated in severe renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, enteric coated, delayed release, as calcium: 333 mg [contains calcium 33 mg and sulfites]
DOSAGE FORMS: CONCISE Tablet, enteric coated, delayed release: Campral®: 333 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — May be administered without regard to meals. Tablet should be swallowed whole; do not crush or chew.
USE — Maintenance of alcohol abstinence
ADVERSE REACTIONS SIGNIFICANT Note: 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: Syncope, palpitation, edema (peripheral) 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%), headache, somnolence, amnesia, tremor, chills Dermatologic: Pruritus (3% to 4%), rash Endocrine and metabolic: Weight gain, libido decreased Gastrointestinal: Anorexia (2% to 5%), flatulence (1% to 3%), nausea (3% to 4%), abdominal pain, dry mouth (1% to 3%), vomiting, dyspepsia, constipation, appetite increased, taste perversion Genitourinary: Impotence Neuromuscular & skeletal: Weakness (5% to 7%), back pain, myalgia, arthralgia Ocular: Abnormal vision Respiratory: Rhinitis, dyspnea, pharyngitis, bronchitis Miscellaneous: Diaphoresis (2% to 3%), suicide attempt
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Angina, asthma, exfoliative dermatitis, gastrointestinal hemorrhage, hallucinations, hypothyroidism, MI, ophthalmitis, pancreatitis, photosensitivity, psychosis, pulmonary embolus, renal calculus, renal failure, seizure, suicidal ideation, suicide attempts, suicide completion
CONTRAINDICATIONS — Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (Clcr <30 mL/minute)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Suicidal ideation/attempt: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns: Alcohol dependence: Appropriate use: Should be used as part of a comprehensive program to treat alcohol dependence. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal. Renal impairment: Use with caution in patients with moderate renal impairment (Clcr 30-50 mL/minute).
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Dosage form specific issues: Sulfites: Traces of sulfites may be present in the formulation.
DRUG INTERACTIONS — No clinically-significant drug-to-drug interactions have been identified.
ETHANOL / NUTRITION / HERB INTERACTIONS Ethanol: Abstinence is required during treatment. Ethanol does not affect the pharmacokinetics of acamprosate; however, the continued use of ethanol will decrease desired efficacy of acamprosate.
Food: Food decreases absorption of acamprosate (not clinically significant).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic in animal studies. No adequate or well-controlled studies in pregnant women; use only if potential benefit outweighs possible risk to the fetus.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — May be taken without regard to meals. Each 333 mg tablet contains 33 mg of elemental calcium.
PRICING — (data from drugstore.com)Tablet, EC (Campral) 333 mg (180): $121.36
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms may include diarrhea and (in chronic overdose) hypercalcemia. Treatment is symptom-directed and supportive.
INTERNATIONAL BRAND NAMES — Acampral (KR); Aotal (FR); Campral (AR, AT, AU, BE, BR, CH, CL, DE, DK, ES, GB, HU, IE, NL, PL, RU, SE); Sobrial (ZA)
MECHANISM OF ACTION — Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion.
PHARMACODYNAMICS / KINETICS Distribution: Vd: 1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: 11%
Half-life elimination: 20-33 hours
Excretion: Urine (as unchanged drug)
U.S. BRAND NAMES — Campral®
PHARMACOLOGIC CATEGORY GABA Agonist/Glutamate Antagonist
DOSING: ADULTS — Alcohol abstinence: Oral: 666 mg 3 times/day (a lower dose may be effective in some patients). Adjustment in patients with low body weight (unlabeled): A lower dose (4 tablets/day) may be considered in patients with low body weight (eg, <60 kg).
Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT Clcr 30-50 mL/minute: Initial dose should be reduced to 333 mg 3 times/day.
Clcr <30 mL/minute: Contraindicated in severe renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, enteric coated, delayed release, as calcium: 333 mg [contains calcium 33 mg and sulfites]
DOSAGE FORMS: CONCISE Tablet, enteric coated, delayed release: Campral®: 333 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — May be administered without regard to meals. Tablet should be swallowed whole; do not crush or chew.
USE — Maintenance of alcohol abstinence
ADVERSE REACTIONS SIGNIFICANT Note: 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: Syncope, palpitation, edema (peripheral) 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%), headache, somnolence, amnesia, tremor, chills Dermatologic: Pruritus (3% to 4%), rash Endocrine and metabolic: Weight gain, libido decreased Gastrointestinal: Anorexia (2% to 5%), flatulence (1% to 3%), nausea (3% to 4%), abdominal pain, dry mouth (1% to 3%), vomiting, dyspepsia, constipation, appetite increased, taste perversion Genitourinary: Impotence Neuromuscular & skeletal: Weakness (5% to 7%), back pain, myalgia, arthralgia Ocular: Abnormal vision Respiratory: Rhinitis, dyspnea, pharyngitis, bronchitis Miscellaneous: Diaphoresis (2% to 3%), suicide attempt
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Angina, asthma, exfoliative dermatitis, gastrointestinal hemorrhage, hallucinations, hypothyroidism, MI, ophthalmitis, pancreatitis, photosensitivity, psychosis, pulmonary embolus, renal calculus, renal failure, seizure, suicidal ideation, suicide attempts, suicide completion
CONTRAINDICATIONS — Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (Clcr <30 mL/minute)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Suicidal ideation/attempt: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns: Alcohol dependence: Appropriate use: Should be used as part of a comprehensive program to treat alcohol dependence. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal. Renal impairment: Use with caution in patients with moderate renal impairment (Clcr 30-50 mL/minute).
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Dosage form specific issues: Sulfites: Traces of sulfites may be present in the formulation.
DRUG INTERACTIONS — No clinically-significant drug-to-drug interactions have been identified.
ETHANOL / NUTRITION / HERB INTERACTIONS Ethanol: Abstinence is required during treatment. Ethanol does not affect the pharmacokinetics of acamprosate; however, the continued use of ethanol will decrease desired efficacy of acamprosate.
Food: Food decreases absorption of acamprosate (not clinically significant).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic in animal studies. No adequate or well-controlled studies in pregnant women; use only if potential benefit outweighs possible risk to the fetus.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — May be taken without regard to meals. Each 333 mg tablet contains 33 mg of elemental calcium.
PRICING — (data from drugstore.com)Tablet, EC (Campral) 333 mg (180): $121.36
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms may include diarrhea and (in chronic overdose) hypercalcemia. Treatment is symptom-directed and supportive.
INTERNATIONAL BRAND NAMES — Acampral (KR); Aotal (FR); Campral (AR, AT, AU, BE, BR, CH, CL, DE, DK, ES, GB, HU, IE, NL, PL, RU, SE); Sobrial (ZA)
MECHANISM OF ACTION — Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion.
PHARMACODYNAMICS / KINETICS Distribution: Vd: 1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: 11%
Half-life elimination: 20-33 hours
Excretion: Urine (as unchanged drug)
Acamprosate: Drug information
(For additional information see "Acamprosate: Patient drug information")
U.S. BRAND NAMES — Campral®
PHARMACOLOGIC CATEGORY GABA Agonist/Glutamate Antagonist
DOSING: ADULTS — Alcohol abstinence: Oral: 666 mg 3 times/day (a lower dose may be effective in some patients). Adjustment in patients with low body weight (unlabeled): A lower dose (4 tablets/day) may be considered in patients with low body weight (eg, <60 kg).
Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT Clcr 30-50 mL/minute: Initial dose should be reduced to 333 mg 3 times/day.
Clcr <30 mL/minute: Contraindicated in severe renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, enteric coated, delayed release, as calcium: 333 mg [contains calcium 33 mg and sulfites]
DOSAGE FORMS: CONCISE Tablet, enteric coated, delayed release: Campral®: 333 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — May be administered without regard to meals. Tablet should be swallowed whole; do not crush or chew.
USE — Maintenance of alcohol abstinence
ADVERSE REACTIONS SIGNIFICANT Note: 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: Syncope, palpitation, edema (peripheral) 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%), headache, somnolence, amnesia, tremor, chills Dermatologic: Pruritus (3% to 4%), rash Endocrine and metabolic: Weight gain, libido decreased Gastrointestinal: Anorexia (2% to 5%), flatulence (1% to 3%), nausea (3% to 4%), abdominal pain, dry mouth (1% to 3%), vomiting, dyspepsia, constipation, appetite increased, taste perversion Genitourinary: Impotence Neuromuscular & skeletal: Weakness (5% to 7%), back pain, myalgia, arthralgia Ocular: Abnormal vision Respiratory: Rhinitis, dyspnea, pharyngitis, bronchitis Miscellaneous: Diaphoresis (2% to 3%), suicide attempt
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Angina, asthma, exfoliative dermatitis, gastrointestinal hemorrhage, hallucinations, hypothyroidism, MI, ophthalmitis, pancreatitis, photosensitivity, psychosis, pulmonary embolus, renal calculus, renal failure, seizure, suicidal ideation, suicide attempts, suicide completion
CONTRAINDICATIONS — Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (Clcr <30 mL/minute)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Suicidal ideation/attempt: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns: Alcohol dependence: Appropriate use: Should be used as part of a comprehensive program to treat alcohol dependence. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal. Renal impairment: Use with caution in patients with moderate renal impairment (Clcr 30-50 mL/minute).
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Dosage form specific issues: Sulfites: Traces of sulfites may be present in the formulation.
DRUG INTERACTIONS — No clinically-significant drug-to-drug interactions have been identified.
ETHANOL / NUTRITION / HERB INTERACTIONS Ethanol: Abstinence is required during treatment. Ethanol does not affect the pharmacokinetics of acamprosate; however, the continued use of ethanol will decrease desired efficacy of acamprosate.
Food: Food decreases absorption of acamprosate (not clinically significant).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic in animal studies. No adequate or well-controlled studies in pregnant women; use only if potential benefit outweighs possible risk to the fetus.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — May be taken without regard to meals. Each 333 mg tablet contains 33 mg of elemental calcium.
PRICING — (data from drugstore.com)Tablet, EC (Campral) 333 mg (180): $121.36
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms may include diarrhea and (in chronic overdose) hypercalcemia. Treatment is symptom-directed and supportive.
INTERNATIONAL BRAND NAMES — Acampral (KR); Aotal (FR); Campral (AR, AT, AU, BE, BR, CH, CL, DE, DK, ES, GB, HU, IE, NL, PL, RU, SE); Sobrial (ZA)
MECHANISM OF ACTION — Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion.
PHARMACODYNAMICS / KINETICS Distribution: Vd: 1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: 11%
Half-life elimination: 20-33 hours
Excretion: Urine (as unchanged drug)
U.S. BRAND NAMES — Campral®
PHARMACOLOGIC CATEGORY GABA Agonist/Glutamate Antagonist
DOSING: ADULTS — Alcohol abstinence: Oral: 666 mg 3 times/day (a lower dose may be effective in some patients). Adjustment in patients with low body weight (unlabeled): A lower dose (4 tablets/day) may be considered in patients with low body weight (eg, <60 kg).
Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT Clcr 30-50 mL/minute: Initial dose should be reduced to 333 mg 3 times/day.
Clcr <30 mL/minute: Contraindicated in severe renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, enteric coated, delayed release, as calcium: 333 mg [contains calcium 33 mg and sulfites]
DOSAGE FORMS: CONCISE Tablet, enteric coated, delayed release: Campral®: 333 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — May be administered without regard to meals. Tablet should be swallowed whole; do not crush or chew.
USE — Maintenance of alcohol abstinence
ADVERSE REACTIONS SIGNIFICANT Note: 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: Syncope, palpitation, edema (peripheral) 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%), headache, somnolence, amnesia, tremor, chills Dermatologic: Pruritus (3% to 4%), rash Endocrine and metabolic: Weight gain, libido decreased Gastrointestinal: Anorexia (2% to 5%), flatulence (1% to 3%), nausea (3% to 4%), abdominal pain, dry mouth (1% to 3%), vomiting, dyspepsia, constipation, appetite increased, taste perversion Genitourinary: Impotence Neuromuscular & skeletal: Weakness (5% to 7%), back pain, myalgia, arthralgia Ocular: Abnormal vision Respiratory: Rhinitis, dyspnea, pharyngitis, bronchitis Miscellaneous: Diaphoresis (2% to 3%), suicide attempt
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Angina, asthma, exfoliative dermatitis, gastrointestinal hemorrhage, hallucinations, hypothyroidism, MI, ophthalmitis, pancreatitis, photosensitivity, psychosis, pulmonary embolus, renal calculus, renal failure, seizure, suicidal ideation, suicide attempts, suicide completion
CONTRAINDICATIONS — Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (Clcr <30 mL/minute)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Suicidal ideation/attempt: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns: Alcohol dependence: Appropriate use: Should be used as part of a comprehensive program to treat alcohol dependence. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal. Renal impairment: Use with caution in patients with moderate renal impairment (Clcr 30-50 mL/minute).
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Dosage form specific issues: Sulfites: Traces of sulfites may be present in the formulation.
DRUG INTERACTIONS — No clinically-significant drug-to-drug interactions have been identified.
ETHANOL / NUTRITION / HERB INTERACTIONS Ethanol: Abstinence is required during treatment. Ethanol does not affect the pharmacokinetics of acamprosate; however, the continued use of ethanol will decrease desired efficacy of acamprosate.
Food: Food decreases absorption of acamprosate (not clinically significant).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic in animal studies. No adequate or well-controlled studies in pregnant women; use only if potential benefit outweighs possible risk to the fetus.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — May be taken without regard to meals. Each 333 mg tablet contains 33 mg of elemental calcium.
PRICING — (data from drugstore.com)Tablet, EC (Campral) 333 mg (180): $121.36
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms may include diarrhea and (in chronic overdose) hypercalcemia. Treatment is symptom-directed and supportive.
INTERNATIONAL BRAND NAMES — Acampral (KR); Aotal (FR); Campral (AR, AT, AU, BE, BR, CH, CL, DE, DK, ES, GB, HU, IE, NL, PL, RU, SE); Sobrial (ZA)
MECHANISM OF ACTION — Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion.
PHARMACODYNAMICS / KINETICS Distribution: Vd: 1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: 11%
Half-life elimination: 20-33 hours
Excretion: Urine (as unchanged drug)
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