Acamprosate (Campral®)

Flatulence, cramps, diarrhea, itchiness, drowsiness, muscle weakness, headaches, anxiety,

insomnia

Less common, but more serious: depression and suicide risk

Reduce dosage (333 mg) for patients with moderate renal impairment.

Patients may still exhibit withdrawal symptoms.

FDA Pregnancy Category C: Safe use during pregnancy has not been established; use at a low

dose only when benefits outweigh risks of alcohol misuse to the fetus.

Severe renal impairment; hypersensitivity to Acamprosate calcium or any of its components

Adverse Effects

Warnings

Dosing & Instructions

References

Contraindications

Goal & Mechanism

Mechanism Exact mechanism unknown, but suspected to

interact with GABA and glutamate systems

Forest Pharmaceuticals. (2005). Campral (Acamprosate ca lcium) delayed-release tablets. Retrieved from

https ://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021431s013lbl.pdf

SAMHSA (2009). Incorporating Alcohol Pharmacotherapies Into Medical Practice: A Review of the Literature—Update. A Treatment Improvement

Protocol (TIP) series, No. 49. Retrieved from https://store.samhsa.gov/shin/content/SMA12-4380/TIP49_Lit_Review_Updates.pdf

Goal Normalizes alcohol-disrupted brain activity, reducing

cravings

Acamprosate is a FDA-approved medication for the treatment of alcohol use disorders.

Take 666 mg by mouth three times a day.

In cases of moderate renal impairment, take 333 mg by mouth three times a day.

Buprenorphine

Subutex®

Sublocade®

2-4 mg dose via sublingual film daily; increase by 2-4

mg increments to a maximum 24 mg if needed

300 mg subcutaneous injection administered monthly

the first 2 months; then 100mg maintenance dose per

month

Headache, nausea, insomnia, constipation, acute hepatic toxicity

Sublocade: Injection site pruritus and pain

Probuphine: Implant site pruritus, pain, and erythema

Subutex should be used for induction only; patients should be switched to Suboxone,

Sublocade, or Probuphine for maintenance therapy.

Monitor fetus for neonatal opioid withdrawal syndrome in pregnant patients.

Probuphine: Serious complications can result from insertion or removal. Pediatric contact

with implant can result in severe respiratory depression and death.

Hypersensitivity to buprenorphine and/or naloxone, hepatic impairment

Adverse Effects

Warnings

Dosing & Instructions

Contraindications

Goal & Mechanism

Mechanism Buprenorphine: partial agonist of µ-opioid receptors

and an antagonist of κ-opioid receptors

Naloxone: µ-opioid receptor antagonist

Goal Partially activates opioid receptors to relieve

withdrawal symptoms

Probuphine®

Suboxone®

74.2 mg inserted subdermally via 4 implants in upper

arm for 6 months.

2-4 mg buprenorphine/0.5-1 mg naloxone via

sublingual film daily; increase by proportionate

increments to maximum 24 mg/6 mg if needed.

Buprenorphine is a FDA-approved medication for the treatment of opioid use disorders.

References Braeburn Pharmaceuticals Inc. (2017). Probuphine® (buprenorphine). Retrieved from

https ://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204442s002s004lbl.pdf

Indivior Inc. (2017). Suboxone ® (buprenorphine and naloxone). Retrieved from

https ://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022410s023lbl.pdf

SAMHSA (2005). Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. A Treatment Improvement Protocol (TIP) series, No.

43. Retrieved from https://store.samhsa.gov/shin/content//SMA12-4214/SMA12-4214.pdf

Bupropion SR (Zyban®

, Rx)

Neuropsychiatric events, insomnia, xerostomia, rash, headaches, hypertension

May cause seizures or increase suicidal thoughts and behaviors in adolescents and young

adults.

FDA Pregnancy Category C*: Safe use during pregnancy has not been established; use only

when benefits outweigh risks of nicotine to the fetus.

Seizure disorders, bulimia or anorexia nervosa, electrolyte imbalance, abrupt alcohol

cessation, benzodiazepines, barbiturates, monoamine oxidase inhibitors (MAOI’s), or antiepileptic medications

Adverse Effects

Warnings

Dosing & Instructions

Contraindications

Goal & Mechanism

Mechanism Weak norepinephrine and dopamine reuptake

inhibitor; nicotinic acetylcholine receptor antagonist

Goal Anti-depressant medication intended to treat the

negative mood effects of nicotine withdrawal

Bupropion SR is a FDA-approved medication for the treatment of nicotine use disorders.

Begin treatment 1 week before quit date.

Days 1-3: 150 mg by mouth once in the morning for 3 days.

Days 4+: 150mg twice daily with at least 8 hours between doses.

Do not exceed 300 mg/day.

Length of treatment is 7-12 weeks, but may be taken longer if necessary.

*FDA Pregnancy Category C:

Animal studies have indicated potential fetal risk, but no adequate and well-controlled studies in humans. Drug

should only be used to treat pregnant or nursing women when potential benefits outweigh the risks.

References

Fiore, M.C., Jaén, C.R., Baker, T.B., et al. (2008) Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S.

Department of Health and Human Services. Public Health Service.

https ://www.ncbi.nlm.nih.gov/books/NBK63952/?_ga=2.41026018.154730992.1498757726-1842036369.1498757726

GlaxoSmithKline. (2017). Zyban (Bupropion HCL) sustained release tablet. Retrieved from

https ://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Zyban/pdf/ZYBAN-PI-MG.PDF

Disulfiram (Antabuse®)

Alcohol ingestion initiates disulfiram reaction within 10-30 minutes

Metallic or garlic aftertaste, drowsiness, acne/dermatitis, headache, impotence

Less common, but more serious: liver toxicity, peripheral neuropathy, psychosis, delirium

Never administer to a patient who is intoxicated.

Never administer to a patient without their full knowledge and consent.

FDA Pregnancy Category C: Safe use during pregnancy has not been established; use at a low

dose only when benefits outweigh risks of alcohol misuse to the fetus.

Coronary artery disease, psychosis, significant liver disease, alcohol still in system,

paraldehyde use, diabetes, or severe use of metronidazole

Adverse Effects

Warnings

Dosing & Instructions

References

Contraindications

Goal & Mechanism

Mechanism Irreversible aldehyde dehydrogenase inhibitor;

blocks the metabolism of alcohol at the

acetaldehyde metabolite

Ris ing Pharmaceuticals, Inc. (2016). Disulfiram. Retrieved from http://medlibrary.org/lib/rx/meds/disulfiram-1/

SAMHSA (2009). Incorporating Alcohol Pharmacotherapies Into Medical Practice: A Review of the Literature—Update. A Treatment Improvement

Protocol (TIP) series, No. 49. Retrieved from https://store.samhsa.gov/shin/content/SMA12-4380/TIP49_Lit_Review_Updates.pdf

U.S. Department of Health and Services. Acamprosate: A New Medication for Alcohol Use Disorders (Vol. 4, Rep. No. (SMA) 05–4114). (2005). Retrieved

October 5, 2017, from https ://store.samhsa.gov/shin/content/MS974/MS974.pdf

Goal Causes unpleasant effects when alcohol is

consumed; used when therapy indication is for

complete abstinence

Disulfiram is a FDA-approved medication for the treatment of alcohol use disorders.

Take no more than the maximum oral dose of 500 mg once daily for 1-2 weeks,

then 250 mg/day for maintenance.

Do not begin therapy until at least 12 hours after last drink because of drug interaction.

Effects can last up to 2 weeks after discontinuing therapy.

Methadone

Dizziness, sedation, nausea, sweating, constipation

Can interact with other drugs metabolized by CYP450, and can cause respiratory depression, long QT syndrome, and liver failure.

FDA Pregnancy Category C: Methadone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged uses of opioids during pregnancy.

Significant respiratory depression, acute or severe asthma, gastrointestinal obstruction, or methadone allergy

Adverse Effects

Warnings

Dosing & Instructions

References

Contraindications

Goal & Mechanism

Mechanism Long acting µ-opioid receptor agonist

Mal linckrodt, Inc. (2017). Methadone Hydrochloride: Medication guide. Retrieved from http://medlibrary.org/lib/rx/meds/methadon e-hydrochloride-

12/page/13/

SAMHSA (2005). Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. A Treatment Improvement Protocol (TIP) series, No.

43. Retrieved from https://store.samhsa.gov/shin/content//SMA12-4214/SMA12-4214.pdf

Goal Relief of withdrawal symptoms by mimicking opioid

effects, but to a much smaller degree

Methadone is a FDA-approved medication for the treatment of opioid use disorder.

Administer an initial single dose of 20-30 mg, then an additional 5-10 mg after 2-4 hours if needed.

Titrate to a dose that prevents opioid withdrawal for 24 hours.

Naltrexone

ReVia®

Vivitrol®

50 mg/day orally. High risk patients should start at

12.5mg or 25mg and titrate up.

380 mg via intramuscular injection is administered

every 4 weeks.

Opioid withdrawal symptoms (nausea, headache, insomnia, fatigue, abdominal pain,

myalgia, anxiety, chills), injection site reaction, potential liver toxicity and suicidal ideation.

Patients should carry ID to alert medical care providers of naltrexone therapy to prevent

exposure to additional opioids.

Safe use during pregnancy has not been established; use at a low dose only when benefits

outweigh risks of alcohol misuse to the fetus.

Acute hepatitis, liver disease, current use of opioids, obesity, or coagulation disorders

Adverse Effects

Warnings

Dosing & Instructions

References

Contraindications

Goal & Mechanism

Mechanism µ-opioid receptor antagonist

Alkermes, Inc. (2010). Vivitrol (Naltrexone). Retrieved from ttps ://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf

Duramed Pharmaceuticals, Inc. (2013). Revia (naltrexone HCl ). Retrieved from

https ://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018932s017lbl.pdf

SAMHSA (2009). Incorporating Alcohol Pharmacotherapies Into Medical Practice: A Review of the Literature—Update. A Treatment Improvement

Protocol (TIP) series, No. 49. Retrieved from https://store.samhsa.gov/shin/content/SMA12-4380/TIP49_Lit_Review_Updates.pdf

Patient must be off opioids for 7-10 days before treatment begins (otherwise the medication will precipitate withdrawal).

Goal Blocks opioids from producing intoxicating effects

Naltrexone is a FDA-approved medication for the treatment of alcohol and opioid use disorders.

Nicotine Replacement Therapy

Patch (OTC)

Gum (OTC) Dosing ≥ 10 cigarettes/day = 21 mg patch daily for 6 weeks, 14 mg patch daily for 2 weeks, 7 mg patch daily for 2 weeks < 10 cigarettes/day = 14 mg patch daily for 6 weeks, 7 mg patch for 2 weeks Instruction for Use Apply to a clean, dry, non-hairy area of skin (between neck and waist) upon waking; patches should not be cut. Patches may be worn in showers/pools.

Dosing < 25 cigarettes/day = 2 mg > 25 cigarettes/day = 4 mg 1 piece every 1-2 hours, up to 24 pieces/day Instruction for Use Chew until tingling feeling; hold in cheek for nicotine absorption. Acidic foods decrease nicotine absorption.

Patch: Irritation at site of application, skin reaction, vivid dreams, insomnia

Gum: Nausea, mouth and throat irritation, heartburn

Lozenge: Nausea, insomnia, hiccups, heartburn, coughing

Nasal Spray: Nasal irritation, rhinorrhea, headache, dependency

Inhaler: Mouth and throat irritation, dyspepsia, headache, unpleasant taste

Careful monitoring of pregnant patients is necessary to assure the cumulative amount of nicotine

(from smoking and replacement therapy) is reduced overall for the fetus. Intermittent dosing

replacement therapies may be preferable to the patch which delivers a steady nicotine dose.

Cardiovascular disease (intermediate post-myocardial infarction, serious arrhythmias and unstable

angina pectoris)

Adverse Effects

Warnings

Contraindications

Lozenge (OTC)

Nasal Spray (Rx) Dosing TTFC = time to first cigarette < 30 min TTFC = 4 mg lozenges > 30 min TTFC = 2 mg lozenges Instruction for Use Lozenge should be absorbed slowly, occasionally moving it from one side of the mouth to the other. Lozenge will not be very effective if chewed.

Dosing 1 dose = 1 spray in each nostril 1-2 doses per hour Instruction for Use Prime and then spray once in each nostril with head slightly tilted back. Do not exceed 5 doses per hour or 40 doses per day

These nicotine replacement therapies are approved by the FDA for the treatment of nicotine use disorders.

Inhaler (Rx) Dosing 1 cartridge = 10 mg of nicotine (2 mg is systemically absorbed) and ~20 minutes of active puffing 6-16 cartridges per day, taper off over 12 weeks Instruction for Use Shake before use, press down on inhaler to release medicine, inhale for 2-5 seconds, hold breath for 10 seconds. Do not use for longer than 6 months.

References

Fiore, M.C., Jaén, C.R., Baker, T.B., et al. (2008) Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S.

Department of Health and Human Services. Public Health Service.

https ://www.ncbi.nlm.nih.gov/books/NBK63952/?_ga=2.41026018.154730992.1498757726-1842036369.1498757726

Novartis Consumer Health, Inc. (2014). Nicotine transdermal system patch. Retrieved from

https ://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf

Pfizer Inc. (2008). Nicotrol ® Inhaler. Retrieved from https://www.pfizer.com/files/products/uspi_nicotrol_inhaler.pdf

Oncken, C., Dornelas, E., Greene, J., Sankey, H., Glasmann, A., Feinn, R., & Kranzler, H. R. (2008). Nicotine Gum for Pregnant Smokers: A Randomized

Control led Trial. Obstetrics and Gynecology, 112(4), 859–867. http://doi.org/10.1097/AOG.0b013e318187e1ec

Varenicline (Chantix®

, Rx)

Nausea, abnormal dreams, constipation, somnambulism, depressed mood, agitation

May cause seizures or increase suicidal thoughts and behaviors.

Reduce dosing if severe renal impairment occurs.

FDA Pregnancy Category C: Safe use during pregnancy has not been established; use at a low

dose only when benefits outweigh risks of nicotine to the fetus.

History of mental illness or hypersensitivity to Chantix®

Adverse Effects

Warnings

Dosing & Instructions

References

Contraindications

Goal & Mechanism

Mechanism Nicotinic acetylcholine receptor; partial

agonist/antagonist

Fiore, M.C., Jaén, C.R., Baker, T.B., et al. (2008) Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S.

Department of Health and Human Services. Public Health Service.

https ://www.ncbi.nlm.nih.gov/books/NBK63952/?_ga=2.41026018.154730992.1498757726-1842036369.1498757726

Pfizer Inc. (2016). Chantix ® (varenicline). Retrieved from http://labeling.pfizer.com/ShowLabeling.aspx?id=557#section -4

Goal Moderates cessation symptoms while blocking the

ability of nicotine to produce intoxicating effects

Varenicline is a FDA-approved medication for the treatment of nicotine use disorders.

Begin dosing 1 week before quit date.

Days 1-3: 0.5 mg once daily Days 4-7: 0.5 mg twice daily.

Take 1 mg twice daily for the remainder of treatment.

Continue treatment for 12-24 weeks.