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Acamprosate (Campral®)

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

Goal & Mechanism

Mechanism Goal Exact mechanism unknown, but suspected to Normalizes alcohol-disrupted brain activity, reducing interact with GABA and glutamate systems cravings

Dosing & Instructions

Take 666 mg by mouth three times a day.

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

Flatulence, cramps, diarrhea, itchiness, drowsiness, muscle weakness, headaches, anxiety, Adverse Effects 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. Warnings 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.

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

References

Forest Pharmaceuticals. (2005). Campral (Acamprosate calcium) 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

Buprenorphine is a FDA-approved medication for the treatment of use disorders. Goal & Mechanism Mechanism Goal Buprenorphine: partial agonist of µ-opioid receptors Partially activates opioid receptors to relieve and an antagonist of -opioid receptors κ withdrawal symptoms Naloxone: µ-opioid Dosing & Instructions Subutex® Sublocade® 300 mg subcutaneous injection administered monthly 2-4 mg dose via sublingual film daily; increase by 2-4 the first 2 months; then 100mg maintenance dose per mg increments to a maximum 24 mg if needed month

Probuphine® Suboxone®

74.2 mg inserted subdermally via 4 implants in upper 2-4 mg buprenorphine/0.5-1 mg naloxone via arm for 6 months. sublingual film daily; increase by proportionate increments to maximum 24 mg/6 mg if needed.

Headache, nausea, insomnia, constipation, acute hepatic toxicity

Adverse Effects 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. Warnings Monitor fetus for neonatal 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.

Contraindications Hypersensitivity to buprenorphine and/or naloxone, hepatic impairment

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 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 SR (Zyban®, Rx)

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

Goal & Mechanism

Mechanism Goal Weak norepinephrine and dopamine reuptake Anti-depressant medication intended to treat the inhibitor; nicotinic acetylcholine receptor antagonist negative mood effects of nicotine withdrawal Dosing & Instructions

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.

Adverse Effects Neuropsychiatric events, insomnia, xerostomia, rash, headaches,

May cause seizures or increase suicidal thoughts and behaviors in adolescents and young adults. Warnings 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 Contraindications cessation, , , monoamine oxidase inhibitors (MAOI’s), or antiepileptic medications

*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 (Antabuse®)

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

Goal & Mechanism

Mechanism Goal Irreversible aldehyde dehydrogenase inhibitor; Causes unpleasant effects when alcohol is blocks the metabolism of alcohol at the consumed; used when therapy indication is for acetaldehyde metabolite complete abstinence

Dosing & Instructions

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.

Alcohol ingestion initiates disulfiram reaction within 10-30 minutes Adverse Effects 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. Warnings 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, Contraindications paraldehyde use, diabetes, or severe use of metronidazole

References

Rising 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

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

Goal & Mechanism

Mechanism Goal Long acting µ-opioid receptor agonist Relief of withdrawal symptoms by mimicking opioid effects, but to a much smaller degree

Dosing & Instructions

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.

Adverse Effects Dizziness, sedation, nausea, sweating, constipation

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

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

References

Mallinckrodt, 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

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

Goal & Mechanism

Mechanism Goal µ-opioid receptor antagonist Blocks opioids from producing intoxicating effects

Dosing & Instructions

ReVia® Vivitrol®

50 mg/day orally. High risk patients should start at 380 mg via intramuscular injection is administered 12.5mg or 25mg and titrate up. every 4 weeks.

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

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

Adverse Effects 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 Warnings 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.

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

References

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 Nicotine Replacement Therapy

These nicotine replacement therapies are approved by the FDA for the treatment of nicotine use disorders. Patch (OTC) Gum (OTC) Dosing Dosing ≥ 10 cigarettes/day = 21 mg patch daily for 6 weeks, 14 mg < 25 cigarettes/day = 2 mg patch daily for 2 weeks, 7 mg patch daily for 2 weeks > 25 cigarettes/day = 4 mg < 10 cigarettes/day = 14 mg patch daily for 6 weeks, 7 mg 1 piece every 1-2 hours, up to 24 pieces/day patch for 2 weeks

Instruction for Use Instruction for Use Apply to a clean, dry, non-hairy area of skin (between neck Chew until tingling feeling; hold in cheek for nicotine and waist) upon waking; patches should not be cut. absorption. Patches may be worn in showers/pools. Acidic foods decrease nicotine absorption. Lozenge (OTC) Nasal Spray (Rx) Dosing Dosing TTFC = time to first cigarette 1 dose = 1 spray in each nostril < 30 min TTFC = 4 mg lozenges 1-2 doses per hour > 30 min TTFC = 2 mg lozenges

Instruction for Use Instruction for Use Lozenge should be absorbed slowly, occasionally moving it Prime and then spray once in each nostril with head slightly from one side of the mouth to the other. tilted back. Lozenge will not be very effective if chewed. Do not exceed 5 doses per hour or 40 doses per day 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.

Patch: Irritation at site of application, skin reaction, vivid dreams, insomnia Gum: Nausea, mouth and throat irritation, heartburn Adverse Effects 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 Warnings (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 Contraindications angina pectoris) 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 Controlled Trial. Obstetrics and Gynecology, 112(4), 859–867. http://doi.org/10.1097/AOG.0b013e318187e1ec

Varenicline (Chantix®, Rx)

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

Goal & Mechanism

Mechanism Goal Nicotinic acetylcholine receptor; partial Moderates cessation symptoms while blocking the agonist/antagonist ability of nicotine to produce intoxicating effects

Dosing & Instructions

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.

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

May cause seizures or increase suicidal thoughts and behaviors. Reduce dosing if severe renal impairment occurs. Warnings 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.

Contraindications History of mental illness or hypersensitivity to Chantix®

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