Pharm 2 exam 1 study guide
Pharm 2 exam 1 study guide NURS 406 001
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This 28 page Study Guide was uploaded by Heather Notetaker on Saturday October 1, 2016. The Study Guide belongs to NURS 406 001 at University of Tennessee - Knoxville taught by Glen E Farr (P) in Fall 2016. Since its upload, it has received 18 views.
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Review Questions 1. Differentiate the “atypical” antipsychotic agents from the “typical” agents as to the following: a. Mechanism of action. What chemical mediator do they innervate? “Typical” antipsychotics (e.g., chlorpromazine—Thorazine®) block postsynaptic dopamine receptors in the mesolimbic system and increase dopamine turnover by blockade of the D 2 somatodendritic autoreceptor. This decrease in dopamine neurotransmission has been correlated to the antipsychotic effects of the phenothiazines. The newer “atypical” or 2 generation antipsychotic drugs are mixed neuroreceptor antagonists (low affinity dopamine D 2 receptor blockade) and high affinity for antagonist effect on 5HT2Aserotonin receptors. Typicals decrease/block dopamine Atypicals low effect on dopamine, high effect on serotonin b. What are the conditions that require these agents to be monitored for? Typical Akathesiarocking back and forth, parkisonlike symptoms, Dystoniamuscle spasms, Tardive dyskinesia Atypical weight gain Receptor Blockade Expected Effects Causes EPS Dopamine D2 prolactin levels—causes gynecomastia Antiemetic effect intractable hiccups Mitigation of some EPS 5HT2 Anxiety and insomnia H1 Drowsiness in appetite and weight Alpha1adrenergic Orthostatic hypotension and dizziness Reflex tachycardia Dry mouth Muscarinic Constipation (Cholinergic) Blurred vision Urinary retention c. What is their role as adjunctive therapy in clients with Alzheimer’s disease? Generally not recommended d. What is the primary advantage in terms of side effects of these agents over the typical antipsychotics like chlorpromazine (Thorazine )? Less EPS e. What is the primary disadvantage? Side effects like weight gain 2. The typical antipsychotic agent thioridazine (Mellaril ) and the atypical agent ziprasidone (Geodon ) have a blackbox warning regarding what condition? thioridazine (Mellaril®)—Black box warning for prolonging the QTc resulting in torsades de pointes arrhythmias and sudden death. Rarely used. Ziprasidone (Geodon ) Concern about potential arrhythmias—prolonged QT interval in higher doses. 2014 FDA warning on Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which may start as a rash and spread all over. FDA warns that patients on the drug who have a fever with a rash and/or swollen lymph glands should seek urgent care. 3. Compare and contrast the various atypical antipsychotics in regard to weight gain in children. a. Zyprexa® (olanzapine) = 8.5 kg (18.7 pounds) b. Seroquel® (quetiapine) = 6.1 kg (13.4 pounds) c. Risperdal® (risperidone) = 5.3 kg (11.7 pounds) d. Abilify® (aripiprazole) = 4.4 kg (9.7 pounds) 4. What is the marketing strategy for the new antipsychotic agent lurasidone (Latuda®) and what is the drug and dosage form for Adasuve®? Lurasidone (Latuda®) th o Approved 2010, this is the 10 atypical. o Marketing claim is “less metabolic effects and onceaday dosing.” Adasuve antipsychotic agent; first and only orally inhaled medication; is approved for schizophrenia or agitation in patients with bipolar disorder. 5. You hear reports of abuse of quetiapine (Seroquel®). When you look it up, you note that it is used in the treatment of schizophrenia and is not a controlled substance. What’s up? There are recent reports that some people are abusing quetiapine (Seroquel®) for its sedating and antianxiety effects, especially among jail inmates or substance abusers. Some people claim to have psychiatric symptoms to get it. Others with legitimate prescriptions skip doses and sell them. It's known on the street as "quell" or "baby heroin." 6. What pharmacokinetic effect of fluoxetine (Prozac ) allows it to be FDA approved for onceaweek administration as Prozac Weekly ? Fluoxetine (Prozac®) Long halflife (46 days for fluoxetine and 4 to 16 days for its active metabolite norfluoxetine), so need a 5week “washout” period prior to initiating therapy with a MAOI. Other SSRIs halflife is ~2448 hours Combined with olanzapine (Zyprexa® as Symbyax®) to treat bipolar disease and treatmentresistant depression (TRD). Approved for PMDD as Sarafem in 10 & 20 mg 7day blister packs and for once weekly administration in stabilized (not for initial therapy) clients as Prozac Weekly . The onceweekly formulation consists of a 4week supply containing 90 mg of fluoxetine with an enteric coating that delays release of the ingredient into the bloodstream. Approved in pediatric patients > age 8 years for major depressive disorder) and > age 7 years for obsessivecompulsive disorder. 7. Regarding the tricyclic antidepressant medications: a. Why are they used less frequently today? The February 18, 2015 issue of the BMJ reported a British observational study looking at the associations between various antidepressants and rates of suicide and attempted suicide or selfharm among people with depression. According to the data, there were similar rates of suicide and attempted suicide or selfharm during periods of treatment with SSRIs and tricyclic and related antidepressants. Anticholinergic effects (dry mouth, constipation, urinary retention, tachycardia, flushing, etc.). Elderly are more sensitive to the anticholinergic effects and may develop confusion or delirium. Cardiotoxic effects (dysrhythmias)—treat with lidocaine or other antidysrhythmic agents. Use another class of antidepressant for clients with heart disease. Weight gain. b. What is their primary sign of toxicity? dysrythmias c. How long does it generally take for them to become effective? Generally takes a few weeks to reach full antidepressant effects, but side effects can be seen within a few hours. 8. What is the FDA pregnancy description of the SSRIs? A study in the July 8, 2015 issue of the BMJ suggests that the risk of birth defects may increase slightly when pregnant women take the SSRIs paroxetine and fluoxetine early in pregnancy. However, no such associations were found for sertraline, citalopram, or escitalopram. The researchers stress that if the associations are causal, the absolute risk for birth defects is still small. “Neonates exposed to SSRI/SNRI late in 3rd trimester have developed adverse effects requiring prolonged hospitalization, respiratory support, tube feeding. Adverse effects may arise immediately upon delivery.” 9. What is a side effect of the SSRIs that bupropion (Wellbutrin®) may be helpful in overcoming? Bupropion (Wellbutrin®): May actually improve sexual function since it has more dopaminergic effects. A study in the April 2001 issue Journal of Sex and Marital Therapy reported that one lady had a “spontaneous orgasm” at the grocery store. According to a report in the January 25, 2005 New York Times, a patient reported a spontaneous 2hour orgasm after taking bupropion (Wellbutrin®). 10. Why would a prescriber add Lmethylfolate to a prescription for an SSRI? In patients with major depressive disorder who had incomplete or no response to SSRI therapy, addition of Lmethylfolate 15 mg daily led to improved response rate and increased degree of change in depression symptom scores as compared to placebo. 11. What two chemical mediators does duloxetine (Cymbalta®) block? Seratonin & Norepinephrine 12. What type of drug is milnacipran (Savella®) and what is it approved for? A selective serotonin and norepinephrine dual reuptake inhibitor approved for the management of fibromyalgia. It is not presently approved for any psychiatric use. 13. What is the antidepressant bupropion (Wellbutrin®) also FDA approved under the name Zyban® for the treatment of? It is also indicated for use as an aide to smoking cessation in a sustainedrelease oral dosage form, Zyban®, alone or in combination with nicotine transdermal systems (NTS). Dopamine and norepinephrine are increased by nicotine, thus this drug provides a similar effect to smoking. 14. Describe the problem(s) that are likely to occur in the newborn infant when antidepressant venlafaxine (Effexor®) is continued throughout pregnancy. They could have withdrawal symptoms 15. Which antidepressant is most often associated with priapism? Trazadone 16. What type of drug is vortioxetine (Trintellix®)? An Atypical Antidepressant it is similar to the SSRIs (most listings refer to it as an SSRI), but is being called an “atypical antidepressant” and a "serotonin modulator and stimulator” since it works by inhibiting the reuptake of serotonin and as a partial agonist of serotonin. It may cause more nausea than some of the others. 17. A client you are caring for has developed cataracts and asks if it might be associated with her use of St. John’s Wort. Your evidencedbased answer? It causes a significant degree of photosensitivity and drug interactions by inducing the cytochrome P450 system. The photosensitivity issue has now been linked to an increased risk of cataracts. People who spend a significant amount of time in the sun should avoid taking St. John's wort. Efficacy: Numerous studies have been conducted on St. John’s Wort with conflicting results. 18. In 2004, the FDA ordered the manufacturers of all SSRIs to add a boxed warning on their labels warning that: use in children 18 and under can cause suicide. In 2007 this was expanded to all adults up to 25 19. Describe the occurrence, symptoms and treatment of “Serotonin Syndrome.” All serotonergic drugs can cause serotonin syndrome, a rare but potentially life threatening condition characterized by altered mental status, fever, tachycardia, hypertension, agitation, tremor, myoclonus, hyperreflexia, ataxia, incoordination, diaphoresis, shivering, and gastrointestinal symptoms. It occurs only very rarely with SSRI monotherapy at recommended doses. Serotonin syndrome occurs most commonly as a result of interactions with other drugs. Serotonergic drugs and MAOIs should not be used concurrently or within 2 weeks of each other; up to 5 weeks may be required with fluoxetine. Some drugs with MAOI activity, such as the antimicrobial agent linezolid (Zyvox, and generics), and some drugs that may not be recognized as serotonergic, such as dextromethorphan, sumatriptan (Imitrex®), tramadol (Ultram®), methadone, and St. John's wort, can cause serotonin syndrome when taken concurrently with an SSRI or SNRI. Treatment: No specific therapeutic approach to the treatment of serotonin syndrome has been fully evaluated in the literature. The most common treatment involves the use of the benzodiazepines, the antiserotonergic agent cyproheptadine (Periactin®), and propranolol. 20. Which foods should a client on the MAOI antidepressants avoid? Interaction with tyramine in foods, beer (especially draft beer) and wine to cause hypertensive crisis. Must be cautious with many foods and beverages. 21. What is the product EMSAM® and what is it used for? A monoamine oxidase type B inhibitor (found primarily in the brain) that prevents catabolism of dopamine in the brain. It is metabolized to amphetamine. EMSAM® in a transdermal system for the treatment of depression. 22. What are the signs and symptoms of toxicity from lithium therapy? Lithium has a very narrow therapeutic index and clients frequently become toxic on the drug. The practitioner (and the client) must monitor for toxicity: Nausea & vomiting Fatigue Tremors (May use a βblocker to reduce tremors) Anorexia Late stage toxicity involves seizures A report published online May 20, 2015 in the Lancet found that lithium is associated with a decline in renal function, hypothyroidism, and hypercalcemia. 23. List the controlled substance schedule of each of the following: a. SSRIs N/A b. MAOIs N/A c. Atypical antipsychotics N/A d. Phenothiazines N/A 24. What is the 2007 FDA warning on all “sleeping pills?” The FDA requires that the labels for all drugs in the class of sedativehypnotic compounds be updated to include stronger language about the potential risks of severe allergic reactions and complex sleeprelated behaviors, such as driving or preparing food when not fully awake, in patients taking these treatments. Most of these agents have always mentioned the risk of somnambulism (sleep walking) as a risk. 25. You hear talk on the street of “totem poles” or “Bars”. What are they referring to? Xanax 26. What is the unique quality of buspirone (BuSpar®) as compared to benzodiazepines? Buspirone (BuSpar®) o Similar in efficacy to benzodiazepines o Works best in a “benzodiazepine virgin” o Does not have additive effect with alcohol, so driving is not impaired o Has a low abuse potential (not a controlled substance), but is sometimes sold on the street as Xanax® since it looks similar. Anxiolytics such as buspirone (BuSpar®) seem best for clients that are very hyperactive and aggressive. 27. What is the primary use of flumazenil (Romazicon®)? Flumazenil (Romazicon®) A parenteral benzodiazepine antagonist used to treat benzodiazepine overdose and to reverse benzodiazepine sedation during anesthesia. It does not reverse the actions of barbiturates, opiate agonists, or tricyclic antidepressants. Administered only by rapid I.V. injection because it is highly irritating, and care should be taken to avoid extravasation. While flumazenil reverses benzodiazepineinduced sedation, it has no proven effectiveness in the treatment of hypoventilation induced by benzodiazepines. Any beneficial effects on ventilatory response from flumazenil use can be outlived by the effects of the benzodiazepines. Prompt detection of hypoventilation with suitable ventilatory support is essential, especially in reversal of acute benzodiazepine overdosage. Because binding is competitive and flumazenil has a much shorter duration of action (~2 hours) than do most benzodiazepines, it is possible for the effects of flumazenil to dissipate sooner than the effects of the benzodiazepine. Watch for resedation. 28. Regarding propofol (Diprivan ): What is its primary use? What is it sometimes called? Is it a controlled substance? Propofol is used both for the induction and maintenance of general anesthesia. It also has several offlabel uses including: conscious sedation, postoperative nausea and vomiting, and refractory status epilepticus and delirium tremens. It is not classified as a Controlled Substance. Available as an emulsion that is white and “milky”, so often called “Milk of Amnesia.” Also called “Dancing with the White Rabbit” when abused by health care workers. 29. List the controlled substance schedule of each of the following: a. Sedativehypnotic benzodiazepines C IV b. Anxiolytic benzodiazepines C IV c. Chloral hydrate (Noctec®) C IV d. Zaleplon (Sonata ) C IV e. Eszopiclone (Lunesta®) C IV f. Zolpidem (Ambien®) C IV g. Ramelteon (Rozerem®) N/A 30. Describe the indications for use of midazolam (Versed®). A water soluble benzodiazepine used in the I.V. form preop to sedate prior to certain procedures (e.g., endoscopy) Provides almost total amnesia to the procedure 31. What is the last cranial nerve to be anesthetized? 8 (hearing) 32. What two types of drugs are FDA approved for the pharmacological management of Alzheimer's disease? Acetylcholinesterase inhibitors and NeuropeptideModifying Agent: Memantine (Namenda®) 33. What is the current thinking about coconut oil and vitamin E for Alzheimer’s? Caprylidene (Axona®) is a firstinclass “medical food” that contains a proprietary formulation of mediumchain triglycerides (MTC’s), specifically caprylic triglyceride, which is derived from coconut and palm oils, which is designed to elevate serum ketone levels to provide an alternative energy substrate to glucose in the brain of patients with AD. According to Natural Medicines Comprehensive Database, April 2012, coconut is getting a lot of attention for treating Alzheimer's disease. That's because it contains a high concentration of medium chain triglycerides (MCTs). MCTs are thought to improve brain metabolism and decrease betaamyloid damage in the brain. But the evidence is weak. It's too soon to recommend it (and Axona®) for Alzheimer's disease. Vitamin E This treatment effect translates into a clinically meaningful delay in progression in the vitamin E group of 6.2 months Cocoanut oil too early to tell if it will help 34. What is the pharmacological problem with combining diphenhydramine (Benadryl®) with rivastigmine (Exelon®)? Anticholinergic agents, e.g., antihistamines like diphenhydramine and TCAs, will negate some of the positive effects of the acetylcholinesterase inhibitors 35. List the controlled substance schedule of each of the following: a. Amphetamines C II b. Methylphenidate C II c. Modafinil (Provigil®) C IV d. Armodafinil (Nuvigil®) C IV e. Atomoxetine (Strattera®) N/A f. Guanfacine (Intuniv®) N/A g. Orlistat (Xenical®) OTC h. Lisdexamfetamine (Vyvanse®) C II 36. What is the most recent FDA approval for lisdexamfetamine (Vyvanse®)? 2015 approval for “binge eating” 37. What is the indication(s) for modafinil (Provigil®)? How does it differ from Nuvigil®? modafinil (Provigil®) is being used for Narcolepsy/sleep disorders It is in Schedule IV and was originally considered less likely to be abused compared with other treatments for EDS since it was reported not to increase dopamine. This has been subsequently refuted and we now find that is does increase dopamine in the nucleus accumbens and is subject to abuse. It is marketed as a “nonamphetamine wake promoting agent.” Armodafinil (Nuvigil®), the active singleisomer of modafinil. It is a Schedule IV controlled substance being marketed to “keep you awake.” It has a longer halflife and AUC than modafinil (Provigil®) 38. What is the current recommendation from the American Heart Association prior to beginning therapy for ADHD with stimulant drugs? What about the American Academy of Pediatrics? American Heart Association Urges EKG for Children Prior to Starting ADHD Drugs April 21, 2008, doi: 10.1161/CIRCULATIONAHA.107.189473 In 2008, the American Academy of Pediatrics (AAP) stated it would be reasonable to consider obtaining an ECG in such children. In July 2008, The Medical Letter consensus is that routine ECGs and echocardiograms are not indicated before starting stimulants in patients with an unremarkable history and physical examination. According to the NEJM, November 1. 2011, there is no association between the use of certain ADHD medications and adverse cardiovascular events, but the FDA continues to recommend that the drugs not be used in patients with serious heart problems. The American Academy of Pediatrics updated its guidelines recommending that children as young as aged 4 to 5 with moderate to severe attentiondeficit hyperactivity disorder (ADHD) symptoms who don't see a significant improvement with behavior therapy should be treated with methylphenidate. (However, except for shortacting dextroamphetamine, are FDA approved for use in children <6 years old.) The guidelines advise that patients between the ages of 4 and 18 should undergo evaluations for ADHD if they show signs of the condition. 39. Compare and contrast the following drugs for treatment of obesity: a. Phentermine (AdipexP®, Suprenza®) C IV controlled release, can treat obesity or overweight and weight conditions (hypertension, type 2 diabetes, ect) b. Orlistat (Xenical®, Alli®) indicated in clients with a BMI >30 or BMI 27> with at least one comorbidity. Approved as a Rx drug in 120 mg capsules, this compound blocks pancreatic lipases and prevents GI absorption of fat by as much as onethird. Orlistat also the absorption of fatsoluble vitamins, so vitamin supplementation is recommended. Subsequently approved for OTC sale as Alli® (pronounced AL eye) in 60 mg capsules. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. Systemic absorption is not needed for activity. Separate from its effects on weight, it is also approved to delay the onset of type 2 diabetes in obese patients, including children age 1218. It is not absorbed systemically and thus has no effect on the CNS. It does, however, cause adverse GI events that tend to subside after a few months of therapy. “gastric anabuse” Possibility of severe liver injury, or increase in acute kidey injury c. Lorcaserin (Belviq®) Approved for the treatment of obesity in patients with a BMI >30. For patients with weightrelated comorbidities, the drug is indicated for individuals with a BMI >27. Small potential for euphoria and abuse so is a Schedule IV Controlled Substance. agonist of the 5hydroxytryptamine (5HT, or serotonin) receptor 5HT2C. It works selectively on the central 5HT2C receptors, with a functional selectivity of about 15 and 100 times that for 5 HT2A and 5HT2B, respectively (BP and HR were a concern because of possible hypertension through this) The most common side effects observed in studies were upper respiratory tract infection, headache, and nausea; discontinuation rates in clinical trials were similar to those for placebo. Belviq® seems to be the best tolerated. d. Phentermine/Topiramate (Qsymia®) FDA approved Qsymia® (“Qsemia”), a controlledrelease preparation of two already approved drugs, phentermine and topiramate, for weight loss and maintenance of weight loss for people who are obese (BMI ≥30), or those who are overweight (BMI ≥ 27) and have weightrelated conditions such as hypertension, type 2 diabetes, or dyslipidemia. Since it contains phentermine, it is Schedule IV. The FDA approval came despite some concerns about raised blood pressure and birth defects. Qsymia® seems to lead to the most weight loss, an average of 20 pounds more than placebo at 1 year. Qsymia® contains topiramate which can cause impaired cognition, tingling hands and feet, and birth defects if taken during pregnancy. e. Bupropion/Naltrexone (Contrave®) FDA approved Contrave® (naltrexone/bupropion) as a treatment option for chronic weight management in addition to a reduced calorie diet and physical activity. The drug, which the agency rejected in 2011, is approved for use in adults with a BMI of 30 or greater or those with a BMI of 27 or greater who have at least one weightrelated condition such as hypertension, type 2 diabetes or dyslipidemia. The Medical Letter, November 10, 2014 concludes: “The combination of naltrexone and bupropion (Contrave®) taken as an adjunct to diet and exercise resulted in weight loss of about 59% in the first year of use in clinical trials. As with other drugs for this indication, its effectiveness may wane in the second year and thereafter. Nausea is common, and constipation, headache, insomnia and (rarely) seizures can occur.” Contrave® contains bupropion to suppress appetite, plus naltrexone to decrease food cravings. Contrave® causes the most nausea, due to the naltrexone. Do not to use Contrave® with opioids, because the naltrexone will block opioid effects. f. Liraglutide (Saxenda®) FDA approved the injectable GLP1 analogue liraglutide, used for the treatment of Type 2 diabetes as Victoza®, for chronic weight management in adults with a body mass index (BMI) of at least 30 or those with a BMI of 27 or more who also have at least one weightrelated comorbid condition. This is the first oncedaily GLP1 analogue for the treatment of obesity. In the SCALE Obesity and Prediabetes study, treatment with Saxenda® was associated with a mean weight loss of 8% after 56 weeks, versus 2.6% for placebotreated subjects. Saxenda is the fourth therapy cleared for the treatment of obesity since 2012, following the approvals of Belviq® (lorcaserin) and Qsymia® (phentermine/topiramate) in 2012, as well as Contrave® (bupropion/naltrexone) earlier in 2014. 40. Compare and contrast the following drugs for the management of Attention Deficit Hyperactivity Disorder (ADHD): a. Atomoxetine (Strattera®) It works primarily by enhancing norepinephrine, which is thought to control behaviors related to attention and impulsivity. Non stimulant. Since it effects norepinephrine, it should not be taken within two weeks of a MAOI. Must have a “washout” period. Black box warning of suicidal thoughts. Not a CS. b. Methylphenidate (Ritalin®) CNS stimulation, leading to insomnia, nervousness, increased blood pressure, priapism and tachyarrhythmias. Rare chance of priapism. In 2013, the FDA warned that methylphenidate can in "rare instances" lead to priapism in males. c. Amphetamines (e.g., dextroamphetamine—Dexedrine® and Adderall ) Amphetamines stimulate the entire CNS and cause release of excessive dopamine, which regulates pleasure in the brain. Use of amphetamines, especially Adderall , is increasing dramatically. This is partly due to the negative publicity over methylphenidate. The most commonly available product is a combination of d and l amphetamine (levoamphetamine/dextroamphetamine) available as Adderall® and Adderall XR . It is also approved for adult ADHD. d. Lisdexamfetamine (Vyvanse®) A prodrug to dextroamphetamine that is bound to lysine and is inactive until GI enzymes cleave off the lysine. The idea is to reduce its abuse potential since Vyvanse® is not likely to be effective if people try to snort or inject it. Oral absorption is also slower, thus it is longeracting. This reduces the chance of euphoria at normal doses, but not at higher doses. That's why Vyvanse® is still a CII drug. 2015 approval for “bingeeating” e. Guanfacine (Intuniv®) In 2009, the FDA approved Intuniv® (guanfacine) to treat ADHD in children and adolescents aged 6 to 17 years. Guanfacine under the brand name Tenex® has long been approved for hypertension. f. Clonidine (Kapvay®) In 2010, the FDA approved the nonstimulant medication Kapvay® (clonidine hydrochloride) in an extendedrelease, twice daily oral formulation for the treatment of ADHD in children and adolescents ages 617 years. Kapvay® is the first and only FDAapproved ADHD treatment indicated for use as addon therapy to stimulant medication. It can also be used as monotherapy when treating ADHD. Clonidine under the name Catapres® has long been used to treat hypertension. 41. What are “Bath Salts” and what do they do? Are they the same as “Flakka”? These aren't really bath salts, they're actually designer stimulants derived from the naturally occurring compound cathinone, e.g., 3,4methylenedioxypyrovalerone (MDPV) or 4methylmethcathinone (mephedrone) aka “meowmeow.” They mimic the effects of cocaine on the CNS. “Gravel” or “Flakka” follows a long line of synthetic drugs that have popped up in recent years such as spice and bath salts (it is in the cathinone class). Gravel is a synthetic drug that was first seen in 2014 and contains alpha pyrrolidinopentiophenone, a synthetic stimulant acting on the cardiovascular and central nervous system. It looks a lot like crack (rocks or gravel) and can be smoked, snorted or even shot up. The effects of this are paranoia, euphoria, hallucinations, and kidney failure. Both, However, are in the Carthinone class 42. What is Alli® and what, in addition to GI adverse effects, are two recent adverse effects associated with it? Approved as a Rx drug in 120 mg capsules, this compound blocks pancreatic lipases and prevents GI absorption of fat by as much as onethird. Orlistat also the absorption of fatsoluble vitamins, so vitamin supplementation is recommended. It is not absorbed systemically and thus has no effect on the CNS. It does, however, cause adverse GI events that tend to subside after a few months of therapy. Psyllium (Metamucil®) can reduce some of the GI side effects by helping to absorb some of the excess fat. Adverse GI effects include oily spotting, flatus with discharge, fecal urgency and fecal incontinence. Could be called “Gastric Antabuse®.” In 2010, the FDA required a revised label for orlistat (Xenical®, Alli®) to include new safety information about rare cases of severe liver injury. A Canadian study in the April 12, 2011 Archives of Internal Medicine showed a 2% increase in acute kidney injuries within one year of patients starting orlistat. 43. List three uses for acetazolamide (Diamox®). Limited usefulness in epilepsy, glaucoma and as a diuretic, but widely used for high altitude sickness. 44. What are the primary side effects of phenytoin (Dilantin®) when used in the treatment of epilepsy? Why do you need to encourage good oral hygiene in clients taking this drug chronically? Adverse effects include alteration of vitamin D, resulting in bone disease and osteoporosis, diplopia/nystagmus, ataxia, sedation and gingival hyperplasia. 45. Lamotrigine (Lamictal®) has a black box warning regarding: Lamotrigine (Lamictal®) Boxed warning regarding severe rash, including SJS. 46. As of 2009, FDA requires that all antiepileptic drugs warn of the possibility of: In 2009, the FDA began requiring a warning that antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behaviors. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. A Medication Guide should be dispensed at the pharmacy with every prescription and read by all patients before taking AEDs. 47. Do all antiepileptic drugs increase suicide risk? Do all antiepileptic drugs decrease the efficacy of oral contraceptives? Yes and no 48. Discuss cannabidiol (“Cannabis Oil”) as to: a. What is it? The marijuana liquid compound cannabidiol (CBD) does not contain THC, the psychoactive part of marijuana that creates a "high," b. What is it used for? Seizures c. What is its legal status in Tennessee legal as long as these parameters are met The oil contains less than 0.9% of THC. The person in possession retains proof of the legal order or recommendation from the issuing state. That person also retains proof that the person or person’s family member has been diagnosed with intractable seizures or epilepsy by a physician licensed to practice in Tennessee. 49. Outline the current treatment recommendations for the prevention and treatment of children who have simple febrile seizures. o Continuous or intermittent antiepileptic or antipyretic medication is not recommended for the prevention on febrile seizures. o In the unusual case of febrile status epilepticus, intravenous lorazepam (Ativan®) and buccal midazolam (Versed®) are firstline agents. 50. What four drugs are FDA approved for Restless Legs Syndrome and how do they work? o Ropinirole (Requip®)—the dose for PD is much higher than for RLS. o Pramipexole (Mirapex®) o Rotigotine (Neupro® transdermal system) o Gabapentin enacarbil (Horizant®)—forms gabapentin (Neurontin®). 51. Why would a person most likely be prescribed cyclobenzaprine (Flexeril®)? 52. A client without a need for a muscle relaxant request that carisoprodol (Soma®) be prescribed concurrently with their narcotic analgesic. You suspect “abuse.” Can you offer a pharmacological explanation for this? o Is often effective but can cause significant sedation and dizziness. o High abuse potential due to one of its metabolites, meprobamate. Some use it to enhance or prolong the effects of opioids. o It became a Schedule IV controlled substance in Tennessee in April 2011. 53. List the controlled substance schedule of each of the following: a. Pregabalin (Lyrica®) C V b. Carisoprodol (Soma®) C IV 54. Why is carbidopa added to levodopa to form Sinemet®? Carbidopa (Lodosyn®) prevents peripheral conversion of levodopa by inhibiting the enzyme dopadecarboxylase. 55. Why would a client with Parkinson’s disease be prescribed pimavanserin (Nuplazid®)? Pimavanserin (Nuplazid®) tablets were approved in 2016 for the treatment of hallucinations and delusions associated with psychosis in Parkinson's disease (PD). Hallucinations or delusions occur in as many as 50% of patients with PD at some time during the course of their illness. 56. List the mechanism of action and a significant side effect of each of the following drugs for treating Parkinson’s disease: a. selegiline (Eldepryl®, Carbex®) A monoamine oxidase type B inhibitor (found primarily in the brain) that prevents catabolism of dopamine in the brain. Selegiline is used orally as Eldepryl®. Zelapar® and Carbex® for Parkinson’s disease. Also available as EMSAM® in a transdermal system for the treatment of depression. The lowerdose (6 & 9 mg) patch is administered once daily without tyramine dietary modifications. In doses < 10 mg/day it does not cause hypertension with tyramine like MAOA inhibitors do. The Medical Letter, June 2006 concluded: “Monoamine oxidase inhibitors can be effective for patients with moderate to severe depression who do not respond to other drugs. Hopefully, transdermal selegiline (Emsam®) could prove to be helpful for such patients without causing the serious adverse effects that have limited use of these agents, but more data are needed.” b. tolcapone (Tasmar®) Approved only for those who do not respond to entacapone (Comtan®). Liver monitoring required every 2 weeks. No longer marketed in Canada. Prescriber’s are advised to use an informed consent form when prescribing it. c. ropinirole (Requip®) Approved for RLS, but more often for PD d. benztropine (Cogentin®) 57. A client reports that “a friend” taking Mirapex® has started “gambling a lot.” Do you think this could be related to the drug? Yes, because it is a dopamine agonist. There have been reports for compulsive behaviors, including gambling. Review Questions 1. What are the major sideeffects of more than a onetime dose of glucocorticoids? 2. Why is it usually necessary to taper a course of oral corticosteroids? To prevent HPA axis suppression and adrenal shutdown 3. What is the difference between a physiologic dose and pharmacological dose of a “steroid”? Which is higher? Physiologic doses of corticosteroids are used for replacement therapy in adrenocortical insufficiency (Addison's Disease). Pharmacological doses are used for their antiinflammatory effects in: Osteoarthritis and other rheumatic and pain disorders (usually shortterm and 34 injections/year due to cartilage and tendon damage) Collagen diseases (e.g., Systemic Lupus Erythematosus) Allergic disorders Ophthalmic and otic disease Respiratory diseases (asthma, COPD, croup) Inflammatory bowel disease, e.g., ulcerative colitis Dermatitis, eczema, psoriasis Transplant clients and those with autoimmune disorders may use corticosteroids for their immunosuppressive effects. 4. You have an order for methylprednisolone 4 mg tablets twice daily and the pharmacy sends dexamethasone 4 mg tablets to be given twice daily. You administer without question since they are both corticosteroids. Is this appropriate? 5. What are the primary indications or uses of desmopressin (DDAVP®, Stimate®)? Desmopressin (DDAVP®), an analog of vasopressin, is synthetic antidiuretic hormone (ADH) that may be administered orally, intranasally, or parenterally. o It has a longer duration of action than vasopressin and a more favorable adverse effect profile, and has replaced vasopressin as the drug of choice for central diabetes insipidus. It causes less stimulation of smooth muscle than does vasopressin. o It is used to treat: Central diabetes insipidus (controls the polyuria, polydipsia and dehydration) Pituitary surgery or trauma (controls the polyuria and polydipsia) Nocturnal enuresis (bedwetting) Hemophilia A or Type I von Willebrand’s disease (controls bleeding —mechanism not clear) 6. Describe the recent FDA warning for desmopressin and the approval status of desmopressin products. Risk of overhydration (water intoxication) from either form of ADH is high. The FDA has issued a “Safety Alert” warning that some patients taking desmopressin, including children who take desmopressin for enuresis, may be at risk of seizures due to hyponatremia and death. 7. A parent asks about the best way to treat her 5 yearold son to help prevent “wetting the bed.” What would you recommend? o Anticholinergic treatment, particularly with tricyclic antidepressants like imipramine, are sometimes useful in children who have urinary urgency, restricted bladder capacity from detrusor hyperactivity at night, and combined daytime wetting and nocturnal incontinence as well as in children who do not respond to desmopressin (level of evidence, B). o Desmopressin (DDAVP®) is most effective for children with monosymptomatic enuresis, nocturnal polyuria, and normal bladder capacity (level of evidence, A). DDAVP® is a synthetic form of antidiuretic hormone which causes the kidneys to reabsorb fluid and reduce urine output. Remind parents not to give their child too much drug or too much fluid at night while using DDAVP®. The drug causes water retention, which could lead to seizures. 8. What effect does pregnancy have on the need for thyroid hormone therapy? Even a slightly underactive thyroid—too mild for symptoms—during pregnancy might trigger premature birth and babies born with lower IQs. Most experts suggest increasing levothyroxine doses by 1/3 as soon as pregnancy is confirmed. o The current consensus is to check TSH every 6 weeks during pregnancy. o Most pregnant women will eventually need a 50% higher levothyroxine dose. 9. Differentiate between levothyroxine (LT4) and the other agents used in the treatment of hypothyroidism. 10. What is the association between levothyroxine sodium (Synthroid®, etc.) and: a. osteoporosis? b. fatigued and/or obese euthyroid clients? c. concurrent calcium or soy ingestion? d. treating obesity? 11. Explain the optimum way to take levothyroxine sodium (Synthroid®, etc.) as to when to take, with what, etc. Long acting, providing for once daily dosing, but takes about 6 weeks to reach steady state concentrations Available in tablets in increasing increments of 12.5 µg or 25 µg ranging in dose from 25 µg to 300 µg. o Use about 1.7 µg/kg/day or 100125 µg/day for most younger clients as a replacement dose, but start at a lower dose and titrate up. As one ages, the requirement usually decreases and the dose can be as low as 0.5 µg/kg/day. This will reduce the risk of fracture and atrial fibrillation. o So, older clients and those with heart disease should start with less, normally 25 to 50 µg. Higher doses can lead to A. fib and other arrhythmias. Interesting note is that canines require ~15 µg/kg/day—almost 10 times the human dose. 12. A client is concerned about taking radioactive iodine and how much limitation she will have in contact with others. Outline your “patient education” information you would provide. Patients should allow only 10 minutes of “hug time” with children and should keep about 3 feet away most of the time. 13. Describe the purpose of giving someone potassium iodide following a nuclear accident? These agents block accumulation of radioactive iodine in the thyroid, which helps prevent thyroid cancer, but does not protect other parts of the body or protect against other forms of radiation. 14. Thioamides, such as propylthiouracil (PTU) and methimazole (Tapazole®) are used to treat what condition? How do they work? Hyperthyroidism (Graves disease) 15. What is the recent boxed warning on propylthiouracil? 2010 boxed warning regarding reports of severe liver injury and acute liver failure, in some cases fatal, that have been reported in both adult and pediatric patients who used this drug. 16. List three drugs (other than “sugars”) that may increase blood glucose. 17. What is the current thinking on the use of insulin in clients with type 2 diabetes? 18. Describe inhaled insulin powder (Afrezza®) from the following standpoints: a. Is it absorbed more or less quickly than subcutaneous injection? More quickly because it’s inhaled b. What does the FDA require that all patients be prescreened with prior to prescribing? All patients are prescreened with spirometry testing. c. Does it cause more or less weight gain and hypoglycemia than injected insulin? This seems to result in less weight gain and hypoglycemia than injected insulin d. Is the cost of Afrezza® more, less or about the same as other rapidacting insulins? Cost is about twice the cost of other rapidacting insulins: $280 v. $160 19. In what ways do insulin lispro (Humalog®), aspart (NovoLog ) and glulisine (Apidra®) differ from Regular (R) human insulin, e.g., Humulin®? Generally given subcutaneously, but can give Regular (R) (Humulin®, Novolin®) insulin I.V. in emergencies. Note that insulin analogs, e.g., lispro (Humalog®), aspart (NovoLog®), glulisine (Apidra®), glargine (Lantus®), and detemir (Levemir®) should not be administered I.V. 20. Describe the pharmacokinetic differences in the basal insulins glargine (Lantus®) and detemir (Levemir®) Unlike the other available basal formulations, NPH insulin and Lantus® (insulin glargine), Levemir® is soluble at a neutral pH. 21. What is Toujeo® and how does it differ from Lantus®? Like Lantus®, it is a oncedaily, longacting basal insulin to treat adults with both type 1 and type 2 diabetes but lasts a few hours longer than Lantus®. It has a more gradual and prolonged release of insulin from subcutaneous depot than Lantus®, thus might cause less hypoglycemia. 22. What is the primary use for repaglinide (Prandin®) and nateglinide (Starlix ) and when should these agents be taken in relation to a meal? Repaglinide (Prandin®) and nateglinide (Starlix®), which works in a manner similar to sulfonylureas, is used by type 2 patients to manage mealrelated glucose foods and in type 2 clients on glargine insulin (Lantus®) as a bolus. It is taken before or with meals. 23. What were the primary findings of: a. The Diabetes Control and Complications Trial (DCCT) The report of the Diabetes Control and Complications Trial (DCCT) in NEJM 1993; 329:977986, provides a rationale for more intensive glucose control, which can reduce nephropathy, neuropathy and retinopathy. b. The Kumamoto Trial The Kumamoto study examined whether intensive glycemic control could decrease the frequency or severity of diabetic microvascular complications in 110 patients with type 2 diabetes. c. The UKPDS The landmark United Kingdom Prospective Diabetes Study (UKPDS) is a 20year, prospective randomized clinical trial of 4209 patients which compared the effects of intensive therapy to achieve tight blood glucose control to conventional therapy on the microvascular and macrovascular complications of type 2 diabetes. 24. What is the approximate reduction in1c levels generally achieved by optimum doses of antidiabetic agents? Intensive therapy significantly the mean A1c, 9.4% to 7.1%, compared to conventional therapy and produced reductions in the risk of progression of: Retinopathy 65% Nephropathy 70% DCCT UKPDS Kumamoto A1c reduction 9 to 7% 8 to 7% 9.4 to 7.1% 25. Describe the 2016 changes with metformin regarding dosing and renal function. In a response to mounting evidence, in 2016, the FDA ruled that metformin can be used safely in patients with mild and, in some cases, moderate kidney impairment after decades of warning against it. Metformin previously had been contraindicated for patients with renal disease or dysfunction, as suggested by serum creatinine levels at or above 1.5 mg/dL for men and 1.4 mg/dL for women, or abnormal creatinine clearance. There was a concern for lactic acidosis. 26. A client on your floor is going for a CT with contrast. She is currently taking metformin. Why did the physician issue the order to hold the metformin 48 hours after the CT? However, even with data to suggest that metformin does not cause lactic acidosis, most facilities have the policy that metformin should be withheld 48 hours after procedures in patients undergoing radiologic studies involving intravascular administration of iodinated contrast media, e.g., diatrizoate (Hypaque®), iothalamate (Conray®), iodixanol (Visipaque®), ioversol (Optiray®), because use of such products may result in acute alteration of renal function. Some clinicians recommend holding metformin prior to any surgical procedure or in patients receiving anesthesia since restricted fluid intake may adversely affect renal function. 27. Among the sulfonylureas, which one is now considered the “best” choice for treating type 2 diabetes? And why? Metformin? 28. What is the primary adverse effect of the alpha glucosidase inhibitors (e.g., acarbose—Precose® and miglitol—Glyset )? Flatulence (gas), abdominal discomfort, diarrhea. Adverse GI effects diminish in frequency and intensity over time. 29. What oral agent is generally considered the “firstline” drug for obese or dyslipidemic clients with type 2 diabetes? 30. Outline the recommended drug treatment of a 12 yearold child with type 2 diabetes. Begin with diet modification and an exercise program. Patients should be encouraged to do at least 30 minutes of physical activity a day. The ADA recommends metformin (Glucophage ) for firstline drug 31. What are the reasons that the “glitazones” rosiglitazone (Avandia ) and pioglitazone (Actos ) have basically disappeared in the U.S.? Several toxicities? 32. What are the advantages of the Bydureon® pen over the previous formulation of Bydureon®? Available as twice a day injection (Byetta®) and as Bydureon®, a onceaweek injection of exenatide. 33. What were the findings of the Diabetes Prevention Program? Results show that medication or a combination of “prescribed” diet and exercise can prevent type 2 diabetes or delay type 2 diabetes in patients with impaired glucose tolerance (IGT). 34. Explain the source, indication and mechanism of action of exenatide (Byetta®). What is its role as a “diet drug”? 35. Why would a client with type 2 diabetes and hypertension be treated with an ACE inhibitor (e.g., Capoten®) or an ARB (e.g., Avapro®)? Current diabetes guidelines still recommend starting an ACEI or ARB for this MICROalbuminuria, even in patients without hypertension. That's because MICROalbuminuria was thought to be an early marker for kidney disease, but it turns out this isn't true. Now we know that adding an ACEI or ARB at this early stage does NOT reduce the risk of progression to endstage renal disease. It's a different story for diabetes patients who spill more protein, enough to be called MACROalbuminuria. 36. What are the current guidelines on insulin storage? Bottom line: Unopened insulin vials kept under refrigeration are stable until their labeled expiration dates. For opened vials, ADA suggests that patients be instructed to store vials at room temperature for about one month and to avoid temperature extremes. 37. Bromocriptine has long been used for conditions other than diabetes. What are those? What is the mechanism of action of this drug under the name Cycloset®? Bromocriptine is a synthetic dopamine agonist that is also indicated for pituitary tumors and a variety of hyperprolactinemia syndromes. It is also commonly recognized as a treatment for Parkinson's disease, and was the first dopamine agonist marketed for this purpose. The mechanism of action in treating diabetes is not completely understood. It is thought to involve increased dopaminergic activity in the hypothalamus. It is a synthetic dopamine agonist that is also indicated for Parkinson’s disease and many hyperprolactinemia syndromes. 38. Why is insulin a restricted substance by the International Olympic Committee? 39. What is the role of becaplermin (Regranex®) in the treatment of a client with diabetes? Becaplermin (Regranex®)—a topical gel of recombinant human plateletderived growth factor (rhPDGF) that increases proliferation of cells that repair wounds and form granulation tissue. Used for diabetic leg and foot ulcers. Boxed warning to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. 40. A type2 diabetes client you’re for caring tells you he is taking “Welchol®, which I looked up and it said it was for cholesterol. What’s going on?” Your response? It is the first and only medication approved to reduce both A1C and LDL cholesterol. However, it may increase triglycerides, which are usually present in clients with diabetes. 41. Compare and contrast the following incretins based on their mechanism of action, route of administration, efficacy and effect on weight: a. Sitagliptin (Januvia®) b. Saxagliptin (Onglyza®) c. Liraglutide (Victoza®) d. Exenatide (Byetta®, Bydureon®) e. Linagliptin (Tradjenta®) f. Albiglutide (Tanzeum®) g. Dulaglutide (Trulicity®) h. Lixisenatide (Adlyxin®) 42. Why would a client with diabetes taking Glynase Prestabs® (glyburide) also be taking Cymbalta® or Lyrica®? 43. What is the mechanism of action of canagliflozin (Invokana®) for the treatment of adults with type 2 diabetes? However, later in 2016, The Medical Letter, July 18, 2016, reported on a study (NEJM, June 14, 2016) that found that use of empagliflozin (Jardiance®) has been shown to slow progression of renal disease in patients with type 2 diabetes and established cardiovascular disease. Whether the other two SGLT2 inhibitors, canagliflozin (Invokana®) and dapagliflozin (Farxiga®), have cardiovascular or renal benefits is unknown. All three of these drugs could increase serum creatinine and decrease eGFR, particularly in elderly patients with hypovolemia and other risk facto
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