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Answer: (b) 500 mg. Risedronate (Actonel) With Calcium is a co-package product containing Risedronate sodium tablets, 35 mg for once weekly dosing and calcium carbonate tablets, USP (1250 mg, equivalent to 500 mg elemental calcium) for daily dosing for the remaining 6 days of the week. Each package contains a 28-day course of therapy. Risedronate (Actonel) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. It is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Risedronate (Actonel) should be taken at least 30 minutes before the first food or drink of the day other than water. Risedronate (Actonel) should not be taken at the same time as other medications, including calcium. To facilitate delivery to the stomach, Risedronate (Actonel) should be swallowed while the patient is in an upright position and with a full glass of plain water (6 to 8 oz). Patients should not lie down for 30 minutes after taking the medication. Risedronate (Actonel) is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min). No dosage adjustment is necessary in patients with a creatinine clearance ≥ 30 mL/min or in the elderly. One 1250 mg calcium carbonate tablet (500 mg elemental calcium) orally, taken with food daily on each of the remaining six days (Days 2 through 7 of the 7-day treatment cycle). Arthralgia, myalgia and nausea are commonly reported side effects of Risedronate (Actonel).

What is an elemental calcium amount in Actonel With Calcium?

b

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Answer: (c) Vitamin D3. Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Fosamax Plus D contains Alendronate sodium, a bisphosphonate, and Cholecalciferol (vitamin D3). Cholecalciferol (vitamin D3) is a secosterol that is the natural precursor of the calcium-regulating hormone calcitriol (1,25 dihydroxyvitamin D3). It is indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. The recommended dosage is one 70 mg Alendronate/2800 international units vitamin D3 or one 70 mg Alendronate/5600 international units vitamin D3 tablet once weekly.

Which of the following active ingredients found in Fosamax Plus D?

c

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Answer: Management of chronic weight reduction. The U.S. Food and Drug Administration today approved Contrave (Naltrexone hydrochloride and Bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). The most common adverse reactions reported with Contrave include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

FDA has recently approved Contrave (Naltrexone hydrochloride and Bupropion hydrochloride extended-release tablets). Contrave is indicated for the treatment of:

c

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Answer:II and III only. 1. S.T.E.P.S. stands for System for Thalidomide Education and Prescribing Safety, a proprietary education and restrictive distribution program for Thalomid (Thalidomide). The S.T.E.P.S. program was developed because of the toxicity associated with fetal exposure to Thalomid (Thalidomide) and to minimize the chance of fetal exposure to Thalomid (Thalidomide). 2. Thalidomide in combination with Dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma and Erythema Nodosum Leprosum. 3. All prescribers must register in the S.T.E.P.S. Prescriber Registry via the Prescriber Registration Card that is located in every S.T.E.P.S. folder. 4. Only licensed prescribers may register. They should complete, sign, and return the Prescriber Registration Card. Prescriptions cannot be issued by telephone under this program. 5. Prescribers shall not prescribe more than 4 weeks (28 days) of therapy with no automatic refills. A patient shall be informed that all prescriptions must be filled within 7 days (NOT 3 days).

Which of the following statements are TRUE about S.T.E.P.S. Programs? I. All prescriptions prescribed under these programs must be filled within 3 days. II. Prescribe no more than 4 weeks (28 days) of therapy, with no automatic refills. III. All prescribers must register in the S.T.E.P.S. Prescriber Registry via the Prescriber Registration Card that is located in every S.T.E.P.S. folder.

c

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Answer:(d), All. Ebola hemorrhagic fever (Ebola HF) is one of numerous Viral Hemorrhagic Fevers. It is a severe, often fatal disease in humans and nonhuman primates (such as monkeys, gorillas, and chimpanzees). Ebola HF is caused by infection with a virus of the family Filoviridae, genus Ebolavirus. When infection occurs, symptoms usually begin abruptly. The first Ebolavirus species was discovered in 1976 in what is now the Democratic Republic of the Congo near the Ebola River. Since then, outbreaks have appeared sporadically. There are five identified subspecies of Ebolavirus. Four of the five have caused disease in humans: Ebola virus (Zaire ebolavirus); Sudan virus (Sudan ebolavirus); Taï Forest virus (Taï Forest ebolavirus, formerly Côte d'Ivoire ebolavirus); and Bundibugyo virus (Bundibugyo ebolavirus). The fifth, Reston virus (Reston ebolavirus), has caused disease in nonhuman primates, but not in humans.

Which of the following information is/are TRUE about Ebola Hemorrhagic Fever? I. It is a viral hemorrhagic fevers. II. It is a severe, often fatal disease in humans and nonhuman primates. III. It is caused by infection with a virus of the family Filoviridae.

d

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Answer: (a) I only, Cardioviva is a natural, over-the-counter probiotic supplement. The probiotic strain in Cardioviva is Lactobacillus reuteri. It is clinically proven to support healthy Cholesterol levels in adults. The suggested dose is one 100 mg capsule twice daily with meals. Gas and bloating are commonly reported side effects of Cardioviva.

Which of the following information about Cardioviva is/are TRUE? I. It is a natural, over-the-counter probiotic supplement. II. It is clinically proven to support healthy knee cartilage in adults. III. The probiotic strain in Cardioviva is Lactobacillus acidophilus.

a

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Answer: (d), All. The Ebola virus currently raging in West Africa has a well-earned reputation as one of the world's most deadly illnesses. But experts stress that early and intense medical care can greatly improve a person's chances of survival. There's no cure or vaccine for Ebola, which wreaks life-threatening havoc within the body by attacking multiple organ systems at the same time. Instead, doctors must fall back on the basics of "good meticulous intensive care,"supporting the patient and targeting treatment toward the organs that are under attack by the virus. The virus is particularly tough to combat because once it gets into the human body, it attacks so many different tissues. In contrast, most viruses tend to target one specific organ. For example, influenza goes after the respiratory system. Ebola attacks every organ system, including the heart, lungs, brain, liver and kidneys. It even attacks a person's blood, thinning it and causing Ebola's trademark bleeding from multiple orifices.

Which of the following information about the Ebola virus is/are TRUE? I. There's no cure or vaccine for Ebola. II. Ebola wreaks life-threatening havoc within the body by attacking multiple organ systems at the same time. III. Experts stress that early and intense medical care can greatly improve a person's chances of survival.

d

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Answer: (d), Flonase. The U.S. Food and Drug Administration (FDA) has approved Flonase Allergy Relief (fluticasone propionate 50 mcg spray)as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies. Flonase Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms3,4 including runny nose, sneezing, itchy nose, nasal congestion and itchy and watery eyes.Flonase Allergy Relief will be available at full prescription strength and to provide 24-hour non-drowsy allergy relief.

In a near future, which of the following nasal corticosteroids will be available OTC?

d

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Answer: (c) Naloxone. The active ingredients found in Targiniq ER are Oxycodone and Naloxone. It is an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, anxiety, and sweating are commonly reported side effects of (Oxycodone + Naloxone) Targiniq ER.

Targiniq ER is an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Which of the following drugs provides abuse-deterrent property to Targiniq ER?

c

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Answer:(d). CDC Vaccine Storage Recommendations List: Vaccines Require To Be Stored In Referigerator (2 to 8 degrees C): HepA HepB HepA-HepB Hib (Haemophilus influenzae type b) Hib-HepB HPV (Human papilloma virus) Influenza Meningococcal-combinations MMRa* (Measles, mumps, rubella) Pneumococcal Rotavirus Any diphtheria/tetanus toxoid, pertussis combination Vaccines Require To Be Stored In Freezer (-50 to -15 degrees C): VAR Varicella HZV (Herpes Zoster Vaccine) MMRa (Measles, mumps, rubella) MMRV (Measles, mumps, rubella, varicella) * Can be stored in freezer or referigerator.

All of the following vaccines can be stored in a refrigerator EXCEPT:

d

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Answer: (e), Afrezza. The U.S. Food and Drug Administration has recently approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal. Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke. Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.

The U.S. Food and Drug Administration has recently approved Insulin Human Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. It is available under the trade name:

e

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Answer: (b), Bupropion. Bupropion hydrochloride (Wellbutrin) is an antidepressant of the aminoketone class. It is supplied for oral administration as 75-mg (yellow-gold) and 100-mg (red) film-coated tablets. It is indicated for the treatment of major depressive disorder (MDD). The recommended starting dose is 200 mg per day, given as 100 mg twice daily. After 3 days of dosing, the dose may be increased to 300 mg per day, given as 100 mg 3 times daily, with at least 6 hours between successive doses. Dosing above 300 mg per day may be accomplished using the 75-or 100-mg tablets. A maximum of 450 mg per day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at 300 mg per day. Administer the 100-mg tablet 4 times daily to not exceed the limit of 150 mg in a single dose. To minimize the risk of seizure, increase the dose gradually. Increases in dose should not exceed 100 mg per day in a 3-day period. Due to its CNS stimulation property, it shall be avoided in patients suffering from severe anxiety. In such patients, instead Bupropion, one can use Mirtazapine or Paroxetine for its sedative effects. Below is the list of antidepressants and their special effects:

A patient with severe anxiety and depression shall avoid which of the following antidepressants?

b

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Answer: Schedule III controlled drug, [Section 811(g)(3)(A) Controlled Substances Act]. To be exempt from controlled substance requirement, the ratio of Acetaminophen to Butalbital is set to 70:15. In other words, for every 15mg Butalbital, there shall be at least 70 mg or more Acetaminophen required to exempt the formulation from controlled substance requirement. In above prescription, the quantity of Butalbital is 50 mg; to exempt it from controlled substance requirement, we need to mix it with at least 233 mg or more Acetaminophen. The prescriber has requested Acetaminophen quantity to be set to 200mg; therefore the final formulation shall be classified as Schedule III controlled substance. **Please note: Butalbital is classified as Schedule III controlled drug under the DEA. ** Currently, Fioricet (Acetaminophen 3mg, Butalbital 50mg and Caffeine 40mg) is classified as a Schedule III controlled drug under the Georgia State Pharmacy Law. **

A pharmacist receives a new prescription to compound each capsule such a way so that it contains 200mg Acetaminophen, 50mg Butalbital and 40mg Caffeine. The final formulation of this compounded prescription shall be classified as:

a

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Answer: (d) All. The illegal production and distribution of methamphetamine is an increasing problem nationwide. The methamphetamine is a highly addictive drug that can be manufactured in small and portable laboratories. These laboratories are operated by individuals who manufacture the drug in a clandestine and unsafe manner, often resulting in explosions and fires that can injure not only the individuals involved, but their families, neighbors, law-enforcement officers and firemen. The use of methamphetamine can result in fatal kidney and lung disorders, brain damage, liver damage, blood clots, chronic depression, hallucinations, violent and aggressive behavior, malnutrition, disturbed personality development, deficient immune system and psychosis. Children born to mothers who are abusers of methamphetamine can be born addicted and suffer birth defects, low birth weight, tremors, excessive crying, attention deficit disorder and behavior disorders. In addition to the physical consequences to an individual who uses methamphetamine, usage of the drug also produces an increase in automobile accidents, explosions and fires, increased criminal activity, increased medical costs due to emergency room visits, increases in domestic violence, increased spread of infectious diseases and a loss in worker productivity. That environmental damage is another consequence of the methamphetamine epidemic. Each pound of methamphetamine produced leaves behind five to six pounds of toxic waste. Chemicals and byproducts that result from the manufacture of methamphetamine are often poured into plumbing systems, storm drains or directly onto the ground. Clean up of methamphetamine laboratories is extremely resource-intensive, with an average remediation cost of five thousand dollars.

Which of the following statements about methamphetamine is/are TRUE? I. Methamphetamine is a highly addictive drug that can be manufactured in small and portable laboratories. II. The use of methamphetamine can result in fatal kidney and lung disorders, brain damage, liver damage and blood clots. III. Each pound of methamphetamine produced leaves behind five to six pounds of toxic waste. IV. Children born to mothers who are abusers of methamphetamine can be born addicted and suffer birth defects, low birth weight, tremors, excessive crying, attention deficit disorder and behavior disorders.

d

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Answer:(c). A pharmacist, dispensing prescriber, or veterinarian who dispenses a prescription drug which is a controlled substance listed in schedules 2 to 5 shall transmit the data by electronic media or other means as approved by the State Pharmacy Board. The requested data shall be transmitted in the format established by the American Society for Automation in Pharmacy (ASAP) telecommunications format for controlled substances.

A pharmacist, dispensing prescriber, or veterinarian who dispenses a prescription drug which is a controlled substance listed in schedules 2 to 5 shall transmit the data by electronic media or other means as approved by the State Pharmacy Board. The requested data shall be transmitted in the format established by the:

c

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Answer: (b). 1. "Prescription"means: (a). An order given individually for the person for whom prescribed, directly from the practitioner, or the practitioner's agent, to a pharmacist or indirectly by means of an order signed by the practitioner or an electronic transmission from the practitioner to a pharmacist. (b). A chart order written for an inpatient specifying drugs which he or she is to take home upon discharge. 2. "Prescription"does not include a chart order written for an inpatient for use while he or she is an inpatient.

“Prescription” means: I. An order given individually for the person for whom prescribed, directly from the practitioner, or the practitioner’s agent, to a pharmacist. II. A chart order written for an inpatient specifying drugs which he or she is to take home upon discharge. III. A chart order written for an inpatient for use while he or she is an inpatient.

b

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Answer: (d) Acarbose (Precose) is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. It delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, Precose reduces levels of glycosylated hemoglobin in patients with type 2 diabetes mellitus. In contrast to sulfonylureas, Precose does not enhance insulin secretion. The antihyperglycemics action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia. The recommended starting dosage of Acarbose (Precose) is 25 mg given orally three times daily at the start (with the first bite) of each main meal . However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d. Hypoglycemia, gas, bloating and diarrhea are commonly reported side effects of Acarbose (Precose).

A pharmacist is reviewing a new prescription prepared by a pharmacy technician. The prescription label reads: Precose 25mg PO TID x 30 days; Qty: 90 5 Refills. Which of the following acts done by the pharmacist is the most appropriate?

d

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Answer: (b). On January 13, 11, the U.S. Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, including combination acetaminophen and opioid products, to no more than 325 mg per dosage unit. The FDA hasstated that limiting the amount of acetaminophen per dosage unit in prescription products may reduce the risk of severe liver injury from acetaminophen overdosing. The FDA requested this change be effected by January 14. Abbott, the manufacturer of Vicodin, has complied with this directive ahead of the FDA’s requested date and has introduced new formulations of Vicodin (Hydrocodone bitartrate and Acetaminophen tablets, USP) with reduced acetaminophen content in the third quarter of12.Vicodin is available in the following new formulations: 1. VICODIN (hydrocodone bitartrate and acetaminophen tablets, USP) 5 mg/300 mg 2. VICODIN ES (hydrocodone bitartrate and acetaminophen tablets, USP) 7.5 mg/300 mg 3. VICODIN HP (hydrocodone bitartrate and acetaminophen tablets, USP) 10 mg/300 mg.

What would be the new Acetaminophen strength in a newly reformulated Vicodin?

b

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Answer: (c). PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine. PNEUMOVAX 23 is NOT approved for use in children younger than 2 years of age because children in this age group do not develop an effective immune response to capsular types contained in the polysaccharide vaccine. The Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with PNEUMOVAX 23. Routine revaccination of immunocompetent persons previously vaccinated with a23-valent vaccine, is not recommended. All persons in this category should receive the pneumococcal vaccine, including previously unvaccinated persons and persons who have not received vaccine within 5 years (and were <65 years of age at the time of vaccination). For any person who has received a dose of pneumococcal vaccine at age greater than 65 years, revaccination is not indicated. Pneumococcal vaccine is administered intramuscularly or subcutaneously as one 0.5-mL dose. Pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine. Pneumococcal vaccine also may be administered concurrently with other vaccines. The administration of pneumococcal vaccine with combined diphtheria, tetanus, and pertussis (DTP); poliovirus; or other vaccines does not increase the severity of reactions or diminish antibody responses. Canadian and U.S. product labeling do say to consider separating administration of Zostavax and Pneumovax 23 by at least four weeks, since concurrent administration of these vaccines can reduce patients’ immune responses to Zostavax.

Which of the following information regarding Pneumovax 23 is TRUE?

c

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Answer: (d). If more than one non-oral live vaccine (e.g., live attenuated influenza vaccine [LAIV], varicella, mumps) needs to be administered, it is recommended that thevaccines be given on the same day. However, if this is not possible, doses of the live vaccines should be separated by at least four weeks. The four-week interval reduces the interference of immune response to the firstvaccine by the second vaccine. This rule for separation does not apply to the administration of oral live vaccines not given on the same day: typhoid and rotavirus. These vaccines can be given less than four weeks apart. However, this scenario isn’t likely to occur because the age groups for which these vaccines are recommended do not overlap. In addition, parenteral or intranasal administration of a live vaccine is not thought to affect the immune response of a subsequently administered oral live vaccine. A live vaccine and an inactivated vaccine can be administered without regard to the timing of the other. Antipyretics/analgesics such as acetaminophen or ibuprofen should not routinely be given prior to immunization. They might reduce a patient’s immune response. However, if needed, these meds can be used for treatment of fever and pain as needed following vaccination.

Which of the following statements is NOT TRUE about vaccines or immunizations?

d

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Answer: (c). Since both the 250 mg and 500 mg tablets of amoxicillin/clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin/clavulanate potassium 250 mg tablets are not equivalentto one 500 mg amoxicillin/clavulanate potassium tablet. Therefore two 250 mg amoxicillin/clavulanate potassium tablets should not be substituted for one 500 mg amoxicillin/clavulanate potassium tablet.

A pharmacist receives a new prescription for Augmentin 500 mg. The prescription reads 1 tab po bid x 10 days. A technician in the pharmacy fills and processes the prescription using 250 mg of Augmentin instead, since the pharmacy is out of stock of 500 mg Augmentin tablets. The pharmacist who is doing the final check of the prescription should:

c

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Answer: (e). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of Tyzeka (Telbivudine) alone or in combination with antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Tyzeka. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue antihepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Which of the following is/are reported side effects of Tyzeka? I. Lactic acidosis II. Severe hepatomegaly with steatosis III. Acute exacerbations of hepatitis B

e

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Answer: (e). Elixir contains 5 to 40% alcohol. All of the mentioned drugs have been found to interact with alcohol and may produce disulfiram-like reactions. Ethanol is generally converted to acetaldehyde by an alcohol dehydrogenase enzyme, which is then subsequently converted to acetic acid by action of aldehyde dehydrogenase enzyme. Accumulation of acetaldehyde may be responsible for producing hot flashing, throbbing headaches and disulfiram-like reactions. All of the above drugs inhibit the aldehyde dehydrogenase enzyme and produce disulfiram-like reactions. Therefore, the final dosage form of these all mentioned drugs could not be an elixir.

The final dosage form of which of the following drug(s) could not be an elixir ? I. Cefobid II. Moxalactam III. Flagyl

e

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Answer: (e). Brovana (Arformoterol tartrate) is a selective beta2-adrenergic bronchodilator. It is indicated for the long term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is for use by nebulization only. The recommended dose of Brovana (Arformoterol tartrate) inhalation solution for COPD patients is 15 mcg administered twice a day (morning and evening) by nebulization. A total daily dose greater than 30 mcg (15 mcg twice daily) is not recommended. Brovana should be stored refrigerated in foil pouches. Asthenia, fever, headache, vomiting, hyperkalemia, leukocytosis, nervousness, and tremor are reported side effects of Brovana.

Which of the following would indicate that a patient understands why he is taking Brovana?

e

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Answer: (c). Risperdal (Risperidone) is classified as an antipsychotic agent. It is available in tablet, oral solution and orally disintegrating tablet form. Each tablet for an oral administration contains 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, or 4 mg Risperidone. It is also available as a 1 mg/mL oral solution. Risperdal M-Tab (orally disintegrating tablets) are available in 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. It is indicated for the acute and maintenance treatment of schizophrenia. On October 6, 2006 - The U.S. Food and Drug Administration (FDA) approved Risperdal (Risperidone) orally disintegrating tablets, an adult antipsychotic drug, for the symptomatic treatment of irritability in autistic children and adolescents. The approval is the first for the use of a drug to treat behaviors associated with autism in children. These behaviors are included under the general heading of irritability, and include aggression, deliberate self-injury, and temper tantrums. The dosage of Risperdal should be individualized according to the response and tolerability of the patient. The total daily dose of Risperdal can be administered once daily or half the total daily dose can be administered twice daily. Caution should be exercised with dosage for smaller children who weigh less than 15 kg. NMS, tardive dyskinesia, extrapyramidal symptoms and agitation are reported side effects of the drug.

The FDA has recently approved Risperdal-M Tab for which of the following indications?

c

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Answer: (b). Pylera capsules are a combination antimicrobial product containing Bismuth subcitrate potassium, Metronidazole, and Tetracycline hydrochloride for oral administration. Each hard gelatin capsule contains: 1. Bismuth subcitrate potassium, 140 mg 2. Metronidazole, 5 mg 3. Tetracycline hydrochloride, 5 mg Pylera capsules, in combination with Omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence. Each dose of Pylera includes 3 capsules. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime for 10 days. Patients should be instructed to swallow the Pylera capsules whole with a full glass of water (8 ounces). One Omeprazole 20 mg capsule should be taken twice a day with Pylera after the morning and evening meal for 10 days.

Pylera is indicated for the treatment of:

b

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Answer: (c). Fentora (Fentanyl buccal tablet) is a potent opioid analgesic, intended for buccal mucosal administration. Fentora is formulated as a flat-faced, round, beveled-edge white tablet. Fentora is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of Fentanyl across the oral mucosa. Fentora employs the OraVescent drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of Fentanyl through the buccal mucosa. Each tablet contains Fentanyl citrate equivalent to Fentanyl base: 100, 200, 300, 400, 600 and 800 micrograms. It is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal Fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. This product must not be used in opioid non-tolerant patients because life-threatening hypoventilation and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, Fentora is contraindicated in the management of acute or postoperative pain. Physicians should individualize treatment using a progressive plan of pain management. For opioid-tolerant patients not being converted from Actiq, the initial dose of Fentora is always 100 mcg.

Fentora is an effervescent buccal formulation of the potent opioid analgesic:

c

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Answer: (e). Ativan (Lorazepam) is classified as the benzodiazepine class of drugs. It is indicated for the treatment of anxiety and insomnia. The parenteral form of Lorazepam reduces the severity and duration of nausea and vomiting associated with emetogenic cancer therapy. It is available in tablet, concentrated oral solution and injection form. Sedation, depression, constipation, lethargy, fatigue, diplopia and nystagmus are reported side effects of the drug. Librium (Chlordiazepoxide), Tranxene (Clorazepate), Valium (Diazepam) and Serax (Oxazepam) are indicated for the relief of acute alcohol withdrawal symptoms like agitation, tremor, impending and acute delirium.

Which of the following sedative hypnotic agents is useful as an antiemetic agent for treatment of cancer chemotherapy-induced nausea and vomiting?

e

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Answer: (d). Travatan Z (Travoprost) is a new formulation of Travatan solution in which benzalkonium chloride is replaced with SofZia, a robust ionic buffered preservative system that is gentle to the ocular surface. Travoprost is a synthetic prostaglandin F analogue. It is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, who are intolerant of or insufficiently responsive to other intraocular pressure lowering medications. The recommended dosage is one drop in the affected eye(s) once daily in the evening. It should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.

What is the major difference between Travatan and Travatan Z?

d

8

None

Answer: (d). Noxafil (Posaconazole) is a triazole antifungal agent available in a suspension for an oral administration. It is a white, cherry flavored immediate-release suspension containing 40 mg of Posaconazole per ml. It is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT)recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. It is also indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. Each dose of Noxafil should be administered during or immediately (i.e. within 20 minutes) following a full meal. In patients who cannot eat a full meal, each dose of Noxafil should be administered with a liquid nutritional supplement or an acidic carbonated beverage. For patients who cannot eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage, alternative antifungal therapy should be considered or patients should be monitored closely for breakthrough fungal infections. A pharmacist should instruct a patient to shake Noxafil oral suspension well before use. Arrhythmias, QT prolongation and liver toxicity are reported side effects of the drug.

Which of the following auxiliary labels requires before dispensing Noxafil?

d

7

None

Answer: (e). Humira (Adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). It is supplied as a sterile, preservative-free solution of Adalimumab for subcutaneous administration. It is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and Crohn's disease. The recommended dose of Humira for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 40 mg administered every other week. The recommended dose of Humira for patients 4 to 1 years of age with polyarticular juvenile idiopathic arthritis is based on weight of patients. The recommended dose of Humira for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. Patients treated with Humira are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Humira should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1. Active tuberculosis, including reactivation of latent tuberculosis. 2. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. 3. Bacterial, viral and other infections due to opportunistic pathogens.

Humira is NOT indicated for which of the following?

e

6

None

Answer: (d). Abilify (Aripiprazole) is classified as an antipsychotic agent. It is indicated for the treatment of schizophrenia. The recommended therapeutic dose of the drug is 10 to 30 mg once a day without regard to meals. NMS, tardive dyskinesia, extrapyramidal symptoms and agitation are reported side effects of Abilify. It is available as a tablet for an oral administration.

Abilify is indicated for the treatment of:

d

5

None

Answer: (c). Xolegel contains the antifungal agent Ketoconazole 2% in a topical anhydrous gel vehicle for topical administration. It is indicated for the topical treatment of seborrheic dermatitis in immuno competent adults and children 12 years of age and older. The gel should be applied once daily to the affected area for 2 weeks. Xolegel is for topical use only, and not for oral, ophthalmic, or intra vaginal use.

What is the name of the active ingredient in Xolegel?

c

4

None

Answer: (e). Zelapar orally disintegrating tablets contain Selegiline hydrochloride as an active ingredient. Selegiline is best known as an irreversible inhibitor of monoamine oxidase (MAO). It is available for oral administration (not to be swallowed) in a strength of 1.25 mg. It is indicated as an adjunct in the management of patients with Parkinson&#39;s disease (not the hypertension) being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to the therapy.&nbsp; Treatment should be initiated with 1.25 mg given once a day for at least 6 weeks. After 6 weeks, the dose may be escalated to 2.5 mg given once a day if a desired benefit has not been achieved and the patient is tolerating Zelapar. It should be taken in the morning before breakfast and without liquid. A severe hypertensive crisis, orthostatic/postural hypotension, dizziness, somnolence, ECG abnormality, nausea, dyspepsia, abnormal dreams, and infection are reported side effects of Zelapar.

A physician writes the following prescription: Zelapar 1.25 mg tablets qty. 30 1 tab p.o. daily for hypertension. Which of the following would be the MOST APPROPRIATE action of the pharmacist?

e

3

None

Answer: (a). Gardasil is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine: 1. Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18. 2. Genital warts (condyloma acuminata) caused by HPV types 6 and 11. It is also indicated in boys and men 9 through 26 years of age for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11.

Gardasil is a vaccine indicated for the prevention of which of the following diseases caused by Human Papillomavirus (HPV)?

a

2

None

Answer: (c). The active ingredient of Abelcet is Amphotericin B. It is also available under the following trade names: Amphotec (a powder for injection), and Ambisome (a liposomal form). It should be given parenterally via an I.V. infusion. It is an antifungal agent. It is indicated for the treatment of invasive fungal infections caused by invasive aspergillosis. The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. Abelcet should be administered by intravenous infusion at a rate of 5 mg/kg/h. If the infusion time exceeds hours, mix the contents by shaking the infusion bag every hours. Patients should be pretreated with antipyretics, antihistamines, antiemetics and with Meperidine to reduce the signs and symptoms of shaking chills and fever. Abdominal pain, anorexia, anxiety, hypokalemia, anemia, nephrotoxicity and diarrhea are reported side effects of the drug.

An active ingredient of Ablecet is:

c

1

None

Answer: (c). Orapred ODT (Prednisolone sodium phosphate disintegrating tablets) is a sodium salt of the phosphoester of the glucocorticoid prednisolone. It is indicated in the treatment of the atopic dermatitis, Crohn's disease, ulcerative colitis and acute exacerbations of chronic obstructive pulmonary disease (COPD). Dosage of Orapred ODT should be individualized according to the severity of the disease and the response of the patient. The initial dose of Orapred ODT may vary from 0 to 60 mg (prednisolone base) per day, depending on the specific disease entity being treated. Fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain are commonly reported side effects of Orapred.

Which of the following is an orally disintegrating tablet formulation of prednisolone, used to treat exacerbations of asthma and other inflammatory diseases and conditions in children?

c