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Lesson 1 - Introduction to Pharmacology Assignment Answer Key

Assignment 1 - At Your Service Review the At Your Service scenario on page 171 of the Pharmacy Technician Practice and Procedures textbook. Then answer the following question.

Is this a side effect of naproxen and what should she do? Answer: Inform the pharmacist of the situation regarding Mary Smith. The pharmacist will examine the patient’s drug profile and determine if any other medications may be contributing to this problem. Both the stomach distress and drowsiness are side effects of naproxen. The pharmacist will counsel Mary on the proper taking of her prescription and suggest that she take her medicine with some food or milk to avoid the stomach problems. In addition, the pharmacist will attempt to find out about the intensity of the drowsiness. Depending on its severity, the pharmacist may recommend that the patient speak to her doctor.

Assignment 2 - Critical Thinking

1. A patient picks up a prescription from the pharmacy and begins to read the drug monograph that accompanies the prescription. He or she becomes disturbed after reading the side effects associated with the prescription. How would you handle the situation? What would you say to the patient?

2. A 180-lb man is picking up a prescription for Coumadin for both his wife (110 lb) and himself. He notices the strength for his prescription is for 2.5 mg each day and his wife’s prescription is 7.5 mg every day. He is perplexed at the differences in the dosing on the prescription and asks if a mistake was made. You check the original prescriptions the man presented to the pharmacy and the prescriptions were filled correctly. How would you explain this situation to the man regarding the dosing?

3. A pregnant woman is having an antibiotic prescription filled for a respiratory infection. She did not mention to her physician that she was pregnant. What would you do to find out if the prescription is safe for her to take? Where would you find the information?

4. A diabetic patient is purchasing strips for his glucometer. He mentions to you that because of the cost of the test strips, he is testing his blood only every other day. What would you do after hearing the patient’s statement?

5. A customer presents a prescription for Wellbutrin XL 150 mg. The physician has approved the use of a generic product. The patient is surprised that the cost of the prescription is 65% less than the brand name product. The patient wants to know if it is the same drug. What type of testing occurs to ensure that it will provide the same results as the brand name?

Answers: Possible answers may include: 1. Explain to the patient that the possible side effects are only added as a precaution

and not everyone reacts the same to a certain medication. Let the patient know that chances are he won’t experience any of these side effects but if he did to consider whether the positive effects of taking the medication outweighs the negative ones of the side effects. Also, advise him that the dosage can be changed if he finds he is bothered by side effects or that he may seek additional medical treatment in order to get the drug changed.

2. Explain to the patient that the difference in the dosage is affected by many different factors such as gender, age, weight, physiological, pathological and genetic to name a few.

3. Check to see what pregnancy category the antibiotic fell under and then check on the FDA website to see if the prescribed antibiotic was safe for a pregnant woman.

4. Suggest to the patient that he get a prescription from his doctor so the strips would be covered.

5. Explain to the patient that all drugs whether they are generic or brand name go through strict testing by the FDA before they are released. One such test performed by the FDA is called Bioavailability.

Assignment 3 - HIPAA Scenario

Paul is a pharmacy technician who was recently hired to work in a small retail pharmacy. His friends stop by occasionally to chat with him when they shop at the store. One day his friend Sam asks him if he can refill his wife’s prescription for her pain medication. When Paul asks Sam for the name of the medication, Sam tells him that it is Tylenol with codeine #3. Paul checks the wife’s profile, sees a prescription for acetaminophen with codeine #3, and processes the refill for Sam. Later in the day, Sam calls the pharmacy and informs the pharmacist the wrong medication was dispensed to him and the medicine is not controlling the pain. The pharmacist speaks to Sam and informs him the generic medication was dispensed. Two days later, Sam’s wife calls in a refill for the same medication. After several minutes Paul learns that Sam’s wife never received the refill he gave to Sam. Afraid to admit that he allowed Sam to refill the prescription without any authorization from his spouse, Paul goes to his supervisor for help.

Discussion Questions:

1. How would you explain to Sam the difference between a brand name drug and the generic drug?

2. What factors could affect how the medication works in the body?

3. Could someone have an addiction in this situation and if so, what type? Answers: Possible answers may include:

1. Explain to Sam the only difference in the generic drug from the brand drug is in the pricing with the generic being cheaper to purchase. They both contain the same active ingredients.

2. There are many different factors that would affect how it worked in the body including, age, gender, weight, physiological, pathological and genetic factors.

3. There could be drug dependence here as the prescribed drug is considered a narcotic which can alter ones mood or perception. And considering Sam did not give the prescribed medication to his wife to whom it was prescribed it is assumed he used it for himself, therefore making his motives suspect and indicating he may be addicted to the drug.

Assignment 4 - Internet Activities

1. Visit www.fda.gov and identify 10 medications that have recently been approved to be available as a generic drug.

2. Visit www.fda.gov and find information on adverse event reporting. What type of information is required when filling out this form?

3. Visit your state board of pharmacy web site and review the regulations regarding generic drug substitution. What conditions must be met in dispensing generic medications in your state?

4. Visit www.fda.gov and identify medications that have had medical and clinical pharmacology review conducted. Answers: Possible answers may include: 1. 10 medications approved to be available as a generic drug:

1. FINASTERIDE 2. BUPIVACAINE HYDROCHLORIDE 3. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 4. METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 5. RABEPRAZOLE SODIUM 6. TERBUTALINE SULFATE 7. FELODIPINE 8. OCTREOTIDE ACETATE 9. METHYLPHENIDATE HYDROCHLORIDE 10. VANCOMYCIN HYDROCHLORIDE

2. The Adverse Event Reporting System (AERS) is a computerized information database

designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. Some of the information required on the form includes; month the event occurred, number of reported deaths, and Reported Deaths with One or More Allergic/Hypotensive Symptom(s).

3. A. A pharmacist shall substitute a less expensive drug product containing the . active

ingredients, dosage form and strength as the drug product prescribed, ordered or demanded, provided that the following conditions are met: The prescription is written on a form which meets the requirements of subdivision six of section sixty-eight hundred ten of this article and the prescriber does not prohibit

http://www.fda.gov/

http://www.fda.gov/

http://www.fda.gov/

substitution, or in the case of oral prescriptions, the prescriber must expressly state whether substitution is to be permitted or prohibited. Any oral prescription that does not include such an express statement shall not be filled; and B. The substituted drug product is contained in the list of drug products established pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law; and C. The pharmacist shall indicate on the label affixed to the immediate container in which the drug is sold or dispensed the name and strength of the drug product and its manufacturer unless the prescriber specifically states otherwise. The pharmacist shall record on the prescription form the brand name or the name of the manufacturer of the drug product dispensed.

4. Medications that have had medical and clinical pharmacology review conducted. Drug Sponsor Medical

Review Clinical Pharmacology Review

Statistical Review BPCA or PREA or Both

Abacavir - Ziagen GlaxoSmithKline Medical(PDF - 588KB)

Clinical pharmacology (PDF - 248KB)

None PREA

Abatacept - Orencia Bristol-Myer-Squibb

Medical(PDF -8MB)[*note for vision impaired users]

Clinical pharmacology (PDF -4MB)[*note for vision impaired users]

Statistical (PDF -24MB)[*note for vision impaired users]

PREA

Acetaminophen - Ofirmev

Cadence Pharmaceuticals, Inc.

Medical(PDF -2MB) Medical(PDF -21KB)

Clinical pharmacology (PDF - 2MB)

None PREA

Acyclovir, Hydrocortisone - Xerese

Medivir AB Medical(PDF -1MB)

Clinical pharmacology (PDF -120 KB)

Statistical (PDF -1MB) PREA

Adalimumab - Humira Abbot Medical(PDF -9MB)[*note for vision impaired users]



PREA

Adapalene - Epiduo Galderma Laboratories LP

Medical(PDF -1MB)

Clinical pharmacology (PDF 1MB)


Adapalene Lotion, 0.1% - Differin Lotion, 0.1%

Galderma Laboratories LP


Clinical pharmacology (PDF -752KB)

Statistical (PDF -417KB)

PREA

Adefovir - Hepsera Gilead Sciences Inc

Medical(PDF -1MB)



Both

Albuterol sulfate HFA - Ventolin HFA

GlaxoSmithKline Medical(PDF -1MB)



BPCA

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm129534.pdf



http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM072801.pdf

































Alcaftadine - Lastacaft Vistakon Pharmaceuticals

Medical(PDF -597KB)



Alfuzosin - Uroxatral Sanofi-aventis U.S., Inc.

Medical(PDF -850KB)



BPCA

Almotriptan - Axert Johnson and Johnson

Medical(PDF -9MB)

Clinical pharmacology (PDF -1MB)

None BPCA

Amoxicillin/APC -111 - Moxatag

MiddleBrook Pharmaceuticals

Medical(PDF -3MB)



Amoxicillin/Clavulanate potassium - Augmentin XR

GlaxoSmithKline Medical(PDF -67KB)


None PREA

Anastrozole - Arimidex AstraZeneca Medical(PDF -2MB)



BPCA

Argatroban - Argatroban

ENCYSIVE Pharmaceuticals Inc.

Medical(PDF -168KB)

Clinical pharmacology (PDF -450 KB)

None BPCA

Aripiprazole - Abilify Otsuka Pharmaceutical Company

Medical(PDF -2MB)



Both

Aripiprazole - Abilify Otsuka Pharmaceutical Company

Medical(PDF -1MB) Medical Addendum(PDF -64KB)

None Statistical (PDF -338KB)

PREA

Aripiprazole - Abilify Otsuka Pharmaceutical Development & Commercialization, Inc

Medical(PDF -1.24MB)


PREA

Aripiprazole - Abilify Otsuka Pharmaceutical Company, Ltd.

Medical(PDF -2MB)

Clinical pharmacology (PDF -51KB


BPCA

Atazanavir - Reyataz Bristol-Myers Squibb Company

Medical(PDF -4MB)


None PREA

Azelastine hydrochloride - Astepro

MEDA Medical(PDF -633KB) Medical(PDF -3MB)


Statistical (PDF -204KB) Statistical (PDF -985KB)

PREA

Azelastine hydrochloride and Fluticasone proprionate - Dymista

Meda Pharmaceuticals, Inc.

Medical(PDF -1MB)



Azithromycin - Zmax Pfizer Medical(PDF -76KB)


None PREA
























































Balanced salt ophthalmic solution with hypromellose, dextrose and glutathione - Navstel Intraocular Irrigating Solution

Alcon, Inc. Medical(PDF -4 MB)


None PREA

Beclomethasone dipropionate - QNASL Nasal Aerosol

Teva Branded Pharmaceutical Products R&D, Inc

Medical(PDF -3MB)


Statistical (PDF -6KB) PREA

Bendamustine hydrochloride - Treanda

Teva Pharmaceuticals

Medical(PDF -6MB)


None PREA

Benzyl Alcohol - Ulesfia Asphyxiator

Sciele Pharma, Inc Medical(PDF -299KB)



PREA

Bepotastine besilate - Bepreve

Ista Pharmaceuticals, Inc.

Medical(PDF -2MB)



PREA

Besifloxacin hydrochloride - Besivance

Bausch & Lomb Medical(PDF -2MB)[*note for vision impaired users]



PREA

Bicalutamide - Casodex

AstraZeneca Pharmaceuticals

Medical(PDF -1MB)



BPCA

Bivalirudin - Angiomax The Medicines Company

Medical(PDF -717KB)


None BPCA

Brimonidine tartrate - Timolol maleate - Combigan

Allergen, Inc. Medical(PDF -2MB)[*note for vision impaired users]

Clinical pharmacology (PDF -137KB)[*note for vision impaired users]

Statistical (PDF -716KB)[*note for vision impaired users]

PREA

Candesartan Cilexitil - Atacand

Astra Zeneca Medical(PDF -1MB)



BPCA

Caspofungin acetate - Cancidas

Merck Medical(PDF -3MB)



Both

Ciclesonide - Alvesco Aventis Medical(PDF -9MB)



PREA

Ciclesonide - Omnaris NYCOMED Medical(PDF -2MB)



PREA

Ciprofloxacin otic solution - Cetraxal

Parexel International

Medical(PDF -282KB)



PREA

Clindamycin phosphate/Benzoyl peroxide -Acanya Gel

Dow Pharmaceutical Sciences, Inc.

Medical(PDF -2MB)



PREA

Clonidine hydrochloride - Kapvay

Shinoga Medical(PDF 1MB)


Statistical (PDF -532MB)

PREA






























































Clopidogrel bisulfate - Plavix

Sanofi Aventis U.S. LLC

Medical(PDF -478MB)


Biopharmaeutic review (PDF -551KB)


BPCA

Colchicine - Colcrys United Research Laboratories, Inc./Mutual Pharmaceuticals Company Inc.

Medical(PDF -51KB)


None BPCA

Colesevelam hydrochloride - Welcho

Daiichi-Sankyo Medical(PDF -8MB )

None Statistical (PDF -4MB) Both

Darunavir - Prezista Tibotec Medical(PDF -2MB)

Clinical pharmacology (PDF - 949KB)

None Both

Darunavir - Prezista Tibotec, Inc Medical(PDF -1.8MB)

Medical(PDF -478KB)

Medical(PDF -286KB)

Clinical pharmacology (PDF -2.7MB)


None BPCA

Desmopressin acetate Ferring Pharmaceuticals Inc.

Medical(PDF -287KB)

Clinical pharmacology (PDF -850KB )

None PREA

Dexmethylphenidate hydrochloride - Focalin XR

Novartis Pharmaceuticals Corporation

Medical(PDF -333KB)



PREA

Didanosine - Videx EC Bristol-Myers Squibb Company

Medical(PDF -483KB)


None PREA

Divalproex - Depakote ER and Depakote Sprinkle

Abbott Medical(PDF -100KB) Medical(PDF -2MB) Medical(PDF -1MB)

Medical(PDF -352KB)



None Both

Docetaxel - Taxotere Sanofi-Aventis Medical(PDF -1MB)



BPCA

Drospirenone/Ethinyl estradiol/Levomefolate calcium and Levomefolate calcium - Beyaz

Bayer HealthCare Pharmaceuticals Inc.

Medical(PDF -2MB)


Statistical (PDF -399KB) Statistical Addendum(PDF -22KB)

PREA

Drospirenone, Ethinyl estradiol, and Levomefolate calcium - Safyral

Bayer HealthCare Pharmaceuticals Inc.

Medical(PDF -2MB)



PREA

Eplerenone - Inspra GD Searle LLC Medical(PDF -1MB)



Both


























































Escitalopram - Lexapro Forest Laboratories, Inc.

Medical(PDF -1MB)



BPCA

Esomeprazole magnesium - Nexium

AstraZeneca Medical(PDF -1MB)



PREA

Esomeprazole magnesium - Nexium

AstraZeneca Medical(PDF -1MB)



Both

Esomeprazole sodium - Nexium I.V.

AstraZeneca LP Medical(PDF -644KB)


None PREA

Estradiol valerate and estradiol valerate/dienogest - Natazia

Bayer HealthCare Pharmaceuticals, Inc.

Medical(PDF -1.9MB)



PREA

Etravirine - Intelence Janssen Products, L.P.

Medical(PDF -945KB)


None PREA

Everolimus - Afinitor Novartis Pharmaceuticals Corporation

Medical(PDF -3MB)


None BPCA

Ezetimbe/simvastatin - Vytorin

Merck Schering-Plough Singapore Co., LLC

Medical(PDF -2MB)



Both

Ezetimbe - Zetia Merck Schering Plough Singapore Co., LLC

Medical(PDF -336KB)



Both

Famciclovir - Famvir Novartis Pharmaceutical Corporation

Medical(PDF -779KB)


None Both

Fluocinolone acetonide - Derma-Smoothe/FS

Hill Dermaceuticals, Inc

Medical(PDF -943KB)



PREA

Fluticasone propionate - Flovent HFA

Glaxo Group LTD DBA GlaxoSmithkline

Medical(PDF -334KB)


None PREA

Fosamprenavir calcium - Lexiva

ViiV Healthcare Company

Medical(PDF -2MB)


None Both

Fulvestrant - Faslodex AstraZeneca Pharmaceuticals LP

Medical(PDF -194KB) Medical(PDF -538KB)



PREA

Gadobenate dimeglumine - MultiHance

Bracco Diagnostics Inc.

Medical(PDF -1MB)



PREA

Gadobutrol - Gadavist Bayer Healthcare Pharmaceuticals, Inc

Medical(PDF -989KB)



PREA

Gatifloxacin - Zymar Allergan, Inc. Medical(PDF -573KB)



BPCA
































































Gatifloxacin - Zymaxid Allergan, Inc. Medical(PDF -3MB)



PREA

Granisetron hydrochloride - Kytril

Hoffmann-La Roche Inc.

Medical (PDF -409KB)



PREA

Guanfacine - Intuniv Shire Development, Inc.

Medical(PDF -440KB)



PREA

Guanfacine hydrochloride - Intuniv

Shire Development, Inc.

Medical(PDF -465kb) Medical(PDF -35KB) Medical(PDF -118KB)



PREA

HalfLytely and Bisacodyl Tablets Bowel Prep Kit - PEG 3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl - HalfLytely and Bisacodyl Tablet Bowel Prep Kit

Braintree Laboratories, Inc

Medical(PDF -676KB)



PREA

Helioblock SX - Anthelios 40

L’Oreal USA Medical(PDF -4MB)


None PREA

Hydroxyprogesterone caproate - Makena

Hologic, Inc Medical(PDF -439KB)



PREA

Imiquimod - Zyclara Cream, 3.75%

Graceway Pharmaceuticals, LLC

Medical(PDF -1.50MB)



PREA

Insulin Aspart - NovoLog

Novo Nordisk, Inc. Medical(PDF -1MB)



PREA

Insulin glulisine - Apidra

Sanofi-Aventis Medical(PDF -745KB)



PREA

Ivermectin - Sklice Sanofi-Topaz, Inc Medical(PDF -2MB)



PREA

Ixabepilone - Ixempra Bristol-Myers Squibb Company

Medical(PDF -643KB)



BPCA

Lamotrigine - Lamictal XR




Both


GlaxoSmithKline Medical(PDF -6 MB)


PREA





PREA




























































Lansoprazole Oral Suspension - Prevacid

TAP Pharmaceutical Products

Medical(PDF -1,023KB)



BPCA

Levetiracetam - Keppra

UCB, Inc. Medical(PDF -1MB)


Statistical (PDF -2MB) Both

Levocetirizine dihydrochloride - Xyzal

UCB, Inc. Medical(PDF -97KB)


None Both

Levocetirizine dihydrochloride - Xyzal

UCB, Inc. Medical(PDF -1MB)


None Both

Levofloxacin - Levaquin

Ortho McNeil Janssen Pharmaceuticals Inc

Medical(PDF -239KB)



PREA

Levonorgestrel-releasing intrauterine system - Mirena

Bayer HealthCare Pharmaceuticals

Medical(PDF -1MB)



PREA

Levonorgestrel - Plan B one step

Duramed Medical(PDF -116KB) Medical(PDF -315KB)

Clinical pharmacology (PDF -47KB) Clinical pharmacology (PDF -72KB)


PREA

Lidocaine hydrochloride - Akten

Akorn, Inc. Medical(PDF -120KB)



PREA

Lisdexamfetamine dimesylate - Vyvanse


Medical(PDF -2MB)

None (PDF) Statistical (PDF -676KB)

PREA

Lisdexamfetamine dimesylate - Vyvanse


Medical(PDF -688KB)


PREA

Lopinavir/ritonavir - Kaletra

Abbott Medical(PDF -3MB)


None Both

Loteprednol etabonate 0.5% and tobramycin 0.3% - Zylet

Bausch & Lomb Medical(PDF -37MB) Medical(PDF -24KB)

None None PREA

Loteprednol etabonate and tobramycin ophthalmic suspension - Zylet

Bausch & Lomb, Incorporated

Medical(PDF -84KB)

None None BOTH

Mannitol - Aridol Pharmaxis Ltd Medical(PDF - 396KB)



Methylphenidate hydrochloride - Quillivant

NextWave Pharmaceuticals, Inc.

Medical(PDF -201KB)

Memo(PDF -320KB)



Statistical (PDF -241KB

PREA























































Methylphenidate Transdermal System - Daytrana

Shire Pharmaceuticals




PREA

Mometasone furoate - Asmanex Twisthaler

Schering Plough Corporation

Medical(PDF -4MB)



PREA

Mometasone furoate - Nasonex

Schering-Plough Medical(PDF 155KB)


PREA

Mometasone furoate monohydrate - Nasonex

Schering-Plough Medical(PDF 435KB)



PREA

Mometasone furoate and formoterol fumarate - Dulera

Schering-Plough Medical(PDF -1MB)



PREA

Montelukast sodium - Singulair

Merck Sharp & Dohme Corp.

Medical(PDF -2MB)



PREA

Moxifloxacin hydrochloride ophthalmic solution 0.5% as base - Moxeza AF

Alcon Research Ltd.

Medical(PDF -615KB)



PREA

Nevirapine - Viramune Boehringer Ingelheim

Medical(PDF -1MB)


None PREA

Nitric Oxide - INOmax INO Therapeutics Medical(PDF -1MB)



Both

Norethindrone acetate and ethinyl estradiol, ethinyl estradiol, and ferrous fumarate - Lo Loestrin Fe

Warner Chilcott Company, Inc.

Medical(PDF -166KB)



PREA

Norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets - TBD

Warner Chilcott, LLC

Medical(PDF -505KB)



PREA

Olanzapine - Zyprexa Eli Lilly Medical(PDF -41KB) Medical(PDF -40KB) Medical(PDF -62KB)


BPCA Summary(PDF -76KB


Statistical (PDF -452KB) Statistical Addendum(PDF -159KB)

Both
























































Olmesartan Medoxomil - Benicar

Daiichi Sankyo Medical(PDF -2MB)



Both

Olopatadine hydrochloride - Patanase

Alcon Research, Ltd.

Medical(PDF -3MB)



Olopatadine hydrochloride - Patanase


Medical(PDF -3.2MB)



Both

Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp.

Medical(PDF -1MB)



PREA

Omeprazole magnesium - Prilosec

AstraZeneca LLP Medical(PDF -318KB)


None PREA

Paliperidone - Invega Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Medical(PDF -289MB)



PREA

Pancrelipase - Creon Abbott Products Inc.

Medical(PDF -702KB)



PREA

Pancrelipase - Pancreaze

Johnson & Johnson Pharmaceutical Research & Development, L.L.C

Medical(PDF -2MB)



PREA

Pancrelipase - Pertyze Digestive Care, Inc.

Medical(PDF -4MB)



PREA

Pancrelipase - Ultrase Axcan Scandipharm, Inc.

Medical(PDF -4MB) Safety(PDF -230KB) Safety(PDF -119KB)



None PREA

Pancrelipase - Zenpep Eurand Pharmaceuticals Ltd.

Medical(PDF -2MB)



PREA

Pantoprazole sodium - Protonix

Wyeth Pharmaceuticals, Inc.

DD Summary Review(PDF -907KB) CDTL Review(PDF -597KB) Medical(PDF -11MB) Medical Addendum(PDF -260KB)



Both

























































Pegfilgrastim - Neulasta

Amgen Medical(PDF -965KB) [*note for vision impaired users]

Clinical pharmacology (PDF -945KB) [*note for vision impaired users]

None PREA

Peginterferon - PegIntron

Schering-Plough Research Institute

Medical(PDF -937KB)



Pemetrexed disodium - Alimta

Eli Lilly and Company

Medical(PDF -632KB)



BPCA

Phentolamine - OraVerse

Novalar Pharmaceuticals, Inc.

Medical(PDF -4MB)



PREA

Pilocarpine hydrochloride - Isopto Carpine


Medical(PDF -4MB)



Quetiapine fumarate - Seroquel

Astra-Zeneca Medical(PDF -3MB) Medical Addendum(PDF -700KB)



Both

Rabeprazole sodium - Aciphex

Eisai Medical Research Inc.

Medical(PDF -611KB)


None PREA

Raltegravir - Isentress Merck Sharp & Dohme Corp

Medical(PDF -3MB)


None PREA

Retapamulin - Altabax GlaxoSmithKline Medical(PDF -359KB)


None PREA

Ribavirin / Peginterferon alfa-2a - Copegus / Pegasys

Hoffmann-La Roche Inc

Medical(PDF -1MB)


Medical (PDF -1MB) PREA

Risedronate sodium - Actonel

Procter & Gamble Pharmaceuticals, Inc

Medical(PDF -437KB)



Both

Rizatriptan - Maxalt-MLT

Merck Research Laboratories

Medical(PDF -2.6MB) Medical(PDF -659KB) CTDL Review(PDF -221KB) CTDL Addendum(PDF -112KB) DD Memo(PDF -22KB)



BPCA

Rocuronium bromide - Zemuron

Organon USA, Inc. Medical(PDF -1MB)


None Both

Rosuvastatin - Crestor AstraZeneca Pharmaceuticals LP

Medical(PDF -3MB)



Both





























































Saquinavir mesylate - Invirase

Hoffmann-La Roche Inc.

Medical(PDF -366 KB)



PREA

Somatropin - Accretropin

Cangene Corporation

Medical(PDF -3MB)



Spinosad - Natroba Suspension, 0.9%

ParaPRO Medical(PDF -278KB)



PREA

Sterile Intraocular - Navstel Intraocular Irrigating Solution

Alcon, Inc. Medical(PDF -8MB)


None PREA

Tamsulosin hydrochloride - Flomax

Boehringer Ingelheim

Medical(PDF -3MB)



BPCA

Technetium Tc99m - Cardiolite

Bristol Myers Squibb

Medical(PDF -561KB)



BPCA

Temsirolimus - Torisel Wyeth Pharmaceuticals, a Pfizer Company

Medical(PDF -2MB)



BPCA

Tenofovir disoproxil fumarate - Viread

Gilead Medical(PDF -3MB)



Tenofovir disoproxil fumarate - Viread

Gilead Sciences, Incorporated

Medical(PDF -647KB)



BPCA

Terbinafine - Lamisil Novartis Pharmaceuticals Corp.

Medical(PDF -6MB)[*note for vision impaired users]



BPCA

Tipranavir - Aptivus Boehringer Ingelheim Pharmaceuticals, Inc.

Medical(PDF -2MB)



Both

Tocilizumab - Actemra Genentech, Inc. A Member of the Roche Group

Medical(PDF -1.4MB)

Clinical pharmacology (PDF 670KB)


PREA

Topiramate - Topamax

Janssen Pharmaceuticals, Inc.

Medical(PDF -7MB)


None PREA

Topiramate - Topamax Johnson and Johnson Pharmaceutical Research & Development L.L.C.

Medical(PDF -3MB)


None BPCA

Triamcinolone acetonide - Triesence

Alcon, Inc. Medical(PDF -2MB)



PREA

Triamcinolone acetonide - Nasacort AQ

Sanofi Aventis Medical(PDF -882KB)



PREA































































http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm

Ulipristal acetate - Ella Laboratoire HRA Pharma

Medical(PDF -1MB)

Clinical pharmacology (PDF -2MB) Clinical pharmacology Addendum (PDF -46KB)


Valacyclovir hydrochloride - Valtrex


Clinical pharmacology (PDF -506KB) Clinical pharmacology (PDF -646KB)

None Both

Valganciclovir hydrochloride - Valcyte

Hoffmann-La Roche, Inc.


Clinical pharmacology (PDF -179KB) Clinical pharmacology (PDF -2MB)

None Both

Valsartan - Diovan Novartis Medical(PDF -1MB)


Statistical (PDF -2MB) BPCA

Varenicline - Chantix Pfizer, Inc. None Clinical pharmacology (PDF -93KB)

None PREA

Zidovudine, ZDV - Retrovir



None PREA

Zidovudine - Retrovir ViiV Healthcare Co Medical(PDF -757KB)

Clinical pharmacology (PDF -285)

None PREA

Ziprasidone - Geodon Pfizer Medical(PDF -2MB) Medical Addendum(PDF -63KB)



PREA

Zoledronic acid - Zometa

Novartis Pharmaceutical Corp.

Medical(PDF -2MB)



BPCA

Zolmitriptan - Zomig AstraZeneca Medical(PDF -2MB)



PREA

Assignment 5 - Apply Your Knowledge Using the following website: http://www.pdr.net/drug-summary/rectiv?druglabelid=1469

1. Identify the different dosage forms for nitroglycerin, their strengths, and routes of administration. What conclusions can you make regarding dose and route of administration? Answer: Answers may include: Nitroglycerin comes in the following forms:













































1) Patch – (Minitran, Nitro-Dur) - 0.1mg/hr, 0.2mg/hr, 0.4mg/hr, 0.6mg/hr [30s]; (Nitro-Dur) 0.1mg/hr, 0.2mg/hr, 0.3mg/hr, 0.4mg/hr, 0.6mg/hr, 0.8mg/hr [30s].

Adults: Initial: 0.2-0.4mg/hr patch for 12-14 hrs/day. Remove patch for 10-12 hrs/day. (Nitro-Dur) Elderly: Start at low end of dosing range.

2) Ointment – (Nitro-Bid) - Oint: 2% (15mg/inch) [1g (48s), 30g, 60g] Adults: Initial: Apply 0.5 inch bid (once in the am and 6 hrs later). Titrate: May increase to 1 inch bid, then to 2 inches bid. Should have 10-12 hr nitrate-free period.

3) Spray – (Nitrolingual, NitroMist) - Spray: 400mcg/spray Adults: Acute Relief: 1 or 2 sprays at the onset of attack onto or under the tongue. Max: 3 sprays/15 min. If chest pain persists, prompt medical attention is recommended. Prophylaxis: May be used 5-10 min prior to engaging in activities that might precipitate an acute attack.

4) Tablet – (Nitrostat) - Tab, SL: 0.3mg, 0.4mg, 0.6mg Adults: Treatment: 1 tab SL or in buccal pouch at 1st sign of acute attack. May repeat every 5 min until relief is obtained. If pain persists after a total of 3 tabs in 15 min, or if pain is different than typically experienced, prompt medical attention is recommended. Prophylaxis: Take 5-10 min prior to engaging in activities that may cause acute attack. Elderly: Start at lower end of dosing range.

5) Ointment – (Rectiv) - Oint: 0.4% (4mg/g) [30g tube] Adults: Apply 1 inch of oint intra-anally q12h for up to 3 weeks.

The dosage and route of administration is dependent on whether the drug is used as a preventative measure or as a treatment to the symptoms. If it is to be used as a preventive measure a slower release into the bloodstream is effective thus you would use the patch or ointment, whereas if you were treating the symptoms you would use the spray or tablets which would be absorbed quicker and provide immediate relief.

2. Select an antibiotic and finds the correct dosing for an infant, a child, an adult, a patient with liver problems, and the patient with kidney problems. What conclusions can you make regarding this medication?

Answer: Answers may vary. Example answer: Amoxicillin. Infant – Suspension – (Sus: (Amoxicillin-Clavulanate Potassium) 600mg-42.9mg/5mL [75mL, 125mL, 200mL] ) Pediatrics: ≥3 Months (<40kg): 90mg/kg/day divided q12h for 10 days based on amoxicillin component (600mg/5mL). Refer to PI for dosing based on weight. Child - Chewable Tablet – (Amoxicillin) (≥40kg: Dose as adult. <40kg: Ear/Nose/Throat/SSSI/GU: (Mild/Moderate) 25mg/kg/day given in divided doses q12h or 20mg/kg/day given in divided doses q8h. (Severe) 45mg/kg/day given in divided doses q12h or 40mg/kg/day given in divided doses q8h. LRTI: 45mg/kg/day given in divided doses q12h or 40mg/kg/day given in divided doses q8h. Continue for a minimum of 48-72 hrs beyond the time that patient becomes asymptomatic or evidence of bacterial eradication has been obtained. S. pyogenes Infections: At least 10 days. Acute Gonorrhea/Uncomplicated Anogenital and Urethral Infections: Prepubertal: 50mg/kg with 25mg/kg probenecid as single dose (not for <2 yrs). Neonates/Infants: ≤12 Weeks: Max: 30mg/kg/day divided q12h. Adult - Capsule or Tablet - (Amoxicillin) Adults: Ear/Nose/Throat/SSSI/GU: (Mild/Moderate) 500mg q12h or 250mg q8h. (Severe) 875mg q12h or 500mg q8h. LRTI: 875mg q12h or 500mg q8h. Continue for a minimum of 48-72 hrs beyond the time that patient becomes asymptomatic or evidence of bacterial eradication has been obtained. Streptococcus pyogenes Infections: At least 10 days. Acute Gonorrhea/Uncomplicated Anogenital and Urethral Infections: 3g as single dose. H. pylori: (Dual Therapy) 1g + 30mg lansoprazole, both q8h for 14 days. (Triple Therapy) 1g + 30mg lansoprazole + 500mg clarithromycin, all q12h for 14 days. GFR 10-30mL/min: 250-500mg q12h. GFR <10mL/min: 250-500mg q24h. Hemodialysis: 250-500mg q24h; additional dose during and at end of dialysis. Patient with Liver Problems – (capsule or tablet) – There is no warning for adverse reactions or problems taking it if patient has liver problems. Patient with kidney problems - (capsule or tablet) - There is no warning for adverse reactions or problems taking it if patient has kidney problems. Antibiotics are a fairly safe and common medication in the treatment of infection due to a variety of illnesses. As with any medication a patient should be monitored esp. if they have liver or kidney problems and should be advised to discontinue use and seek further medical treatment if a problem should arise while taking the medication.

3. A doctor prescribed the following medication for a patient:

Zithromax #6 Two caps stat, then one cap po d

What type of dose is the first dose taken by the patient? Answer: Loading dose

Why would a physician prescribe it this way? Answer: To obtain a therapeutic response quicker for the patient than would normally be expected.

4. John doe is prescribed Coreg 6.25 mg twice a day. What would you call this type of dose? Answer: A maintenance dose

5. Make a list of foods that interact with Coumadin. Answer: Answers will vary. Example Answer: Eat a normal, balanced diet. Talk to your healthcare provider before you make any diet changes. Do not eat large amounts of leafy, green vegetables. Leafy, green vegetables contain vitamin K. Certain vegetable oils also contain large amounts of vitamin K. Too much vitamin K can lower the effect of COUMADIN. Some examples of foods that can interact with this medication are: Kale Spinach Brussels sprouts Parsley Collard greens Mustard greens Chard Green tea

6. A pharmacy patient is dropping off his prescription and you ask if he would like the generic medication if one is available. The patient asks what the difference is between the brand-name and the generic medicines. How do you respond? Answer: Answers will vary. The generic name is nonproprietary and is given to the drug by the manufacturer. The branch name is the proprietary or trade name and is protected by trademark law.

Assignment 6 - Practice Your Knowledge This assignment will help you to become aware of the various warnings and drug interactions of over-the-counter medications.

1. Visit a local retail pharmacy and select a medication from each of the following categories.

2. Record the warnings found on the back of the box for each product. Answer: Answers will vary. This will help you locate specific information using actual labels.

Medication Drug Interactions Warnings

Advil

Afrin Nasal Spray

Aleve

Alka-Seltzer

Bayer Aspirin

Benadryl

Chlor-Trimeton

Claritin

Cortaid

Imodium AD

Lotrimin

Melatonin

Metamucil

Milk of magnesia

Mylanta

Neosporin

Pepcid AC

Robitussin

Saint John’s wort

Sudafed

Tavist-D

Tylenol

Vicks cough syrup

Vitron C

Zostrix

lesson 1 - introduction to pharmacology assignment answer …s3.amazonaws.com/careertec/pharmacy...

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