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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
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]
Clinical pharmacology (PDF -1MB)[*note for vision impaired users]
Statistical (PDF -3MB)[*note for vision impaired users]
PREA
Adapalene - Epiduo Galderma Laboratories LP
Medical(PDF -1MB)
Clinical pharmacology (PDF 1MB)
Statistical (PDF -2MB) PREA
Adapalene Lotion, 0.1% - Differin Lotion, 0.1%
Galderma Laboratories LP
Medical(PDF -2MB) Medical(PDF -38KB)
Clinical pharmacology (PDF -752KB)
Statistical (PDF -417KB)
PREA
Adefovir - Hepsera Gilead Sciences Inc
Medical(PDF -1MB)
Clinical pharmacology (PDF -634KB)
Statistical (PDF -309KB)
Both
Albuterol sulfate HFA - Ventolin HFA
GlaxoSmithKline Medical(PDF -1MB)
Clinical pharmacology (PDF -133KB)
Statistical (PDF -310KB)
BPCA
Alcaftadine - Lastacaft Vistakon Pharmaceuticals
Medical(PDF -597KB)
Clinical pharmacology (PDF -741KB)
Statistical (PDF -1MB) PREA
Alfuzosin - Uroxatral Sanofi-aventis U.S., Inc.
Medical(PDF -850KB)
Clinical pharmacology (PDF -942KB)
Statistical (PDF -447KB)
BPCA
Almotriptan - Axert Johnson and Johnson
Medical(PDF -9MB)
Clinical pharmacology (PDF -1MB)
None BPCA
Amoxicillin/APC -111 - Moxatag
MiddleBrook Pharmaceuticals
Medical(PDF -3MB)
Clinical pharmacology (PDF -751KB)
Statistical (PDF -1MB) PREA
Amoxicillin/Clavulanate potassium - Augmentin XR
GlaxoSmithKline Medical(PDF -67KB)
Clinical pharmacology (PDF -264KB)
None PREA
Anastrozole - Arimidex AstraZeneca Medical(PDF -2MB)
Clinical pharmacology (PDF -5MB)[*note for vision impaired users]
Statistical (PDF -102KB)
BPCA
Argatroban - Argatroban
ENCYSIVE Pharmaceuticals Inc.
Medical(PDF -168KB)
Clinical pharmacology (PDF -450 KB)
None BPCA
Aripiprazole - Abilify Otsuka Pharmaceutical Company
Medical(PDF -2MB)
Clinical pharmacology (PDF -4MB)
Statistical (PDF -381KB)
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)
None Statistical (PDF -728KB)
PREA
Aripiprazole - Abilify Otsuka Pharmaceutical Company, Ltd.
Medical(PDF -2MB)
Clinical pharmacology (PDF -51KB
Statistical (PDF -800KB)
BPCA
Atazanavir - Reyataz Bristol-Myers Squibb Company
Medical(PDF -4MB)
Clinical pharmacology (PDF -913KB)
None PREA
Azelastine hydrochloride - Astepro
MEDA Medical(PDF -633KB) Medical(PDF -3MB)
Clinical pharmacology (PDF -540KB)
Statistical (PDF -204KB) Statistical (PDF -985KB)
PREA
Azelastine hydrochloride and Fluticasone proprionate - Dymista
Meda Pharmaceuticals, Inc.
Medical(PDF -1MB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -2MB) PREA
Azithromycin - Zmax Pfizer Medical(PDF -76KB)
Clinical pharmacology (PDF -67KB)
None PREA
Balanced salt ophthalmic solution with hypromellose, dextrose and glutathione - Navstel Intraocular Irrigating Solution
Alcon, Inc. Medical(PDF -4 MB)
Clinical pharmacology (PDF -49KB)
None PREA
Beclomethasone dipropionate - QNASL Nasal Aerosol
Teva Branded Pharmaceutical Products R&D, Inc
Medical(PDF -3MB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -6KB) PREA
Bendamustine hydrochloride - Treanda
Teva Pharmaceuticals
Medical(PDF -6MB)
Clinical pharmacology (PDF -1MB)
None PREA
Benzyl Alcohol - Ulesfia Asphyxiator
Sciele Pharma, Inc Medical(PDF -299KB)
Clinical pharmacology (PDF -268KB)
Statistical (PDF -932KB)
PREA
Bepotastine besilate - Bepreve
Ista Pharmaceuticals, Inc.
Medical(PDF -2MB)
Clinical pharmacology (PDF -693KB)
Statistical (PDF -696KB)
PREA
Besifloxacin hydrochloride - Besivance
Bausch & Lomb Medical(PDF -2MB)[*note for vision impaired users]
Clinical pharmacology (PDF -684KB)
Statistical (PDF -1MB)[*note for vision impaired users]
PREA
Bicalutamide - Casodex
AstraZeneca Pharmaceuticals
Medical(PDF -1MB)
Clinical pharmacology (PDF -579KB)
Statistical (PDF -207KB)
BPCA
Bivalirudin - Angiomax The Medicines Company
Medical(PDF -717KB)
Clinical pharmacology (PDF -2MB)
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)
Clinical pharmacology (PDF -991KB)
Statistical (PDF -435KB)
BPCA
Caspofungin acetate - Cancidas
Merck Medical(PDF -3MB)
Clinical pharmacology (PDF -465KB)
Statistical (PDF -352KB)
Both
Ciclesonide - Alvesco Aventis Medical(PDF -9MB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -300KB)
PREA
Ciclesonide - Omnaris NYCOMED Medical(PDF -2MB)
Clinical pharmacology (PDF -165KB)
Statistical (PDF -158KB)
PREA
Ciprofloxacin otic solution - Cetraxal
Parexel International
Medical(PDF -282KB)
Clinical pharmacology (PDF -245KB)
Statistical (PDF -511KB)
PREA
Clindamycin phosphate/Benzoyl peroxide -Acanya Gel
Dow Pharmaceutical Sciences, Inc.
Medical(PDF -2MB)
Clinical pharmacology (PDF -487KB)
Statistical (PDF -836KB)
PREA
Clonidine hydrochloride - Kapvay
Shinoga Medical(PDF 1MB)
Clinical pharmacology (PDF -225KB)
Statistical (PDF -532MB)
PREA
Clopidogrel bisulfate - Plavix
Sanofi Aventis U.S. LLC
Medical(PDF -478MB)
Clinical pharmacology (PDF -568KB)
Biopharmaeutic review (PDF -551KB)
Statistical (PDF -72KB)
BPCA
Colchicine - Colcrys United Research Laboratories, Inc./Mutual Pharmaceuticals Company Inc.
Medical(PDF -51KB)
Clinical pharmacology (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)
Clinical pharmacology (PDF -793KB)
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)
Clinical pharmacology (PDF -830KB)
Statistical (PDF -151KB)
PREA
Didanosine - Videx EC Bristol-Myers Squibb Company
Medical(PDF -483KB)
Clinical pharmacology (PDF -830KB)
None PREA
Divalproex - Depakote ER and Depakote Sprinkle
Abbott Medical(PDF -100KB) Medical(PDF -2MB) Medical(PDF -1MB)
Medical(PDF -352KB)
Clinical pharmacology (PDF -100KB)
Clinical pharmacology (PDF -100KB)
None Both
Docetaxel - Taxotere Sanofi-Aventis Medical(PDF -1MB)
Clinical pharmacology (PDF -671KB)
Statistical (PDF -427KB)
BPCA
Drospirenone/Ethinyl estradiol/Levomefolate calcium and Levomefolate calcium - Beyaz
Bayer HealthCare Pharmaceuticals Inc.
Medical(PDF -2MB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -399KB) Statistical Addendum(PDF -22KB)
PREA
Drospirenone, Ethinyl estradiol, and Levomefolate calcium - Safyral
Bayer HealthCare Pharmaceuticals Inc.
Medical(PDF -2MB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -186KB)
PREA
Eplerenone - Inspra GD Searle LLC Medical(PDF -1MB)
Clinical pharmacology (PDF -798KB)
Statistical (PDF -338KB)
Both
Escitalopram - Lexapro Forest Laboratories, Inc.
Medical(PDF -1MB)
Clinical pharmacology (PDF -655KB)
Statistical (PDF -772KB)
BPCA
Esomeprazole magnesium - Nexium
AstraZeneca Medical(PDF -1MB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -491KB)
PREA
Esomeprazole magnesium - Nexium
AstraZeneca Medical(PDF -1MB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -336KB)
Both
Esomeprazole sodium - Nexium I.V.
AstraZeneca LP Medical(PDF -644KB)
Clinical pharmacology (PDF -2MB)
None PREA
Estradiol valerate and estradiol valerate/dienogest - Natazia
Bayer HealthCare Pharmaceuticals, Inc.
Medical(PDF -1.9MB)
Clinical pharmacology (PDF -494KB)
Statistical (PDF -391KB)
PREA
Etravirine - Intelence Janssen Products, L.P.
Medical(PDF -945KB)
Clinical pharmacology (PDF -2MB)
None PREA
Everolimus - Afinitor Novartis Pharmaceuticals Corporation
Medical(PDF -3MB)
Clinical pharmacology (PDF -2MB)
None BPCA
Ezetimbe/simvastatin - Vytorin
Merck Schering-Plough Singapore Co., LLC
Medical(PDF -2MB)
Clinical pharmacology (PDF -200KB)
Statistical (PDF -179KB)
Both
Ezetimbe - Zetia Merck Schering Plough Singapore Co., LLC
Medical(PDF -336KB)
Clinical pharmacology (PDF -86KB)
Statistical (PDF -375KB)
Both
Famciclovir - Famvir Novartis Pharmaceutical Corporation
Medical(PDF -779KB)
Clinical pharmacology (PDF -354KB)
None Both
Fluocinolone acetonide - Derma-Smoothe/FS
Hill Dermaceuticals, Inc
Medical(PDF -943KB)
Clinical pharmacology (PDF -276KB)
Statistical (PDF -507KB)
PREA
Fluticasone propionate - Flovent HFA
Glaxo Group LTD DBA GlaxoSmithkline
Medical(PDF -334KB)
Clinical pharmacology (PDF -890KB)
None PREA
Fosamprenavir calcium - Lexiva
ViiV Healthcare Company
Medical(PDF -2MB)
Clinical pharmacology (PDF -5MB)
None Both
Fulvestrant - Faslodex AstraZeneca Pharmaceuticals LP
Medical(PDF -194KB) Medical(PDF -538KB)
Clinical pharmacology (PDF -437KB)
Statistical (PDF -774KB)
PREA
Gadobenate dimeglumine - MultiHance
Bracco Diagnostics Inc.
Medical(PDF -1MB)
Clinical pharmacology (PDF -455KB)
Statistical (PDF -545KB)
PREA
Gadobutrol - Gadavist Bayer Healthcare Pharmaceuticals, Inc
Medical(PDF -989KB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -375KB)
PREA
Gatifloxacin - Zymar Allergan, Inc. Medical(PDF -573KB)
Clinical pharmacology (PDF -60KB)
Statistical (PDF -376KB)
BPCA
Gatifloxacin - Zymaxid Allergan, Inc. Medical(PDF -3MB)
Clinical pharmacology (PDF -119KB)
Statistical (PDF -611KB)
PREA
Granisetron hydrochloride - Kytril
Hoffmann-La Roche Inc.
Medical (PDF -409KB)
Clinical pharmacology (PDF -17KB)
Statistical (PDF -38KB)
PREA
Guanfacine - Intuniv Shire Development, Inc.
Medical(PDF -440KB)
Clinical pharmacology (PDF -286KB)
Statistical (PDF -493KB)
PREA
Guanfacine hydrochloride - Intuniv
Shire Development, Inc.
Medical(PDF -465kb) Medical(PDF -35KB) Medical(PDF -118KB)
Clinical pharmacology (PDF -4MB)
Statistical (PDF -173KB)
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)
Clinical pharmacology (PDF -37KB)
Statistical (PDF -236KB)
PREA
Helioblock SX - Anthelios 40
L’Oreal USA Medical(PDF -4MB)
Clinical pharmacology (PDF -2MB)
None PREA
Hydroxyprogesterone caproate - Makena
Hologic, Inc Medical(PDF -439KB)
Clinical pharmacology (PDF -36KB)
Statistical (PDF -598KB)
PREA
Imiquimod - Zyclara Cream, 3.75%
Graceway Pharmaceuticals, LLC
Medical(PDF -1.50MB)
Clinical pharmacology (PDF -1.31MB)
Statistical (PDF -326KB)
PREA
Insulin Aspart - NovoLog
Novo Nordisk, Inc. Medical(PDF -1MB)
Clinical pharmacology (PDF -85KB)
Statistical (PDF -159KB)
PREA
Insulin glulisine - Apidra
Sanofi-Aventis Medical(PDF -745KB)
Clinical pharmacology (PDF -714KB)
Statistical (PDF -391KB)
PREA
Ivermectin - Sklice Sanofi-Topaz, Inc Medical(PDF -2MB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -909KB)
PREA
Ixabepilone - Ixempra Bristol-Myers Squibb Company
Medical(PDF -643KB)
Clinical pharmacology (PDF -389KB)
Statistical (PDF -447KB)
BPCA
Lamotrigine - Lamictal XR
GlaxoSmithKline Medical(PDF -52KB)
Clinical pharmacology (PDF -3MB)
Statistical (PDF -226KB)
Both
Lamotrigine - Lamictal XR
GlaxoSmithKline Medical(PDF -6 MB)
None Statistical (PDF -472KB)
PREA
Lamotrigine - Lamictal XR
GlaxoSmithKline Medical(PDF -840KB)
Clinical pharmacology (PDF -38KB)
Statistical (PDF -391KB)
PREA
Lansoprazole Oral Suspension - Prevacid
TAP Pharmaceutical Products
Medical(PDF -1,023KB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -54KB)
BPCA
Levetiracetam - Keppra
UCB, Inc. Medical(PDF -1MB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -2MB) Both
Levocetirizine dihydrochloride - Xyzal
UCB, Inc. Medical(PDF -97KB)
Clinical pharmacology (PDF -668KB)
None Both
Levocetirizine dihydrochloride - Xyzal
UCB, Inc. Medical(PDF -1MB)
Clinical pharmacology (PDF -419KB)
None Both
Levofloxacin - Levaquin
Ortho McNeil Janssen Pharmaceuticals Inc
Medical(PDF -239KB)
Clinical pharmacology (PDF -828KB)
Statistical (PDF -39KB)
PREA
Levonorgestrel-releasing intrauterine system - Mirena
Bayer HealthCare Pharmaceuticals
Medical(PDF -1MB)
Clinical pharmacology (PDF -358KB)
Statistical (PDF -71KB)
PREA
Levonorgestrel - Plan B one step
Duramed Medical(PDF -116KB) Medical(PDF -315KB)
Clinical pharmacology (PDF -47KB) Clinical pharmacology (PDF -72KB)
Statistical (PDF -26KB)
PREA
Lidocaine hydrochloride - Akten
Akorn, Inc. Medical(PDF -120KB)
Clinical pharmacology (PDF -57KB)
Statistical (PDF -292KB)
PREA
Lisdexamfetamine dimesylate - Vyvanse
Shire Development, Inc.
Medical(PDF -2MB)
None (PDF) Statistical (PDF -676KB)
PREA
Lisdexamfetamine dimesylate - Vyvanse
Shire Development, Inc.
Medical(PDF -688KB)
None Statistical (PDF -792KB)
PREA
Lopinavir/ritonavir - Kaletra
Abbott Medical(PDF -3MB)
Clinical pharmacology (PDF -904KB)
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)
Clinical pharmacology (PDF -226KB)
Statistical (PDF -2MB) PREA
Methylphenidate hydrochloride - Quillivant
NextWave Pharmaceuticals, Inc.
Medical(PDF -201KB)
Memo(PDF -320KB)
Clinical pharmacology (PDF -67KB)
Clinical pharmacology (PDF -225KB)
Statistical (PDF -241KB
PREA
Methylphenidate Transdermal System - Daytrana
Shire Pharmaceuticals
Medical(PDF -2MB) Medical(PDF -36KB)
Clinical pharmacology (PDF -568KB)
Statistical (PDF -162KB)
PREA
Mometasone furoate - Asmanex Twisthaler
Schering Plough Corporation
Medical(PDF -4MB)
Clinical pharmacology (PDF -595KB)
Statistical (PDF -548KB) Statistical (PDF -250KB)
PREA
Mometasone furoate - Nasonex
Schering-Plough Medical(PDF 155KB)
None Statistical (PDF -627KB)
PREA
Mometasone furoate monohydrate - Nasonex
Schering-Plough Medical(PDF 435KB)
Clinical pharmacology (PDF -143KB)
Statistical (PDF -176KB)
PREA
Mometasone furoate and formoterol fumarate - Dulera
Schering-Plough Medical(PDF -1MB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -433KB)
PREA
Montelukast sodium - Singulair
Merck Sharp & Dohme Corp.
Medical(PDF -2MB)
Clinical pharmacology (PDF -74KB)
Statistical (PDF -94KB)
PREA
Moxifloxacin hydrochloride ophthalmic solution 0.5% as base - Moxeza AF
Alcon Research Ltd.
Medical(PDF -615KB)
Clinical pharmacology (PDF -235KB)
Statistical (PDF -580KB)
PREA
Nevirapine - Viramune Boehringer Ingelheim
Medical(PDF -1MB)
Clinical pharmacology (PDF -926KB)
None PREA
Nitric Oxide - INOmax INO Therapeutics Medical(PDF -1MB)
Clinical pharmacology (PDF -45KB)
Statistical (PDF -612KB)
Both
Norethindrone acetate and ethinyl estradiol, ethinyl estradiol, and ferrous fumarate - Lo Loestrin Fe
Warner Chilcott Company, Inc.
Medical(PDF -166KB)
Clinical pharmacology (PDF -50KB)
Statistical (PDF -31KB)
PREA
Norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets - TBD
Warner Chilcott, LLC
Medical(PDF -505KB)
Clinical pharmacology (PDF -21KB)
Statistical (PDF -106KB)
PREA
Olanzapine - Zyprexa Eli Lilly Medical(PDF -41KB) Medical(PDF -40KB) Medical(PDF -62KB)
Medical(PDF -2MB) Medical(PDF -604KB)
BPCA Summary(PDF -76KB
Clinical pharmacology (PDF -962KB)
Statistical (PDF -452KB) Statistical Addendum(PDF -159KB)
Both
Olmesartan Medoxomil - Benicar
Daiichi Sankyo Medical(PDF -2MB)
Clinical pharmacology (PDF -964KB)
Statistical (PDF -527KB)
Both
Olopatadine hydrochloride - Patanase
Alcon Research, Ltd.
Medical(PDF -3MB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -3MB) PREA
Olopatadine hydrochloride - Patanase
Alcon Research, Ltd.
Medical(PDF -3.2MB)
Clinical pharmacology (PDF -791KB)
Statistical (PDF -315KB)
Both
Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp.
Medical(PDF -1MB)
Clinical pharmacology (PDF -845KB)
Statistical (PDF -703KB)
PREA
Omeprazole magnesium - Prilosec
AstraZeneca LLP Medical(PDF -318KB)
Clinical pharmacology (PDF -869KB)
None PREA
Paliperidone - Invega Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Medical(PDF -289MB)
Clinical pharmacology (PDF -447KB)
Statistical (PDF -252KB)
PREA
Pancrelipase - Creon Abbott Products Inc.
Medical(PDF -702KB)
Clinical pharmacology (PDF -58KB)
Statistical (PDF -84KB)
PREA
Pancrelipase - Pancreaze
Johnson & Johnson Pharmaceutical Research & Development, L.L.C
Medical(PDF -2MB)
Clinical pharmacology (PDF -546KB)
Statistical (PDF -326KB)
PREA
Pancrelipase - Pertyze Digestive Care, Inc.
Medical(PDF -4MB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -736KB)
PREA
Pancrelipase - Ultrase Axcan Scandipharm, Inc.
Medical(PDF -4MB) Safety(PDF -230KB) Safety(PDF -119KB)
Clinical pharmacology (PDF -116KB)
Clinical pharmacology (PDF -1MB)
None PREA
Pancrelipase - Zenpep Eurand Pharmaceuticals Ltd.
Medical(PDF -2MB)
Clinical pharmacology (PDF -502KB)
Statistical (PDF -377KB)
PREA
Pantoprazole sodium - Protonix
Wyeth Pharmaceuticals, Inc.
DD Summary Review(PDF -907KB) CDTL Review(PDF -597KB) Medical(PDF -11MB) Medical Addendum(PDF -260KB)
Clinical pharmacology (PDF -8MB)
Statistical (PDF -721KB)
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)
Clinical pharmacology (PDF -825KB)
Statistical (PDF -1MB) PREA
Pemetrexed disodium - Alimta
Eli Lilly and Company
Medical(PDF -632KB)
Clinical pharmacology (PDF -207KB)
Statistical (PDF -364KB)
BPCA
Phentolamine - OraVerse
Novalar Pharmaceuticals, Inc.
Medical(PDF -4MB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -762KB)
PREA
Pilocarpine hydrochloride - Isopto Carpine
Alcon Research, Ltd.
Medical(PDF -4MB)
Clinical pharmacology (PDF -462KB)
Statistical (PDF -1MB) PREA
Quetiapine fumarate - Seroquel
Astra-Zeneca Medical(PDF -3MB) Medical Addendum(PDF -700KB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -776KB)
Both
Rabeprazole sodium - Aciphex
Eisai Medical Research Inc.
Medical(PDF -611KB)
Clinical pharmacology (PDF -682KB)
None PREA
Raltegravir - Isentress Merck Sharp & Dohme Corp
Medical(PDF -3MB)
Clinical pharmacology (PDF -3MB)
None PREA
Retapamulin - Altabax GlaxoSmithKline Medical(PDF -359KB)
Clinical pharmacology (PDF -408KB)
None PREA
Ribavirin / Peginterferon alfa-2a - Copegus / Pegasys
Hoffmann-La Roche Inc
Medical(PDF -1MB)
Clinical pharmacology (PDF -69KB)
Medical (PDF -1MB) PREA
Risedronate sodium - Actonel
Procter & Gamble Pharmaceuticals, Inc
Medical(PDF -437KB)
Clinical pharmacology (PDF -636KB)
Statistical (PDF -255KB)
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)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -374KB) Statistical (PDF -381KB)
BPCA
Rocuronium bromide - Zemuron
Organon USA, Inc. Medical(PDF -1MB)
Clinical pharmacology (PDF -877KB)
None Both
Rosuvastatin - Crestor AstraZeneca Pharmaceuticals LP
Medical(PDF -3MB)
Clinical pharmacology (PDF -603KB)
Statistical (PDF -482KB)
Both
Saquinavir mesylate - Invirase
Hoffmann-La Roche Inc.
Medical(PDF -366 KB)
Clinical pharmacology (PDF -706KB)
Statistical (PDF -446KB)
PREA
Somatropin - Accretropin
Cangene Corporation
Medical(PDF -3MB)
Clinical pharmacology (PDF -7MB)
Statistical (PDF -2MB) PREA
Spinosad - Natroba Suspension, 0.9%
ParaPRO Medical(PDF -278KB)
Clinical pharmacology (PDF -50KB)
Statistical (PDF -46KB) Statistical (PDF -23KB)
PREA
Sterile Intraocular - Navstel Intraocular Irrigating Solution
Alcon, Inc. Medical(PDF -8MB)
Clinical pharmacology (PDF -85KB)
None PREA
Tamsulosin hydrochloride - Flomax
Boehringer Ingelheim
Medical(PDF -3MB)
Clinical pharmacology (PDF -1MB)
Statistical (PDF -253KB)
BPCA
Technetium Tc99m - Cardiolite
Bristol Myers Squibb
Medical(PDF -561KB)
Clinical pharmacology (PDF -571KB)
Statistical (PDF -357KB)
BPCA
Temsirolimus - Torisel Wyeth Pharmaceuticals, a Pfizer Company
Medical(PDF -2MB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -250KB)
BPCA
Tenofovir disoproxil fumarate - Viread
Gilead Medical(PDF -3MB)
Clinical pharmacology (PDF -474KB)
Statistical (PDF -1MB) PREA
Tenofovir disoproxil fumarate - Viread
Gilead Sciences, Incorporated
Medical(PDF -647KB)
Clinical pharmacology (PDF -1.66MB)
Statistical (PDF -774KB)
BPCA
Terbinafine - Lamisil Novartis Pharmaceuticals Corp.
Medical(PDF -6MB)[*note for vision impaired users]
Clinical pharmacology (PDF -3MB)[*note for vision impaired users]
Statistical (PDF -2MB)[*note for vision impaired users]
BPCA
Tipranavir - Aptivus Boehringer Ingelheim Pharmaceuticals, Inc.
Medical(PDF -2MB)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -589KB)
Both
Tocilizumab - Actemra Genentech, Inc. A Member of the Roche Group
Medical(PDF -1.4MB)
Clinical pharmacology (PDF 670KB)
Statistical (PDF -543KB)
PREA
Topiramate - Topamax
Janssen Pharmaceuticals, Inc.
Medical(PDF -7MB)
Clinical pharmacology (PDF -1MB)
None PREA
Topiramate - Topamax Johnson and Johnson Pharmaceutical Research & Development L.L.C.
Medical(PDF -3MB)
Clinical pharmacology (PDF -986KB)
None BPCA
Triamcinolone acetonide - Triesence
Alcon, Inc. Medical(PDF -2MB)
Clinical pharmacology (PDF -802KB)
Statistical (PDF -402KB)
PREA
Triamcinolone acetonide - Nasacort AQ
Sanofi Aventis Medical(PDF -882KB)
Clinical pharmacology (PDF -810KB)
Statistical (PDF -615KB)
PREA
Ulipristal acetate - Ella Laboratoire HRA Pharma
Medical(PDF -1MB)
Clinical pharmacology (PDF -2MB) Clinical pharmacology Addendum (PDF -46KB)
Statistical (PDF -3MB) PREA
Valacyclovir hydrochloride - Valtrex
GlaxoSmithKline Medical(PDF -719KB)
Clinical pharmacology (PDF -506KB) Clinical pharmacology (PDF -646KB)
None Both
Valganciclovir hydrochloride - Valcyte
Hoffmann-La Roche, Inc.
Medical(PDF -1MB) Medical(PDF -358KB)
Clinical pharmacology (PDF -179KB) Clinical pharmacology (PDF -2MB)
None Both
Valsartan - Diovan Novartis Medical(PDF -1MB)
Clinical pharmacology (PDF -10MB)
Statistical (PDF -2MB) BPCA
Varenicline - Chantix Pfizer, Inc. None Clinical pharmacology (PDF -93KB)
None PREA
Zidovudine, ZDV - Retrovir
GlaxoSmithKline Medical(PDF -767KB)
Clinical pharmacology (PDF -686KB)
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)
Clinical pharmacology (PDF -2MB)
Statistical (PDF -359KB)
PREA
Zoledronic acid - Zometa
Novartis Pharmaceutical Corp.
Medical(PDF -2MB)
Clinical pharmacology (PDF -615KB)
Statistical (PDF -422KB)
BPCA
Zolmitriptan - Zomig AstraZeneca Medical(PDF -2MB)
Clinical pharmacology (PDF -703KB)
Statistical (PDF -368KB)
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
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