Otopharmacology Test 1

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What does the FDA require on all medication labels?

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This is a study set that covers cell biology/physiology and drug delivery with specific focus on the mechanisms of the ear.

59 Terms

1

What does the FDA require on all medication labels?

  • Name of the product

  • Table of drug facts

  • Active ingredients

  • Proper use and purpose

  • Warnings

  • Directions

  • Allergic reactions/harmful side effects

  • Inactive ingredients

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2

What are the drug levels/schedules?

C-I, C-II, C-III, C-IV, C-V

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3

What determines a C-I categorization?

High potential for abuse, with no currently accepted medical use in the US. Considered dangerous when used without medical supervision

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4

What are some examples of C-I drugs?

MDMA, ecstasy, LSD, GHB, heroin

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5

What determines a C-II categorization?

High potential for abuse, but with some accepted medical uses in the US. Abuse leads to physical and/or psychological dependence and is considered dangerous

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6

What are some examples of C-II drugs?

Morphine, cocaine, PCP, opium

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7

What determines a C-III categorization?

Potential for abuse, but lower than previous categories. There are accepted medical uses, and abuse can lead to mild physical dependence or great psychological dependence

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8

What are some examples of C-III drugs?

Ketamine, codeine, lysergic acid, anabolic steroids

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9

What determines a C-IV categorization?

Relatively low potential for abuse. Have accepted medical uses in the US. Abuse leads to limited dependence

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10

What are some examples of C-IV drugs?

benzodiazepines, phenobarbital

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11

What determines a C-V categorization?

Low potential for abuse. Have accepted medical uses in the Us. Abuse may lead to limited dependence.

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12

What are some examples for C-V drugs?

pyrovalerone, retigabine

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13

What are the health professional guidelines for drug management?

  • Access a CURRENT drug reference

  • Controlled substances have to be locked securely

  • Conceal and secure prescription pads at office

  • Keep accurate records of controlled substances

  • Keep up to date with FDA/DEA

  • Establish working rapport with pharmacist

  • Maintain ethical relationship with pharmaceutical reps as part of Affordable Care Act, and Sunshine act, requires reporting compensation/gifts

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14

What are the top 10 drug classifications?

  • Lipid-lowering agents

  • Antidepressants

  • Narcotic analgesics

  • Beta-blockers

  • Antihypertensives

  • Diuretics

  • Antidiabetics

  • Antibiotics

  • Proton pump inhibitors

  • Anticoagulants

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15

What do lipid lowering agents do?

Lowers low density lipoprotein (LDL) cholesterol

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16

What do antidepressants do?

Improves symptoms of depression. Also used for anxiety and other neurological disorders

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17

What do narcotic analgesics do?

Relieve severe pain

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18

What do Beta blockers do?

Lowers heart rate and blood pressure

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19

What do antihypertensives do?

Lowers blood pressure

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20

What do diuretics do?

Increases urinary output

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21

What do antibiotics do?

Eliminates infection

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22

What do proton pump inhibitors do?

Decreases acidity of stomach

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23

What do anticoagulants do?

Decreases clotting in blood

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24

What 4 names do a drug have?

Generic, trade, chemical, and official

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25

What is a generic drug name?

Common or general name assigned to drug by the US Adopted Name Council

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26

Do generic names have an upper or lower case initial letter?

Lower

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27

What is a trade drug name?

Proprietary or brand name owned by pharmaceutical company

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28

Do trade names have an upper or lower case initial letter?

Upper

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29

What is a chemical drug name?

The exact molecular formula of the drug

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30

What is a official drug name?

Name of the drug as it appears in the official reference, the United States Pharmacopeia/National Formulary (USP/NF). Generally, the same as the generic name

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31

What is tall man lettering?

Upper case lettering often used to highlight difference between confused drugs. Ex: CeleXA vs CeleBREX

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32

Indications

List of medical conditions of diseases for which the drug is meant to be used

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33

Actions

description of cellular changes that occur as a result of the drug (technical)

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34

Contraindications

a list of conditions for which the drug should NOT be given

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35

Cautions

a list of conditions or types of patients that warrant closer observations for specific side effects

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36

Side effects/adverse reactions

a list of possible unpleasant or dangerous secondary effects, other than the desired effects

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37

Interactions

a list of drugs or foods that may alter the effect of the drug and usually should not be given during the course of therapy

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38

What are the routes of drug administration?

  • Oral

  • Digestive Tract (enteral)

  • Buccal / Sublabial / Sublingual

  • Respiratory Tract / Endotracheal

  • Injection / Infusion (tissue or blood)

  • Ophthalmologic

  • Urogenital

  • Rectal (enteral)

  • Nasal

  • Topical / Transdermal

  • Otologic

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39

What is First Pass Metabolism?

A phenomenon of drug metabolism where the concentration of a drug is greatly reduced before it reaches the systemic circulation during the process of absorption in the liver and gut wall

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40

What are the challenges to get drugs to the inner ear?

Anatomical

  • Difficult area to access

  • Blood-inner ear barrier

  • Limited labyrinthine artery supply

Mechanistic

  • Variations in RWM permeability

  • Biotherapeutic instability

  • Uncontrolled drug elimination

  • ·Nonspecific drug delivery

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41

What are inner ear drug delivery approaches?

  • Intratympanic injection

  • Hydrogel

  • CI

  • Round window micro catheter

  • Silverstein microwick

  • Cochleostomy

  • Nanoparticle

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42

Why is active transport different than passive transport?

Active transport requires energy (ATP), whereas passive doesn’t (facilitated diffusion)

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43

What is signal transduction?

When a receptor binds to its substrate and causes a conformational change in the receptor, this change in shape will cause it to either release something inside the cell or bind to something else inside the cell

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44

What are the functional roles of proteins?

  • Stabilization of the membrane

  • Selective transport of both ions and large molecules

  • Anchor the membrane to adjacent cells or substrates

  • Communication

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45

What is the cochlear protein that is a likely player when sound is converted into electrical signals?

Protocadherin-15

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46

What’s the difference between apoptosis and necrosis?

Apoptosis is described as an active, programmed process of autonomous cellular dismantling that avoids eliciting inflammation. Necrosis has been characterized as passive, accidental cell death resulting from environmental perturbations with uncontrolled release of inflammatory cellular contents.

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47

What do cellular adhesion molecules (CAMs) do?

Help guide white blood cells to the injured areas

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48

What are the DNA pairs?

  • A-T

  • T-A

  • C-G

  • G-C

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49

What protein are cilia?

Microtubules

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50

What microfilament works with mechanical strength, phagocytosis, and motility?

Actin

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51

Free Radical

An atom, molecule, or ion that has at least one unpaired valence electron

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52

Pharmacokinetics describes how the body affects a specific chemical after administration through the mechanisms of absorption and distribution, metabolism, and the effects and routes of excretion. (what the body does to the drug)

Pharmacokinetics

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53

Biochemical and physiologic effects of drugs on the human body (what a drug does to the body)

Pharmacodynamics

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54

The range of doses at which a medication is effective without unacceptable adverse events. Drugs with a narrow TI have a narrow window between their effective doses and those at which they produce adverse toxic effects.

Therapeutic Index

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55

The time required for a quantity (of substance) to reduce to half of its initial value

Half Life

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56

What did the US Food, Drug, and Cosmetic Act do?

Gave authority to the FDA to oversee the safety of food, drugs, medical devices, and cosmetics

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57

What did the Pure Food and Drug Act do?

Ban mislabeled food products, required that active ingredients be placed on the label of a drug's packaging, and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.

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58

What did the Pediatric Rule do?

Ensure that drugs commonly used for the treatment of children are actually tested for pediatric use

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59

What did the Controlled Substances Act do?

Established Drug Enforcement Administration (DEA), created tighter controls on some substances, and categorized drugs into 5 Levels

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