OTC drugs quick hits

Question 1

how are OTC drugs regulated by the FDA?

Answer 1

via OTC drug monographs (a kind of “recipe book” covering acceptable ingrdients, doses, formulations, and labeling)

Question 2

5 risks of OTC drugs? (M I OS)

Answer 2

intentional and unintendend mis use

accidental ingestion

intentional OD

worsened outcome due to self-management

Question 3

FDA decides if drug is ________

Answer 3

safe for direct selling

Question 4

what are the 6 hidden drug/classes in OTC drugs? (AAACSS)

Answer 4

alcohol - cough/cold; mouthwashes

antihistamine - analgesics; menstrual products and sleep aides

aspirin or other salicyclates -antidiarrheals; cold/allergy, analgesics

caffeine - menstrual period stimulants

sodium - analgesics, antancids; cough/cold drugs, laxatives

sympathomimetis - analgesics, asthma products; cough/cold/allergy drugs; hemorrhoidal products

Question 5

acid reducers - H2 antagonits : which two drugs?

comment?

Answer 5

cimetidine + nizatinide

use< 2 weeks, not <12YOA

Question 6

PPIs: which drug

comment?

Answer 6

omeprazole

use < 2 weeks not <18 YOA

Question 7

antidiarrheals

which two drugs?

when do you not used the?

Answer 7

bismuth salicyclate

loperamide

not for use if diarrhea is accompanied by fever >101 degree F or blood or mucus in stool

Question 8

allergy/colds

which 4 dugs?

comment?

which one most sedating

Answer 8

drugs: chlorpheniarmine, cetrizine, diphenydramine, and loratidine
comment: hayfever responds to ant-histamine alone for colds, sympathomimeitc decogenstant co-formulated = 2nd gen = non-sedating

diphenhydramine = most sedaing of listed 1st gen agents

Question 9

analgesics and antipyretics

which 3 drugs?

comment

Answer 9

acetaminophen

apsirin

ibuprofen

acetaminophen available in liquid formulation; max doese <4g/day. caution with regular alcohol use (hepatotoxicity). long term use increases risk of stroke, MI

Question 10

antitussives

which two drugs?

comment

Answer 10

codieine and dextromethorphan

central suppression of cough relfex, codiene schedule V, restricted in some states

Dex is non-narcotic but is abused; hallucinongen

Question 11

expectorants

which drug?

comment

Answer 11

guaifenesin

often used with antihistamines + antitussive in combination

Question 12

decogenstants - topical + systemtic

which drug?

comment

Answer 12

phenyephrine

systemic(pseudoepherdien + phenlyephrine)

use for <3 days to avoid rebound congestion

often used with antihistamine + antitussive + analgeisc in combo. may cause systemic toxcitiy

note: pseudoephedrine has methamphetamine precursor

Question 13

stimulants

which drug?

comment

Answer 13

caffeine

toxicity in high doses

Question 14

weight loss aid?

which drug?

comment

Answer 14

orlistat

approved for >18YOA as part of diet/exercise plan, recent concern over liver tox. FDA monitors

Question 15

OTC pain meds

what is ADE of acetaminponen

which 2 drug classes does it interact with?

caution in what? (CAPA)

Answer 15

ADE: hepatotoxicity

intreractions: hepatotoxic drugs(azoles, macrolides, warafin) + CYP inducers
cautions: C-cirrhosis A-alcohol use A-anticoagulation P-poor nutrition >60yrd old

Question 16

OTC pain meds

NSAIDS

which ADE: (7)

interactions: bleed and cardio meds(4 catergories here)

cautions

Answer 16

>60 yr old man with renal failure, GI bleed and gastritis, Nausea, diarrhea, and tinnitus

ADE: GI bleed and gastrits, Nausea and diarrhea, tinnitus, renal failure

interactions: warfarin

antihypertensives

alpha and beta blockers

ACEI and ARBS

caution in: Renal failure(prostaglandin inhibition), CHF, gout(blocks elimination of uric acid) , cirrhosis, apsirin sensitive ashtma(shunts metabolites of arachidonic acid to pro-inflammatory pathway –>leukotriene syntehsis)

Question 17

which drug must be labeled if contained in a product ? “hidden ingredient case”

Answer 17

acetaminophen

Question 18

what are 2, 2nd gen antihistamines: what happens if you push dose too high?

Answer 18

loratidine and cetrizine

push dose too high and CNS effects WILL occur

Question 19

what is an first gen anti-histamine used for motion sickness?

Answer 19

diphendyramine

recall: transmission of sensatin from the inner ear(motion) to the cerebellum occurs via H1 and muscarinic receptor function

Question 20

coughs and colds:

3 drugs?

Answer 20

anticholineric anihistamines

pseudoephedrine

topical nasal decongestant

Question 21

anticholinergic antihistamine ADE?

4 drug interactions? (TAP O)

cautions(2)

Answer 21

anti- DUMBELLS

interactions: TCA, antiparkinson, phenothiazine, oxybutin
cautions: Closed angle glaucoma and dementia

Question 22

pseudoephedrine

9 ADEs?

3 intreactions: BDM

cautions: 7

Answer 22

ADE: HTN + vasopasm

arrhythmia + stroke

seizures + hallucincations

chronic headaches

insomnia + tremor

interactions: Beta blockers, digoxin, Monoamine oxidase inhibotrs;

CAutions: CHD + HTN

Thyroid disase + diabetes mellitus

prostatic hypertrophy + urinary retention

closed-angle glaucoma

Question 23

topical nasal decongestants: 2 ADEs

Answer 23

rhinitis medicamentosa

HTN

Question 24

MOA of dextromethorphan:

what demethylates this drug? consequences?

has effects like?

what is it combined with to discourage abuse?

Answer 24

MOA: non-opiate blocker in cough center (normally no sedative, analgesic or additive properties)

demethylated by CYP2D6; enzyme deficient is some individuals(5-10% white europeans)–>rapid acute toxicity and in excess, side effects include: dry mouth and throat, tachycardia, warm feeling, inability to concentrate

>2mg/kg —>phenycylcinde-like effects

combination of products contain ingredients that limit dosing(guaifenesin) or have toxicity(chlorpheniramine)

Question 25

in kids <6 years old, what should you use for cough and colds?

Answer 25

1. honey

just as good as dextromethorphan, but increased risk of transmitting botulism to infants <1

Question 26

3 common OTC that may affect BP:

PIP

Answer 26

phenylephrine

pseudoephedrine

ibuprofen

Question 27

which medications most commonly abused by persons 12-25?

which age = more girls abusing? which age = more boys abusing?

Answer 27

cough and cold medicines

others: doxylamine, dimenphyarinate, diphendyramne

caffience

nicotine replacement

12-17 = females more likely to abuse

18-25= males

Question 28

OTC and dyspesia + heart burn:

which three drug classes

Answer 28

antacids

H2 antagonists-

PPIs

Question 29

OTC and dyspepsia

antacids:

which ADE (DECK)?

inreactions? 6

cautions (CHRK)

Answer 29

ADE: DECK = diarrhea, electrolyte imbalance, constipation, kidney stones

interactions: ibuprofen, sulfonyluera, ferrous sulfate, tetracycline, ciprofloxacin, isoniazid
cautions: kidney stones, hypercalcemia, renal failure, CHF

Question 30

H2 antagonist: cimetidine, nizetinide

ADE: HDDC

interaction: 2
cautions: think GI

Answer 30

ADE: headache, dizziness, constipation, diarrhea

interactions: Cimetidine is CYP2C19 inhibitor; interaction w/fluozetine, diazepma, phenytoin,

ALL H2 blockers change gastric pH and can affect bioavailability of drugs

Cautions: Cirrhosis, GI bleed, renal failure

Question 31

PPIs: omepraxole

ADE:

interactions:

caution

Answer 31

PPIs:

ADE: headache, dizziness, constipation, diarrhea

interactions: both CYP2C19 inhibitors

All PPIs change gastric pH and and affect bioavailability of drugs

ADE: cirrhosis, GI bleeding, renal failure

Question 32

antidiarrheals: bismuth subsalicylate( peptobismol and kaopectate)

ADE:TFF

interactions:

cautions:

Answer 32

ADE: discolored feces, discolored tongue, fecal impaction

Interactions: warfarin, tetracycline, steroids, valproic acid, uricosuric acid, antacids

cautions: anticoagulation, infections, diarrhea

Question 33

medication: loperamide

ADE: FEDuP

interactions:
cautions: DIC

Answer 33

ADE: FEDuP- fluid loss, electrolyte imabalance, Dehydration, Paralytic ileus

interactions: none

Cautions: diarrhea, infections, cirrhosis

Question 34

OTC constipation products

which two drugs?

Answer 34

bisacodyl senna

magnesium hydroxide,

magnesium sulfate

Question 35

bisacodyl senna

ADE:

interactions

cautions

Answer 35

ADE: electrolyte imbalance, cathartic action

interactions: none
cautions: none

Question 36

magnesium hydroxide

ADE: EE why?

interactions: 4

cautions:

Answer 36

ADE: electrolyte imbalance and edema (potential for chelation of concurrent drugs and alteration of bioavailability by neutralization of pH)

interactions: quinolones, azoles, thyroid drugs, digoxin
cautions: renal failure, bone disease

Question 37

children:

what is the DOC for pain relief?

when should you avoid aspirin?

decongestants for whom?

what about H2 blockers?

Answer 37

DOC: acetaminophen

Aspirin(use in Kawasaki’s diseas)- don’t use –> Reye syndrome (encephalopathy, microvesicular fatty chnages, transaminase elevation)

decongestants are ok for kids >6 BUT safety not established

H2 blcokers are safe, but liquid formulations (easier for admin) are not OTC.

Question 38

5 considerations in the elderly?

NGPAG

Answer 38

increase risk NSAIDs and kidney disease/GI bleeding

increase risk glaucoma/UT block w/pseudopehedrine

Pseudopehedrien interaction(beta-blockers, antidepressants, insulin, MAOIs_

interaction w/antihistamine may be significant (worsen asthma, narrow angle-glaucoma, prostatic enlargment, confusion, delirium, dizziness, -falls and fractures)

more susceptible to ADE of GI drugs(diarrhea/dehydration (Mg) or constipation(AI) - mg antacids if no renal impairment; drug interaction w/cimetidine most likely

Question 39

sleep aids:

2 drugs?

comment