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PL Detail-Document #311205
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additional insight related to the Recommendations published in−
PHARMACIST’S LETTER / PRESCRIBER’S LETTER
December 2015
Alcohol and Drug Interactions
Many drugs interact with alcohol to some extent. There are two main types of alcohol-drug interactions: pharmacokinetic and pharmacodynamic.
Pharmacokinetic interactions occur when alcohol alters the metabolism or excretion of the drug or vice versa. Pharmacodynamic interactions refer to
additive effects of alcohol and certain drugs, particularly in the central nervous system (e.g., sedation).1 Alcohol is primarily metabolized in the liver
by several enzymes. The most important enzymes are aldehyde dehydrogenase and CYP2E1. In people consuming alcohol occasionally, CYP2E1
metabolizes only a small fraction of the ingested alcohol. In contrast, chronic heavy drinking can increase CYP2E1 activity up to ten-fold, resulting
in higher proportion of alcohol being metabolized by CYP2E1 rather than alcohol dehydrogenase. Therefore, the effect of alcohol on the interacting
drug may be different depending on chronic or acute alcohol use.3 Alcohol can also increase the risk of hepatoxicity with some drugs. See our PL
Chart, Liver Function Test Scheduling, for more on drugs that require liver function monitoring. Alcohol is contraindicated with a number of
extended-release formulations (e.g., Opana ER [U.S.], various other opioids) due to the risk of dose dumping of the formulation or increased
availability of the drug and potential overdose.2 Many other extended-release formulations also have warnings about alcohol such as Ritalin LA
(U.S.), Gralise (U.S.), Durlaza (U.S.), etc.4,15,26 In general, be cognizant of patients who are using extended-release formulations and counsel on the
potential risks associated with alcohol consumption. In addition, remind patients that some OTC meds (e.g., cough syrups, laxatives) may contain up
to 10% alcohol.8 Finally, it is important to note that the elderly may be at higher risk with alcohol-drug interactions, due to the fact that alcohol
metabolism may be slowed and alcohol itself may increase the risk of falls, serious injury, etc.8 This chart includes selected alcohol-drug interactions
and recommendations for alcohol consumption. Note that the chart is not all-inclusive and that product labeling for meds may advise avoiding use
with alcohol due to the potential for additive CNS effects. In addition, comorbidities related to alcoholism such as cirrhosis, GI effects, etc, may
require additional considerations related to drug therapy.
Abbreviations: CNS=central nervous system; GI=gastrointestinal; MAOIs=monoamine oxidase inhibitors; NSAIDs= nonsteroidal antiinflammatory drugs; PDE-5=phosphodiesterase-5; TCAs=tricyclic antidepressants.
Drug or
Drug Class
Clinical Effects and
Possible Mechanisms
Analgesics (Non-Opioids)
Acetaminophen
 Chronic alcohol use can increase blood levels of the acetaminophen
metabolite, N-acetyl-p-benzoquinoneimine (NAPQ), which is hepatotoxic,
and reduce blood levels of acetaminophen. The mechanism is increased
metabolism of acetaminophen by CYP2E1.1,5 It may also increase the risk
of kidney disease through an unknown mechanism.6
 Acute alcohol use in large amounts may increase the risk of liver toxicity
with acetaminophen similar to chronic alcohol use5
Recommendations and
Comments
 U.S. product labeling for acetaminophen
products states that severe liver damage may
occur in adults who have 3 alcoholic
drinks/day while taking acetaminophen7
More. . .
Copyright © 2015 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #311205: Page 2 of 9)
Drug or
Drug Class
Clinical Effects and
Possible Mechanisms
Recommendations and
Comments
Analgesics (Non-Opioids), continued
Aspirin
 Aspirin or NSAIDs and alcohol may have additive or synergistic
NSAIDs
damaging effects on the gastric mucosal barrier leading to an increased
risk of GI hemorrhage, in a dose-dependent manner1,5,7,8
 Advise against chronic NSAID use in
regular drinkers, especially in heavy drinkers
(e.g., 3 alcoholic drinks/day)9
 Product labeling for aspirin extended-release
capsules (Durlaza) recommend not taking
the drug within 2 hours prior or 1 hour
following consumption of alcohol due to
possible interference of alcohol with the
controlled-release property of the
formulation26
Analgesics (Opioids): In addition to enhanced sedative effects, concurrent use of alcohol and opioids increases the risk of fatal overdose due to
respiratory depression.1,8,10
Extended-release
 Co-ingestion of alcohol and some extended-release opioids may lead to
 In general, advise against concomitant use of
7
opioids
“dose dumping” or delivery of a potentially fatal dose of the opioid
alcohol and all opioids22
 Extended-release formulations that are known
to be adversely affected by alcohol include
Nucynta ER, Opana ER (U.S.), Embeda
(U.S.), Kadian, and Zohydro ER (U.S.)2,2730,35,36
 Warn patients about the potential effects of
alcohol on methadone, such as an increased
risk of fatal overdose. In general, advise
against concomitant use of alcohol and
opioids.7,22
Anticoagulants/Antiplatelets: Alcohol may increase the risk of falls, and therefore the risk of bleeding, with anticoagulants/antiplatelets.12
Warfarin
 Acute ingestion of alcohol may reduce metabolism of warfarin,10 although
 Advise patients about the potential effects of
small to moderate amounts (2 to 3 drinks) don’t seem to have an effect11
alcohol use on the effects of warfarin, and
monitor more frequently if dietary habits,
 Chronic use of alcohol has been associated with both increases and
including alcohol consumption, change12
decreases in the effects of warfarin and there are conflicting data.5,10,11
Patients with liver disease may be more likely to have potentiation of
warfarin’s effects with alcohol use.12
Methadone
 Chronic alcohol use reduces the effects of methadone due to increased
hepatic metabolism of methadone7
 Acute alcohol ingestion increases the effects of methadone due to decreased
hepatic metabolism of methadone7
More. . .
Copyright © 2015 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #311205: Page 3 of 9)
Drug or
Drug Class
Antidepressants
Bupropion
Clinical Effects and
Possible Mechanisms
 Bupropion may reduce alcohol tolerance7,10
 Both acute alcohol ingestion and abrupt discontinuation of alcohol use can
increase the risk for seizures, and bupropion can also reduce the seizure
threshold10
 Tyramine, which is found in some beers and wines, interacts with MAOI
inhibitors leading to severe hypertension.10,13
 Alcohol and MAOIs may have additive CNS effects10
Recommendations and
Comments
 Advise patients to minimize or avoid the use
of alcohol with bupropion10
 Advise patients to avoid the use of alcohol
with MAOIs1
 In general, dietary restrictions for MAOIs
should be followed for at least two weeks
following discontinuation of MAOIs10
TCAs
 Alcohol may increase the sedative effects of tricyclic antidepressants, their
 Consider the use of SNRIs or SSRIs for
blood levels (e.g., amitriptyline), and the risk of orthostatic
patients who consume alcohol, as the risk for
hypotension.1,3,5,7,12,13
an interaction appears to be limited1
 Alcohol-enhanced CNS depression may be
more prevalent in the first week of TCA
therapy7
Antidiabetics: Alcohol suppresses gluconeogenesis and may generally increase the risk of hypoglycemia.1 However, there may also be a risk that
calories from alcohol consumption can worsen glycemic control.10,14
Sulfonylureas
 Alcohol may cause a disulfiram-like reaction in patients who are taking
 Advise patients taking sulfonylureas against
chlorpropamide, glyburide, tolazamide, or tolbutamide1,8
heavy alcohol consumption and to avoid
alcohol completely during the fasting state or
if symptoms of hypoglycemia occur after any
consumption14
Insulins
 Alcohol ingestion may cause severe and unpredictable effects of insulin on  Advise patients using insulin against heavy
blood sugar due to its effects on gluconeogenesis14
alcohol consumption and to avoid
consumption of alcohol on an empty
stomach14
Metformin
 Concomitant ingestion of alcohol and metformin may cause nausea and
 Advise patients taking metformin against
weakness8
heavy alcohol consumption, either acute or
chronic, and to monitor for signs and
 Alcohol ingestion may lead to increased blood levels of lactic acid with
symptoms of lactic acidosis (e.g., muscle or
metformin use1,25
stomach pain, slowed heart rate, dizziness) if
alcohol is consumed25
MAOIs
More. . .
Copyright © 2015 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #311205: Page 4 of 9)
Drug or
Drug Class
Clinical Effects and
Possible Mechanisms
Recommendations and
Comments
Antiepileptics: Moderate social drinking does not seem to cause a clinically relevant interaction in most cases, although additive sedation can be
an issue.7,10
Perampanel
 Concomitant use of alcohol and perampanel (especially high doses) can
 Advise patients about possible effects of
Fycompa
lead to an increased risk of CNS depression and psychiatric effects such as
alcohol and perampanel, and recommend
anger, confusion, and depression10
limiting activity until the effects of
concomitant use are known for each
individual.10 (Avoid use of alcohol per
Canadian labeling.)31
Phenytoin
 Acute alcoholic intake may increase phenytoin levels, while chronic alcohol  Advise patients about possible effects of
use may decrease levels33
alcohol and phenytoin
Antihistamines: Drowsiness may be increased when antihistamines are used with alcohol, and psychomotor effects such as on driving abilities
may be significantly impacted, especially with sedating antihistamines.7
First-generation
 Alcohol may increase sedation and dizziness associated with first Advise against alcohol consumption with firstantihistamines
generation antihistamines, especially in older adults, due to additive CNS
generation antihistamines.22 Consider
1,8,13
effects
recommending a non-sedating antihistamine
instead of a first-generation antihistamine, but
warn patients about the possibility of an
interaction since responses may differ between
individuals.7
Antihypertensives: Moderate to heavy chronic drinking (>2 drinks/day) increases blood pressure.7,16 In addition, alcohol consumption can
acutely lead to hypotension and additive effects with vasodilators.
Alpha-1 Alcohol may increase the risk of postural hypotension with alpha-blockers,  Advise patients about possible effects of
adrenergic
shortly after its ingestion8
alcohol and alpha-blockers
blockers
Beta-blockers
 Alcohol may increase the hypotensive effects of beta-blockers7
 Advise patients about possible effects of
alcohol and beta-blockers
Calcium channel
 Alcohol may increase the risk of postural hypotension with calcium channel  Advise patients about possible effects of
blockers
blockers, shortly after its consumption5,7
alcohol and calcium channel blockers
 Chronic use of verapamil may increase blood levels of alcohol and reduce
its rate of metabolism7
 Alcohol may increase blood levels of nifedipine5
More. . .
Copyright © 2015 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #311205: Page 5 of 9)
Drug or
Drug Class
Antimicrobials
Doxycycline
Clinical Effects and
Possible Mechanisms
Recommendations and
Comments
 Chronic heavy use of alcohol may lead to subtherapeutic levels of
doxycycline due to an increase in its rate of metabolism7
 Consider doubling the dose of doxycycline in
alcoholic patients or substitute a noninteracting drug for doxycycline7
 Note that concurrent ingestion of ethanol and
tetracycline may slightly increase blood levels
of tetracycline10
Griseofulvin
(U.S.)
Isoniazid
 Griseofulvin may increase the effects of alcohol, such as nausea, vomiting,
tachycardia, and severe hypotension8,17,22
 Heavy or chronic alcohol ingestion (i.e., daily) may increase the risk of
hepatotoxicity with isoniazid and increase the clearance of isoniazid7,8,10,22
 Advise patients to avoid alcohol while taking
griseofulvin22
 Advise patients to avoid alcohol while taking
isoniazid10,22,24
Ketoconazole
 Alcohol may increase the risk of a disulfiram-like reaction with oral
ketoconazole7
 Alcohol may increase the risk of hepatotoxicity with oral ketoconazole24
 Advise patients to avoid alcohol while taking
ketoconazole7
Metronidazole
 Alcohol may increase the risk of a disulfiram-like reaction with
metronidazole. There may also be a risk with vaginal metronidazole
formulations due to small amounts of systemic absorption, although it
appears to be small.7
 The risk may be low, but advise patients to
avoid alcohol while taking metronidazole and
for 72 hours after metronidazole has been
stopped7,22
Tinidazole (U.S.)
 Alcohol may increase the risk of a disulfiram-like reaction with tinidazole7
 The risk may be low, but advise patients to
avoid alcohol while taking tinidazole and for
72 hours after it has been stopped7,22
 Concomitant use of alcohol and atypical antipsychotics can lead to additive
CNS effects and postural hypotension, especially with olanzapine and
quetiapine7
 Advise patients to avoid alcohol while taking
antipsychotics7,22
 Concomitant use of alcohol and phenothiazines can lead to an increased
risk of sedation13
 May increase the risk of extrapyramidal side effects7
 Advise patients to avoid alcohol while taking
antipsychotics22
Antipsychotics
Atypicals
Phenothiazines
More. . .
Copyright © 2015 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #311205: Page 6 of 9)
Drug or
Drug Class
Clinical Effects and
Possible Mechanisms
Recommendations and
Comments
Muscle Relaxants: Concurrent use of muscle relaxants and even small amounts of alcohol can lead to additive CNS depressant effects. 7
Sedative-Hypnotics
Barbiturates
 Concomitant use of barbiturates and even small amounts of alcohol can
lead to additive CNS effects7
 Warn patients of possible effects, such as
increased sedation and impaired psychomotor
skills, as well as the potential for hangover
effects where a barbiturate could continue to
interact with alcohol the next day7
 Warn patients of possible effects, such as
increased sedation and impaired psychomotor
skills.7 Consider advising against concomitant
use of alcohol and benzodiazepines.22
Benzodiazepines
 Concomitant use of benzodiazepines and alcohol can lead to additive CNS
effects. This is especially true with long-acting benzodiazepines or with
greater amounts of alcohol7,10
 Acute alcohol ingestion may increase blood levels of some benzodiazepines
(e.g., diazepam, triazolam) by increasing their absorption7,10
Nonbenzodiazepine
hypnotics (e.g., “Z
drugs,” ramelteon,
suvorexant
[Belsomra])
Chloral hydrate
 Concomitant use of alcohol and non-benzodiazepine hypnotics can lead to
additive CNS effects and risk of “complex behaviors” (e.g., sleep-driving,
etc)5,23
 Advise against the use of alcohol with nonbenzodiazepine hypnotics.22 Besides
interacting with these drugs, alcohol is
associated with insomnia.18
 Concomitant use of alcohol and chloral hydrate can lead to additive CNS
effects in addition to reduced metabolism of both agents10
 Advise patients to separate consumption of
significant amounts of alcohol from the use of
chloral hydrate by 12 to 24 hours10
 Advise patients to avoid alcohol while taking
meprobamate7
Meprobamate
 Meprobamate can increase alcohol-associated intoxication7
(U.S.)
 Chronic use of alcohol may increase metabolism of meprobamate8
Sexual Dysfunction Treatments
Flibanserin (U.S.)  Concomitant use of alcohol and flibanserin may lead to severe hypotension
(Addyi)
and syncope19
PDE5 inhibitors
(e.g., sildenafil,
etc)
 Concomitant use of alcohol and PDE-5 inhibitors may rarely increase the
risk of postural hypotension and increased heart rate (seen with tadalafil),
especially when several drinks are consumed7
 Advise patients to abstain from alcohol (from
any source) during treatment with flibanserin
and for 2 days after discontinuation.19
 Advise patients about the possible effects of
alcohol and PDE-5 inhibitors, and remind
them that alcohol can worsen erection
difficulties as well7
More. . .
Copyright © 2015 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #311205: Page 7 of 9)
Drug or
Drug Class
Clinical Effects and
Possible Mechanisms
Recommendations and
Comments
Statins: Alcohol abuse may increase the risk of side effects with statins.34
Miscellaneous Agents
Acitretin
 Increased duration of teratogenic potential in women10
 Tell women of reproductive potential to
completely avoid alcohol and alcohol Alcohol increases the transesterification of acitretin to etretinate, a
10
containing drugs while taking acitretin and for
teratogen which can remain in the body for years
2 months after the drug is stopped10
Methotrexate
 Ingestion of ~2 or more alcoholic drinks per week may increase the risk of
methotrexate-induced liver toxicity.7 Patients being treated for psoriasis
may be at higher risk than those being treated for rheumatoid arthritis.20
 Consider advising patients against
consumption of alcohol during treatment with
methotrexate.7 See our PL Detail-Document,
Using Methotrexate Safely for Rheumatoid
Arthritis, for more information.
Metoclopramide
 Concomitant use of alcohol and metoclopramide can lead to additive CNS
effects7
 Metoclopramide may increase blood levels of alcohol due to increased
gastric emptying7
 Consider advising patients to avoid alcohol
while taking metoclopramide21
Varenicline
Champix-Canada,
Chantix-U.S.
 Concomitant use of alcohol may increase alcohol-associated intoxication,
and increase the risk of unusual or aggressive behavior10 (per Canadian
labeling, increased risk of psychiatric adverse events).32
 Advise patients about possible effects of
alcohol and varenicline, and recommend
limiting alcohol intake until the effects of
concomitant use are known for each
individual10,32
Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making
clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national
organizations. Information and internet links in this article were current as of the date of publication.
More. . .
Copyright © 2015 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #311205: Page 8 of 9)
Project Leader in preparation of this PL DetailDocument:
Stacy A. Hester, R.Ph., BCPS,
Assistant Editor
References
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Weathermon R, Crabb DW. Alcohol and medication
interactions. Alcohol Res Health 1999;23:40-54.
Product information for Opana ER. Endo. Malvern,
PA 19355. April 2014.
Masters SB. Chapter 23. The Alcohols. In:
Katzung BG, Masters SB, Trevor AJ, eds. Basic &
Clinical Pharmacology, 12e.
New York, NY:
McGraw-Hill; 2012.
Product information for Ritalin LA. Novartis. East
Hanover, NJ 07936. July 215.
Chan LN, Anderson GD.
Pharmacokinetic and
pharmacodynamic drug interactions with ethanol
(alcohol). Clin Pharmacokinet 2014;53:1115-36.
Thompson D. Acetaminophen and alcohol a bad
mix, study suggests.
November 4, 2013.
http://www.webmd.com/mentalhealth/addiction/news/20131104/tylenol-and-alcohola-bad-mix-study-suggests. (Accessed November 6,
2015).
Baxter K, Preston CL (eds).
Stockley's Drug
Interactions. [online] London: Pharmaceutical Press
http://www.medicinescomplete.com/.
(Accessed
November 6, 2015).
National Institute on Alcohol Abuse and Alcoholism.
Mixing
alcohol
with
medicines.
2014.
http://pubs.niaaa.nih.gov/publications/Medicine/medi
cine.htm. (Accessed November 6, 2015).
Kaufman DW, Kelly JP, Wiholm BE, et al. The risk of
acute major upper gastrointestinal bleeding among
users of aspirin and ibuprofen at various levels of
alcohol consumption.
Am J Gastroenterol
1999;94:3189-96.
Clinical Pharmacology [database online]. Tampa,
FL:
Gold
Standard,
Inc.;
2015.
http://www.clinicalpharmacology.com.
(Accessed
November 6, 2015).
Cropp JS, Bussey HI. A review of enzyme induction
of warfarin metabolism with recommendations for
patient
management.
Pharmacotherapy
1997;17:917-28.
Ageno W, Gallus AS, Wittkowsky A, et al. Oral
anticoagulant therapy: antithrombotic therapy and
prevention of thrombosis, 9th ed: American College
of Chest Physicians evidence-based clinical practice
guidelines. Chest 2012;141(Suppl 2):e44S-88S.
National Institute on Alcohol Abuse and Alcoholism.
Alcohol
Alert.
January
1995.
http://pubs.niaaa.nih.gov/publications/aa27.htm.
(Accessed November 6, 2015).
American Diabetes Association. Alcohol. June 6,
2014.
http://www.diabetes.org/food-andfitness/food/what-can-i-eat/making-healthy-foodchoices/alcohol.html.
(Accessed November 6,
2015).
15. Product information for Gralise. Depomed. Newark,
CA 94560. December 2012.
16. National Heart, Lung, and Blood Institute. The
Seventh Report of the Joint National Committee on
Prevention, Detection, Evaluation, and Treatment of
High Blood Pressure (JNC 7).
August 2004.
http://www.nhlbi.nih.gov/guidelines/hypertension/jnc7
full.pdf. (Accessed November 6, 2015).
17. Product information for griseofulvin.
Sandoz.
Princeton, NJ 08540. August 2013.
18. Schutte-Rodin S, Broch L, Buysse D, et al. Clinical
guideline for the evaluation and management of
chronic insomnia in adults. J Clin Sleep Med
2008;4:487-504.
19. Product information for Addyi. Sprout. Raleigh, NC
27609. August 2015.
20. Whiting-O’keefe
QE,
Fye KH,
Sack
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meta-analysis. Am J Med 1991;90:711-6.
21. Product information for Reglan. ANI. Baudette, MN
56623. December 2014.
22. FDA.
Avoid
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http://www.fda.gov/downloads/drugs/resourcesforyou
/consumers/buyingusingmedicinesafely/ensuringsafe
useofmedicine/generaluseofmedicine/ucm229033.pd
f. (Accessed November 6, 2015).
23. Hesse LM, von Moltke LL, Greenblatt DJ. Clinically
important drug interactions with zopiclone, zolpidem,
and zaleplon. CNS Drugs 2003;17:513-32.
24. PL Detail-Document, Oral Ketoconazole Warnings.
Pharmacist’s Letter/Prescriber’s Letter. September
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25. Product information for Glucophage. Bristol-Myers
Squibb. Princeton, NJ 08543. June 2015.
26. Product information for Durlaza. New Haven. North
Haven, CT 06473. September 2015.
27. Product information for Nucynta ER.
Janssen.
Titusville, NJ 08560. April 2014.
28. Product information for Embeda. Pfizer. New York,
NY 10017. October 2014.
29. Product information for Zohydro ER.
Pernix
Therapeutics. Morristown, NJ 07960. May 2015.
30. Product monograph for Nucynta ER.
Janssen.
Toronto, ON M3C 1L9. August 2014.
31. Product monograph for Fycompa. Eisai Limited.
Mississauga, ON L4W 5A4. April 2013.
32. Product monograph Champix.
Pfizer Canada.
Kirkland, QC H9J 2M5. April 2015.
33. Product information for Dilantin. Pfizer. New York,
NY 10017. July 2015.
34. Mancini GB, Tashakkor AY, Baker S, et al.
Diagnosis, prevention, and management of statin
adverse effects and intolerance: Canadian Working
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Can J Cardiol
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35. Product information for Kadian.
Actavis.
Parsippany, NJ 07054. August 2014.
36. Product monograph for Kadian. BGP Pharma ULC.
Etobicoke, ON M8Z 2S 6. August 2015.
More. . .
Copyright © 2015 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #311205: Page 9 of 9)
Cite this document as follows:
PL Detail-Document, Alcohol and Drug Interactions.
Letter/Prescriber’s Letter. December 2015.
Evidence and Recommendations You Can Trust…
3120 West March Lane, Stockton, CA 95219 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Copyright  2015 by Therapeutic Research Center
Subscribers to the Letter can get PL Detail-Documents, like this one,
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Pharmacist’s
PL Detail-Document #320207
−This PL Detail-Document gives subscribers
additional insight related to the Recommendations published in−
PHARMACIST’S LETTER / PRESCRIBER’S LETTER
February 2016
Vaccine Administration Strategies
Patients often avoid vaccine recommendations due to fears of pain, injury, and/or needles.1 Those administering vaccines can do a lot to alleviate
these concerns for patients. And, this can help increase rates of vaccination, providing benefit to both individuals and the community. A positive
vaccination experience can also help prevent patients from developing anxiety that could transfer to a general fear of needles/injections with
repercussions into other areas of their health care.1 Below you will find various strategies to help reduce a patient’s fears, prevent injuries, and make
the injections less painful.2 Training on such strategies should be provided to everyone who administers vaccines.2 It is also important to involve and
train patients and caregivers on some of these strategies, beginning prior to the day of vaccination if possible (e.g., providing information prenatally,
at well-child visits, at routine check-ups, etc).2 For more information on the administration of vaccines, see our PL Self-Study Course, Immunization
Update 2015 Part 3: Vaccine Storage and Handling, Administration, and Adverse Events.
Abbreviations: IM = intramuscular; Subcut = subcutaneous
Suggested Checklist to Minimize Patient Anxiety
Be calm, collaborative, and well-informed.2
Let anxious patients/caregivers know what will happen, how it will feel, and what they can do. Provide information in advance if possible.1
Use neutral phrases like “Here I go.” rather than “Here comes the sting.” 2
Be truthful with the patient to promote trust.2
Ensure privacy to help decrease anxiety.2
Suggest anyone with a history of fainting to lie down for the injection, when possible.2
Let caregivers know that their behavior can influence a child’s response and distress. Give them information and tools to help them remain
calm.1 Let caregivers know they should never threaten or scare a child about injections.3
Make sure caregivers remain present with children, especially if less than ten years.1
More. . .
Copyright © 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #320207: Page 2 of 4)
Suggest infants and children sit on their caregivers lap to calm them, and help hold their arms if necessary. But, do not forcibly restrain a child
as this will increase their fear. Sitting provides a stronger sense of control.1,2
Consider having patients hold neonates with skin-to skin contact to reduce acute stress.1
Recommend breastfeeding infants, if acceptable to caregiver, during or shortly after injections.1,2 This can reduce stress with physical comfort,
sucking distraction, and sweet-tasting ingestion.1 Bottle feeding throughout may provide some benefit as well.2
Use distraction to divert attention, particularly in children less than six years, with toys, music, or conversation with an adult.2 Encourage
caregivers to bring a child’s favorite toy, book, blanket, or other comfort item.3
Suggested Checklist to Minimize Pain
Choose the proper needle size based on type of injection (IM vs Subcut) and your patient (i.e., age and weight).
See our PL Chart, Choosing the Correct Needle Size.
Select a 23 to 25 gauge needle for Subcut administration to decrease discomfort.4
Consider topical anesthetic creams, gels, or patches, particularly in children under 12 years if there is significant anxiety or fear of pain.1
Application must be done in advance (exact time will depend on the product chosen) and cost may be a barrier for some patients.1,2
Topical ethyl chloride and other vapocoolants are not generally recommended due to lack of proven effectiveness.5
Don’t recommend oral analgesics, such as acetaminophen, prior to injections.2 They likely don’t help and it has been suggested that they could
decrease the immune response.5,6,7 Save for after the injections for fever or discomfort.2
Sucrose (e.g., TootSweet) is recommended in infants less than two years if they are not breastfed during vaccination for pain control. Give 2 mL
of a 24% to 50% solution one to two minutes before the injection. Give rotavirus oral vaccine first if using as it contains sucrose.1
Encourage deep breaths, then give shot during exhalation when muscles are most relaxed. Have adults take deep breaths and children can blow
out into a toy pinwheel, party blower, or bubble blower.8 Adults can also give a slight cough as you inject the vaccine, being sure that the cough
doesn’t cause any arm movement or result in them holding their breath.2
Don’t pull back the plunger with IM administration.1,2,4 This technique is unnecessary and increases pain due to longer needle contact/dwell time
and the lateral movement/wiggling of the needle.1,2
More. . .
Copyright © 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #320207: Page 3 of 4)
Consider Buzzy, a $40 device that combines vibration and cold to decrease pain. Small studies done mostly in children undergoing venipuncture
show some benefit in pain reduction.9,10
You may hear about ShotBlocker, a disposable plastic disk that is placed to surround the injection site. The device has many blunt contact points
that press into the patient’s skin to “saturate the sensory signals” near the injection site to reduce perceived pain. Studies are small and many do
not show decreased pain in patients getting injections.11,12
DO NOT warm the vaccine (rubbing between your hands), rub or pinch the injection site (manual stimulation), rub the skin adjacent to the
injection site, or apply pressure prior to the injection.13
Suggested Checklist to Reduce Injury
A rare vaccine-related injury, Shoulder Injury Related to Vaccine Administration (SIRVA), is believed occur as a result of inappropriate
administration of IM vaccines.14-16 This particular injury appears to be more than trauma to the tissues and is thought to be an inflammatory
response to the injection of antigenic material into the synovial tissues.15 This can occur when an IM vaccine is administered too high on the arm
and goes into the subdeltoid bursa. Resultant symptoms can include permanent pain, lack of motion, weakness, and impaired
mobility/functionality.15
Inject IM vaccines into the central, thickest part of the deltoid. Injection that are too high (i.e., upper third of the arm) have been associated with
severe shoulder injuries such as rotator cuff tears, bursitis, and tendonitis that could require surgery or permanent injury.4,15
Choose the correct needle size for the size of your patient. Short needles risk underpenetration with potential for skin reactions and decreased
immunogenicity.14 Long needles risk overpenetration with potential for injection into the synovial tissue with possible pain and injury.14
See our PL Chart, Choosing the Correct Needle Size.
Don’t rely on the “Three finger rule” (i.e., inject IM vaccines three finger widths below the upper crest of the arm or acromion process) to find
the right spot for injection. This “rule” won’t always guide you to the correct place (i.e., the thickest part of the deltoid muscle).
Take the same position as recipient (both would usually sit). This helps to give the injection into the correct area of the deltoid.15
Avoid lowering a patient’s shirt down over their shoulder for administration, this can lead to the injection being given too high.17
More. . .
Copyright © 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #320207: Page 4 of 4)
Users of this PL Detail-Document are cautioned to use
their own professional judgment and consult any other
necessary or appropriate sources prior to making
clinical judgments based on the content of this document.
Our editors have researched the information with input
from experts, government agencies, and national
organizations. Information and internet links in this
article were current as of the date of publication.
9.
10.
11.
Project Leader in preparation of this PL DetailDocument: Annette Murray, BScPharm
12.
References
1.
2.
3.
4.
5.
6.
7.
8.
Taddio A, McMurtry CM, Shah V, et al. Reducing
pain during vaccine injections: clinical practice
guideline. CMAJ 2015;187:975-82.
WHO. Reducing pain at the time of vaccination:
WHO position paper, September 2015 –
recommendations. Vaccine (pub online Nov 11,
2015). doi:10.1016/j.vaccine.2015.11.005.
CDC.
Tips for a Less Stressful Shot Visit.
http://www.cdc.gov/vaccines/parents/tools/tipsfactsheet.pdf. (Accessed December 2, 2015).
Angelo LB, Ed. APhA’s Immunization Handbook. 3rd
ed.
Washington, DC: American Pharmacists
Association, 2015.
Shah V, Taddio A, McMurty CM, et al.
Pharmacological and combined interventions to
reduce vaccine injection pain in children and adults:
systematic review and meta-analysis. Clin J Pain
2015;31(Suppl 10):S38-63.
Chen RT, Clark TA, Halperin SA. The yin and yang
of paracetamol and paediatric immunisations.
Lancet 2009;374:1305-6.
Prymula R, Siegrist CA, Chilbek R, et al. Effect of
prophylactic paracetamol administration at time of
vaccination on febrile reactions and antibody
responses in children: two open-label, randomised
controlled trials. Lancet 2009;374:1339-50.
Schechter NL, Bernstein BA, Zempsky WT, et al.
Educational outreach to reduce immunization pain in
office settings. Pediatrics 2010;126:e1541-21.
13.
14.
15.
16.
17.
Schreiber S, Cozzi G, Rutigliano R, et al. Analgesia
by cooling vibration during venipuncture in children
with cognitive impairment.
Acta Paediatr
2016;105:e12-6.
Canbulat Sahiner N, Inal S, Sevim Akbay A. The
effect of combined stimulation of external cold and
vibration during immunization on pain and anxiety
levels in children. J Perianesth Nurs 2015;30:22835.
Drago LA, Singh SB, Douglass-Bright A, et al.
Efficacy of ShotBlocker in reducing pediatric pain
associated with intramuscular injections.
Am J
Emerg Med 2009;27:536-43.
Cobb JE, Cohen LL. A randomized controlled trial of
the ShotBlocker for children’s immunization distress.
Clin J Pain 2009;25:790-6.
Taddio A, Ho T, Vyas C, et al. A randomized
controlled trial of clinician-led tactile stimulation to
reduce pain during vaccination in infants.
Clin
Pediatr (Phila) 2014;53:639-44.
Barnes MG, Ledford C, Hogan K. A “needling”
problem: shoulder injury related to vaccine
administration. J Am Board Fam Med 2012;25:91922.
Atanasoff S, Ryan T, Lightfoot R, Johann-Liang R.
Shoulder injury related to vaccine administration
(SIRVA). Vaccine 2010;28:8049-52.
Dalle-Tezze
T.
National
Vaccine
Injury
Compensation Program (VICP): ?prevention of
SIRVA?
June
4,
2015
http://www.hrsa.gov/vaccinecompensation/sirva0604
2015.pdf. (Accessed November 30, 2015).
Ross M. Compensation growing for botched vaccine
administration.
September 10, 2015. Pharmacy
Times.
http://www.pharmacytimes.com/news/compensationgrowing-for-botched-vaccine-administration.
(Accessed November 30, 2015).
Cite this document as follows: PL Detail-Document, Vaccine Administration Strategies.
Letter/Prescriber’s Letter. February 2016.
Evidence and Recommendations You Can Trust…
3120 West March Lane, Stockton, CA 95219 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Copyright  2016 by Therapeutic Research Center
Subscribers to the Letter can get PL Detail-Documents, like this one,
on any topic covered in any issue by going to www.PharmacistsLetter.com,
www.PrescribersLetter.com, or www.PharmacyTechniciansLetter.com
Pharmacist’s
PL Conversation Starter:
Improving Diabetes Care
PATIENT NAME:_____________________________________________
DOB:_____/_____/_____
There are several Star Ratings quality measures that are related to improving care for patients with diabetes. These
include adherence to diabetes medications, statins, and ACE inhibitors or ARBs; controlling blood glucose and blood
pressure levels; vaccinations; annual eye exams; and improving physical activity. Use this sheet as a guide to start
conversations with your diabetes patients during comprehensive medication reviews (CMRs), medication
synchronization appointments, or during any patient interaction. Tackle one or two topics at a time, but don’t
overwhelm your patients or yourself by doing too much too fast. Start with these ideas and build on the topics below.
1. Assess adherence to diabetes medications and emphasize importance. (Date discussed:____________)
• Ask open-ended questions, such as:
• I know it must be difficult to take all your medicines regularly. How many doses did you
miss in the past week?
• How do you think these medicines are working?
• What are your biggest challenges with taking your medicines?
• Have patients explain how they take their medications and make sure your records match.
• Look at prescription refill information to help assess adherence.
• Assess barriers to adherence: cost, lack of patient buy-in or understanding, forgetfulness, etc.
2. Ensure recommended vaccinations are up to date.
(Date discussed:____________)
• Annual flu shot
• Pneumococcal vaccination with Pneumovax 23 for immunocompetent adult diabetes patients
aged 19 to 64 years. Then at age 65 years, give Prevnar 13 (if not previously given) followed
by a 2nd shot of Pneumovax 23 at least one year later (and at least five years after previous dose).
• Hepatitis B vaccination is recommended for patients with diabetes younger than 60 years of age.
3. Talk about the importance of optimizing glucose control.
(Date discussed:_____________)
• A1C goal should be individualized (6.5% to 8%). Aim for <7% for most patients. Consider
7.5% to 8% for those with a history of severe hypoglycemia, limited life expectancy, advanced
diabetes complications, or excessive comorbid complications.
• Optimal A1C slows progression of microvascular complications such as kidney disease,
retinopathy, neuropathy, etc.
4. Discuss prevention of cardiovascular complications.
(Date discussed:_____________)
• Blood pressure goal of <140/90 mmHg for most. Recommend an ACEI or ARB if appropriate.
• Moderate- to high-intensity statin therapy is recommended for all diabetes patients age 40 to 75
years. Consider a high-intensity statin dose for patients with cardiovascular disease or
additional risk factors.
• Ensure patient is a nonsmoker or support kicking the habit.
• Consider aspirin 75 to 162 mg once daily in those with increased cardiovascular risk.
5. Discuss self-management.
(Date discussed:_____________)
• Encourage regular examination of feet, proper care of nails and skin, and appropriate footwear.
• Recommend home glucose monitoring for all type 1s and some type 2 diabetes patients,
especially if newly diagnosed, changing medications, have an acute illness, or are pregnant.
• Discuss signs and symptoms of hypoglycemia (e.g., tremor, palpitations, sweating, etc), and
review treatment (e.g., taking 15 to 20 g of simple carbs) and prevention strategies.
• Advise getting an annual dilated eye exam.
6. Discuss healthy lifestyle choices (e.g., diet, physical activity, etc).
(Date discussed:____________)
• Even modest weight loss (5% to 10%) can provide clinical benefits.
• Seven hours of brisk walking per week may reduce seven-year mortality by 50%.
• Encourage patients to eat vegetables, drink water rather than soda, and limit sweets and sodium.
• Carbohydrate intake monitoring is critical to achieving glycemic control.
Prepared for use by Pharmacist’s Letter subscribers. Copyright © 2016 by Therapeutic Research Center. [January 2016]
PL Detail-Document #320224
−This PL Detail-Document gives subscribers
additional insight related to the Recommendations published in−
PHARMACIST’S LETTER / PRESCRIBER’S LETTER
February 2016
Frequently Asked Questions About MedGuides
Introduction
The concept of Medication Guides, commonly
called MedGuides, seems simple enough at first
glance. These FDA-approved patient education
handouts are considered part of a drug’s labeling.
In place for over a decade, they are required for a
growing list of drugs. As one encounters different
situations in practice, some interesting questions
pop up. This document provides answers to a
variety of questions about MedGuides.
Questions and Answers About MedGuides
Are MedGuides available in other languages?
What should you give to a non-English speaking
patient?
MedGuides are part of a drug’s
labeling.1
As part of the drug’s labeling,
MedGuides are only required to be available in
English in most locales. The exception to this is
for drug products that are distributed solely in the
Commonwealth of Puerto Rico or in a Territory
where the predominant language is a language
other than English.2 In that case, the predominant
language may be substituted for English.2
Dual-language (English and a foreign
language) MedGuides may be marketed anywhere
in the United States and its territories. FDA does
not review the foreign language version of the
MedGuide. Manufacturers submit certifications
to FDA that the foreign-language labeling is a
complete and accurate translation of the
MedGuide.3
If a patient does not speak English and/or is
not able to read the MedGuide, consider an
alternate mechanism for providing important
information, if possible. For tips on what to do in
these situations, get our PL CE, Enhancing
Patient Counseling with Effective Communication
Skills.
Is the MedGuide content for a brand drug and
its generics the same? Can you use the MedGuide
for a brand name product when the generic is
dispensed, if a MedGuide for the generic product
is not readily available? You do need to dispense
MedGuides with generics of “MedGuide drugs.”
The content of a generic drug’s MedGuide is the
same as the content of the brand drug’s
MedGuide. The exception to this might be for a
short window of time immediately following a
labeling change to a brand product, when the
generic product labeling has not yet been updated.
The MedGuides for brand name and generic
products are each to be distributed with the
product that they are intended for.4 If for some
reason you do not have the MedGuide for a
generic medication, it may be available for
download
from
DailyMed
at
http://dailymed.nlm.nih.gov/dailymed/index.cfm,
or the generic manufacturer’s web site.
Alternatively, you could call the generic
manufacturer for an electronic or paper copy.
Must MedGuides be provided with samples
dispensed from doctors’ offices?
Must
prescribers who dispense drugs in a clinic provide
MedGuides? Yes, MedGuides must be dispensed
with samples and with other drugs that are
dispensed from a clinic to outpatients, if a
MedGuide is required for that particular drug.1
Can a prescriber request that a patient NOT
receive a MedGuide? Yes, a prescriber can
request that a MedGuide NOT be dispensed to a
patient.
However, if the patient asks for
information when the drug is dispensed, the
MedGuide must be dispensed, regardless of the
request by the prescriber.5
Is the pharmacist allowed to edit the content of
a MedGuide to shorten it?
MedGuides contain FDA-approved wording.
In addition FDA has certain other requirements,
such as a minimum font size of ten point.6
Therefore, they should not be altered.4
Are MedGuides required with prescription
refills? Yes, MedGuides must be dispensed with
prescription refills.1
Are MedGuides required for inpatients? What
about other settings, like nursing homes, infusion
centers, etc?
FDA has determined that
More. . .
Copyright © 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #320224: Page 2 of 3)
MedGuides are generally NOT required for
INpatients (hospital or nursing home) because the
medication is being dispensed to a health care
professional for administration to the patient.1 In
inpatient settings, health care professionals are
readily available to provide information and
answer patients’ questions.1
However, a
MedGuide should be made available to the
inpatient or their representative if they request it.1
Another circumstance in which a MedGuide
must be dispensed to an inpatient is when a drug
is subject to a REMS (Risk Evaluation and
Mitigation Strategy) that includes specific
requirements for reviewing or providing a
Medication Guide as part of an ETASU (Element
to Assure Safe Use). Dofetilide (Tikosyn) is an
example. A list of drugs with REMS and
ETASUs, with an overview of their requirements,
can be found at: http://www.accessdata.fda.gov
/scripts/cder/rems/index.cfm.
Patients in OUTpatient clinics, dialysis centers,
infusion centers, etc SHOULD be given
MedGuides the first time the patient receives the
medication, whenever the medication guide
materially changes, or as specified in an ETASU.1
As in the inpatient setting, the MedGuide should
be provided if the patient or his/her representative
requests it.1
See page 7 of the FDA’s MedGuide guidance
for a table summarizing the FDA MedGuide
enforcement discretion policy (http://www.fda.
gov/downloads/Drugs/GuidanceComplianceRegul
atoryInformation/Guidances/UCM244570.pdf).
What’s the difference between a MedGuide
and a Patient Package Insert?
MedGuides may sometimes be confused with
Patient Package Inserts (PPIs). PPIs are another
form of patient product information approved by
FDA. Some drugs, by regulation, are required to
have PPIs that must be distributed to patients (i.e.,
oral contraceptives and estrogens). The PPIs for
oral contraceptives and estrogen products are
intended to fully inform the patient of the benefits
and risks associated with the use of these drugs.
Other drugs are approved on the condition that the
drug is packaged so that patients receive a PPI
when receiving their prescription (e.g., unit-of-use
packaging). Some drugs have PPIs, but the PPIs
are not required to be dispensed to a patient (e.g.,
Fosamax [alendronate]).4
Conclusion
Health care professionals continue to have
questions about MedGuides. The bottom line is
that MedGuides are a mechanism to help inform
patients about the significant risks of some drugs
and drug classes, and to help patients use these
drugs safely and effectively. Pharmacists who fail
to dispense MedGuides appropriately could
potentially face liability, or run afoul of their state
board.7
Potentially, institutional accrediting
bodies could look at MedGuide dispensing as
well, such as if they have a standard that
medications be dispensed in accordance with
federal regulations.
Current MedGuides are
available on our website for printing by accessing
our PL Chart, Drugs Products with Medication
Guides.
Users of this PL Detail-Document are cautioned to use
their own professional judgment and consult any other
necessary or appropriate sources prior to making
clinical judgments based on the content of this
document.
Our editors have researched the
information with input from experts, government
agencies, and national organizations. Information and
internet links in this article were current as of the date
of publication.
Project Leader in preparation of this PL DetailDocument: Melanie Cupp, Pharm.D., BCPS
References
1.
2.
U.S. Department of Health and Human Services.
Food and Drug Administration. Center for Drug
Evaluation and Research (CDER). Center for
Biologics Evaluation and Research (CBER).
Guidance.
Medication Guides.
Distribution
requirements and inclusion in risk evaluation and
mitigation strategies (REMS). November 2011.
http://www.fda.gov/downloads/Drugs/GuidanceCo
mplianceRegulatoryInformation/Guidances/UCM24
4570.pdf. (Accessed January 17, 2016).
Code of Federal Regulations. Title 21, vol 4.
Chapter I--Food and Drug Administration.
Department of Health and Human Services.
Subchapter C--drugs: general. Part 201 labeling.
Subpart A--general labeling provisions. Revised
April
1,
2015.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfcfr/CFRSearch.cfm?CFRPart=201&showFR=1.
(Accessed January 17, 2016).
More. . .
Copyright © 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #320224: Page 3 of 3)
3.
4.
5.
Center for Drug Evaluation and Research. Office
of New Drugs. Manual of Policies and Procedures.
Foreign language labeling. Effective date October
27,
2014.
http://www.fda.gov/downloads/AboutFDA/CentersO
ffices/CDER/ManualofPoliciesProcedures/ucm0820
05.pdf. (Accessed January 22, 2016).
Personal communication (written).
Kristopher
Baumgartner. Strategic Communications. Office of
Communications. Center for Drug Evaluation and
Research. U.S. Food and Drug Administration.
January 21, 2016.
Code of Federal Regulations. Title 21, vol 4.
Chapter I--Food and Drug Administration.
Department of Health and Human Services.
Subchapter C--drugs:
general.
Part 208-Medication Guides for prescription drug products.
Sec. 208.26. Exemptions and deferrals. Subpart
B--general requirements for a Medication Guide.
Revised
April
1,
2015.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfcfr/CFRSearch.cfm?fr=208.26.
(Accessed
January 17, 2016).
6.
7.
Code of Federal Regulations. Title 21, vol 4.
Chapter I--Food and Drug Administration.
Department of Health and Human Services.
Subchapter C--drugs:
general.
Part 208-Medication Guides for prescription drug products.
Subpart B – general requirement for a Medication
Guide. Sec. 208.20 Content and format of a
Medication Guide.
Revised April 1, 2015.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfCFR/CFRSearch.cfm?fr=208.20.
(Accessed
January 17, 2016).
Sasich LD, Sukkari SR. Viewpoint: don’t forget to
give out MedGuides. Drug Topics. April 3, 2006.
http://drugtopics.modernmedicine.com/drugtopics/content/viewpoint-dont-forget-give-outmedguides. (Accessed January 17, 2016).
Cite this document as follows: PL Detail-Document, Frequently Asked Questions About MedGuides.
Pharmacist’s Letter/Prescriber’s Letter. February 2016.
Evidence and Recommendations You Can Trust…
3120 West March Lane, Stockton, CA 95219 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Copyright  2016 by Therapeutic Research Center
Subscribers to the Letter can get PL Detail-Documents, like this one,
on any topic covered in any issue by going to www.PharmacistsLetter.com,
www.PrescribersLetter.com, or www.PharmacyTechniciansLetter.com
Blood Pressure Medications and You
Blood pressure medicines are some of the most commonly used drugs. However, about one-quarter
of people who take meds to lower their blood pressure stop taking them within six months. Up to
one-half stop taking them within one year.
Why are blood pressure medicines so important?
Keeping your blood pressure normal can help you stay healthy. People with high blood pressure
are more likely to be sent to the hospital, to have strokes or heart attacks, and have other health
problems than those who keep their blood pressure normal.
Why do people stop taking their blood pressure medicines?
Like most drugs, blood pressure meds can have side effects. Around two-thirds of people who
take blood pressure meds will have a side effect when the drugs are first started. For example,
diuretics (or “water pills”) can increase how often you need to pee. Cutting back on the amount
of salt in your diet will help to reduce this side effect and make the water pill work better. Water
pills can also cause dizziness or make you feel light-headed when you stand up too fast. Other
blood pressure drugs might make you feel tired. Be sure to ask your prescriber or pharmacist
what types of side effects you can expect with your blood pressure drugs and how long the side
effects will last.
Another reason people stop taking blood pressure meds is that they forget to take them. Some
drugs must be taken more than once each day. If you have trouble remembering to take your
medicine, tell your prescriber or pharmacist. He or she can help you get a medicine that fits best
with your lifestyle.
Some drugs can cost a lot of money. However, there is at least one generic drug available for
every type of blood pressure medicine. If you have trouble paying for your blood pressure drugs
(or any type of drug), let your prescriber or pharmacist know. He or she can help you get a drug
that costs less and/or recommend a patient assistance program to help you pay for your medicine.
What can happen if I stop taking my blood pressure medicine?
Besides increasing your chance for a heart attack or stroke, there are other things that can happen if
you stop taking your blood pressure drugs. When you re-start your drug, your dose may have to be
lowered for a time to help prevent some side effects. Your prescriber will tell you how to slowly
work your way back up to your usual dose.
If you stop taking some blood pressure meds all at once (or “cold turkey”) your blood pressure can
get too high.
What should I do if I have a problem with my blood pressure medicines?
Never stop taking your blood pressure meds without letting your prescriber know. Speak with your
prescriber and/or pharmacist to let them know about any problems you’re having. Then together
you can make sure your blood pressure meds are the best ones for you.
[February 2011]
Prepared for the subscribers of
Pharmacist’s Letter / Prescriber’s Letter to give to their patients.
Copyright © 2010 by Therapeutic Research Center
www.pharmacistsletter.com ~ www.prescribersletter.com