Download Comparison of Nitrate Preparations

Detail-Document #260306
−This Detail-Document accompanies the related article published in−
PHARMACIST’S LETTER / PRESCRIBER’S LETTER
March 2010 ~ Volume 26 ~ Number 260306
Comparison of Nitrate Preparations
(Information specific to U.S. products)
There are numerous nitrate products and formulations available on the market. Choosing the right nitrate product and the appropriate dosing regimen
often causes confusion. Furthermore, clinicians are often not sure about product therapeutic equivalence. Nitrates are widely used in the management
of angina, acute myocardial infarction, and heart failure.1 Nitroglycerin given sublingually is the drug most frequently used for the treatment of
angina attack. Transdermal nitroglycerins, isosorbide mononitrate, and isosorbide dinitrate products are effective in the prevention of angina when
dosed appropriately.2 Isosorbide dinitrate is also the preferred nitrate for heart failure.3 The addition of hydralazine to isosorbide dinitrate improves
efficacy and reduces tolerance.1,3 Nitrate tolerance can develop if an appropriate nitrate-free interval is not maintained. There are several proposed
mechanisms for why nitrate tolerance occurs. These mechanisms include activation of neurohormonal mechanism, plasma volume expansion,
abnormalities in biotransformations of nitrates, abnormalities in nitric oxide signaling mechanisms, superoxide production, and endothelial
dysfunction.1,4 The gold standard for overcoming nitrate tolerance is to maintain a daily nitrate-free interval ranging from 12 to 14 hours for most
long-acting nitrates, but this may vary from 10 hours with some transdermal patches to 18 hours with Dilatrate SR, depending on the dosage form.
The following table outlines the recommended nitrate-free interval and therapeutic equivalence information for currently available nitrate products.
* Denotes Reference Listed Drug (RLD), to which the FDA compared other products. Reference Listed Drugs are drugs identified by the FDA as a product upon
which an applicant relies in seeking approval of its ANDA (Abbreviated New Drug Application).1
Therapeutic Equivalents are drugs that demonstrate BOTH pharmaceutical equivalence (same active ingredient, dosage form, and strength) and bioequivalence
(comparable rate and extent of absorption) as listed in the FDA’s Orange Book.
Product (Manufacturer)
Nitroglycerin Transdermal Patches
Minitran7
(Graceway)
Formulation/Strengths
Therapeutic Equivalents a,5,6,
0.1 mg/hr, 0.2 mg/hr, 0.4 mg/hr,
0.6 mg/hr
*Nitro-Dur (Key Pharms)
*Nitro-Dur8
0.1 mg/hr, 0.2 mg/hr, 0.3 mg/hr,
(Key Pharms)
0.4 mg/hr, 0.6 mg/hr, 0.8 mg/hr
*Nitroglycerin Transdermal
0.1 mg/hr, 0.2 mg/hr, 0.4 mg/hr,
System9
0.6 mg/hr
(Mylan)
Nitroglycerin Extended-Release Capsulesb
Nitro-Time10
2.5 mg, 6.5 mg, 9 mg
(Time Cap)
extended-release capsules
Nitroglycerin extended-release
2.5 mg, 6.5 mg, 9 mg
capsules
extended-release capsules
(Sandoz, Major)
Nitroglycerin (Kremers Urban),
Minitran (Graceway)
Nitroglycerin (Hercon)
Schedulei
Patch ON 12-14 hours; patch OFF
10-12 hrs.7-9
None
None
TID to QID with 10-12 hour dosefree period.10
More. . .
Copyright © 2010 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #260306: Page 2 of 5)
Formulation/Strengths
Therapeutic Equivalents a,5,6,
Schedulei
0.4 mg/spray
None
*Nitromist12,h
(Akrimax)
0.4 mg/spray
None
Anginal attack:j 1-2 sprays. If pain
persists or worsens 5 minutes after
one dose, call 911 before repeating
dose.26
Prophylactic: Use 5-10 min prior to
engaging in attack-provoking
activities.11,12
Nitroglycerin Sublingual Tablets
*Nitrostat13
(Pfizer)
0.3 mg, 0.4 mg, 0.6 mg
None
0.3 mg, 0.4 mg, 0.6 mg
None
2%
None
Product (Manufacturer)
Nitroglycerin Sublingual Sprays
*Nitrolingual Pumpspray11
(Pohl-Boskamp)
Nitroglycerin Sublingual Tablets
(Glenmark)b
Nitroglycerin Ointment
Nitro-Bid14
(Fougera)
Isosorbide Mononitrate Extended-Release
Imdur15
30 mg, 60 mg, 120 mg
c
(Schering-Plough)
Isosorbide Mononitrate extended60 mg
release tablets (Elan)
Isosorbide Mononitrate extendedrelease tablets (Kremers Urban)
*Isosorbide Mononitrate extendedrelease tablets (Kremers Urban)
30 mg
120 mg
Anginal attack:j 1 tablet. If pain
persists or worsens 5 minutes after
one dose, call 911 before repeating
dose.26
Prophylactic use: 5-10 min prior to
engaging in attack-provoking
activities.13
BID, 6 hours apart with 10-12 hour
dose-free interval.14
None
Actavis Elizabeth, Brightstone,
Dexcel, Kremers Urban, KV
Pharm,d West-Ward
Actavis Elizabeth, KV Pharm,d
West-Ward
KV Pharmd
Daily, given in the AM.15,16
More. . .
Copyright © 2010 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
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(Detail-Document #260306: Page 3 of 5)
Product (Manufacturer)
Formulation/Strengths
Isosorbide Mononitrate Immediate-Release
Ismo17
20 mg
(Promius Pharma)
*Monoket (Schwarz Pharma)
10 mg, 20 mg
Isosorbide Dinitrate Extended-Release
Dilatrate-SR18
40 mg extended-release capsule
(Schwarz)
*Isosorbide Dinitrate
40 mg extended-release tablet
(Inwood labs)
Isosorbide Dinitrate Immediate-Release
*Isordil (Biovail)
5 mg, 10 mg, 20 mg, 30 mg, 40 mg
tablet
Therapeutic Equivalents a,5,6,
Actavis Elizabeth, Teva, WestWard,
Monoket (Schwarz Pharma)
10 mg (Actavis Elizabeth),
20 mg (Actavis Elizabeth, Promius,
Teva, West-Ward)
Schedulei
BID, given 7 hours apart.17
None
Corepharma
Daily or BID with a minimum of
18-hour dose-free interval.e,18,19
5 mg (Par, Sandoz, Watson, WestWard)
10 mg (Par, Sandoz, Watson,
West-Ward)
20 mg (Par, Sandoz, West-Ward)
30 mg (Par, West-Ward)
Angina: BID-TID with 14 hour
dose-free interval.20
Isosorbide Dinitrate Sublingual Tablet
*Isosorbide Dinitrate (Watsonf)
2.5 mg, 5 mg sublingual tablet
West-Ward
Anginal attack: May be used to
abort an acute angina episode only
in patients who failed to respond to
SL nitroglycerine.21
Prophylactic use: 15 min prior to
engaging in attack-provoking
activities.2,21
Isosorbide Dinitrate/Hydralazine Hydrochloride
*BiDil22 (NitroMed)
20 mg/37.5 mg
None
CHF: One tablet TID, titrate to
maximum tolerable dose. Not to
exceed 2 tablets TID. May use ½
tablet TID if intolerable side effects
occur.g,22
CHF: Refer to chart, Target Doses
of Heart Failure Medications.
More. . .
Copyright © 2010 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
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(Detail-Document #260306: Page 4 of 5)
a. Substitution laws are regulated by state boards of pharmacy. In most states, pharmacists cannot substitute non-A rated (non-therapeutic
equivalent) products without prescriber approval. Some states allow substitution between products as long as state-specific criteria are met,
such as having the same active ingredient, dosage form, dose, and route of administration.
b. Products have not gone through the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) process and are not
assigned therapeutic equivalence rating by the FDA. There might be other products by various manufacturers not listed.
c. Imdur is listed as a discontinued product according to the Orange Book. Per Schering-Plough, they have withdrawn their NDA, but Imdur
will continue to be manufactured by Schwarz Pharma. However, Schwarz Pharma was not able to confirm this information.23
d. These products are manufactured by Ethex Corporation, a subsidiary of KV Pharmaceuticals. At this time, products manufactured by Ethex
Corporation have been recalled voluntarily as products may have been manufactured under conditions that did not sufficiently comply with
the current Good Manufacturing Practice (cGMP).
e. Data on extended-release isosorbide dinitrate dosing is limited. Only one trial studied the effect of isosorbide dinitrate dosed twice daily,
given six hours apart. Nitrate tolerance was noted after four weeks of therapy.17
f. Not currently manufactured by Watson.24
g. The addition of hydralazine to isosorbide dinitrate improves the efficacy and might reduce tolerance.1,3 Therefore, a nitrate-free period is less
important for this product.25 Manufacturer does not provide specific “scheduling” recommendations.25
h. Nitromist is approved, but not yet marketed. Manufacturer anticipates product launch in June or July 2010.12
i. Dosing schedule for angina, unless otherwise specified.
j. Note that the recommendations are different from product labeling. Current labeling recommends repeating sublingual nitrate dose (1 tablet
or spray) every 5 minutes until relief of chest pain. If pain persists after a total of 3 tablets (3 sprays) in a 15 minute period, seek immediate
medical attention.11,13
Users of this 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 © 2010 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #260306: Page 5 of 5)
Project Leader in preparation of this DetailDocument: Wan-Chih Tom, Pharm.D.
References
1.
Munzel T, Daiber A, Mulsch A. Explaining the
phenomenon of nitrate tolerance.
Cir Res
2005;97;618-28.
2. Parker JD, Parker JO. Nitrate therapy for stable
angina pectoris. N Eng J Med 1998;338:520-31.
3. Hunt SA, American College of Cardiology; American
Heart Association Task Force on Practice Guidelines
(Writing Committee to Update the 2001 Guidelines
for the Evaluation and Management of Heart
Failure). ACC/AHA 2005 Guideline update for the
diagnosis and management of chronic heart failure in
the adult: a report of the American College of
Cardiology/American Heart Association Task Force
on Practice Guidelines (Writing committee to update
the 2001 guidelines for evaluation and management
of heart failure). J Am Coll Cardiol 2005:46:e1-82.
4. Gori T, Parker JD. Nitrate tolerance: a unifying
hypothesis. Circulation 2002;106:2510-3.
5. Electronic Orange Book. Current through December
2009.
http://www.accessdata.fda.gov/scripts/cder/ob/defaul
t.cfm. (Accessed February 8, 2010).
6. Drugs@FDA.
http://www.accessdata.fda.gov/scripts/cder/drugsatfd
a/index.cfm. (Accessed February 8, 2010).
7. Product information for Minitran.
Graceway
Pharmaceuticals, LLC. Bristol, TN 37620. April
2007.
8. Product
information
for
Nitro-Dur.
Key
Pharmaceuticals, Inc.
Kenilworth, NJ 07033.
December 2004.
9. Product information for Nitroglycerin Transdermal
System. Mylan Pharmaceuticals, Inc. Morgantown,
WV 26505. October 2008.
10. Product information for Nitro-Time. Time Cap Labs,
Inc. Farmingdale, NY 11735. March 2005.
11. Product information for Nitrolingual Pumpspray.
Sciele Pharma, Inc. Atlanta, GA 30328. October
2008.
12. Personal communication. Misner J. Akrimax Pharm.
Cranford, NJ 07016. February 22, 2010.
13. Product information for Nitrostat.
Parke-Davis.
Division of Pfizer Inc, New York, NY 10017.
December 2005.
14. Produce information for Nitro-Bid. E. Fougera & Co.
A division of Nycomed US, Inc. Melville, NY 11747.
March 2009.
15. Product information for Imdur. Key Pharmaceuticals,
Inc. Kenilworth, NJ 07033. September 2003.
16. Product information for Isosorbide Mononitrate
Extended-Release
Tablets.
West-Ward
Pharmaceutical Corp.
Eatontown, NJ 07724.
January 2009.
17. Product
information
for
Ismo.
Reddy
Pharmaceuticals, LLC. Bridgewater, NJ 08807.
18. Product information for Dilatrate SR.
Schwarz
Pharma. Milwaukee, WI 53201. October 2006.
19. Personal communication, Anna. Medical information
department. UCB Pharmaceuticals. Rochester, NY
14623. February 10, 2010.
20. Product
information
for
Isordil.
Biovail
Pharmaceuticals, Inc.
Bridgewater, NJ 08807.
March 2007.
21. Product information for Isordil.
Wyeth Labs.
Philadelphia, PA 19101. March 2006
22. Product information for BiDil. NitroMed. Charlotte,
NC 28210. May 2009.
23. Personal communication, MaryAnn.
Medical
information department. Schering-Plough/Merck &
Co, Inc. Whitehouse Station, NJ 08889-0100.
February 9, 2010.
24. Personal communication, Darlene.
Customer
Service Department. Watson Pharmaceuticals, Inc.
Corona, CA 92880. February 16, 2010.
25. Personal communication, Elizabeth.
Medical
information department. NitroMed. Charlotte, NC
28210. February 16, 2010.
26. Anderson JL, Adams CD, Antman EM, et al.
ACC/AHA 2007 guidelines for the management of
patients with unstable angina/non-ST-elevation
myocardial infarction: executive summary. A report
of the American College of Cardiology/American
Heart Association Task Force on Practice Guidelines
(writing committee to revise the 2002 guidelines for
the management of patients with unstable
angina/non-ST-elevation
myocardial
infarction).
Circulation 2007;116:803-77.
Cite this Detail-Document as follows: Comparison of nitrate products. Pharmacist’s Letter/Prescriber’s Letter
2010;26(3):260306.
Evidence and Advice You Can Trust…
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Technician Training Tutorial:
Oral Dosage Forms
There’s a wide variety of oral dosage forms available. Capsules, tablets, and liquids are likely to
come to mind immediately. However, these categories can be broken down further based on a
number of things. There are different kinds of tablets, such as immediate-release, controlledrelease, chewable, orally disintegrating, buccal, and sublingual. For capsules, there are immediaterelease or controlled-release, and they can be filled with powders, beads, granules, or liquids. Of
course, there are oral liquids such as syrups, suspensions, and elixirs, and also lozenges and troches,
powders, sprays, and strips.
Interestingly, the commonly referred to “pill” isn’t really available anymore. Pills, by definition,
are rolled by hand from a paste. The preferred terms now are “capsule” or “tablet,” whichever is
appropriate.
Any of the oral dosage forms can require special considerations when they’re prescribed and
dispensed to patients, or when they’re purchased over-the-counter. We’ll review them in this
Technician Training Tutorial.
Billy Reuben is a 25 year old male patient. He was recently diagnosed with cancer, and has been
getting treatment within the past few weeks. He comes in with this single Rx, and explains that his
mouth is quite sore. Hopefully this Magic Mouthwash will really work some magic. You haven’t
filled an Rx for Magic Mouthwash before, but you know that there are a lot of different recipes for
it. You double check with the pharmacist to see which one you should use.
How do oral dosage forms work?
Most oral dosage forms are meant for absorption into the bloodstream, where they are transported
throughout the body to have their effect. Examples of this would be most oral tablets, capsules, and
liquids. The drug is swallowed, travels down through the gastrointestinal tract, and is absorbed into
the blood through the lining of the stomach or small intestine. The drug can then act on receptors
in different parts of the body, to have its specific effect.
The difference between immediate-release tablets and capsules and controlled-release tablets and
capsules is that controlled-release formulations have some sort of coating or other mechanism to
help release the drug more slowly. Often, this can reduce the number of times a day that a patient
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needs to take a drug. For example, immediate-release diltiazem (Cardizem) is given three or four
times a day. However, controlled-release formulations of diltiazem, like Cardizem CD, etc. can be
given just once a day. (However, you can’t depend on suffixes to have uniform meanings. We
have more information on drug names with suffixes in our Technician Training Tutorial, “What
Drug Names Really Mean.”)
Some drugs, such as proton pump inhibitors (e.g., lansoprazole [Prevacid], esomeprazole [Nexium],
etc), are formulated to delay the release of the drug. This helps ensure that the drug is released in a
specific part of the GI tract so exposure to acid, which could destroy the drug, is reduced.
Most oral liquids can be thought of as similar to immediate-release tablets or capsules. Liquids can
come as suspensions (cloudy), syrups (clear), and the less common elixirs (clear).
Buccal tablets and sublingual tablets are also meant for absorption into the blood. However, the
drug is actually absorbed into the blood through the lining of the mouth instead of the lining of the
stomach or small intestine. These don’t need to be swallowed to be absorbed. Buccal tablets such
as Fentora (U.S. only), a formulation of fentanyl, are placed between the teeth and the cheek.
Sublingual tablets, such as nitroglycerin (Nitrostat), go under the tongue. An advantage to these
types of tablets is that they are absorbed very quickly, since they don’t have to move down through
the esophagus and into the stomach. So it makes sense that some meds for pain, like fentanyl, and
meds for heart trouble, like nitroglycerin, are formulated in this way.
Orally disintegrating tablets (e.g., Maxalt-MLT-U.S. and Maxalt-RPD-Canada [rizatriptan],
Zyprexa Zydis [olanzapine], Zofran ODT [ondansetron], etc), sometimes called wafers, are kind of
tricky. As the name implies, these dissolve in the mouth. However, they usually still need to be
swallowed so that the drug can be absorbed through the stomach. The advantage of orally
disintegrating tablets is that they just fall apart in the saliva, and can then be easily swallowed with
or without taking a drink of liquid. They’re good because patients can’t hold them in their cheeks,
fake swallowing them, and later spit them out. So it makes sense that some medications for
psychiatric conditions, such as olanzapine, are formulated as orally disintegrating tablets. It also
makes sense that anti-nausea medications and triptans for migraines are formulated in this manner,
to provide an option for patients who are too nauseous to drink liquid or swallow a tablet or
capsule.
Powders are another dosage form that requires swallowing, and for the drug to travel to the stomach
for absorption. These can be mixed with liquid and swallowed, or placed on the tongue and washed
down with a drink of liquid. Some examples of powders are Goody’s Headache Powders and BC
Powders, both OTC pain relievers.
Some thin strips, like Triaminic Children’s Thin Strips, help make drugs that need to be absorbed
easier to swallow.
Do ALL oral dosage forms get absorbed into the blood?
No, not all oral dosage forms get absorbed into the blood. There are some medications that are
swallowed, but have local effects in the gastrointestinal tract. Examples of this would include
bismuth (Pepto-Bismol, etc) and sucralfate (Carafate [U.S.], Sulcrate [Canada]). These drugs are
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both used to coat the lining of the stomach to protect it from injury from acid. They are not meant
to be absorbed into the blood.
Most lozenges, sprays, and troches, and some liquids act locally in the mouth or throat. Think
about Chloraseptic (benzocaine/menthol) lozenges, spray, and strips for numbing a sore throat. Or
about nystatin suspension or clotrimazole lozenges, which treat fungal infections in the mouth and
throat. (Some exceptions here include the fentanyl lozenge, Actiq [U.S. only], and nitroglycerin
sprays, Nitrolingual, etc, which are absorbed into the blood stream and ARE NOT used for their
local effects).
You notice that the prescriber has not included directions for how Billy should actually use the
Magic Mouthwash. You know it’s to help with his sore mouth. Since it is a “mouthwash” you
know that you should include instructions to “swish.” However, you wonder if you should put
“swish and spit” or “swish and swallow.” You ask the pharmacist, and he says that for this
recipe, either choice is fine. So you use “swish and spit or swallow.”
How can I help prevent errors with oral dosage forms?
Errors with injectable dosage forms can be very serious, since these drugs are going right into
patients’ bloodstream. However, errors with oral dosage forms can also be very serious. And,
considering that oral dosage forms are much more commonly used, the impact of errors with oral
dosage forms could be greater overall.
Make sure the directions for use are clear. For example, the directions on a label for nystatin
suspension should clearly state to swish in the mouth before swallowing or spitting it out.
Otherwise, the drug may not be effective in clearing a yeast infection from the mouth. It’s also
important for patients to know when these meds should be “swished and spit” or “swished and
swallowed.” The directions for sublingual nitroglycerin should state to place the tablet under the
tongue. Otherwise, the patient might simply swallow it. Don’t assume that the patient knows what
to do. There are endless stories of patients who have used drugs incorrectly because they did not
have explicit information describing how to take them.
Watch that the product can be given as directed. For example, if you know that a patient cannot
swallow a capsule or tablet, these might be inappropriate dosage forms unless they can be crushed
(tablet) or opened (capsule). This is especially true in the hospital setting, where patients are more
likely to have medications given through a feeding tube. Use our helpful chart “Medications That
Should Not Be Crushed” to find this information.
If a dose is ordered that would necessitate the patient taking a fraction (usually half) of a tablet, it’s
important to make sure that dividing the tablet is okay. Often, controlled-release tablets should
NOT be split. We have a Technician Training Tutorial, “Which Tablets and Capsules Can be
Crushed, Opened, or Split?” dedicated to this topic, and an algorithm called “Tablet Splitting: ‘To
Split or Not to Split’.” If you notice that there are problems with the way a tablet or capsule is
supposed to be given, alert the pharmacist.
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Make sure that the patient has a good way to measure out the appropriate dose. For example,
dispensing a measuring device with oral liquids (i.e., calibrated dosing cup, dropper, spoon, or oral
syringe) is a good idea. Using a household teaspoon for measuring oral liquids is a bad idea,
because the amount of liquid they hold can vary. Also, make sure that the dosing units on the Rx
label match the dosing units on the measuring device to avoid confusion for the patient. Consider
marking patients’ doses on the measuring device as well.
In the hospital setting, you’re likely to be packaging individualized doses of oral liquids for
patients. Regardless of your practice setting, NEVER send oral meds in IV syringes. This could
lead to administration of the oral med through an IV line, which is a potentially serious error.
Always package oral liquids in oral syringes that can’t be connected to IV lines, or other packaging
that is specific for oral liquids (e.g., amber bottles, etc).
Suggesting a pill splitter for patients who require a fraction of a tablet is also a good idea. For
patients with poor coordination or eyesight, a special easy-to-use pill splitter might really help, or
the pharmacist might prefer that the tablets be split BEFORE they are dispensed to the patient. In
the hospital setting, you will usually dispense tabs that are already split, instead of whole tabs for
the nurse to split. Double check with the pharmacist if you’re not sure what to do. It’s important to
help ensure that patients get the most accurate dose possible.
You make 240 mL of the Magic Mouthwash for Billy. (He could be using 5 mL up to six times each
day, or 30 mL/day, for seven days, which would be a total of 210 mL.) He’s going to have a little
bit extra, but you include a calibrated dosing cup with his Rx, so that he gets an accurate
measurement for each dose and doesn’t run out.
Do any of these dosage forms require special labeling?
Use auxiliary labels to indicate if a med should be taken with food or on an empty stomach. The
contents of the stomach and changes in acidity caused by meals can cause more or less drug to be
absorbed into the blood depending on the characteristics of the drug. For example, levothyroxine
should be given first thing in the morning on an empty stomach, because calcium, fiber, iron, etc.
found in food can reduce its absorption. On the other hand, the cholesterol-lowering drug
lovastatin (Mevacor) should be taken with food, so that it is absorbed to the fullest extent. Still
other drugs, like amoxicillin/clavulanate (Augmentin [U.S.], Clavulin [Canada]) and ibuprofen,
should be given with food, not because stomach contents affect absorption, but because having
food in the stomach can prevent stomach upset from the drug.
Put on labels that indicate proper storage. Liquids are more likely to require refrigeration than
other oral dosage forms. In fact, they will often have a shorter beyond-use-date than other oral
dosage forms. For more information, use our Technician Training Tutorial, “Dispensing Pediatric
Antibiotic Suspensions.” We also have a helpful chart, “Pediatric Oral Antibiotic and Antifungal
Suspensions and Liquids,” (Detail-Document #231107 [U.S.] or #231122 [Canada]) for more info
on beyond-use-dates of oral suspensions, under refrigeration or at room temp.
It’s uncommon, but refrigeration may be recommended for some capsules or tablets, like some
probiotics and ritonavir (Norvir) capsules. Refrigeration is recommended for ritonavir caps if they
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aren’t going to be used within 30 days. Kaletra (lopinavir/ritonavir) capsules also require
refrigeration if they aren’t going to be used within two months.
Use any other applicable auxiliary labels. Of course, any of the usual auxiliary labels should be
used for oral dosage forms (e.g., “may cause drowsiness,” “avoid exposure to the sun,” etc) as
appropriate. And liquid suspensions will require a “shake before using” label.
Billy’s Magic Mouthwash is a compounded prep, so you include an auxiliary label with the beyonduse-date for the recipe. You also include a “shake before using” auxiliary label on the bottle, since
the recipe included Maalox, which is a suspension.
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