Errors & Omissions
To ensure that we are providing our clients with the
industry’s best and most current clinical information, we
complete a 'post-publication' process and receive feedback regarding
opportunities to add additional information or, in rare cases, correct
an error.
Below is information on revisions, corrections, or
modifications to existing monographs that have been identified in the
past 12 months. Information dating later than 12 months can be accessed
in our Archived Errors & Omissions.
Vasopressin - June 2008
Error in the Dosing - Adults field of the
Vasopressin monograph in Lexi-Drugs handheld applications and the
following print publications, Geriatric Dosage Handbook,
13th edition, Drug Information
Handbook for Nursing, 10th edition, and Drug
Information Handbook for Advanced Practice Nursing, 9th edition.
The monograph previously read:
Dosing-Adults:
GI hemorrhage (unlabeled use):
Continuous I.V. infusion: 0.5 milliunits/kg/hour (0.0005 unit/kg/hour);
double dosage as needed every 30 minutes to a maximum of 10
milliunits/kg/hour
I.V.: Initial: 0.2-0.4 unit/minute, then titrate dose as needed; if
bleeding stops, continue at same dose for 12 hours, taper off over
24-48 hours.
It has been corrected to read:
Dosing-Adults:
GI/variceal hemorrhage (unlabeled use):
Continuous I.V. infusion: Dilute in NS or D5W to 0.1-1 unit/mL. Note:
Other therapies may be preferred.
Variceal hemorrhage (unlabeled use) [AASLD guidelines, 2007]:
Adults: Initial: 0.2-0.4 units/minute, may titrate dose as needed to a
maximum dose of 0.8 units/minute; maximum duration: 24 hours at highest
effective dose continuously (to reduce incidence of adverse effects).
Patient should also receive I.V. nitroglycerin concurrently to prevent
myocardial ischemic complications; monitor closely for signs/symptoms
of ischemia (myocardial, peripheral, bowel)
These changes have been automatically posted to
hand-held reference sources, but the error will persist in the current
print editions.
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Concerns Related to Overdose/Toxicology
Information
Similar to other pharmacology references,
Lexi-Comp’s monographs include a limited presentation of
overdose/toxicology information derived primarily from FDA-approved
product labeling. This should not be considered complete and/or may not
adequately reflect current medical practice, and therefore should not
be the basis of treatment decisions. Optimal care decisions are made
based upon specific patient details. Consider consultation with a
poison control center. To reach poison control centers in the United
States, and its territories, call 1-800-222-1222.
Removal of physostigmine as a treatment option in
tricyclic antidepressant (TCA) overdose/acute toxicity - March 2008
Previous approaches to the management of TCA
overdose
events suggested that physostigmine may be effective in the reversal of
CNS toxicities and/or vagolytic tachyarrhythmias originating from acute
intoxication with agents likely to induce an anticholinergic syndrome.
However, current clinical practice acknowledges the potential for
significant toxicity resulting from this approach.
Clinically significant complications, including
asystole
and seizures, have been reported following the administration of
physostigmine in TCA-poisoned patients. Patients with bradycardia
and/or prolonged QRS duration may be at particular risk for
physostigmine-associated toxicities. Therefore, physostigmine is not
recommended in the setting of TCA intoxication. Treatment of these
patients is complex and requires clinical decisions based upon
patient-specific details. Consultation with a poison control center is
highly recommended.
Changes regarding the use of physostigmine have
been
made to our online and hand-held reference sources; however, these
changes will not be reflected in current editions of our print
publications, including the Drug
Information Handbook, 16th edition, Geriatric Dosage Handbook, 13th
edition, Drug Information Handbook for Psychiatry, 6th edition and
Pediatric Dosage Handbook, 14th edition.
Methocarbamol – March 2008
Error in the Overdosage/Toxicology field of the
Methocarbamol monograph in Lexi-Drugs and reference publications
including Drug
Information Handbook, 16th edition, Geriatric Dosage Handbook, 13th
edition, and Drug
Information Handbook for Psychiatry,6th edition.
The
monograph previously read:
Overdosage/Toxicology:
Symptoms
include
cardiac arrhythmias, nausea, vomiting, drowsiness, and coma. Treatment
is supportive following attempts to enhance drug elimination.
Hypotension should be treated with I.V. fluids and/or Trendelenburg
positioning. Dialysis, hemoperfusion, and osmotic diuresis
have all
been useful in reducing serum drug concentrations. The
patient should
be observed for possible relapses due to incomplete gastric emptying.
It has been corrected to read:
Overdosage/Toxicology: Symptoms
include cardiac arrhythmias, nausea,
vomiting, drowsiness, and coma. Treatment is supportive following
attempts to enhance drug elimination. Hypotension should be treated
with I.V. fluids and/or Trendelenburg positioning. The patient should
be observed for possible relapses due to incomplete gastric emptying.
Dialysis, hemoperfusion and/or osmotic diuresis
were
previously
recommended as possibly efficacious treatment strategies to reduce
serum concentrations of excessive methocarbamol ingestion. However,
clinical literature does not support diuresis or effective removal of
methocarbamol by dialysis in chronic renally impaired patients, so
these practices can no longer be recommended. Current labeling of
methocarbamol states that the effectiveness of hemodialysis in managing
overdose is unknown.
Factor IX Complete (Human) – February 2008
Error in the Use field of the Factor IX Complex (Human)
monograph in Lexi-Drugs and reference publications including Drug
Information Handbook
, 16th edition.
The monograph previously read:
Use: Control bleeding in patients
with factor IX deficiency (hemophilia B or Christmas disease) Note:
Factor IX concentrate containing only factor IX is also
available and preferable for this indication.
Prevention/control of bleeding in hemophilia A patients with
inhibitors to factor VIII
Prevention/control of bleeding in patients with factor VII
deficiency
Emergency correction of the coagulopathy of warfarin excess
in critical situations
It has been corrected to read:
Use: Control bleeding in
patients with factor IX deficiency (hemophilia B or Christmas disease) Note:
Factor IX concentrate containing only factor IX is
also available and preferable for this indication.
Use:
Unlabeled/Investigational:
Emergency correction of the coagulopathy of warfarin excess in critical
situations. Note:
Products contain low/non-therapeutic levels of Factor VII component
Changes to the Dosage field have also been made to
correspond
with the changes in Use fields. These changes have been automatically
posted to online and hand-held reference sources, but the error will
persist in the current print editions.
Topotecan – January 2008
Error in the Use field of the
Topotecan monograph in the Drug Information Handbook
for Oncology, 7th edition and
Lexi-Drugs .
The monograph previously read:
Use: Treatment of nonsmall cell lung
cancer,
myelodysplastic syndrome, sarcoma (pediatrics), neuroblastoma
(pediatrics), refractory solid tumors (pediatrics)
Unlabeled uses: Treatment of nonsmall
cell lung cancer, sarcoma (pediatrics)
It has been corrected to read:
Use: Treatment of ovarian
cancer and small cell lung cancer; cervical cancer (in combination with
cisplatin)
Use:
Unlabeled/Investigational:
Investigational: Treatment of nonsmall cell lung cancer,
myelodysplastic syndrome, sarcoma (pediatrics), neuroblastoma
(pediatrics), refractory solid tumors
These changes have been automatically posted to online
and hand-held reference sources, but the error will persist in the
current print edition.
Lidocaine – August 2007
Error in the Usual Dosage / Dosage (Usual) field of the
Lidocaine monograph in the Pediatric Dosage Handbook,
14th Edition both domestic and international versions and Pediatric
Lexi-Drugs.
The monograph previously read:
Usual Dosage
Children (PALS 2005 guidelines):
E.T.: 2-3 mg; flush with 5 mL of
NS and follow with 5 assisted manual ventilations
It has been corrected to read:
Usual Dosage
Children (PALS 2005 guidelines):
E.T.: 2-3 mg/kg; flush with 5 mL
of NS and follow with 5 assisted manual ventilations
These changes have been automatically posted to online
and hand-held reference sources, but the error will persist in the
current print edition.
Aliskiren – August 2007
Error in the Contraindications field of the Aliskiren
monograph in Lexi-Drugs (both online and handheld
applications)
The monograph previously read:
Contraindications Hypersensitivity to
aliskiren or any component of the formulation; history of idiopathic or
hereditary angioedema; history of ACE inhibitor- or ARB-related
angioedema; bilateral renal artery stenosis; pregnancy
It has been corrected to read:
Contraindications There are no
contraindications listed in manufacturer's labeling.
These changes have been automatically posted to online
and hand-held reference sources.
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