Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and Warnings |
Angiomax (bivalirudin) for Injection
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
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An increased risk of thrombus formation has been associated with the use of Angiomax in
gamma brachytherapy, including fatal outcomes. |
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Avandamet (rosiglitazone maleate and metformin HCl) Tablets
(click product name to read prescribing information) |
WARNINGS
- Rosiglitazone Maleate
- Cardiac
Failure and Other Cardiac Effects
PRECAUTIONS
PATIENT PACKAGE INSERT |
Rosiglitazone, like other thiazolidinediones, alone or in
combination with other antidiabetic agents, can cause fluid retention, which may exacerbate
or lead to heart failure.
In combination with insulin, thiazolidinediones may increase the risk of other cardiovascular
adverse events... (see prescribing information)
In a double-blind study in type 2 diabetes patients with chronic renal failure (112 received 4 mg or 8 mg of rosiglitazone plus
insulin and 108 received insulin alone), there was no difference in cardiovascular adverse
events with rosiglitazone in combination with insulin compared to insulin alone.
Patients treated with combination Avandamet and insulin should be monitored for cardiovascular
adverse events. The combination therapy should be discontinued in patients who do not respond as manifested by
a reduction in HbA1c or insulin dose after 4 to 5 months of therapy or who develop any significant adverse events. |
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Campath (alemtuzumab)
(click product name to read prescribing information) |
WARNINGS
|
Carnpath has been associated with infusion-related events including hypotension, rigors,
fever shortness of breath, bronchospasm, chills, and/or rash. In post-marketing reports,
the following serious infusion-related events were reported: syncope, pulmonary infiltrates, ARDS, respiratory
arrest, cardiac arrhythmias , myocardial infarction and cardiac arrest. |
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Capoten (captopril) Tablets
(click product name to read prescribing information) |
WARNINGS
- Head and Neck Angioedema
- Intestinal Angioedema
|
Intestinal angioedema has been reported in patients treated with ACE inhibitors. These
patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior
history of facial angioedema and C-1 esterase levels were normal. The angioedema was
diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after
stopping the ACE inhibitor. Intestinal angioedema should be included in the differential
diagnosis of patients on ACE inhibitors presenting with abdominal pain. |
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Celexa (citalopram hydrobromide) and Oral Solution
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
|
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior (suicidality), whether or not
they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although
there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression
and the emergence of suicidality in certain patients, a causal role for antidepressants
in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants
should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes,
either increases or decreases... (See prescribing information) |
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Crixivan (indinavir sulfate) Capsules
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- Information for Patients
- Table 8
- Table 9
PATIENT PACKAGE INSERT |
Particular caution should be used when prescribing sildenafil, tadalafil,
or vardenafil in patients receiving indinavir. Coadministration of Crixivan with these medications is expected to substantially
increase plasma concentrations of sildenafil, tadalafil, and vardenafil and
may result in an increase in adverse events, including hypotension, visual changes, and priapism, which have been associated with sildenafil, tadalafil, and vardenafil. |
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Decadron (dexamethasone tablets, USP)
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Cardio-renal
- Gastrointestinal
- Information for Patients
- Drug Interactions
- Nursing Mothers
- Pediatric Use
- Geriatric Use
ADVERSE REACTIONS |
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid
therapy.
Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential
for corticosteroid insufficiency after withdrawal of treatment. |
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Duramorph (morphine sulfate injection)
Please contact Baxter Healthcare Corporation at 1-800-422-9837 for prescribing information. |
WARNINGS
ADVERSE REACTIONS
|
Inflammatory masses such as granulomas, some of which have resulted in serious neurologic impairment
including paralysis, have been reported to occur in patients receiving continuous infusion of opiod analgesics
including Infumorph via indwelling intrathectal catheter. Patients receiving continuous infusion of infumorph via
indwelling intrathecal catheter should be monitored for new neurologic signs or symptoms, further assessment or intervention should be based on the clinical condition
of the individual patient. |
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Effexor (venlafaxine hydrochloride) Tablets
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
PATIENT PACKAGE INSERT |
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior (suicidality), whether or not
they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although
there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression
and the emergence of suicidality in certain patients, a causal role for antidepressants
in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants
should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes,
either increases or decreases... (See prescribing information) |
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Effexor XR (venlafaxine hydrochloride) Extended Release Capsules
(click product name to read prescribing information) |
WARNINGS
Clinical Worsening and
Suicide Risk
PRECAUTIONS
PATIENT PACKAGE INSERT |
Patients with major depressive disorder, both adult and pediatric, may experience
worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until
significant remission occurs. Although there has been a long-standing concern that antidepressants may have
a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not
been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical
worsening and suicidality, especially at the beginning of a course of drug therapy,
or at the time of dose changes, either increases or decreases... (See prescribing information) |
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8.5% FreAmine III (amino acid injection)
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
- Labor and Delivery
- Pediatric Use
- Geriatric Use
|
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration
if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature,
and they require large amounts of calcium and phosphorous solutions, which contain aluminum.
Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise
in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory
determinations are necessary for proper monitoring of central venous nutrition. |
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10% FreAmine III (amino acid injections)
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
- Labor and Delivery
- Pediatric Use
- Geriatric Use
|
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration
if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature,
and they require large amounts of calcium and phosphorous solutions, which contain aluminum.
Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise
in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory
determinations are necessary for proper monitoring of central venous nutrition. |
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3% FreAmine III (amino acid injection) with Electrolytes
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Laboratory Tests
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
|
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration
if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature,
and they require large amounts of calcium and phosphorous solutions, which contain aluminum.
Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise
in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory
determinations are necessary for proper monitoring of central venous nutrition. |
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8.5% FreAmine III (amino acid injection) with Electrolytes
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Laboratory Tests
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
|
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration
if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature,
and they require large amounts of calcium and phosphorous solutions, which contain aluminum.
Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise
in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory
determinations are necessary for proper monitoring of central venous nutrition. |
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6.9% FreAmine HBC (amino acid injection)
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Laboratory Tests
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
|
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration
if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature,
and they require large amounts of calcium and phosphorous solutions, which contain aluminum.
Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise
in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory
determinations are necessary for proper monitoring of central venous nutrition. |
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Infumorph (preservative-free morphine sulfate sterile solution)
Please contact Baxter Healthcare Corporation at 1-800-422-9837 for prescribing information. |
WARNINGS
ADVERSE REACTIONS
|
Inflammatory masses such as granulomas, some of which
have resulted in serious neurologic impairment including paralysis, have been reported
to occur in patients receiving continuous infusion of opiod analgesics including Infumorph via indwelling intrathecal catheter.
Patients receiving continuous infusion of infumorph via indwelling intrathecal catheter
should be monitored for new neurologic signs or symptoms, further assessment or intervention
should be based on the clinical condition of the individual patient. |
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Lexapro (escitalopram oxalate)
Tablets and Oral Solution
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
|
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior (suicidality), whether or not
they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although
there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression
and the emergence of suicidality in certain patients, a causal role for antidepressants
in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants
should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes,
either increases or decreases... (See prescribing information) |
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5.4% NephrAmine (essential amino acid injection)
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Laboratory Tests
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
|
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels
of aluminum at greater than 4 to 5mcg/kg/day accumulate aluminum at levels associated
with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise
in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory
determinations are necessary for proper monitoring of central venous nutrition. Laboratory tests should include
measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and
evaluation of acid-base balance and fluid balance. |
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Neumega (oprelvekin)
(click product name to read prescribing information) |
WARNINGS
- Increased Toxicity Following Myeloablative Therapy
- Fluid Retention
ADVERSE REACTIONS
|
Neumega is not indicated following myeloablative chemotherapy. In a randomized, placebo controlled Phase 2 study, the effectiveness of Neumega was not demonstrated. In
this study, a statistically significant increased incidence in edema, conjunctival bleeding,
hypotension, and tachycardia was observed in patients receiving Neumega as compared to placebo.
Neumega is known to cause serious fluid retention that can result in peripheral edema, dyspnea on
exertion, pulmonary edema, capillary leak syndrome, atrial arrhythmias, and exacerbation
of pre-existing pleura) effusions. Severe fluid retention, some cases resulting in death, was reported following
recent bone marrow transplantation in patients who have received Neumega. |
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Paxil (paroxetine hydrochloride) Tablets
and Oral Suspension
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
|
Patients with major depressive disorder, both adult and pediatric, may experience
worsening of their depression and/or the emergence of suicidal ideation and behavior
(suicidality), whether or not they are taking antidepressant medications, and this
risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants
may have a role in inducing worsening of depression and the emergence of suicidality in
certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless,
patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes,
either increases or decreases. |
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Paxil (paroxetine hydrochloride) Controlled
Release Tablets
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
|
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior (suicidality), whether or not
they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although
there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression
and the emergence of suicidality in certain patients, a causal role for antidepressants
in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants
should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes,
either increases or decreases... (See prescribing information) |
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Serzone (nefazodone hydrochloride) Tablets
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
|
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior (suicidality), whether or not
they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although
there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression
and the emergence of suicidality in certain patients, a causal role for antidepressants
in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants
should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes,
either increases or decreases... (See prescribing information) |
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Taxotere (docetaxel) for Injection Concentrate
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Combination Therapy with Taxotere in Patients with Prostate Cancer
|
The pretreatment regimen for hormone-refractory metastatic prostate cancer is oral dexamethasone 8
mg, at 12 hours, 3 hours and 1 hour before the Taxotere infusion. |
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Twinject (epinephrine) Auto-Injector
Please contact Hollister-Stier Laboratories, LLC at 1-800-992-1120 for prescribing
information. |
WARNINGS
PRECAUTIONS
PATIENT PACKAGE INSERT |
Epinephrine is the preferred treatment for anaphylaxis even though the product contains sodium bisulfite,
which in other products may cause allergic-type reactions including anaphylactic symptoms or life-threatening
asthma in certain susceptible persons.
The alternatives to using epinephrine in anaphylaxis may not be satisfactory. The presence of sulfite in this
product should not deter administration of the drug for treatment of anaphylaxis, even if the patient is sulfite-sensitive. |
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Wellbutrin (bupropion hydrochloride)
Tablets
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
|
Patients with major depressive disorder, both adult and pediatric, may experience
worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until
significant remission occurs. Although there has been a long-standing concern that antidepressants may have
a role in inducing worsening of depression and the emergence of suicidality in certain
patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless,
patients being treated with antidepressants should be observed closely for clinical worsening and suicidality,
especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or
decreases... (See prescribing information) |
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Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
|
Patients with major depressive disorder, both adult and pediatric, may experience
worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until
significant remission occurs. Although there has been a long-standing concern that antidepressants may have
a role in inducing worsening of depression and the emergence of suicidality in certain
patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless,
patients being treated with antidepressants should be observed closely for clinical worsening and suicidality,
especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or
decreases... (See prescribing information) |
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Wellbutrin XL (bupropion hydrochloride extended-release tablets)
(click product name to read prescribing information) |
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
|
Patients with major depressive disorder, both adult and pediatric, may experience
worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until
significant remission occurs. Although there has been a long-standing concern that antidepressants may have
a role in inducing worsening of depression and the emergence of suicidality in certain
patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless,
patients being treated with antidepressants should be observed closely for clinical worsening and suicidality,
especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or
decreases... (See prescribing information) |