Brand (Generic) Name
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Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Ellence (epirubicin hydrochloride)
Injection
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
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Patients should not be treated with Ellence Injection if they
have any of the following conditions: baseline neutrophil count < 1500
cells/mm3; severe myocardial insufficiency, recent myocardial
infarction, severe arrhythmias; previous treatment with anthracyclines
up to the maximum cumulative dose; hypersensitivity to epirubicin,
other anthracyclines, or anthracenediones; or severe hepatic
dysfunction (see WARNINGS and DOSAGE AND ADMINISTRATION).
Before beginning treatment with epirubicin, patients should
recover from acute toxicities (such as stomatitis, neutropenia,
thrombocytopenia, and generalized infections) of prior cytotoxic
treatment.
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Refludan [lepirudin (rDNA)]
for Injection
(click product name to read prescribing information)
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CONTRAINDICATIONS WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Adverse Events Reported in Clinical Trials in HIT
Patients
- Adverse Events Reported in Clinical Trials in Other
Populations
- Adverse Events from Post Marketing Reports
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Refludan is contraindicated
in patients with known hypersensitivity to hirudins or to any of
the components in Refludan [lepirudin (rDNA) for injection].
Hemorrhagic Events: As with other anticoagulants,
hemorrhage can occur at any site in patients receiving Refludan.
An unexpected fall in hemoglobin, fall in blood pressure or any
unexplained symptom should lead to consideration of a hemorrhagic
event. While patients are being anticoagulated with Refludan,
the anticoagulation status should be monitored closely using
an appropriate measure such as the aPTT (see ADVERSE REACTIONS
and DOSAGE AND ADMINISTRATION: Monitoring Section.)
There have been
reports of intracranial bleeding with Refludan the absence
of concomitant thrombolytic therapy (see ADVERSE REACTIONS.)
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Soriatane (acitretin) Capsules
(click product name to read prescribing information)
|
CONTRAINDICATIONS: Pregnancy
Category X
BOXED CONTRAINDICATIONS AND WARNINGS
- Important Information for Males Taking Soriatane
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
PATIENT AGREEMENT/INFORMED CONSENT FOR FEMALE PATIENTS
MEDICATION GUIDE
PREGNANCY PREVENTION PROGRAM BOOKLET |
Numerous changes to stated sections. Please see prescribing
information.
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Targretin
(bexarotene) Capsules
(click product name to read prescribing information)
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CONTRAINDICATIONS
PRECAUTIONS
PATIENT PACKAGE INSERT |
Bexarotene can potentially induce metabolic enzymes and thereby
theoretically reduce the plasma concentrations of oral or other
systemic hormonal contraceptives (see CLINICAL PHARMACOLOGY: Drug-Drug
Interactions and PRECAUTIONS: Drug-Drug Interactions).
Thus, if treatment with Targretin capsules is intended in a woman
with child-bearing potential, it is strongly recommended that
one of the two reliable forms of contraception should be non-hormonal.
|
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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Ancobon (flucytosine)
Capsules
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
- Drug Interactions
- Drug/Laboratory Test Interactions
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy
- Pediatric Use
ADVERSE REACTIONS
- Cardiovascular
- Gastrointestinal
- Psychiatric
|
Bone marrow toxicity can be irreversible and may lead to death
in immunosuppressed patients.
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Cordarone (amiodarone hydrochloride) Tablets
Please contact Wyeth Pharmaceuticals at 1-800-395-9938 for
prescribing information. |
WARNINGS
ADVERSE REACTIONS
|
There have been postmarketing reports
of acute-onset (days to weeks) pulmonary injury in patients
treated with oral Cordarone with or without initial I.V. therapy. Findings
have included pulmonary infiltrates on X-ray, bronchospasm,
wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Some
cases have progressed to respiratory failure and/or death.
Patients with preexisting pulmonary disease have a poorer
prognosis if pulmonary toxicity develops.
Reports suggest that the use of lower loading and maintenance
doses of Cordarone are associated with a decreased incidence
of Cordarone-induced pulmonary toxicity.
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Nubain (nalbuphine hydrochloride) Injection
(click product name to read prescribing information)
|
WARNINGS
- Use in Pregnancy (Other Than Labor)
- Use During Labor and Delivery
PRECAUTIONS
- Information for Patients
- Laboratory Tests
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Usage in Pregnancy
- Teratogenic Effects - Pregnancy Category B
- Non-Teratogenic Effects
ADVERSE REACTIONS
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Severe fetal bradycardia has been reported
when Nubain is administered during labor. Naloxone may reverse
these effects. Although there are no reports of fetal bradycardia
earlier in pregnancy, it is possible that this may occur. This
drug should be used in pregnancy only if clearly needed, if
the potential benefit outweighs the risk to the fetus, and
if appropriate measures such as fetal monitoring are taken
to detect and manage any potential adverse effect on the fetus.
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Rapamune (sirolimus)
Oral Solution and Tablets (click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
- Lipids
- Renal Function
- Interstitial Lung Disease
- Laboratory Tests
- Cyclosporine capsules MODIFIED
- Other Drug Interactions
- Herbal Preparations
- Carcinogenesis, Mutagenesis, and Impairment
of Fertility
- Pregnancy
ADVERSE REACTIONS
- Rapamune Oral Solution
- Rapamune Tablets
- Rapamune following cyclosporine withdrawal
- Other Clinical Experience
|
Renal function should
be closely monitored during the administration of Rapamune
in combination with cyclosporine since long-term
administration can be associated with deterioration of renal
function. Appropriate adjustment of the immunosuppression
regimen, including discontinuation of Rapamune and/or cyclosporine,
should be considered in patients with elevated or increasing
serum creatinine levels.
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Reglan (metoclopramide)
Tablets (click product name to read prescribing information)
|
WARNINGS
- Neuroleptic Malignant Syndrome (NMS)
PRECAUTIONS
- General
- Geriatric Use
- Other Special Populations
ADVERSE REACTIONS
- Neuroleptic Malignant Syndrome
|
There have been rare
reports of an uncommon but potentially fatal symptom complex
sometimes referred to as Neuroleptic Malignant Syndrome (NMS)
associated with metoclopramide. Clinical manifestations
of NMS include hyperthermia, muscle rigidity, altered consciousness,
and evidence of autonomic instability (irregular pulse or blood
pressure, tachycardia, diaphoresis and cardiac arrhythmias). |
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3.3%
Sorbitol Irrigation in Plastic Container
Please contact B. Braun Medical Inc. at 1-800-854-6851 for
prescribing information.
|
WARNINGS
PRECAUTIONS
- General
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy - Teratogenic Effects - Pregnancy Category
C
- Nursing Mothers
- Pediatric Use
- Geriatric Use
ADVERSE REACTIONS |
FOR UROLOGIC IRRIGATION
ONLY. NOT FOR INJECTION.
Hyperglycemia from metabolism of sorbitol may occur in patients
with diabetes mellitus.
Hyperlactatemia from metabolism of sorbitol may potentially
produce a significant lactic acidemia in metabolically compromised
patients. |
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Zestoretic (lisinopril/
hydrochlorothiazide) Tablets (click product name to read prescribing information) |
WARNINGS
- Angioedema
- Intestinal Angioedema
PRECAUTIONS
ADVERSE REACTIONS
|
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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Zocor
(simvastatin) Tablets (click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Heart Protection Study
- Clinical Adverse Experiences
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It is recommended that
liver function tests be performed before the initiation of treatment,
and thereafter when clinically indicated. Patients titrated to
the 80-mg dose should receive an additional test prior to titration,
3 months after titration to the 80-mg dose, and periodically
thereafter (e.g., semiannually) for the first year of treatment. |
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Brand
(Generic) Name |
Sections Modified
|
Aclovate (alclometasone
dipropionate) Cream and Ointment
(click product name to read prescribing information)
|
PRECAUTIONS
|
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Alkeran (melphalan hydrochloride) for
Injection
(click product name to read prescribing information)
|
PRECAUTIONS
|
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4% BranchAmin (branch chained amino
acid) Injection, in Viaflex plastic container
Please contact Baxter Healthcare at 1-800-933-0303 for prescribing
information.
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PRECAUTIONS
- Nursing Mothers
- It is not known whether this drug is excreted in
human milk. Because many drugs are excreted in human
milk, caution should be
exercised when 4% BranchAmin (branch chained amino
acid) Injection is administered
to a nursing mother.
- Geriatric Use
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Econopred (prednisoloneacetate ophthalmic suspension)
Econopred Plus (prednisolone
acetate ophthalmic suspension)
(click product name to read prescribing information)
|
PRECAUTIONS
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Fansidar
(sulfadoxine and pyrimethamine) Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
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Flagyl
375 (metronidazole) Capsules
Flagyl ER (metronidazole)
Extended Release Tablets
Flagyl (metronidazole) Tablets (click product name to read prescribing information) |
PRECAUTIONS
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Maxidex (dexamethasone ophthalmic suspension) (click product name to read prescribing information)
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PRECAUTIONS
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Mobic (meloxicam)
Tablets (click product name to read prescribing information)
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PRECAUTIONS
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Mycostatin (nystatin
lozenges) Pastilles
Please contact Bristol-Myers
Squibb at 212-546-4000 for prescribing information. |
PRECAUTIONS
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Nebcin
(tobramycin sulfate) Injection Vials and Hyporets
Nebcin (tobramycin sulfate) for Injection Vials
Please contact Eli Lilly at 1-800-545-5979 for
prescribing information.
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PRECAUTIONS
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Ovide (malathion)
Lotion (click product name to read prescribing information)
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PRECAUTIONS
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Oxandrin (oxandrolone) Tablets (click product name to read prescribing information) |
PRECAUTIONS
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Patanol
(olopatadine hydrochloride ophthalmic solution) (click product name to read prescribing information)
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PRECAUTIONS
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Potassium
Chloride in 5% Dextrose and Sodium Chloride Injection
(click product name to read prescribing information)
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PRECAUTIONS
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20%
Pro-Sol-sulfite-free (amino
acid) Injection in Viaflex plastic container.
Please contact Baxter Healthcare at 1-800-933-0303
for prescribing information.
|
PRECAUTIONS
- Nursing Mothers
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, and
because of the potential for adverse reactions, e.g., hyperammonemia
in nursing infants, caution should be exercised when 20%
ProSol sulfite-free (amino acid) Injection is administered
to a nursing mother.
- Geriatric Use
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RenAmin (amino acid) Injection
Please contact Baxter Healthcare at 1-800-933-0303 for prescribing
information. |
PRECAUTIONS
- Nursing Mothers
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, and
because of the potential for adverse reactions, e.g., hyperammonemia
in nursing infants, caution should be exercised when RenAmin
(amino acid) Injection is administered to a nursing mother.
- Geriatric Use
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Temovate E (clobetasol
propionate) Emollient Cream Temovate (clobetasol
propionate) Cream and Ointment
Temovate (clobetasol
propionate) Scalp Application
(click product name to read prescribing information)
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PRECAUTIONS
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Topamax
(topiramate) Tablets
Topamax (topiramate) Sprinkle Capsules
Please contact Ortho-McNeil Pharmaceuticals at 1-877-323-2200
for prescribing information.
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PRECAUTIONS
ADVERSE REACTIONS
- Postmarketing and Other Experience
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Ultravist (brand of iopromide) Injection
(click product name to read prescribing information)
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PRECAUTIONS
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Vexol (rimexolone ophthalmic suspension)
(click product name to read prescribing information)
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PRECAUTIONS
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Zosyn (piperacillin sodium/tazobactam
sodium)
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Drug Interactions
ADVERSE REACTIONS
- Nosocomial Pneumonia Trials
- Postmarketing Experience
- Gastrointestinal
- Hematologic
- Immune
- Infections
- Renal
- Skin and Appendages
- Adverse Laboratory Events (Seen During Clinical
Trials)
- Additional laboratory events
- Skeletal
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Zyrtec-D 12 Hour (cetirizine HCl 5
mg and pseudoephedrine HCl 120 mg) Extended Release Tablets (click product name to read prescribing information)
|
PRECAUTIONS
- Activities Requiring Mental Altertness
ADVERSE REACTIONS
- ZYRTEC-D 12 HOUR Extended Release Tablets
- Zyrtec Tablets
|
MedWatch
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Brand
(Generic) Name |
Sections Modified
|
Atacand (candesartan cilexetil) Tablets
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Post-Marketing Experience
- Metabolic and Nutritional Disorders
- Renal
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Biaxin
XL Filmtab (clarithromycin extended-release tablets)
(click product name to read prescribing information)
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ADVERSE REACTIONS
- Post-marketing Experience
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CardioTec (Kit for the Preparation of technetium
Tc99m Teboroxime)
Please contact Bracco Diagnostics at 1-800-447-6883
for prescribing information. |
ADVERSE REACTIONS
Of the 1537 patients that were evaluated during the clinical
development of CardioTec, 7 patients experienced serious
adverse events of whom 4 patients had myocardial infarction,
one each had hyperglycemia and arthralgia, and one patient
experienced dizziness, nausea and lightheadedness. It was
not possible to determine the underlying cause for these
serious adverse events.
In completed clinical trials, adverse events were evaluated
in 1413 adults The most commonly reported non-serious adverse
events were chest pain and nausea, both with the frequency
of 0.4%. The following were adverse events by body systems: Body
as a Whole (1.0%): back pain, chest pain, chest tightness,
fatigue, injection site burning, injection site pain, shakiness; Cardiovascular
(1.0%): angina, AV block, blood pressure decreased, blood
pressure increased, flushing, heart rate decreased, hypertension,
myocardial infarction, palpitation, postural hypotension; Gastrointestinal
(0.6%): diarrhea, nausea, vomiting; Musculoskeletal
(0.3%): arthralgia, jaw pain; Nervous (0.6%): balance
disturbance, dizziness,hypoesthesia, paresthesia, syncope,
taste disturbance; Respiratory (0.3%): dyspnea, wheezing; Skin
and Appendages (0.2%): clamminess, dermatitis, face edema; Vision
(0.1%): eye pain.
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Noritate
(metronidazole) Cream
(click product name to read prescribing information)
|
ADVERSE REACTIONS |
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Primacor (milrinone lactate) Injection
Primacor (milrinone lactate) in 5% Dextrose Injection
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Cardiovascular Effects
- Other Effects
|
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Zagam (sparfloxacin) Tablets
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Postmarketing Adverse Events
|
MedWatch
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|
|