Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and
Warnings |
Fludara (fludarabine) for Injection
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Hematopoietic Systems
- Nervous System
- Gastrointestinal System
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Severe bone marrow suppression, notably anemia, thrombocytopenia
and neutropenia, has been reported in patients treated with Fludara
for Injection.
In 12 pediatric patients with solid tumors, dose-limiting myelosuppression
was observed with a loading dose of 8 mg/m2 followed by 23.5 mg/m2/day
for five days.
Several instances of trilineage bone marrow hypoplasia or aplasia
resulting in pancytopenia, sometimes resulting in death, have been
reported in adult patients.
In a clinical investigation using Fludara for Injection in combination
with pentostatin (deoxycoformycin) for the treatment of refractory
chronic lymphocytic leukemia (CLL) in adults, there was an unacceptably
high incidence of fatal pulmonary toxicity.
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Mykrox (metolazone) Tablets
Please contact Celltech Pharmaceuticals at 1-800-234-5535 for
prescribing information.
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WARNINGS
ADVERSE REACTIONS
- Dermatologic
- Hypersensitivity
- skin necrosis
- petechiae
- pruritus
- skin rashes
- Gastrointestinal
- nausea
- diarrhea
- abdominal pain
|
Cross-allergy may occur when
Mykrox Tablets are given to patients known to be allergic to
sulfonamide-derived drugs, thiazides, or quinethazone.
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Nallpen (nafcillin sodium
injection)
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
|
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC)
REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN
THERAPY.
The first paragraph of the pseudomembranous colitis statements is
now bolded.
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3%
Sorbitol Urologic Irrigation Solution
(click product name to read prescribing information) |
WARNINGS
ADVERSE REACTIONS
|
Not for
use in patients with documented or suspected fructose intolerance.
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Suprax (cefixime)
Tablets and Oral Suspension
(click product name to read prescribing information)
|
WARNINGS
ADVERSE REACTIONS
- Hypersensitivity Reactions
|
Anaphylactic/anaphylactoid
reactions (including shock and fatalities) have been reported with
the use of cefixime. Antibiotics, including Suprax, should be administered
cautiously to any patient who has demonstrated some form of allergy,
particularly to drugs.
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Zaroxolyn (metolazone) Tablets
Please contact Celltech Pharmaceuticals at 1-800-234-5535 for
prescribing information. |
WARNINGS
ADVERSE REACTIONS
- Dermatologic
- Hypersensitivity
- skin necrosis
- petechiae
- pruritus
- Gastrointestinal
|
Cross-allergy may occur when Zaroxolyn is given to patients known to be
allergic to sulfonamide-derived drugs, thiazides, or quinethazone.
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