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Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and
Warnings |
|
Artane (trihexyphenidyl
Hydrochloride) Tablets and Elixir (click product name to read prescribing
information) |
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
- General
- Information for Patients
- Drug Interactions
- Nursing Mothers
- Pediatric Use
ADVERSE REACTIONS
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Artane is contraindicated in patients with hypersensitivity to
trihexyphenidyl HCl or to any of the tablet or elixir ingredients.
Artane is also contraindicated in patients with narrow angle glaucoma.
Blindness after long-term use due to narrow angle glaucoma has been
reported.
Administer with caution in hot weather, especially
when given concomitantly with other atropine-like drugs to the
chronically ill, alcoholics, those who have central nervous system
disease, or those who do manual labor in a hot environment. Anhidrosis
may occur more readily when some disturbance of sweating already
exists.
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Phenergan (promethazine HCl) Syrup and Fortis
Numerous labeling changes so that there is consistency between
the Phenergan Syrup and Fortis labeling and
the Phenergan injection labeling.
Please contact Wyeth-Ayerst at 1-800-395-9938 for
prescribing information.
|
CONTRAINDICATIONS
WARNINGS
- CNS Depression
- Respiratory Depression
- Lower Seizure Threshold
- Bone Marrow Depression
- Neuroleptic Malignant Syndrome (NMS)
- Use in Pediatric Patients
- Other Considerations
PRECAUTIONS
- General
- Information for Patients
- Drug Interactions
- CNS Depressants
- Epinephrine
- Anticholinergics
- Monoamine Oxidase Inhibitors (MAOI)
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy - Teratogenic Effects - Pregnancy Category C
- Pregnancy
- Nonteratogenic Effects
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
ADVERSE REACTIONS
- Central Nervous System
- Cardiovascular
- Dermatologic
- Hematologic
- Gastrointestinal
- Respiratory
- Other
- Paradoxical Reactions (Overdosage)
|
Phenergan Syrup Plain and Phenergan Syrup Fortis:
- Contraindicated in
comatose states, and in individuals known to be hypersensitive or to
have had an idiosyncratic reaction to promethazine or to other
phenothiazines.
- May impair the mental and/or physical abilities required for the
performance of potentially hazardous tasks, such as driving a
vehicle or operating machinery.
- May lead to
potentially fatal respiratory depression. Use in patients with
compromised respiratory function (e.g. COPD, sleep apnea) should
be avoided.
- May lower seizure threshold. It should be used in caution
in persons with seizure disorder or in persons who are using
concomitant medications, such as narcotics or local anesthetics,
which may also affect seizure threshold.
- Used with caution in patients with bone-marrow depression. Leukopenia and granulocytosis have been reported, usually when
Phenergan has been used in association with other known
marrow-toxic agents.
- NMS has been reported in association with promethazine HCl alone
or in combination with antipsychotic drugs.
- Not
recommended for use in pediatric patients less than two years of age.
- Caution should be exercised when administering Phenergan Syrup
Plain and Phenergan Syrup Fortis to pediatric patients 2 years of age
and older because of the potential for fatal respiratory depression.
- Cholestatic jaundice has been reported.
|
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|
Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and
Warnings |
|
Aralen (chloroquine phosphate tablets)
Aralen Hydrochloride (chloroquine hydrochloride injection) (click product name to read prescribing
information) |
WARNINGS
PRECAUTIONS
- Hematological Effects/Laboratory Tests
- Auditory Effects
- Hepatic Effects
- Central Nervous System Effects
- Drug Interactions
- Antacids and kaolin
- Cimetidine
- Ampicillin
- Cyclosporine
- Geriatric Use
ADVERSE REACTIONS
- Special Senses: Ocular
- Musculoskeletal system
- Skin and appendages
- Hematologic system
- Central Nervous system
- Cardiovascular system
|
WARNINGS: Chloroquine resistance is widespread and, at
present, is particularly prominent in various parts of the world
including sub-Saharan Africa, Southeast Asia, the Indian
subcontinent, and over large portions of South America, including
the Amazon basin.
Chloroquine should not be used for
treatment of P. falciparum infections acquired in areas of
chloroquine resistance or malaria occurring in patients where
chloroquine prophylaxis has failed.
WARNINGS/Usage in Pregnancy: There are no adequate and well-controlled studies evaluating
the safety and efficacy of chloroquine in pregnant women. Usage of
chloroquine during pregnancy should be avoided except in the
suppression or treatment of malaria when in the judgment of the
physician the benefit outweighs the potential risk to the fetus. |
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AtroPen
(atropine) Injection
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
- Nursing mothers
- Pediatric Use
ADVERSE REACTIONS
- Cardiovascular
- Eye
- Gastrointestinal
- General
- Central Nervous system
- Psychiatric
- Genitourinary
- Pulmonary
- Dermatologic
PATIENT PACKAGE INSERT
|
AtroPen should be administered with extreme
caution to individuals with significant renal insufficiency or a
recent myocardial infarction. |
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Cefotan (cefotetan disodium for injection) for
Intravenous or Intramuscular Use
Cefotan (cefotetan injection) for Intravenous Use
Only
(click product name to read prescribing
information)
|
WARNINGS |
There appears to be an increased risk of developing hemolytic anemia
on cefotetan relative to other cephalosporins of at least three fold.
Patients who receive courses of cefotetan for the treatment or
prophylaxis of infections should have periodic monitoring for signs
and symptoms of hemolytic anemia including a measurement of
hematological parameters where appropriate.
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| Cognex
(Tacrine Hydrochloride Capsules) (click product name to read prescribing
information)
|
WARNINGS
- Cardiovascular Conditions
|
Because of its pharmacological action, Cognex may
have vagotonic effects on the sinoatrial and atrioventricular nodes
possibly leading to bradycardia and/or heart block. These effects
may be particularly harmful to patients with conduction
abnormalities, bradyarrythmias, or a sick sinus syndrome, but may
also occur in patients without known preexisting cardiac disease.
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Duramorph (morphine sulfate injection)
Please contact Wyeth-Ayerst at 1-800-395-9938
for prescribing information.
|
WARNINGS
|
Overdoses may cause respiratory depression, coma and death. |
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Infumorph
(preservative-free morphine sulfate sterile solution)
Please contact Wyeth-Ayerst at 1-800-395-9938
for prescribing information.
|
WARNINGS
|
Morphine sulfate may be habit
forming. Overdoses may cause respiratory depression, coma and death. |
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| Venofer (iron
sucrose injection)
(click product name to read prescribing
information)
|
WARNINGS
PRECAUTIONS
- General
- Hypersensitivity Reactions
- Hypotension
- Pediatric Use
- Geriatric Use
ADVERSE REACTIONS
- Adverse Events Observed in Studies A, B, and C
- Body as a Whole
- Cardiovascular Disorders, General
- Gastrointestinal System Disorders
- Central and Peripheral Nervous System
- Musculoskeletal System
- Respiratory System
- Skin and appendages
- Adverse Events Observed in Two Post-Marketing Safety Studies
|
Hypersensitivity reactions have
been reported with injectable iron products. See PRECAUTIONS
and ADVERSE REACTIONS.
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| Zemuron (rocuronium bromide) for
Injection (click product name to read prescribing
information) |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
|
Although rare, severe anaphylactic reactions to neuromuscular blocking
agents, including Zemuron, have been reported. These reactions have, in
some cases, been life threatening. Due to the potential severity of these
reactions, the necessary precautions, such as the immediate availability
of appropriate emergency treatment, should be taken.
Special precautions should be taken in patients who have had previous
anaphylactic reactions to other neuromuscular blocking agents, since
allergic cross-reactivity has been reported in this class of drugs.
|
MedWatch Home | Safety Information | Submit
Report | How to
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Back
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MedWatch Home | Safety Information | Submit
Report | How to
Report | Download
Forms | Join
the E-list | Comments
Back
to Summary Page
| Brand
(Generic) Name |
Sections Modified |
|
Arava (leflunomide) Tablets
(click product name to read prescribing
information)
|
ADVERSE REACTIONS
|
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|
Buprenex (buprenorphine hydrochloride) Injectable
Please contact Reckitt Benckiser at 1-877-782-6966
for prescribing information.
|
ADVERSE REACTIONS
|
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Flovent (fluticasone propionate) Inhalation Aerosol
(click product name to read prescribing
information)
|
ADVERSE REACTIONS
|
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Flovent (fluticasone propionate inhalation powder)
Rotadisk
(click product name to read prescribing
information)
|
ADVERSE REACTIONS
-
Ear, Nose, and Throat
-
Eye
-
Respiratory
|
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Lactated Ringer's
Injection
Please contact Baxter Healthcare at 1-800-933-0303 for
prescribing information. |
ADVERSE REACTIONS
Allergic reactions or anaphylactoid symptoms
such as localized or generalized urticaria and pruritis; periorbital, facial, and/or laryngeal
edema; coughing, sneezing, and/or difficulty with breathing have been reported during administration
of Lactated Ringer's Injection, USP. The reporting frequency of these signs and symptoms is
higher in women during pregnancy.
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Ultane (sevoflurane) Volatile Liquid for Inhalation
Please contact Abbott Laboratories at 1-800-633-9110
for prescribing information.
|
ADVERSE REACTIONS
- Adverse Events During Post-Marketing Experience
Rare cases of malignant hyperthermia (see CONTRAINDICATIONS and
WARNINGS) and allergic reactions, such as rash, urticaria, pruritis,
bronchospasm, anaphylactic or anaphylactoid reactions (see CONTRAINDICATIONS) have been reported.
|
MedWatch Home | Safety Information | Submit
Report | How to
Report | Download
Forms | Join
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|
|
