Brand
(Generic) Name |
Sections
Modified |
Summary
of Changes to Contraindications and Warnings |
Travatan
(travoprost ophthalmic solution)
(click product name to read prescribing information) |
CONTRAINDICATIONS
PRECAUTIONS
|
Known hypersensitivity to
travoprost, benzalkonium chloride or any other ingredients in this
product. |
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Zyban
(bupropion hydrochloride) Sustained-Release Tablets
(click product name to read prescribing information)
|
CONTRAINDICATIONS
WARNINGS
- Patient Factors
- Clinical Situations
- Concomitant Medications
- Hepatic Impairment
PRECAUTIONS
- Hepatic Impairment
- Renal Impairment
- Information for Patients
- Drug Interactions:
- Levodopa and Amantadine
- Drugs that Lower Seizure Threshold
- Smoking Cessation
- Alcohol
- Geriatric Use
ADVERSE REACTIONS
- Hemic and Lymphatic
- Nervous System
INFORMATION FOR PATIENTS |
ZYBAN is contraindications
in patients undergoing abrupt discontinuation of alcohol or sedatives
(including benzodiazepines).
ZYBAN should be discontinued and not started in patients who
experience a seizure while on treatment.
Predisposing factors that may increase the risk of seizure with
bupropion use include history of head trauma or prior seizure,
central nervous system (CNS) tumor, the presence of severe hepatic
cirrhosis, and concomitant medications that lower seizure threshold.
Circumstances associated with an increased seizure risk include,
among others, excessive use of alcohol or sedatives (including
benzodiazepines); addiction to opiates....
Hepatic Impairment: ZYBAN should be used with extreme caution
in patients with severe hepatic cirrhosis. In these patients
a reduced frequency of dosing is required, as peak bupropion levels
are substantially increased and accumulation is likely to occur
in such patients to a greater extent than usual. The dose
should not exceed 150 mg every other day in these patients. |
Brand
(Generic) Name |
Sections
Modified |
Summary
of Changes to Contraindications and Warnings |
Avelox
(moxifloxacin hydrochloride) Tablets
Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Postmarketing Adverse Event Reports
PATIENT INFORMATION |
Achilles and other tendon
ruptures that required surgical repair or resulted in prolonged
disability have been reported with quinolones, including moxifloxacin.
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|
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|
Demerol (meperidine
hydrochloride, USP)
(click product name to read prescribing information)
|
WARNINGS
- Drug Abuse and Dependence
- Controlled Substance
- Drug Interactions
- Usage in Pregnancy
- Teratogenic Effects
- Labor and Delivery
- Nursing Mothers
PRECAUTIONS
- Drug Interactions
- Acyclovir
- Cimetidine
- Phenytoin
- Ritonavir
- Special Risk Patients
- Usage in Hepatically Impaired Patients
- Usage in Renally Impaired Patients
- Pregnancy
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
ADVERSE REACTIONS |
Monoamine Oxidase (MAO)
Inhibitors added to WARNINGS section, subsection Drug Interactions.
Teratogenic Effects: Pregnancy Category C. Although
teratogenic effects in humans have not been documented, there
are no adequate and well-controlled studies in pregnant women.
Meperidine is known to cross the placental barrier.
Nursing Mothers: Meperidine appears in the milk of nursing
mothers receiving the drug. Due to the potential for serious
adverse reactions in nursing infants, a decision should be made
whether to discontinue nursing or to discontinue the drug, taking
into account the potential benefits of the drug to the nursing
women.
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Midamor
(amiloride hydrochloride) Tablets
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS |
"An angiotensin II
receptor antagonist" added to the list of agents that when
administered concomitantly with amiloride hydrochloride may increase
the risk of hyperkalemia. |
|
|
|
Moduretic
(amiloride HCl-hydrochlorothiazide) Tablets
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
|
"An angiotensin II receptor antagonist"
added to the list of agents that when administered concomitantly
with amiloride hydrochloride may increase the risk of hyperkalemia. |
|
|
|
Myambutol
(ethambutol hydrochloride) (click product name to read
prescribing information) |
WARNINGS
PRECAUTIONS
- Pregnancy
- Teratogenic Effects: Pregnancy Category
- Geriatric Use
ADVERSE REACTIONS |
MYAMBUTOL may produce decreases in
visual acuity which appear to be due to optic neuritis. This
effect may be related to dose and duration of treatment. This
effect is generally reversible when administration of the drug is
discontinued promptly. However, irreversible blindness has
been reported.
Liver toxicities including fatalities have been reported.
Baseline and periodic assessment of hepatic function should be
performed. |
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|
|
Rogaine
(5% minoxidil topical solution) For Men Extra Strength Please
contact Pharmacia Consumer Healthcare at 1-800-ROGAINE (1-800-764-2463)
for Product Insert. |
WARNINGS |
The phrase "Flammable: Keep away from fire or flame" has
been added to the WARNINGS section.
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Zinc Chloride Injection,
USP
Please contact Abbott Laboratories
at 1-800-255-5162 for Product Insert. |
WARNINGS
PRECAUTIONS
|
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 phosphate solutions,
which contain aluminum.
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."
|
Brand
(Generic) Name |
Sections
Modified |
Bactrim
(sulfamethoxazole and trimethoprim) DS Tablets and Tablets, USP
(click product name to read prescribing information) |
PRECAUTIONS
- Geriatric Use
- Drug Interactions
|
|
|
Benicar
(olmesartan medoxomil) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- Carcinogenesis, Mutagenesis, Impairment of Fertility
ADVERSE REACTIONS
- Post-Marketing Experience
|
|
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BiCNU
(carmustine for injection)
(click product name to read prescribing information) |
PRECAUTIONS |
|
|
Blocadren
(timolol maleate) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS |
|
|
CeeNU
(lomustine) Capsules
(click product name to read prescribing information) |
PRECAUTIONS |
|
|
CellCept
(mycophenolate mofetil capsules and tablets)
CellCept (mycophenolate
mofetil for oral suspension) Oral Suspension
CellCept Intravenous (mycophenolate
mofetil hydrochloride for injection)
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS |
|
|
Lyophilized
Cytoxan (cyclophosphamide for Injection, USP)
Cytoxan Tablets (cyclophosphamide tablets, USP)
Please contact Bristol-Myers
Squibb Company at 212-546-4000 for Product Insert. |
PRECAUTIONS |
|
|
Fragmin
(dalteparin sodium) Injection
(click product name to read prescribing information) |
PRECAUTIONS |
|
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Gastrocrom
(cromolyn sodium, USP) Oral Concentrate
(click product name to read prescribing information) |
PRECAUTIONS
|
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Macrobid
(nitrofurantoin monohydrate/ macrocrystals) Capsules
(click product name to read prescribing information) |
PRECAUTIONS |
|
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Macrodantin
(nitrofurantoin macrocrystals) Capsules
(click product name to read prescribing information) |
PRECAUTIONS |
|
|
Mytelase
(ambenonium chloride) Capsules
Please contact Sanofi-Synthelabo
Inc. at 1-800-446-6267 for Product Insert. |
PRECAUTIONS |
|
|
Nexium
(esomeprazole magnesium) Delayed-Release Capsules
(click product name to read prescribing information) |
PRECAUTIONS |
|
|
Protonix
IV (pantoprazole sodium) for Injection
(click product name to read prescribing information) |
PRECAUTIONS |
|
|
Pulmicort
Respules (budesonide inhalation suspension)
(click product name to read prescribing information) |
PRECAUTIONS |
|
|
Sandimmune
Intravenous (cyclosporine injection)
Sandimmune (cyclosporine) Oral
Solution
Sandimmune (cyclosporine) Soft
Gelatin Capsules
(click product name to read prescribing information)
|
PRECAUTIONS
- Drugs That May Potentiate Renal Dysfunction
- Drugs That Alter Cyclosporine Concentrations
- Drugs That Increase Cyclosporine Concentrations
- Drugs/Dietary Supplements That Decrease Cyclosporine
Concentrations
- Nonsterodial Anti-Inflammatory Drug (NSAID) Interactions
- Methotrexate Interaction
- Other Drug Interactions
|
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Tensilon
(edrophonium chloride) Injectable Solution
(click product name to read prescribing information) |
PRECAUTIONS |
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|
Talwin
Nx (pentazocine hydrochloride and naloxone hydrochloride) Tablets
Please contact Sanofi-Synthelabo
Inc. at 1-800-446-6267 for Product Insert. |
PRECAUTIONS
ADVERSE REACTIONS
"Headache, chills, insomnia, weakness, urinary retention, paresthesia,
serious skin reactions, including erythema multiforme, Stevens-Johnson
syndrome and toxic epidermal necrolysis." |
|
|
Zemplar
(paricalcitol injection)
(click product name to read prescribing information) |
PRECAUTIONS
- Carcinogenesis, Mutagenesis, Impairment of Fertitly
ADVERSE REACTIONS
- Adverse Events During Post-marketing Experience
|