Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Accutane (isotretinoin
capsules)
(click product name to read prescribing information)
|
CONTRAINDICATIONS & BOXED WARNING
PRECAUTIONS
- Initial Paragraph
- Wholesalers
- Prescribers
- All Patients
- Female Patients of Childbearing
Potential
- Pharmacists
- Information for Patients
MEDICATION GUIDE
|
CONTRAINDICATIONS & BOXED WARNING
Because of Accutane's
teratogenicity and to minimize fetal exposure, Accutane is
approved for marketing only under
a special restricted distribution program approved by the Food and
Drug Administration. This program is called iPLEDGE.
Accutane must only be prescribed by prescribers who are
registered and activated with the iPLEDGE program. Accutane must
only be dispensed by a pharmacy registered and activated with
iPLEDGE, and must only be dispensed to patients who are registered
and meet all the requirements of iPLEDGE.
For additional details, see MedWatch 08/12/2005 Safety Alert.
|
|
|
|
Mobic (meloxicam) Tablets and Oral
Suspension
(click product name to read prescribing information)
|
CONTRAINDICATIONS
BOXED WARNING
-
Cardiovascular Risk
-
Gastrointestinal Risk
WARNINGS
-
Cardiovascular Effects
- Gastrointestinal (GI) Effects - Risk of
GI Ulceration, Bleeding, and Perforation
- Renal Effects
- Advanced Renal Disease
- Skin Reactions
PRECAUTIONS
-
Hepatic Effects
-
Hematological Effects
-
Information for Patients
-
Laboratory Tests
-
Drug Interactions
-
Furosemide
-
Lithium
-
Methotrexate
-
Warfarin
- Pregnancy
- Teratogenic Effects: Pregnancy
Category C.
- Nonteratogenic Effects
- Labor and Delivery
- Nursing Mothers
ADVERSE REACTIONS
MEDICATION GUIDE
|
CONTRAINDICATIONS
Mobic is contraindicated for
the treatment of peri-operative pain in the setting of coronary
artery bypass graft (CABG) surgery.
BOXED WARNING
Cardiovascular Risk
NSAIDs may cause an increased
risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients with cardiovascular disease or risk
factors for cardiovascular disease may be at greater risk.....
Gastrointestinal Risk
NSAIDs cause an increased risk
of serious gastrointestinal adverse events including bleeding,
ulceration, and perforation of the stomach or intestines, which
can be fatal. These events can occur at any time during use and
without warning symptoms. Elderly patients are at greater risk for
serious gastrointestinal events.
WARNINGS
Cardiovascular Thrombotic
Events
Clinical trials of several
COX-2 selective and nonselective NSAIDs of up to three years
duration have shown an increased risk of serious cardiovascular
(CV) thrombotic events, myocardial infarction, and stroke, which
can be fatal.....
Hypertension
NSAIDs, including Mobic, can
lead to onset of new hypertension or worsening of preexisting
hypertension, either of which may contribute to the increased
incidence of CV events. Patients taking thiazides or loop
diuretics may have impaired response to these therapies when
taking NSAIDs.....
Congestive Heart Failure and
Edema
Fluid retention and edema have
been observed in some patients taking NSAIDs. Mobic should be used
with caution in patients with fluid retention, hypertension, or
heart failure.
Gastrointestinal (GI)
Effects - Risk of GI Ulceration, Bleeding, and Perforation
.....Patients with a
prior history of peptic ulcer disease and/or gastrointestinal
bleeding who use NSAIDs have a greater than 10-fold increased risk
for developing a GI bleed compared to patients with neither of
these risk factors. Other factors that increase the risk for GI
bleeding in patients treated with NSAIDs include concomitant use
of oral corticosteroids or anticoagulants, longer duration of
NSAID therapy, smoking, use of alcohol, older age, and poor
general health status.....
Renal Effects
Long-term administration of
NSAIDs has resulted in renal papillary necrosis and other renal
injury. Renal toxicity has also been seen in patients in whom
renal prostaglandins have a compensatory role in the maintenance
of renal perfusion.
Advanced Renal Disease
No information is available
from controlled clinical studies regarding the use of Mobic in
patients with advanced renal disease. Therefore, treatment with
Mobic is not recommended in these patients with advanced renal
disease. If Mobic therapy must be initiated, close monitoring of
the patient's renal function is advisable.
Skin Reactions
NSAIDs, including Mobic, can
cause serious skin adverse events such as exfoliative dermatitis,
Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis
(TEN), which can be fatal. These serious events may occur without
warning. Patients should be informed about the signs and symptoms
of serious skin manifestations and use of the drug should be
discontinued at the first appearance of skin rash or any other
sign of hypersensitivity.
|
MedWatch
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Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications and Warnings
|
Adderall
(mixed salts of a single-entity amphetamine
product) Tablets
(click product name to read prescribing information)
|
BOXED WARNING
WARNINGS
- Sudden Death and Pre-existing
Structural Cardiac Abnormalities
ADVERSE REACTIONS
- Cardiovascular
- Sudden Death
- Myocardial
Infarction
- Central Nervous
System
- Depression
- Seizures
- Stroke
|
BOXED WARNING
Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events.
WARNINGS
Sudden death has been
reported in association with amphetamine treatment at usual
doses in children with structural cardiac abnormalities.
Adderall generally should not be used in children or adults with
structural cardiac abnormalities.
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|
FazaClo (clozapine, USP)
Orally Disintegrating Tablets
(click product name to read prescribing information)
|
BOXED WARNING
-
Increased Mortality in Elderly Patients with
Dementia-related Psychosis
WARNINGS
|
BOXED WARNING
Elderly patients with dementia-related psychosis treated with
atypical antipsychotic drugs are at an increased risk of death
compared to placebo.....
WARNINGS
Elderly patients with dementia-related psychosis treated with
atypical antipsychotic drugs are at an increased risk of death
compared to placebo. Fazaclo (clozapine, USP) is not approved
for the treatment of patients with dementia-related psychosis.
|
|
|
|
Geodon (ziprasidone HCl)
Capsules
Geodon (ziprasidone mesylate)
for Injection
(click product name to read prescribing information)
|
BOXED WARNING
WARNINGS
|
BOXED WARNING
Elderly patients with
dementia-related psychosis treated with atypical antipsychotic
drugs are at an increased risk of death compared to placebo.....
.....Although the causes of
death were varied, most of the deaths appeared to be either
cardiovascular (e.g., heart failure, sudden death) or infectious
(e.g., pneumonia) in nature. Geodon (ziprasidone) is not
approved for the treatment of patients with dementia-related
psychosis.
WARNINGS
Elderly patients with
dementia-related psychosis treated with atypical antipsychotic
drugs are at an increased risk of death compared to placebo.
Geodon (ziprasidone) is not approved for the treatment of
patients with dementia-related psychosis.
|
|
|
|
Premarin (conjugated
estrogens, USP) for Injection
(click product name to read prescribing information)
|
BOXED WARNING
- Women's Health Initiative Memory
Study (WHIMS)
WARNINGS
- Cardiovascular Disorders
- Coronary Heart Disease and Stroke
- Venous Thromboembolism (VTE)
- Dementia
PRECAUTIONS
ADVERSE REACTIONS
- Genitourinary System
- Vaginal Candidiasis
- Ovarian Cancer
- Endometrial
Hyperplasia
- Endometrial Cancer
- Breasts
- Cardiovascular
- Deep and Superficial Venous
Thrombosis
- Thrombophlebitis
- Miscellaneous
- Urticaria
- Angioedema
- Increased Triglycerides
|
BOXED WARNING
The Women's Health
Initiative Memory Study (WHIMS), a sub-study of the Women's
Health Initiative (WHI), reported
increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 5.2 years of
treatment with conjugated estrogens alone and during 4 years of
treatment with conjugated estrogens combined with
medroxyprogesterone acetate, relative to placebo. It is unknown
whether this finding applies to younger postmenopausal women.
WARNINGS
Cardiovascular Disorders
Coronary Heart Disease and
Stroke
In the estrogen alone
sub-study of the WHI study, an
increased risk of stroke was observed in women receiving
Premarin (0.625 mg conjugated estrogens) per day compared to
women receiving placebo (44 vs. 32 per 10,000 women-years). The
increase in risk was observed in year one and persisted.
Venous Thromboembolism (VTE)
In the estrogen alone
sub-study of the WHI study, an
increased risk of deep vein thrombosis was observed in women
receiving Premarin compared to placebo (21 vs. 15 per 10,000
women-years). The increase in VTE risk was observed during the
first year.
Dementia
..... In the estrogen alone
sub-study, after an average follow-up of 5.2 years, 28 women in
the estrogen alone group and 19 women in the placebo group were
diagnosed with probable dementia.....
.....In the estrogen plus
progestin sub-study, after an average follow-up of 4 years, 40
women in the estrogen plus progestin group and 21 women in the
placebo group were diagnosed with probable dementia.....
|
|
|
|
Premarin (conjugated
estrogens) Vaginal Cream
(click product name to read prescribing information)
|
BOXED WARNING
- Women's Health Initiative Memory
Study (WHIMS)
WARNINGS
- Cardiovascular Disorders
- Coronary Heart Disease and Stroke
- Venous Thromboembolism (VTE)
- Dementia
PRECAUTIONS
ADVERSE REACTIONS
- Genitourinary System
- Cardiovascular
|
BOXED WARNING
The Women's Health
Initiative Memory Study (WHIMS), a sub-study of the Women's
Health Initiative (WHI), reported
increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 5.2 years of treatment with
oral conjugated estrogens alone and during 4 years of treatment
with conjugated estrogens combined with medroxyprogesterone
acetate, relative to placebo. It is unknown whether this finding
applies to younger postmenopausal women.
WARNINGS
Cardiovascular Disorders
Coronary Heart Disease and
Stroke
In the estrogen alone
sub-study of the WHI study, an
increased risk of stroke was observed in women receiving
Premarin compared to women receiving placebo (44 vs. 32 per
10,000 women-years). The increase in risk was observed in year
one and persisted.
Venous Thromboembolism (VTE)
In the estrogen alone
sub-study of the WHI study, an
increased risk of deep vein thrombosis was observed in women
receiving Premarin compared to placebo (21 vs. 15 per 10,000
women-years). The increase in VTE risk was observed during the
first year.
Dementia
..... In the estrogen alone
sub-study, after an average follow-up of 5.2 years, 28 women in
the estrogen alone group and 19 women in the placebo group were
diagnosed with probable dementia.....
.....In the estrogen plus
progestin sub-study, after an average follow-up of 4 years, 40
women in the estrogen plus progestin group and 21 women in the
placebo group were diagnosed with probable dementia.....
|
|
|
|
Risperdal Consta (risperidone)
Long-Acting Injection
(click product name to read prescribing information)
|
BOXED WARNING
- Increased Mortality in Elderly Patients
with Dementia-related Psychosis
WARNINGS
- Increased Mortality in Elderly Patients
with Dementia-related Psychosis
|
BOXED WARNING
Elderly patients with dementia-related
psychosis treated with atypical antipsychotic drugs are at an
increased risk of death compared to placebo......
.....Although the causes of death were
varied, most of the deaths appeared to be either cardiovascular
(e.g., heart failure, sudden death) or infectious (e.g.,
pneumonia) in nature. Risperdal Consta (risperidone) is not
approved for the treatment of patients with dementia-related
psychosis.
WARNINGS
Elderly patients with
dementia-related psychosis treated with atypical antipsychotic
drugs are at an increased risk of death compared to placebo.
Risperdal Consta (risperidone) is not approved for the treatment
of dementia-related psychosis.
|
|
|
|
Risperdal (risperidone)
Tablets and Oral Solution
Risperdal M-Tab (risperidone)
Orally
Disintegrating Tablets
(click product name to read prescribing information)
|
BOXED WARNING
- Increased Mortality in Elderly Patients
with Dementia-related Psychosis
WARNINGS
- Increased Mortality in Elderly Patients
with Dementia-related Psychosis
|
BOXED WARNING
Elderly patients with dementia-related
psychosis treated with atypical antipsychotic drugs are at an
increased risk of death compared to placebo......
.....Although the causes of death were
varied, most of the deaths appeared to be either cardiovascular
(e.g., heart failure, sudden death) or infectious (e.g.,
pneumonia) in nature. Risperdal (risperidone)
is not approved for the treatment of patients with
dementia-related psychosis.
WARNINGS
Elderly patients with
dementia-related psychosis treated with atypical antipsychotic
drugs are at an increased risk of death compared to placebo.
Risperdal (risperidone) is not approved
for the treatment of dementia-related psychosis.
|
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 |
Summary of Changes to Contraindications
and Warnings |
AndroGel (testosterone
gel) 1%
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
ADVERSE REACTIONS
See Table 3 and Text
PATIENT PACKAGE INSERT |
Increases in serum PSA from baseline
values were seen in approximately 18% of individuals in an open
label study of 162 hypogonadal men treated with AndroGel for up
to 42 months. Most of these increases were seen within the first
year of therapy. |
|
|
|
Dianeal Low Calcium Peritoneal
Dialysis Solution in Ambu-Flex III Container
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
See information regarding the Proper Method for Heating
Solution Prior to Administration
|
The use of 5 or 6 liters of
dialysis solution is not indicated in a single exchange
Do not use 6 liter product
with Pac-X or Pac-Xtra hardware.
|
|
|
|
Dianeal Low Calcium Peritoneal
Dialysis Solution UltraBag System
(click product name to read prescribing information)
|
WARNINGS
PRECAUTIONS
- General
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
See information regarding the Proper Method for Heating
Solution Prior to Administration. |
.....Contamination of the patient
connector may result in peritonitis.
Excessive use of Dianeal Low
Calcium peritoneal dialysis solution with 4.25% dextrose during
a peritoneal dialysis treatment can result in significant
removal of water from the patient.
After the pull ring
has been removed from the outlet of the Luer lock system, check
for broken connector frangible seal as evidenced by continuous
fluid flow from port. A few drops of solution within the
connector or protector cap may be present. If a continuous
stream or droplets of fluid are noted with the Luer lock or Lineo
connector systems, discard solution because sterility may be
impaired.
During solution
drainage, fibrin strands may be observed in the solution and may
become attached to the blue connector frangible closure of the
Luer lock system. In occasional instances, partial or complete
obstruction of draining may occur. Manipulation of the connector
frangible closure in the tubing may free the fibrin obstruction. |
|
|
|
Dianeal PD-1 Peritoneal Dialysis
Solution in Ambu-Flex III Container
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
See information regarding the Proper Method for Heating
Solution Prior to Administration.
|
The use of 5 liters of
dialysis solution is not indicated in a single exchange.
|
|
|
|
Dianeal PD-2 Peritoneal Dialysis
Solution Ambu-Flex III Plastic Container
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
See information regarding the Proper Method for Heating
Solution Prior to Administration. |
The use of 5 liters of
dialysis solution is not indicated in a single exchange. |
|
|
|
Dianiel PD-2 Peritoneal Dialysis
Solution UltraBag System
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
See information regarding the Proper Method for Heating
Solution Prior to Administration.
|
.....Contamination of the patient
connector may result in peritonitis.
Excessive use of Dianeal
PD-2 peritoneal dialysis solution with 4.25% dextrose
during a peritoneal dialysis treatment can result in
significant removal of water from the patient.
After the pull
ring has been removed from the outlet of the Luer lock system,
check for broken connector frangible seal as evidenced by
continuous fluid flow from port. A few drops of solution
within the connector or protector cap may be present. If a
continuous stream or droplets of fluid are noted with the Luer
lock or Lineo connector systems, discard solution
because sterility may be impaired.
During solution
drainage, fibrin strands may be observed in the solution and
may become attached to the blue connector frangible closure of
the Luer lock system. In occasional instances, partial or
complete obstruction of draining may occur. Manipulation of
the connector frangible closure in the tubing may free the
fibrin obstruction. |
|
|
|
Diovan (valsartan) Tablets
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- Impaired Renal Function
- Geriatric Use
ADVERSE REACTIONS
- Post-Myocardial Infarction
- Post-Marketing Experience
- Clinical Laboratory Test
Findings
PATIENT PACKAGE INSERT |
Caution
should be observed when initiating therapy in patients with
heart failure or post-myocardial infarction
patients. Patients with heart failure or post-myocardial
infarction patients given Diovan commonly
have some reduction in blood pressure, but discontinuation of
therapy because of continuing
symptomatic hypotension usually is not necessary when dosing
instructions are followed. In controlled
trials in heart failure patients, the incidence of hypotension
in valsartan-treated patients was 5.5%
compared to 1.8% in placebo-treated patients. In the Valsartan
in Acute Myocardial Infarction Trial
(VALIANT), hypotension in post-myocardial infarction patients
led to permanent discontinuation of
therapy in 1.4% of valsartan-treated patients and 0.8% of
captopril-treated patients. |
|
|
|
Nubain
(nalbuphine HCl) Injection
(click product name to read prescribing information) |
WARNINGS
- Use During Labor and Delivery
ADVERSE REACTIONS
- Allergic Reactions
- Events Observed During Post-marketing
Surveillance of Nubain
|
.....Fetal and neonatal adverse effects
that have been reported following the administration of
nalbuphine to the mother during labor include fetal
bradycardia, respiratory depression at birth, apnea, cyanosis,
and hypotonia. Some of these events may be life-threatening.
Maternal administration of naloxone during labor has
normalized these effects in some cases..... |
|
|
|
Relafen (nabumetone) Tablets
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
|
Studies
to date have not identified any subset of patients not at risk
of developing peptic ulceration and bleeding. Except for a prior
history of serious GI events and other risk factors known to
be associated with peptic ulcer disease, such as alcoholism,
smoking, other medications known to increase the risk of
gastrointestinal ulcer (e.g., oral corticosteroids), etc., no
risk factors (e.g., age, sex) have been associated with
increased risk. Elderly or debilitated patients seem to tolerate
ulceration or bleeding less well than other individuals and most
spontaneous reports of fatal GI events are in this population. |
|
|
|
Ventavis (iloprost) Inhalation Solution
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- Information for Patients
ADVERSE REACTIONS
|
Ventavis is intended
for inhalation administration only via either of two pulmonary
drug delivery devices: the Ineb AAD System or the Prodose
AAD System.
Vital signs should be
monitored while initiating Ventavis. In patients with low systemic
blood pressure, care should be taken to avoid further hypotension.
|
|
|
|
Zocor (simvastatin) Tablets
(click product name to read prescribing information) |
WARNINGS
- Myopathy/Rhabdomyolysis
- HMG-CoA Reductase
Inhibitors
- Potent Inhibitors of
CYP3A4
- Gemfibrozil, Particularly
with Higher Doses of Simvastatin
- Other Lipid-Lowering Drugs
(other Fibrates or ≥1 g/day of Niacin)
- Cyclosporine or Danazol,
with Higher Doses of Simvastatin
- Amiodarone or Verapamil,
with Higher Doses of Simvastatin
- Table 8: Drug
Interactions Associated with Increased Risk of Myopathy/Rhabdomyolys
PRECAUTIONS
|
As with other HMG-CoA
reductase inhibitors, the risk of myopathy/rhabdomyolysis is dose
related.....
All patients starting
therapy with simvastatin or whose dose of simvastatin is being
increased, should be advised of the risk of myopathy and told to
report promptly any unexplained muscle pain, tenderness or
weakness. Simvastatin therapy should be discontinued immediately
if myopathy is diagnosed or suspected.....
The risk of myopathy/rhabdomyolysis
is increased by concomitant use of simvastatin with the following:
-
Potent inhibitors
of CYP3A4
-
Gemfibrozil,
particularly with higher doses of simvastatin
-
Other
lipid-lowering drugs (other fibrates or ≥1 g/day of
niacin)
-
Cyclosporine or
Danazol, with higher doses of simvastatin
-
Amiodarone or
verapamil, with higher doses of simvastatin
Please see prescribing
information to review Table 8. |
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 |
Aldara (imiquimod) Cream, 5%
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Pregnancy: Category C
ADVERSE REACTIONS
- Post-marketing Adverse Events
PATIENT PACKAGE INSERT |
|
|
Augmentin
(amoxicillin/clavulanate potassium) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
|
|
|
Chloromycetin
Sodium Succinate (chloramphenicol sodium succinate for
injection, USP)
Please contact King
Pharmaceuticals Inc. at 1-800-776-3637 for prescribing
information. |
PRECAUTIONS
|
|
|
Compazine
(prochlorperazine)
Tablets
(click product name to read prescribing information) |
PRECAUTIONS
|
|
|
Copegus
(ribavirin, USP) Tablets
(click product name to read prescribing
information) |
PRECAUTIONS
- Carcinogenesis, Mutagenesis,
Impairment of Fertility
ADVERSE REACTIONS
- Thrombotic Thrombocytopenic Purpura
|
|
|
Cordarone
(amiodarone HCl) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- Drug Interactions
- CYP3A4 and p-glycoprotein
- Other Substances
ADVERSE REACTIONS
- Post-marketing Reports
-
Acute Renal Failure
-
Renal Impairment
-
Renal Insufficiency
-
Agranulocytosis
|
|
|
Cosmegen (dactinomycin
for Injection) for Injection [Actinomycin D]
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
|
|
|
5% Dextrose and Electrolyte
No. 48 Injection (Multiple Electrolytes and Dextrose injection,
Type 1, USP) in Aviva Plastic Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
|
|
|
5% Dextrose and Electrolyte
No. 75 Injection (Multiple Electrolytes and Dextrose Injection,
Type 3, USP) in Aviva Plastic Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
|
|
|
Dextrose and Sodium
Chloride Injection, USP in Aviva Plastic Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
- Geriatric Use
|
|
|
Diuril
(chlorothiazide) Oral Suspension
Please contact Merck
& Co., Inc. at 1-866-342-5683 for prescribing information. |
PRECAUTIONS
|
|
|
Lactated
Ringer's Injection, USP in Aviva Plastic Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
|
Lactated
Ringer's and 5% Dextrose Injection, USP in Aviva Plastic
Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
- Geriatric Use
|
|
|
Lexxel (enalapril
maleate-felodipine ER) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
|
|
|
Micro-K LS Packets
(potassium chloride) Extended Release Formulation for Liquid Suspension
(click product name to read prescribing information) |
PRECAUTIONS
|
|
|
Osmitrol Injection (mannitol
injection, USP) in Aviva
Plastic Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
|
|
|
Pentetate Calcium Trisodium
Injection
For prescribing
information, please contact Hameln Pharmaceuticals GmbH,
c/o B & H Consulting Services Inc. at 1-908-704-1691. |
PRECAUTIONS
Patient Data Treatment Form now included
in the PRECAUTIONS section. |
|
|
Penetrate Zinc
Trisodium
For
prescribing information, please contact Hameln
Pharmaceuticals GmbH, c/o B & H Consulting Services Inc. at
1-908-704-1691. |
PRECAUTIONS
Patient Data Treatment Form now included
in the PRECAUTIONS section. |
|
|
Plasma-Lyte A Injection pH 7.4
(Multiple Electrolytes Injection, Type 1, USP) in Aviva Plastic Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
|
|
|
Plasma-Lyte 56 Injection (Multiple Electrolytes
Injection, Type 1, USP) in
Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
- Geriatric Use
|
|
|
Plasma-Lyte 56 and 5% Dextrose
Injection (Multiple Electrolytes and Dextrose Injection, Type 1,
USP) in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
- Geriatric Use
|
|
|
Plasma-Lyte 148 Injection
(Multiple Electrolytes Injection, Type 1, USP) in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
|
|
|
Plasma-Lyte 148 and 5% Dextrose Injection
(Multiple Electrolytes and Dextrose Injection, Type 1, USP)
in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
- Geriatric Use
|
|
|
Plasma-Lyte M and 5% Dextrose
Injection (Multiple Electrolytes and Dextrose Injection, Type 2,
USP) in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
- Geriatric Use
|
|
|
Plasma-Lyte R Injection (Multiple Electrolytes
Injection, Type 2, USP) in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
- Geriatric Use
|
|
|
Potassium Chloride in 5% Dextrose
Injection, USP
in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
- Nursing Mothers
|
|
|
Potassium Chloride in
5% Dextrose and Sodium Chloride Injection, USP
in Aviva Plastic Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
|
|
|
Potassium Chloride in Lactated
Ringer's and 5% Dextrose Injection, USP in Aviva Plastic
Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
|
|
|
Potassium Chloride in Sodium Chloride
Injection, USP in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
|
|
|
Ringer's Injection, USP in Aviva
Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
- Geriatric Use
|
|
|
Ringer's and 5% Dextrose Injection,
USP in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
|
|
|
Sodium Chloride Injection, USP in Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
|
|
|
3% and 5% Sodium Chloride Injection, USP in
Aviva Plastic Container
(click product name to read prescribing information)
|
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, mutagenesis, impairment of fertility
- Labor and Delivery
- Nursing Mothers
|
|
|
Sodium Lactate Injection, USP (M/6
Sodium Lactate) in Aviva Plastic Container
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Labor and Delivery
- Nursing Mothers
- Geriatric Use
|
|
|
|
|
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MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
|
|