Brand (Generic) Name
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Sections Modified |
Summary of Changes to Contraindications and Warnings
|
Avastin (bevacizumab) for Intravenous Use
Prescribing
Information
|
BOXED WARNING
- Gastrointestinal Perforations
- Hemorrhage
WARNINGS
- Hemorrhage
- Neutropenia and Infection
- Proteinuria
- Congestive Heart Failure
PRECAUTIONS
- Drug Interactions
- In Study 6, based on
limited data, there did not appear to be a difference in the
mean exposure of either carboplatin or paclitaxel when each
was administered alone or in combination with Avastin.....
- Geriatric Use
- n Study 5 patients age 65 and older
receiving carboplatin, paclitaxel, and Avastin had a greater
relative risk for proteinuria as compared to younger
patients.
ADVERSE REACTIONS
-
Initial Section
- Neutropenia and Infection
- Adverse Reactions in Clinical Trials
- The data
described below reflect exposure to Avastin in 1529 patients,
including 665 receiving Avastin for at least
6 months and 199 receiving Avastin for at least one year.
Avastin was studied primarily in placebo- and
active-controlled trials (n = 501, and n = 1028,
respectively).
- Gastrointestinal Perforation
- Wound Healing Complications
- The
incidence of post‑operative wound healing and/or bleeding
complications was increased in patients with mCRC receiving
Avastin as compared to patients receiving only
chemotherapy.....
- Hemorrhage
- Arterial Thromboembolic Events
- Venous
Thromboembolic Events
- The
incidence of NCI-CTC Grade 3-4 venous thromboembolic events
was higher in patients with mCRC or NSCLC receiving Avastin
with chemotherapy as compared to those receiving chemotherapy
alone.....
- Hypertension
- Neutropenia and Infection
- Metastatic Carcinoma of the Colon and Rectum
- Initial Section
- .....Only
NCI-CTC Grade 3-5 non-hematologic and Grade 4-5 hematologic
adverse events related to treatment were reported. The median
age was a 61 years, 40% were female, 87% were Caucasian, 99%
received prior chemotherapy for metastatic colorectal cancer,
26% had received prior radiation therapy, and the 49% had an
ECOG performance status of 0.....
- Non-Squamous, Non-Small Cell Lung Cancer
- Table 7:
NCI‑CTC Grade 3-5 Non‑Hematologic and
Grade 4 and 5 Hematologic Adverse Events in Study 5.....
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BOXED WARNING/Gastrointestinal Perforations
.....The incidence of
gastrointestinal perforation (gastrointestinal perforation,
fistula formation, and/or intra‑abdominal abscess) in patients
with colorectal cancer and in patients with non-small cell lung
cancer (NSCLC) receiving Avastin was 2.4% and 0.9%,
respectively.....
BOXED
WARNING/Hemorrhage
Fatal pulmonary hemorrhage
can occur in patients with NSCLC treated with chemotherapy and
Avastin. The incidence of severe or fatal hemoptysis was 31% in
patients with squamous histology and 2.3% in patients with NSCLC
excluding predominant squamous histology. Patients with recent
hemoptysis (≥1/2 tsp of red blood) should not receive Avastin.....
WARNINGS/Hemorrhage
In Study 6, four of 13 (31%)
Avastin‑treated patients with squamous cell histology and two of
53 (4%) Avastin‑treated patients with histology other than
squamous cell, experienced serious or fatal pulmonary hemorrhage
as compared to none of the 32 (0%) patients receiving
chemotherapy alone.....
.....In Study 5, the rate of
pulmonary hemorrhage requiring medical intervention for the PC
plus Avastin arm was 2.3% (10 of 427) compared to 0.5% (2 of
441) for the PC alone arm. There were seven deaths due to
pulmonary hemorrhage reported by investigators in the PC plus
Avastin arm as compared to one in the PC alone arm. Generally,
these serious hemorrhagic events presented as major or massive
hemoptysis without an antecedent history of minor hemoptysis
during Avastin therapy. Do not administer Avastin to patients
with recent history of hemoptysis of ≥1/2 tsp of red
blood.....
WARNINGS/Neutropenia
and Infection
Increased
rates of severe neutropenia, febrile neutropenia, and infection
with severe neutropenia (including some fatalities) have been
observed in patients treated with myelosuppressive chemotherapy
plus Avastin.
WARNINGS/Proteinuria
.....In Studies 1, 3
and 5 the incidence of NCI‑CTC Grade 3 and 4 proteinuria,
characterized as >3.5 gm/24 hours, ranged up to 3.0% in Avastin‑treated
patients.
Nephrotic syndrome occurred
in seven of 1459 (0.5%) patients receiving Avastin in clinical
studies.....
WARNINGS/Congestive Heart Failure
Congestive heart failure (CHF),
defined as NCI‑CTC Grade 2-4 left ventricular dysfunction, was
reported in 25 of 1459 (1.7%) patients receiving Avastin in
clinical studies....
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ChloraPrep with Tint (2% chlorhexidine gluconate (w/v) topical
solution) 26-mL Applicator
Please contact Medi-Flex, Inc. at 1-800-523-0502 for
prescribing information.
|
BOXED WARNING
WARNINGS
|
BOXED WARNING
Avoid getting solution into hairy areas.
Solution may take much longer to dry or may not dry completely.
WARNINGS
Do not use with
electrocautery procedures until dry.
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Coumadin Tablets (warfarin sodium
tablets, USP) Crystalline
Coumadin for Injection (warfarin sodium
for injection, USP)
Prescribing
Information
Medication Guide
See MedWatch Safety Alert posted 10/6/2006 for
additional information on Coumadin labeling revisions.
|
BOXED WARNING (new)
PRECAUTIONS
- Drug-Drug and Drug-Disease Interactions
- The following factors, alone or in combination,
may be responsible for increased PT/INR response.....
- Exogenous Factors
- Potential drug interactions with Coumadin are
listed below by drug class and by specific drugs.
- Specific Drugs Reported
- Argatroban
- Atenolol
- Bivalirudin
- Ezetimibe
- Lepirudin
- Miconazole (intravaginal, oral, systemic)
- Valdecoxib
- Information for Patients
ADVERSE REACTIONS
- Adverse reactions reported infrequently include:
- Hypotension
- Anemia
- Pallor
- Angina Syndrome
- Chest Pain
- Loss of Consciousness
- Syncope
- Coma
MEDICATION GUIDE (new)
|
BOXED WARNING/WARNING: Bleeding Risk
Warfarin sodium can cause major or fatal
bleeding. Bleeding is more likely to occur during the starting
period and with a higher dose (resulting in a higher INR). Risk
factors for bleeding include high intensity of anticoagulation (INR
>4.0), age ≥65, highly variable INRs, history of
gastrointestinal bleeding, hypertension, cerebrovascular
disease, serious heart disease, anemia, malignancy, trauma,
renal insufficiency, concomitant drugs, and long duration of
warfarin therapy. Regular monitoring of INR should be performed
on all treated patients. Those at high risk of bleeding may
benefit from more frequent INR monitoring, careful dose
adjustment to desired INR, and a shorter duration of therapy.
Patients should be instructed about prevention measures to
minimize risk of bleeding and to report immediately to
physicians signs and symptoms of bleeding.
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Remicade (infliximab) for IV Injection
Prescribing Information
Medication Guide |
BOXED WARNING
CONTRAINDICATIONS
WARNINGS
- Risk of Infections
- Hypersensitivity
- Malignancies
PRECAUTIONS
- Information for Patients
- Pediatric Use
- Safety and effectiveness of Remicade in patients with
juvenile rheumatoid arthritis and pediatric patients with
ulcerative colitis and plaque psoriasis have not been
established.
- Geriatric Use
- In rheumatoid arthritis and plaque psoriasis clinical
trials, no overall differences were observed in effectiveness
or safety in 181 patients with rheumatoid arthritis and 75
patients with plaque psoriasis.....
ADVERSE REACTIONS
- Initial Paragraph
- Infusion-related Reactions
- Infusion Reactions
- The infusion reaction rates remained stable in psoriasis.....
- Delayed Reactions/Reactions Following Readministration
- Infections
- In Remicade clinical studies in patients with ulcerative
colitis, infections treated with antimicrobials.....
- Immunogenicity
- In the psoriasis Study II,.....
- Hepatotoxicity
- Table 11: Proportion of patients with elevated ALT in
Clinical Trials
- Adverse Reactions in Psoriasis Studies
- Other Adverse Reactions
- Safety data are available from 4779 Remicade-treated
adult patients, including 1304 with 1326
rheumatoid arthritis, 1106 with Crohn's disease, 484 with
ulcerative colitis, 202 with ankylosing spondylitis,
293 with psoriatic arthrtis, 1373 with plaque psoriasis and 17
with other conditions.....
MEDICATION GUIDE (new)
|
BOXED WARNING/Risk of
Infections Patients treated
with Remicade are at increased risk for infections, including
progression to serious infections leading to
hospitalization or death. These infections have included bacterial
sepsis, tuberculosis, invasive fungal and other opportunistic
infections. Patients should be educated about the
symptoms of infection, closely monitored for signs and symptoms of
infection during and after treatment with Remicade, and
should have access to appropriate medical care. Patients who
develop an infection should be evaluated for appropriate
antimicrobial therapy and for serious infections Remicade should
be discontinued.
Tuberculosis (frequently disseminated or
extrapulmonary at clinical presentation) has been observed in
patients receiving Remicade. Patients should be evaluated for
tuberculosis risk factors and be tested for latent tuberculosis
infection prior to initiating Remicade and during
therapy. Treatment of latent tuberculosis infection should be
initiated prior to therapy with Remicade. Treatment of
latent tuberculosis in patients with a reactive tuberculin test
reduces the risk of tuberculosis reactivation in patients
receiving Remicade. Some patients who tested negative for latent
tuberculosis prior to receiving Remicade have developed active
tuberculosis. Physicians should monitor patients receiving
Remicade for signs and symptoms of active tuberculosis, including
patients who tested negative for latent
tuberculosis infection.
CONTRAINDICATIONS
Remicade should not be re-administered to patients
who have experienced a severe
hypersensitivity reaction to Remicade. Additionally, Remicade
should not be administered to patients with known hypersensitivity
to inactive components of the product or to any murine
proteins.
WARNINGS/Risk of Infections
See highlighted prescribing information for
revised/new text.
WARNINGS/Hypersensitivity
.....However, in some cases, serum sickness-like
reactions have been observed in patients after initial Remicade
therapy (i.e., as early as after the second dose), and when
Remicade therapy was reinstituted following an extended period
without Remicade treatment.....
WARNINGS/Malignancies
In the controlled portions of clinical trials of
some TNF-blocking agents including Remicade, more malignancies
(excluding lymphoma and nonmelanoma skin cancer [NMSC]) have been
observed in patients receiving those TNF-blockers compared with
control patients.....
.....In controlled and open-label portions of
Remicade clinical trials, 5 patients developed lymphomas among
5707 patients treated with Remicade.....
Psoriasis patients should be monitored for nonmelanoma skin
cancers (NMSCs), particularly those patients who have had prior
prolonged phototherapy treatment. In the maintenance portion
of clinical trials for Remicade, NMSCs were more common in
patients with previous phototherapy.....
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Seroquel (quetiapine fumarate) Tablets
Prescribing Information
Medication Guide
|
BOXED WARNING
- Suicidality in Children and Adolescents
WARNINGS
PRECAUTIONS
- Cholesterol and Triglyceride Elevations
- Transaminase Elevations
- Suicide
- Geriatric Use
ADVERSE REACTIONS
- Initial Section
- Adverse Findings Observed in Short-Term,
Controlled Trials
- Adverse Events Associated with Discontinuation
of Treatment in Short-Term, Placebo- Controlled Trials
-
Bipolar Disorder
- Table 3: Treatment-Emergent Adverse Experience
Incidence in 8-Week Placebo-Controlled Clinical Trials for the
Treatment of Bipolar Depression
- Dose Dependency of Adverse Events in Short-Term,
Placebo-Controlled Trials
- Extrapyramidal Symptoms
- In two placebo-controlled clinical trials
for the treatment of bipolar depression.....
- Vital Signs and Laboratory Studies
- Weight Gain
- In bipolar depression trials.....
- ECG Changes
- In bipolar depression trials.....
MEDICATION GUIDE (new)
|
BOXED WARNINGS/Suicidality
in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and
behavior (suicidality) in short-term studies in children and
adolescents with major depressive disorder (MDD) and other
psychiatric disorders. Anyone considering the use of Seroquel or
any other antidepressant in a child or adolescent must balance
this risk with the clinical need. Patients who are started on
therapy should be observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and
caregivers should be advised of the need for close observation and
communication with the prescriber. Seroquel is not approved for
use in pediatric patients.....
WARNINGS/Clinical Worsening and Suicide Risk
See section for new prescribing information.
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Back to Top | Back to Summary Page
Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications
and Warnings |
Allegra (fexofenadine hydrochloride) Tablets and
Oral Suspension
Prescribing Information |
CONTRAINDICATIONS
PRECAUTIONS
- Information for Patients
- Interactions with Fruit Juices
- Pediatric Use
ADVERSE REACTIONS
- Table 3: Adverse experiences reported in placebo-controlled
studies in pediatric subjects with allergic rhinitis aged 6
months to 5 years of age at rates greater than 2%
- Chronic Idiopathic Urticaria
- The safety of fexofenadine hydrochloride in
the treatment of chronic idiopathic urticaria in pediatric
patients 6 months to 11 years of age is based on the safety
profile of fexofenadine hydrochloride in adults and pediatric
patients.....
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CONTRAINDICATIONS
Allegra Tablets and Allegra Oral Suspension are
contraindicated in patients with known hypersensitivity to any of
the ingredients.
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Opana (oxymorphone hydrochloride) Injection
Prescribing Information
|
CONTRAINDICATIONS
WARNINGS
- Respiratory Depression
- Misuse, Abuse and Diversion of Opioids
- Interactions with Alcohol and Drugs of Abuse
- Drug Abuse and Addiction
- Interactions with Other Central Nervous System Depressants
- Head Injury and Increased Intracranial Pressure
- Hypotensive Effect
- Hepatic Impairment
PRECAUTIONS
- General
- Interactions with Mixed Agonist/Antagonist Opioid Analgesics
- Ambulatory Surgery and Post-Operative Use
- Use in Pancreatic/Biliary Tract Disease
- Physical Dependence and Tolerance
- Information for Patients/Caregivers
- Use in Drug and Alcohol Addiction
- Drug-Drug Interactions
- Use with CNS Depressants
- Use with Mixed Agonist/Antagonist Opioid Analgesics
- Other
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy
- Initial Section
- Teratogenic Effects
- Non-teratogenic Effects
- Labor and Delivery
- Nursing Mothers
- Geriatric Use
- Hepatic Impairment
- Renal Impairment
- Gender Differences
ADVERSE REACTIONS
- Cardiac Disorders
- Eye Disorders
- Gastrointestinal Disorders
- General Disorders and Administration Site Conditions
- Hepatobilliary Disorders
- Immune System Disorders
- Metabolism and Nutrition Disorders
- Nervous System Disorders
- Psychiatric Disorders
- Renal and Urinary Disorders
- Respiratory, Thoracic, and Mediastinal Disorders
- Skin and Subcutaneous Tissue Disorders
- Social Circumstances
- Vascular Disorders
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CONTRAINDICATIONS
AND WARNINGS See prescribing information for
revised/new text.
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0.9% Sodium Chloride Irrigation, USP
Prescribing Information |
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
- General
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, Mutagenesis, Impairment of
Fertility
- Pregnancy - Teratogenic Effects - Pregnancy
Category C
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
ADVERSE REACTIONS
|
CONTRAINDICATIONS
0.9% Sodium Chloride Irrigation, USP is not for
injection by usual parenteral routes.
An electrolyte solution should not be used for
irrigation during electrosurgical procedures.
WARNINGS
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter
the systemic circulation in relatively large volumes; thus,
irrigation solutions must be regarded as systemic drugs.
Absorption of large amounts can cause fluid and/or solute overload
resulting in dilution of serum electrolyte concentrations,
overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely
proportional to the electrolyte concentrations of the administered
parenteral solutions. The risk of solute overload causing
congested states with peripheral and pulmonary edema is directly
proportional to the electrolyte concentration.
Do not warm above 150°F (66°C).
After opening container, its contents should be
used promptly to minimize the possibility of bacterial growth or
pyrogen formation.
Discard unused portion of irrigating solution
since it contains no preservatives. |
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Vicoprofen (hydrocodone bitartrate and ibuprofen
tablets
Prescribing Information
Medication Guide
|
CONTRAINDICATIONS
WARNINGS
- Cardiovascular Effects
- Cardiovascular Thrombotic Events
- Hypertension
- Congestive Heart Failure and Edema
- Misuse Abuse and Diversion of Opioids
- Gastrointestinal (GI) Effects - Risk of GI Ulceration,
Bleeding and Perforation
- Renal Effects
- Advanced Renal Disease
- Anaphylactoid Reactions
- Skin Reactions
PRECAUTIONS
- General
- Hepatic Effects
- Hematological Effects
- Information for Patients
- Laboratory Tests
- Drug Interactions
- Antidepressants
- Aspirin
- Diuretics
- Lithium
- Mixed Agonist/Antagonist Opioid Analgesics
- Neuromuscular Blocking Agents
- Pregnancy
- Labor and Delivery
- Nursing Mothers
MEDICATION GUIDE (new) |
CONTRAINDICATIONS
Vicoprofen is contraindicated in patients with
known hypersensitivity to hydrocodone or ibuprofen. Patients known
to be hypersensitive to other opioids may exhibit
cross-sensitivity to hydrocodone.
Vicoprofen should not be given to patients who
have experienced asthma, urticaria, or allergic-type reactions
after taking aspirin or other NSAIDs. Severe, rarely fatal,
anaphylactic-like reactions to NSAIDs have been reported in such
patients.
Vicoprofen is contraindicated for the treatment of
peri-operative pain in the setting of coronary artery bypass graft
(CABG) surgery.
WARNINGS
See WARNINGS section for revised/new
prescribing information.
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Back to Top | Back to Summary Page
Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Depacon (valproate sodium injection)
Prescribing Information |
WARNINGS
- Usage in Pregnancy
-
Human Data
- Congenital Malformations
- Neural Tube Defects
- Other Adverse Pregnancy Effects
|
See WARNINGS/Usage
in Pregnancy section for revised prescribing information. |
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Depakene (valproic acid capsules and oral
solution, USP)
Prescribing Information |
WARNINGS
- Usage in Pregnancy
-
Human Data
- Congenital Malformations
- Neural Tube Defects
- Other Adverse Pregnancy Effects
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See WARNINGS/Usage in Pregnancy section for
revised prescribing information.
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Depakote (divalproex sodium) Delayed-Release
Tablets
Prescribing Information |
WARNINGS
- Usage in Pregnancy
-
Human Data
- Congenital Malformations
- Neural Tube Defects
- Other Adverse Pregnancy Effects
|
See WARNINGS/Usage in Pregnancy
section for revised prescribing information.
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Depakote ER (divalproex sodium) Extended-Release Tablets
Prescribing Information
|
WARNINGS
- Usage in Pregnancy
-
Human Data
- Congenital Malformations
- Neural Tube Defects
- Other Adverse Pregnancy Effects
|
See WARNINGS/Usage in Pregnancy section for
revised prescribing information.
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Depakote (divalproex sodium coated particles in
capsules) Sprinkle Capsules
Prescribing Information |
WARNINGS
- Usage in Pregnancy
-
Human Data
- Congenital Malformations
- Neural Tube Defects
- Other Adverse Pregnancy Effects
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See WARNINGS/Usage in Pregnancy section for
revised prescribing information.
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Heparin Sodium Injection, USP
Prescribing Information
See MedWatch Safety Alert posted 12/08/2006 for
additional information on Heparin labeling revisions.
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WARNINGS
- Thrombocytopenia
- Heparin-induced Thrombocytopenia (HIT) and
Heparin-induced Thrombocytopenia Thrombosis (HITT)
- Delayed Onset of HIT and HITT
PRECAUTIONS
- General
- Thrombocytopenia, Heparin-induced
Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia
and Thrombosis (HITT)
ADVERSE REACTIONS
|
WARNINGS/Thrombocytopenia
Thrombocytopenia has been reported to occur in patients receiving
heparin with a reported incidence up to 30%. Platelet counts
should be obtained at baseline and periodically during heparin
administration. Mild thrombocytopenia (count greater than
100,000/mm3) may remain stable or reverse even if
heparin is continued. However, thrombocytopenia of any degree
should be monitored closely. If the count falls below 100,000/mm3
or if recurrent thrombosis develops (see Heparin induced
Thrombocytopenia and Heparin-induced Thrombocytopenia and
Thrombosis), the heparin product should be discontinued,
and, if necessary, an alternative anticoagulant
administered.
WARNINGS/Heparin-induced Thrombocytopenia (HIT) and
Heparin-induced Thrombocytopenia Thrombosis (HITT)
Heparin-induced Thrombocytopenia (HIT) is a serious
antibody-mediated reaction resulting from irreversible aggregation
of platelets. HIT may progress to the development of venous and
arterial thromboses, a condition referred to as Heparin-induced
Thrombocytopenia and Thrombosis (HITT). Thrombotic events may also
be the initial presentation for HITT.
WARNINGS/Delayed Onset of HIT and HITT
Heparin-induced thrombocytopenia and heparin-induced
thrombocytopenia and thrombosis can occur up to several weeks
after the discontinuation of heparin therapy. Patients presenting
with thrombocytopenia or thrombosis after discontinuation of
heparin should be evaluated for HIT and HITT. |
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Hep-Lock (heparin lock flush solution, USP)
Prescribing Information
See MedWatch Safety Alert posted 12/08/2006 for
additional information on Heparin labeling revisions. |
WARNINGS
- Thrombocytopenia
- Heparin-induced Thrombocytopenia (HIT) and
Heparin-induced Thrombocytopenia and Thrombosis (HITT)
- Delayed Onset of HIT and HITT
PRECAUTIONS
- General
- Thrombocytopenia, Heparin-induced
Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia
and Thrombosis (HITT)
ADVERSE REACTIONS
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WARNINGS/Thrombocytopenia
Thrombocytopenia has been reported to occur in patients receiving
heparin with a reported incidence of 0 to 30%. Platelet counts
should be obtained at baseline and periodically during heparin
administration. Mild thrombocytopenia (count greater than
100,000/mm3) may remain stable or reverse even if
heparin is continued. However, thrombocytopenia of any degree
should be monitored closely. If the count falls below 100,000/mm3
or if recurrent thrombosis develops (see Heparin-induced
Thrombocytopenia and Heparin-induced Thrombocytopenia and
Thrombosis), the heparin product should be discontinued and, if
necessary, an alternative anticoagulant administered.
WARNINGS/Heparin-induced Thrombocytopenia (HIT)
and Heparin-induced Thrombocytopenia and Thrombosis (HITT)
Heparin-induced Thrombocytopenia (HIT) is a
serious antibody-mediated reaction resulting from irreversible
aggregation of platelets. HIT may progress to the development of
venous and arterial thromboses, a condition referred to as
Heparin-induced Thrombocytopenia and Thrombosis (HITT). Thrombotic
events may also be the initial presentation for HITT. These
serious thromboembolic events include deep vein thrombosis,
pulmonary embolism, cerebral vein thrombosis, limb ischemia,
stroke, myocardial infarction, mesenteric thrombosis, renal
arterial thrombosis, skin necrosis, gangrene of the extremities
that may lead to amputation, and possibly death. Thrombocytopenia
of any degree should be monitored closely. If the platelet count
falls below 100,000/mm3
or if recurrent thrombosis develops, the heparin product
should be promptly discontinued and alternative anticoagulants
considered if patients require continued anticoagulation.
WARNINGS/Delayed Onset of HIT and HITT
Heparin-induced Thrombocytopenia and
Heparin-induced Thrombocytopenia and Thrombosis can occur up to
several weeks after the discontinuation of heparin therapy.
Patients presenting with thrombocytopenia or thrombosis after
discontinuation of heparin should be evaluated for HIT and HITT. |
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Hep-Lock U/P Preservative-Free (heparin lock flush
solution, USP)
Prescribing Information
See MedWatch Safety Alert posted 12/08/2006 for
additional information on Heparin labeling revisions.
|
WARNINGS
- Thrombocytopenia
- Heparin-induced Thrombocytopenia (HIT) and
Heparin-induced Thrombocytopenia and Thrombosis (HITT)
- Delayed Onset of HIT and HITT
PRECAUTIONS
- General
- Thrombocytopenia, Heparin-induced
Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia
and Thrombosis (HITT)
ADVERSE REACTIONS
|
WARNINGS/Thrombocytopenia
Thrombocytopenia has been reported to occur in patients receiving
heparin with a reported incidence of 0 to 30%. Platelet counts
should be obtained at baseline and periodically during heparin
administration. Mild thrombocytopenia (count greater than
100,000/mm3) may remain stable or reverse even if
heparin is continued. However, thrombocytopenia of any degree
should be monitored closely. If the count falls below 100,000/mm3
or if recurrent thrombosis develops (see Heparin-induced
Thrombocytopenia and Heparin-induced Thrombocytopenia and
Thrombosis), the heparin product should be discontinued and, if
necessary, an alternative anticoagulant administered.
WARNINGS/Heparin-induced Thrombocytopenia (HIT)
and Heparin-induced Thrombocytopenia and Thrombosis (HITT)
Heparin-induced Thrombocytopenia (HIT) is a
serious antibody-mediated reaction resulting from irreversible
aggregation of platelets. HIT may progress to the development of
venous and arterial thromboses, a condition referred to as
Heparin-induced Thrombocytopenia and Thrombosis (HITT). Thrombotic
events may also be the initial presentation for HITT. These
serious thromboembolic events include deep vein thrombosis,
pulmonary embolism, cerebral vein thrombosis, limb ischemia,
stroke, myocardial infarction, mesenteric thrombosis, renal
arterial thrombosis, skin necrosis, gangrene of the extremities
that may lead to amputation, and possibly death. Thrombocytopenia
of any degree should be monitored closely. If the platelet count
falls below 100,000/mm3
or if recurrent thrombosis develops, the heparin product
should be promptly discontinued and alternative anticoagulants
considered if patients require continued anticoagulation.
WARNINGS/Delayed Onset of HIT and HITT
Heparin-induced Thrombocytopenia and
Heparin-induced Thrombocytopenia and Thrombosis can occur up to
several weeks after the discontinuation of heparin therapy.
Patients presenting with thrombocytopenia or thrombosis after
discontinuation of heparin should be evaluated for HIT and HITT. |
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Strattera (atomoxetine HCl) Capsules
Prescribing Information
Medication Guide |
WARNINGS
- Serious Cardiovascular Events
- Sudden Death and Pre-Existing Structural Cardiac
Abnormalities or Other Serious Heart Problems
- Children and Adolescents
- Adults
- Assessing Cardiovascular Status in Patients Being Treated
with Atomoxetine
- Emergence of New Psychotic or Manic Symptoms
MEDICATION GUIDE
- What should I tell my doctor before taking Strattera?
- Other important safety information about Strattera
|
WARNINGS See
highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative for
all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events.
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Taxotere (docetaxel) Injection Concentrate
Prescribing Information
Patient Package Insert
|
WARNINGS
PRECAUTIONS
- Geriatric Use
- Among the 221 patients treated with Taxotere
in combination with cisplatin and fluorouracil in the gastric
cancer study, 54 were 65 years of age or older and 2 patients
were older than 75 years.....
- Of the 174 patients who received the induction
treatment with Taxotere in combination with cisplatin and
fluorouracil for SCCHN (TAX323).....
- The clinical study of Taxotere in combination
with cisplatin and fluorouracil in patients with SCCHN
(TAX323).....
ADVERSE REACTIONS
PATIENT PACKAGE INSERT |
WARNINGS/Hematologic Effects
In gastric cancer patients treated with Taxotere
in combination with cisplatin and fluorouracil (TCF), febrile
neutropenia and/or neutropenic infection occurred in 12% of
patients receiving G-CSF compared to 28% who did not. Patients
receiving TCF should be closely monitored during the first and
subsequent cycles for febrile neutropenia and neutropenic
infection.
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Vytorin (ezetimibe/simvastatin tablets)
Prescribing Information
Patient Package Insert
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WARNINGS
- Myopathy/Rhabdomyolysis
- Table 7: Drug Interactions Associated with
Increased Risk of Myopathy/Rhabdomyolysis
PRECAUTIONS
ADVERSE REACTIONS
-
Post-marketing Experience
PATIENT PACKAGE INSERT
- What are the possible side
effects of Vytorin?
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WARNINGS/Myopathy/Rhabdomyolysis See highlighted
WARNINGS section for new text. |
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Brand
(Generic) Name |
Sections Modified |
Abilify (aripiprazole) Tablets and Oral Solution
Abilify Discmelt (aripiprazole) Orally
Disintegrating Tablets
Prescribing Information
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PRECAUTIONS
- Drug-Drug Interactions
- Potential for Abilify to Affect Other Drugs
- No effect of aripiprazole was seen on the
pharmacokinetics of lithium or valproate.
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Avandaryl (rosiglitazone maleate and
glimepiride) Tablets
Prescribing Information
Patient Package Insert
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PRECAUTIONS
- Weight Gain
- Table 5: Weight Changes (kg) From Baseline at Endpoint
During Clinical Trials.....
ADVERSE REACTIONS
- Initial Section
- Table 9: Adverse Events (≥5% in Any
Treatment Group) Reported by Drug-Naïve Patients in a 28-Week
Double-Blind Clinical Trial of Avandaryl
- Pediatric Use
PATIENT PACKAGE INSERT
- What is Avandaryl?
- What are possible side effects of Avandaryl?
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Byetta (exenatide injection)
Prescribing Information
Patient Package Insert
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PRECAUTIONS
- Information for Patients
- Each dose of Byetta should be administered
as a SC injection in the thigh, abdomen, or upper arm at any
time within the 60-minute period before the
morning and evening meals (or before the two main meals of
the day, approximately 6 hours or more apart).....
ADVERSE REACTIONS
PATIENT PACKAGE INSERT
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Cubicin
(daptomycin for injection)
Prescribing Information
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PRECAUTIONS
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Factive (gemifloxacin mesylate) Tablets
Prescribing Information
Patient Package Insert |
PRECAUTIONS
- Information for Patients
- Patients should be counseled:
- .....that increases
of the International Normalized Ratio (INR), or prothrombin
time (PT), and/or clinical episodes of bleeding have been
noted with concurrent administration of warfarin or its
derivatives, and Factive.....
- Drug Interactions
- .....However, post-marketing reports of increases
in the INR, and/or PT, and/or clinical episodes of bleeding in
patients have been noted with the use of quinolones, including
Factive, and warfarin, or its derivatives. In addition,
infectious disease and its accompanying inflammatory process,
age and general status of the patient are risk factors for
increased anticoagulation activity.....
PATIENT PACKAGE INSERT
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Ferrlecit (sodium ferric gluconate complex
in sucrose injection)
Prescribing Information |
PRECAUTIONS
ADVERSE REACTIONS
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Flovent HFA (fluticasone propionate) Inhalation
Aerosol
Prescribing Information
Patient Package Insert
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PRECAUTIONS
- Information for Patients
- Use Flovent HFA only with the actuator
supplied with the product. When the counter reads 020, contact
the pharmacist for a refill of medication or consult the
physician to determine whether a prescription refill is
needed. Discard the inhaler when the counter reads 000. Never
try to alter the numbers or remove the counter from the metal
canister.
PATIENT PACKAGE INSERT
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Gleevec (imatinib mesylate) Tablets
Prescribing Information
The labeling revisions provide for the
treatment of the following conditions: adult dermafibrosarcoma protuberans (DFSP), adult myelodysplastic
syndrome/myeloproliferative diseases (MDS/MPD), adult Ph+ acute
lymphoblastic leukemia (ALL) monotherapy, adult aggressive
systemic mastocytosis (ASM), and adult hypereosinophilic
syndrome/chronic eosinophilic leukemia (HES/CEL). |
PRECAUTIONS
- Hypereosinophilic Cardiac Toxicity
- Severe Congestive Heart Failure and Left Ventricular
Dysfunction
ADVERSE REACTIONS
- Acute Lymphoblastic Leukemia
- Myelodyplastic/Myeloproliferative Diseases
- Table 14: Adverse Experiences Reported (more than one
patient) in MPD Patients.....
- Aggressive Systemic Mastocytosis
- Hypereosinophilic Syndrome and Chronic Eosinophilic Leukemia
- Dermatofibrosarcoma Protuberans
- Table 15: Adverse Experiences Reported in DFSP
Patients.....
- Table 16: Laboratory Abnormalities Reported in DFSP
Patients.....
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Gleevec (imatinib mesylate) Tablets Prescribing Information
The labeling revisions provide for updated text to the package
insert to include the results of the final 2 year rat
carcinogenicity study. |
PRECAUTIONS
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Namenda (memantine hydrochloride)
Tablets and Oral Solution
Please contact Forest Pharmaceuticals, Inc. at 1-800-678-1605 for
prescribing information.
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PRECAUTIONS
- Special Populations
- Hepatic Impairment - Namenda undergoes partial hepatic metabolism, with about 48% of administered dose excreted in urine as unchanged drug or as the sum of parent drug and the N-glucuronide conjugate (74%). No dosage adjustment is needed in patients with mild or moderate hepatic impairment. Namenda should be administered with caution to patients with severe hepatic impairment.
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Neulasta (pegfilgrastim)
Prescribing Information
Patient Package Insert
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PRECAUTIONS
- Drug Interaction
- Increased hematopoetic activity of the bone marrow in
response to growth factor therapy has been associated with
transient positive bone imaging changes. This should be
considered when interpreting bone-imagine results.
PATIENT PACKAGE INSERT
- What are the ingredients in Neulasta?
- The needle cover on the single-use prefilled syringe
contains dry natural rubber (laxex), which should not be
handled by persons sensitive to this substance.
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Neupogen (filgrastim)
Prescribing Information
Patient Package Insert
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PRECAUTIONS
- Drug Interaction
- Increased hematopoetic activity of the bone marrow in
response to growth factor therapy has been associated with
transient positive bone imaging changes. This should be
considered when interpreting bone-imagine results.
PATIENT PACKAGE INSERT
- What are the ingredients in Neupogen?
- The needle cover on the single-use prefilled syringe
contains dry natural rubber (laxex), which should not be
handled by persons sensitive to this substance.
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Nexium (esomeprazole
magnesium) Delayed-Release Capsules
Nexium (esomeprazole magnesium) for
Delayed-Release Oral Suspension
Prescribing Information
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PRECAUTIONS
- Information for Patients
- Administration Options
- Nexium Delayed-Release Capsules
- Nexium For Delayed-Release Oral Suspension
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Prinivil (lisinopril) Tablets
Prescribing Information
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PRECAUTIONS
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Prinzide (lisinopril/hydrochlorothiazide)
Tablets
Prescribing Information
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PRECAUTIONS
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Risperdal Consta (risperidone) Long Acting
Injection
Please contact Janssen, L.P. at 1-800-526-7736 for
prescribing information.
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PRECAUTIONS
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Risperdal (risperidone) Tablets and Oral Solution
Risperdal M-TAB (risperidone) Orally
Disintegrating Tablets
Prescribing Information |
PRECAUTIONS
- Use in Patients with Concomitant Illnesses
- Clinical experience with Risperdal in
patients with certain concomitant systemic illnesses is limited.
Patients with Parkinson's Disease or Dementia with Lewy Bodies
who receive antipsychotics, including Risperdal, are reported to
have an increased sensitivity to antipsychotic medications.
Manifestations of this increased sensitivity have been reported
to include confusion, obtundation, postural instability with
frequent falls, extrapyramidal symptoms, and clinical features
consistent with the neuroleptic malignant syndrome.
- Pediatric Use
- The efficacy and safety of Risperdal in
the treatment of irritability associated with autistic disorder
were established in two 8-week, placebo-controlled trials in 156
children and adolescent patients, aged 5 to 16 years.....
- The safety and effectiveness of Risperdal
in pediatric patients with autistic disorder less than 5 years
of age have not been established.
ADVERSE REACTIONS
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Viagra (sildenafil
citrate) Tablets
Prescribing Information
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PRECAUTIONS
- Information for Patients
- Sildenafil is also marketed as Revatio for
pulmonary arterial hypertension.
- Drug Interactions
- Effects of Other Drugs on Viagra
- In a study of healthy male volunteers,
co-administration of sildenafil at steady state (80mg t.i.d.)
with endothelin receptor antagonist bosentan (a moderate inducer
of CYP3A4, CYP2C9 and possibly cytochrome P4502C19) at steady
state (125 mg b.i.d.) resulted in 63% decrease of sildenafil AUC
and a 55% decrease in sildenafil Cmax.....
- Effects of Viagra on Other Drugs
- Sildenafil at steady state (80mg t.i.d.)
resulted in a 50% increase in AUC and a 42% increase in Cmax of
bosentan (125 b.i.d.)
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Brand
(Generic) Name |
Sections Modified |
Aricept (donepezil hydrochloride) Oral Solution
Prescribing Information
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ADVERSE REACTIONS
- Severe Alzheimer's Disease
- Adverse Events Leading to Discontinuation
- Most Frequent Adverse Clinical Events Seen in
Association with the Use of Aricept
-
Adverse Events Reported in Controlled Trials
- Table 4: Adverse Events Reported in Controlled
Clinical Trials in Severe Alzheimer's Disease in at Least 2%
of Patients Receiving Aricept.....
- Other Adverse Events Observed During Clinical
Trials
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Aricept (donepezil hydrochloride tablets)
Aricept ODT (donepezil hydrochloride) Orally
Disintegrating Tablets
Prescribing Information
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ADVERSE REACTIONS
- Severe Alzheimer's Disease
- Adverse Events Leading to Discontinuation
- Most Frequent Adverse Clinical Events Seen in
Association with the Use of Aricept
-
Adverse Events Reported in Controlled Trials
- Table 4: Adverse Events Reported in Controlled
Clinical Trials in Severe Alzheimer's Disease in at Least 2%
of Patients Receiving Aricept.....
- Other Adverse Events Observed During Clinical
Trials
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Cialis (tadalafil) Tablets
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing Surveillance
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Hepsera (adefovir dipivoxil) Tablets
Prescribing Information
Patient Package Insert
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ADVERSE REACTIONS
- Initial Section
- Patients who received Hepsera for up to 240
weeks in Study 438 reported adverse reactions similar in
nature.....
- Laboratory Abnormalities
- No patients with adequate renal function
treated with Hepsera developed a serum creatinine increase ≥0.5 mg/dL from baseline
by week 48.....
- .....For patients who chose to continue
Hepsera for up to 240 weeks in Study 438, 4 of 125 patients
(3%) had a confirmed increase of 0.5 mg/dL from baseline. The
creatinine elevation resolved in 1 patient who permanently
discontinued treatment and remained stable in 3 patients who
continued treatment.....
PATIENT PACKAGE INSERT
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Rapamune (sirolimus) Oral Solution and
Tablets
Prescribing Information |
ADVERSE REACTIONS
- Other Clinical Experience
- The safety and efficacy of conversion from
calcineurin inhibitors to sirolimus in maintenance renal
transplant population has not been established. In an ongoing
study evaluating the safety and efficacy of conversion from
calcineurin inhibitors to sirolimus (target concentrations of 12
- 20 ng/mL, by chromatographic assay).....
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Yaz (drospirenone and ethinyl
estradiol) Tablets
Prescribing Information
Patient Package Insert |
ADVERSE REACTIONS
-
The following adverse reactions have been
reported in patients receiving oral contraceptives and are
believed to be drug-related:
- Possible diminution in lactation when given
immediately postpartum
- Mood changes, including depression
- Vaginitis, including candidiasis
- Decrease in serum folate levels
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Exacerbation of systemic lupus erythematosus
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Exacerbation of porphyria
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Exacerbation of chorea
- Aggravation
of varicose veins
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Anaphylactic/anaphylactoid reactions, including urticaria,
angioedema, and severe reactions with respiratory and
circulatory symptoms
- The following adverse reactions have been
reported in users of oral contraceptives and a causal
association has been neither confirmed nor refuted:
- Dysmenorrhea
- Optic neuritis, which may lead to partial or
complete loss of vision
- Pancreatitis
- The most frequent (>1%) treatment-emergent
adverse events, listed in descending order, reported with the
use of Yaz in the PMDD clinical trials, which may or not be drug
related, included.....
PATIENT PACKAGE INSERT
- Yaz may also be taken to treat premenstrual
dysphoric disorder (PMDD) if you choose to use the Pill for
birth control.....
- You should only use Yaz for treatment of PMDD if
you.....
- Yaz has not been shown to be effective for
the treatment of premenstrual syndrome (PMS).....
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Brand
(Generic) Name |
Sections Modified |
Humatrope (somatropin [rDNA origin] for Injection)
Patient Package Insert |
PATIENT PACKAGE INSERT
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Intron A (interferon alfa-2b, recombinant)
for Injection
Medication Guide |
MEDICATION GUIDE
- Instructions for Preparing
and Giving a Dose of Intron A Multidose Pen
- Storing Intron A Solution
Multidose Pen for Injection
- Discard any unused Intron A pen remaining after 4 weeks.
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Topamax (topiramate) Tablets
Topamax (topiramate capsules) Sprinkle Capsules
Patient Package Insert |
PATIENT PACKAGE INSERT
(new) |
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