Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications and Warnings |
Aldurazyme (laronidase) Solution for Intravenous Infusion Only
Prescribing Information
|
BOXED WARNING (new)
WARNINGS
- Anaphylaxis and Allergic Reactions (see BOXED WARNING)
ADVERSE REACTIONS
- Initial Paragraph
- In clinical studies, the most common adverse reactions requiring intervention...
- In postmarketing experience with Aldurazyme...
- Immunogenicity
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BOXED WARNING
WARNING: Risk of Anaphylaxis
Life-threatening anaphylactic reactions have been observed in some patients during Aldurazyme infusions. Therefore, appropriate medical support should be readily available when Aldurazyme is administered. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions, and require additional monitoring.
WARNINGS: Anaphylaxis and Allergic Reactions (see BOXED WARNING)
See prescribing information for revised text. |
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Emtriva (emtricitabine) Capsules and Oral Solution
Prescribing Information
Patient Package Insert |
BOXED WARNING
WARNINGS
- Patients Co-infected with HIV and Hepatitis B Virus
PATIENT PACKAGE INSERT
- What is the most important information I should know about Emtriva?
- If you are also infected with the Hepatitis B Virus (HBV)...
- What are the possible side effects of Emtriva?
- "flare-ups" of Hepatitis B Virus infection...
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BOXED WARNING
...Emtriva is not approved for the treatment of Chronic Hepatitis B Virus (HBV) Infection...
WARNINGS: Patients Co-infected with HIV and Hepatitis B Virus
...Emtriva is not approved for the treatment of chronic HBV infection...
...In some patients infected with HBV and treated with Emtriva, the exacerbations of hepatitis B were associated with liver
decompensation and liver failure... |
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Lotronex (alosetron hydrochloride) Tablets
Prescribing Information (in new labeling format)
Medication Guide
|
BOXED WARNING
- WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS
WARNINGS AND PRECAUTIONS
- Serious Complications of Constipation
- Ischemic Colitis
- Prescribing Program for Lotronex
ADVERSE REACTIONS
- Clinical Trials Experience
- Initial Paragraph
- Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Geriatric Use
- Hepatic Impairment
- Renal Impairment
PATIENT COUNSELING INFORMATION
- Physician and Patient Responsibilities
MEDICATION GUIDE
- There is a special prescribing program for Lotronex.
- What is Lotronex?
- Who should not take Lotronex?
- What should I talk about with my doctor before taking Lotronex?
- What are the possible side effects of Lotronex?
- How should I store Lotronex?
- General information about the safe and effective use of Lotronex.
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BOXED WARNING
WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS
...Only physicians who have enrolled in the Prometheus Prescribing Program for Lotronex based on their understanding of the benefits and risks, should prescribe Lotronex...
WARNINGS AND PRECAUTIONS
Serious Complications of Constipation
...Complications of constipation have been reported with use of 1 mg twice a daily and with lower doses. A dose response relationship has not been established for serious complications of constipation...
Ischemic Colitis
Some patients have experienced ischemic colitis without warning...
...Ischemic colitis has been reported with use of 1 mg twice daily and with lower doses. A dose-response relationship has not been established. Ischemic colitis was reported in one patient receiving placebo.
Prescribing Program for Lotronex
(See highlighted text for labeling revisions.) |
Back to Summary Page | Back to Top
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Advair Diskus (fluticasone propionate and salmeterol inhalation powder)
Prescribing Information (in new labeling format)
Medication Guide |
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Deterioration of Disease and Acute Episodes
- Pneumonia
- Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors
ADVERSE REACTIONS
- Clinical Trials Experience in Asthma
- Adult and Adolescent Patients 12 Years of Age and Older
- Table 2
- Clinical Trials Experience in Chronic Obstructive Pulmonary Disease
- Short-Term (6 Months to 1 Year) Trials
- Table 3
- Postmarketing Experience
- Musculoskeletal, Connective Tissue, and Bone Disorders
- Psychiatric Disorders
- Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.
DRUG INTERACTIONS
- Inhibitors of Cytochrome P450 3A4
- Initial Paragraph
- Ketoconazole: Salmeterol
- Beta-Adrenergic Receptor Blocking Agents
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Pediatric Use
- Geriatric Use
- Hepatic Impairment
- Renal Impairment
PATIENT COUNSELING INFORMATION
MEDICATION GUIDE
- What is Advair Diskus
- Chronic Obstructive Pulmonary Disease
- Who should not use Advair Diskus?
- What should I tell my healthcare provider before using Advair Diskus?
- ...are allergic to any of the ingredients in Advair Diskus...
- How do I use Advair Diskus?
- What are the possible side effects with Advair Diskus?
- The most common side effects with Advair Diskus include...
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CONTRAINDICATIONS
Severe hypersensitivity to milk proteins...
WARNINGS AND PRECAUTIONS
Deterioration of Disease and Acute Episodes
Advair Diskus should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Advair Diskus has not been studied in patients with acutely deteriorating asthma or COPD...
Pneumonia
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.
Lower respiratory tract infections, including pneumonia, have been reported in patients
with COPD following the inhaled administration of corticosteroids, including fluticasone propionate and Advair Diskus. In 2 replicate 12-month studies of 1,579 patients with COPD, there was a higher incidence of pneumonia reported in patients receiving Advair Diskus 250/50 (7%) than in those receiving salmeterol 50 mcg (3%). The incidence of pneumonia in the patients treated with Advair Diskus was higher in patients over 65 years of age (9%) compared with the incidence in patients less than 65 years of age (4%)... Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors
The use of strong CYP 3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin,
indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Advair Diskus is not recommended because increased systemic corticosteroid and increased
cardiovascular adverse effects may occur... |
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Amitiza (lubiprostone)
Capsules
Prescribing Information (in new labeling format)
|
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
- Clinical Studies Experience
- Chronic Idiopathic Constipation
- Table 1
- Nausea
- Diarrhea
- Less common adverse reactions
- Irritable Bowel Syndrome with Constipation
- Table 2
- Less common adverse reactions
- Postmarketing Experience
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Geriatric Use
- Irritable Bowel Syndrome with Constipation
NONCLINICAL TOXICITY
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Carcinogenesis
- Impairment of Fertility
PATIENT COUNSELING INFORMATION
- Dosing Instructions
- Irritable Bowel Syndrome with Constipation
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CONTRAINDICATIONS
Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONS: Dyspnea
In clinical trials conducted to study Amitiza in treatment of chronic idiopathic constipation
and IBS-C there were reports of dyspnea. This was
reported at 2.5% of the treated chronic idiopathic constipation population
and at 0.4% in the treated IBS-C population. Although not classified as serious
adverse events, some patients discontinued treatment on study because of
this event. There have been postmarketing reports
of dyspnea when using Amitiza 24 mcg...
...These events have usually been described as a sensation of chest tightness and
difficulty taking in a breath, and generally have an acute onset within
30-60 minutes after taking the first dose. They generally resolve within a
few hours after taking the dose, but
recurrence has been frequently reported with subsequent doses. |
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Crixivan (indinavir sulfate) Capsules
Prescribing Information
Patient Package Insert |
CONTRAINDICATIONS
WARNINGS
- Drug Interactions
- Rosuvastatin (added)
- ...Dosage reduction for midazolam...
PRECAUTIONS
- Drug Interactions
- Table 8: Drugs That Should Not Be Coadministered with Crixivan
- Table 9: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
- HMG-CoA Reductase Inhibitors
- Midazolam (parenteral administration)
PATIENT PACKAGE INSERT
- Can Crixivan be taken with other medications?
- Medicines you should not take with Crixivan
- In addition, you should not take Crixivan with the following:
- Medicines you can take with Crixivan
- Intravenous Versed (midazolam) - If you take Crixivan with Intravenous Versed, your doctor may adjust the does of Versed.
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CONTRAINDICATIONS
Table 7: Drug Interactions With Crixivan: Contraindicated Drugs
Drug Class: Sedative/hypnotics
Oral midazolam (added as contraindicated drug)
(See highlighted text for labeling revisions.)
WARNINGS
Drug Interactions
Caution should be exercised if HIV protease inhibitors, including Crixivan, are used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A4 pathway (e.g., atorvastatin or rosuvastatin).
...If Crixivan with or without ritonavir is co-administered with parenteral midazolam, it should be done in a setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered. |
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Tigan (trimethobenzamide hydrochloride) Injectable for Intramuscular Use Only
Prescribing Information
|
CONTRAINDICATIONS
PRECAUTIONS
- General
- Adjustment of Dose in Renal Failure
- Geriatric Use
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CONTRAINDICATIONS
The injectable form of Tigan is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide.
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Back to Summary Page | Back to Top
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Actonel (risedronate sodium) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert
|
WARNINGS AND PRECAUTIONS
- Upper Gastrointestinal Adverse Reactions
- Musculoskeletal Pain
ADVERSE REACTIONS
- Clinical Studies Experience
- Treatment of Postmenopausal Osteoporosis
- Daily Dosing
- Table 1
- Gastrointestinal Adverse Events
- Musculoskeletal Adverse Events
- Laboratory Test Findings
- Once-a-week Dosing
- Gastrointestinal Adverse Events
- Monthly Dosing
- Two Consecutive Days per Month
- Acute Phase Reactions
- Gastrointestinal Adverse Events
- Ocular Adverse Events
- Laboratory Test Findings
- Once a Month
- Acute Phase Reactions
- Gastrointestinal Adverse Events
- Ocular Adverse Events
- Laboratory Test Findings
- Prevention of Postmenopausal Osteoporosis
- Daily Dosing
- Once-a-week Dosing
- Treatment and Prevention of Glucocorticoid-induced Osteoporosis
- Treatment of Paget's Disease
- Postmarketing Experience
- Gastrointestinal Adverse Events
PATIENT COUNSELING INFORMATION
- If the dose of Actonel 150 mg once a month is missed...
PATIENT PACKAGE INSERT
- How should I take Actonel?
- What is my Actonel schedule?
- What should I avoid while taking Actonel?
- What are the possible side effects of Actonel?
- Other possible side effects may include...
- Call you doctor for medical advice about side effects.
- How should I store Actonel?
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WARNINGS AND PRECAUTIONS
Upper Gastrointestinal Adverse Reactions
...Patients should discontinue use if new or worsening symptoms occur...
Musculoskeletal Pain
...Consider discontinuing use if severe symptoms develop.
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Augmentin (amoxicillin/clavulanate potassium) Tablets
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- …Diarrhea is a common problem caused
by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with
use of nearly all antibacterial agents, including Augmentin, and may range
in severity from mild diarrhea to fatal colitis. Treatment with
antibacterial agents alters the normal flora of the colon leading to
overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the
development of CDAD. Hypertoxin producing strains
of C. difficile cause increased morbidity
and mortality, as these infections can be refractory to antimicrobial
therapy and may require colectomy. CDAD must be considered
in all patients who present with diarrhea following antibiotic use. Careful
medical history is necessary since CDAD has been reported to occur over two
months after the administration of
antibacterial agents.
If CDAD is suspected or confirmed, ongoing
antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte
management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be
instituted as clinically indicated.
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Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- …Diarrhea is a common problem caused
by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with
use of nearly all antibacterial agents, including Augmentin ES-600, and may range
in severity from mild diarrhea to fatal colitis. Treatment with
antibacterial agents alters the normal flora of the colon leading to
overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the
development of CDAD. Hypertoxin producing strains
of C. difficile cause increased morbidity
and mortality, as these infections can be refractory to antimicrobial
therapy and may require colectomy. CDAD must be considered
in all patients who present with diarrhea following antibiotic use. Careful
medical history is necessary since CDAD has been reported to occur over two
months after the administration of
antibacterial agents.
If CDAD is suspected or
confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate
fluid and electrolyte management, protein supplementation, antibiotic treatment
of C. difficile, and surgical evaluation
should be instituted as clinically indicated. |
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Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- …Diarrhea is a common problem caused
by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with
use of nearly all antibacterial agents, including Augmentin XR, and may range
in severity from mild diarrhea to fatal colitis. Treatment with
antibacterial agents alters the normal flora of the colon leading to
overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the
development of CDAD. Hypertoxin producing strains
of C. difficile cause increased morbidity
and mortality, as these infections can be refractory to antimicrobial
therapy and may require colectomy. CDAD must be considered
in all patients who present with diarrhea following antibiotic use. Careful
medical history is necessary since CDAD has been reported to occur over two
months after the administration of
antibacterial agents.
If CDAD is suspected or
confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate
fluid and electrolyte management, protein supplementation, antibiotic treatment
of C. difficile, and surgical evaluation
should be instituted as clinically indicated.
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Declomycin (demeclocycline hydrochloride) Tablets
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- …Diarrhea is a common problem caused
by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Declomycin (demeclocycline hydrochloride), and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation,
antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Evamist (estradiol transdermal spray)
Prescribing Information (in new labeling format)
|
WARNINGS AND PRECAUTIONS
- Malignant Neoplasms
- Dementia
USE IN SPECIFIC POPULATIONS
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WARNINGS AND PRECAUTIONS
Malignant Neoplasms: Breast Cancer
The most important randomized clinical trial providing information about this issue in estrogen alone users is the Women’s Health Initiative (WHI) substudy of daily conjugated estrogens (CE 0.625 mg)...
The most important randomized clinical trial providing information about this issue in estrogen plus progestin users is the Women’s Health Initiative (WHI) substudy of daily CE 0.625 mg plus medroxyprogesterone acetate (MPA 2.5 mg)...
Observational studies have also reported an increased risk of breast cancer for
estrogen plus progestin therapy, and a smaller increased risk for estrogen
alone therapy, after several years of use. The risk increased with duration of
use, and appeared to return to baseline over about 5 years after stopping treatment...
Dementia
...Since both substudies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women... |
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Levaquin (levofloxacin) Tablets and Oral Solution
Levaquin (levofloxacin) Injection, for Intravenous Use
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use
Prescribing Information (in new labeling format)
Patient Package Insert
|
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
- Serious and Otherwise Important Adverse Reactions
USE IN SPECIFIC POPULATIONS
- Geriatric Use
- Severe, and sometimes fatal, cases of hepatotoxicity have been reported postmarketing in association with Levaquin...
PATIENT COUNSELING INFORMATION
- Serious and Potentially Serious
Adverse Reactions
PATIENT PACKAGE INSERT
- What are possible side effects of Levaquin?
- Hepatotoxicity (liver damage)...
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WARNINGS AND PRECAUTIONS
Postmarketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with Levaquin. No evidence of serious drug-associated hepatotoxicity was detected in clinical trials of over 7,000 patients. Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most cases occurred within 6 days. Most cases of severe hepatotoxicity were not associated with hypersensitivity [see Warnings and Precautions (5.2)]. The majority of fatal hepatotoxicity reports occurred in patients, 65 years of age or older and most were not associated with hypersensitivity. Levaquin should be discontinued immediately if the patient develops signs and symptoms of hepatitis... |
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Luvox (fluvoxamine maleate) Tablets
Prescribing Information (in new labeling format)
|
WARNINGS AND PRECAUTIONS
- Other Potentially Important Drug Interactions
- Warfarin and Other Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, etc.)
- Abnormal Bleeding
PATIENT COUNSELING INFORMATION
|
WARNINGS AND PRECAUTIONS
Other Potentially Important Drug Interactions: Warfarin and Other Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, etc.)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Thus, patients should be cautioned about the use of such drugs concurrently with fluvoxamine...
Abnormal Bleeding
SSRI’s and SNRI’s, including Luvox Tablets, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRI’s and SNRI’s have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of Luvox Tablets and NSAID’s, aspirin, or other drugs that affect coagulation [see section 5.7]. |
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Nafcillin Injection, USP
in PL 2040 Plastic Container For Intravenous Use Only Galaxy Container
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- …Diarrhea is a common problem caused
by antibiotics which usually ends when the antibiotic is discontinued...
|
WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Nafcillin Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Neulasta (pegfilgrastim)
Prescribing Information
Patient Package Insert
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WARNINGS
ADVERSE REACTIONS
- Postmarketing Experience (new subsection)
PATIENT PACKAGE INSERT
- What is Neulasta used for?
- What are possible serious side effects of Neulasta?
- Serious Allergic Reactions
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WARNINGS
Allergic Reactions
Allergic reactions to Neulasta, manifesting as anaphylaxis, angioedema, or urticaria have been reported in postmarketing experience... |
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Orencia (abatacept)
Lyophilized Powder for Intravenous Infusion
Prescribing Information (in new labeling format)
Patient Package Insert |
WARNINGS AND PRECAUTIONS
- Hypersensitivity
- Infections
- Immunizations
ADVERSE REACTIONS
- Clinical Studies Experience in Juvenile Idiopathic Arthritis
- Postmarketing Experience
DRUG INTERACTIONS
- Other Biologic RA Therapy
USE IN SPECIFIC POPULATIONS
NONCLINICAL TOXICITY
- Carcinogenesis, Mutagenesis, Impairment of Fertility
PATIENT COUNSELING INFORMATION
- Concomitant Use With Biologic Medications for RA
- Hypersensitivity
- Infections
- Immunizations
- Pregnancy and Nursing Mothers
- Blood Glucose Testing
PATIENT PACKAGE INSERT
- What is Orencia?
- What should I tell my doctor before treatment with Orencia?
- Tell your doctor about all the medicines you take...
- What are the possible side effects of Orencia?
- Common side effects of Orencia in both adults and children...
- In children, other side effects may include...
- General information about Orencia
- What are the ingredients in Orencia?
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WARNINGS AND PRECAUTIONS
Hypersensitivity
...Of the 190 patients with juvenile idiopathic arthritis treated with Orencia in clinical trials, there was one case of a hypersensitivity reaction (0.5%)...
Infections
...Anti-rheumatic therapies have been associated with hepatitis B reactivation. Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with Orencia. In clinical studies with Orencia, patients who screened positive for hepatitis were excluded from study.
Immunizations
...It is recommended that patients with juvenile idiopathic arthritis be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating Orencia therapy. |
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Oxacillin (oxacillin) Injection, Solution in Plastic Container
For Intravenous Use Only
Galaxy Container (PL 2040)
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- …Diarrhea is a common problem caused
by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Oxacillin Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Pipracil
(piperacillin for injection) for Intravenous and Intramuscular Use
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- ...Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Pipracil, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Prevacid (lansoprazole) Delayed-Release Capsules
Prevacid (lansoprazole) Delayed-Release Oral Suspension
Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Drug Interactions
- Atazanavir
- ...It is theoretically possible that Prevacid may also interfere...
ADVERSE REACTIONS
- Clinical
- Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen...
- Laboratory Values
- Blood Potassium Increased
- Blood Urea Increased
- Crystal Urine Present
- Hemoglobin Decreased
- Positive Fecal Occult Blood
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clarithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Timentin (ticarcillin disodium and clavulanate potassium) for Intravenous Administration
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- ...Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Timentin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Timentin
(ticarcillin disodium and clavulanate potassium)
Injection
Galaxy (PL 2040) Plastic Container
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- ...Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Timentin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Unasyn (ampicillin
sodium/sulbactam sodium)
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- ...Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Unasyn, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Vyvanse (lisdexamfetamine dimesylate) Capsules
Prescribing Information (in new labeling format)
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WARNINGS AND PRECAUTIONS
- Prescribing and Dispensing
ADVERSE REACTIONS
- Clinical Studies Experience
- Initial Section
- Adverse Reactions Occurring at an Incidence of 2% or more Among Vyvanse Treated Patients in Clinical Trials
- Adverse Reactions Associated with the Use of Amphetamine
- Central Nervous System
- Gastrointestinal
- Other Gastrointestinal Disturbances
- Allergic
DRUG INTERACTIONS
- Agents that Increase Blood Levels of Amphetamines
- Urinary Alkalinizing Agents
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Labor and Delivery
- Pediatric Use
PATIENT COUNSELING INFORMATION
- Controlled Substance Status/Potential for Abuse, Misuse, and Dependence
- Serious Cardiovascular Risks
- Psychiatric Risks
- Growth
- Pregnancy
- Nursing
- Impairment in Ability to Operate Machinery or Vehicles
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WARNINGS AND PRECAUTIONS
Prescribing and Dispensing
The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Vyvanse should be used with caution in patients who use other sympathomimetic drugs. |
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Zosyn (piperacillin and tazobactam injection)
in Galaxy Containers (PL 2040 Plastic)
Prescribing Information
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WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- ...Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Zosyn, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Zosyn (piperacillin and tazobactam for injection) Individual Vials
Prescribing Information
Zosyn (piperacillin and tazobactam for injection) Pharmacy Bulk Package
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- ...Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Zosyn, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. |
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Brand
(Generic) Name
|
Sections Modified |
Cardiolite Kit for the Preparation of Technetium Tc99m Sestamibi for Injection
Prescribing Information (in new labeling format)
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USE IN SPECIFIC PATIENTS
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Cetrotide (cetrorelix acetate for injection)
Prescribing Information |
PRECAUTIONS
- General
- Cases of hypersensitivity reactions,
including anaphylactoid reactions with the
first dose, have been reported during postmarketing surveillance…
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Dibenzyline (phenoxybenzamine hydrochloride
capsules, USP)
Prescribing Information
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PRECAUTIONS
- Carcinogenesis and Mutagenesis
- Case reports of carcinoma in humans after long-term treatment with phenoxybenzamine have been reported. Hence long-term use of phenoxybenzamine is not recommended. Carefully weigh the benefits and risks before prescribing this drug...
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Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) Capsules
Prescribing Information |
PRECAUTIONS
- Ultra-rapid Metabolizers of Codeine
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Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension)
Prescribing Information |
PRECAUTIONS
- Geriatric Use (new subsection)
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Pilopine HS (pilocarpine hydrochloride ophthalmic gel) 4%
Prescribing Information |
PRECAUTIONS
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Propranolol Hydrochloride Injection, USP
Prescribing Information |
PRECAUTIONS
- General
- ...Withdrawal may lead to a return of elevated intraocular pressure.
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Pulmicort Flexhaler (budesonide inhalation powder) For Oral Inhalation Only
Prescribing Information
Patient Package Insert |
PRECAUTIONS
- General
- Initial Paragraph
- Pulmicort Flexhaler contains small amounts of lactose...
- Information for Patients
ADVERSE REACTIONS
- Adverse Event Reports from Other Sources
PATIENT PACKAGE INSERT
- Before Using Your Pulmicort Flexhaler
- What are the ingredients in Pulmicort Flexhaler?
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Synthroid (levothyroxine sodium tablets, USP)
Prescribing Information |
PRECAUTIONS
- Information for Patients
- Agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine sodium tablets. Therefore, levothyroxine sodium tablets should not be administered within 4 hours of these agents.
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Tenormin (atenolol) Tablets
Prescribing Information |
PRECAUTIONS
- Drug Interactions
- Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and
chronotropic effects...
- Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers...
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate...
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Brand
(Generic) Name
|
Sections Modified |
Copegus (ribavirin,
USP) Tablets
Prescribing Information |
ADVERSE
REACTIONS
|
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Enablex (darifenacin) Extended-Release Tablets
Prescribing Information
|
ADVERSE REACTIONS
- Postmarketing Experience (new subsection)
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Flomax (tamsulosin hydrochloride) Capsules
Prescribing Information |
ADVERSE REACTIONS
|
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Lexiva (fosamprenavir calcium) Tablets and Oral Suspension
Prescribing Information (in new labeling format)
Patient Package Insert
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ADVERSE REACTIONS
- Postmarketing Experience
- Skin and Subcutaneous Tissue Disorders
PATIENT PACKAGE INSERT
- What are the possible side effects of Lexiva?
- ...Swelling of the face, lips, and tongue (angioedema) has also been reported. Tell your healthcare provider if you get a rash or develop facial swelling after starting Lexiva.
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Navane (thiothixene) Capsules
Navane (thiothixene hydrochloride) Concentrate
Prescribing Information |
ADVERSE REACTIONS
- Extrapyramidal Symptoms
- Dystonia, Class Effect (new subsection)
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RotaTeq (rotavirus vaccine, live, oral, pentavalent) Oral Solution
Prescribing Information (in new labeling format)
Patient Package Insert |
ADVERSE REACTIONS
- Postmarketing Experience
- Gastrointestinal Disorders
- Intussusception (including death)
PATIENT COUNSELING INFORMATION
PATIENT PACKAGE INSERT
- What other important information should I know?
- ...Death due to intussusception has also occurred...
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Singulair (montelukast sodium) Granule
Singulair (montelukast sodium) Tablet, Chewable
Singulair (montelukast sodium) Tablet, Film Coated
Prescribing Information
Patient Package Insert
See MedWatch Safety Alert posted 03/27/2008 for additional information on Singulair
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ADVERSE REACTIONS
- Postmarketing Experience
- Psychiatric Disorders
- Anxiousness
- Suicidal thinking and behavior (including suicide)
PATIENT PACKAGE INSERT
- Less common side effects that have happened with Singulair include:
- Behavior and Mood related changes
- Feeling anxious
- Suicidal thoughts and actions (including suicide)...
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Theophylline in 5% Dextrose Injections, USP
Prescribing Information
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ADVERSE REACTIONS
- ...Hypercalcemia has been reported in a patient with hyperthyroid disease at therapeutic theophylline concentrations.
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Zerit (stavudine) Capsules
Zerit (stavudine) for Oral Solution
Prescribing Information
Patient Package Insert
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ADVERSE REACTIONS
- Observed During Clinical Practice
- Metabolic Disorders
- Diabetes Mellitus and Hyperglycemia
PATIENT PACKAGE INSERT
- What are the possible side effects of Zerit?
- Other Side Effects
- ...high blood sugar (hyperglycemia or diabetes)...
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NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)
Patient Package Insert
Prescribing Information |
PATIENT PACKAGE INSERT
- How do I insert NuvaRing?
- How do I remove NuvaRing?
- Call your healthcare provider right away if you get any of the symptoms listed below...
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