Brand (Generic) Name |
Sections Modified
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Summary of Changes to Contraindications and Warnings |
Aranesp (darbepoetin alfa) for Injection
Prescribing Information
See MedWatch Safety Alert posted 03/12/2008 for additional information on Erythropoiesis Stimulating Agents.
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BOXED WARNING
WARNINGS
- Decreased progression-free survival and overall survival...
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BOXED WARNING
Cancer
...ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of > 12 g/dL.
WARNINGS
Decreased progression-free survival and overall survival:
Cancer Study 3 (the ‘PREPARE’ study) was a randomized controlled study in which Aranesp was administered to prevent anemia conducted in 733 women receiving neo-adjuvant breast cancer treatment. An interim analysis was performed after a median follow-up of approximately 3 years at which time the survival rate was lower (86% vs. 90%, HR 1.42, 95% CI: 0.93, 2.18) and relapse-free survival rate was lower (72% vs. 78%, HR 1.33, 95% CI: 0.99, 1.79) in the Aranesp-treated arm compared to the control arm.
Cancer Study 4 (protocol GOG 191) was a randomized controlled study that enrolled 114 of a planned 460 cervical cancer patients receiving chemotherapy and radiotherapy. Patients were randomized to
receive Epoetin alfa to maintain hemoglobin between 12 and 14 g/dL or to transfusion support as needed. The study was terminated prematurely due to an increase in thromboembolic events in Epoetin alfa-treated patients compared to control (19% vs. 9%)... |
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Epogen (epoetin alfa) for Injection
Prescribing Information
See MedWatch Safety Alert posted 03/12/2008 for additional information on Erythropoiesis Stimulating Agents. |
BOXED WARNING
WARNINGS
- Decreased progression-free survival and overall survival...
|
BOXED WARNING
Cancer
ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of > 12 g/dL.
WARNINGS
Decreased progression-free survival and overall survival:
Cancer Study 3 (the ‘PREPARE’ study) was a randomized controlled study in which darbepoetin alfa was administered to prevent anemia conducted in 733 women receiving neo-adjuvant breast cancer treatment. An interim analysis was performed after a median follow-up of approximately 3 years at which time the survival rate was lower (86% vs. 90%, HR 1.42, 95% CI: 0.93, 2.18) and relapse-free survival rate was lower (72% vs. 78%, HR 1.33, 95% CI: 0.99, 1.79) in the darbepoetin alfa-treated arm compared to the control arm.
Cancer Study 4 (protocol GOG 191) was a randomized controlled study that enrolled 114 of a planned 460 cervical cancer patients receiving chemotherapy and radiotherapy. Patients were randomized to receive Epoetin alfa to maintain hemoglobin between 12 and 14 g/dL or to transfusion support as needed. The study was terminated prematurely due to an increase in thromboembolic events in Epoetin alfa-treated patients compared to control (19% vs. 9%)... |
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Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Avodart (dutasteride) Soft Gelatin Capsules
Prescribing Information
Patient Package Insert |
CONTRAINDICATIONS
ADVERSE REACTIONS
- Postmarketing Experience
- Immune System Disorders
- Serious Skin Reactions
- Angioedema
PATIENT PACKAGE INSERT
- How should I take Avodart?
- Swallow the capsule whole because the contents of the capsule may irritate your lips, mouth, or throat.
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CONTRAINDICATIONS
...Avodart is contraindicated for patients with known hypersensitivity (e.g., angioedema) to dutasteride, other 5α-reductase inhibitors, or any component of the preparation.
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Reyataz (atazanavir sulfate) Capsules
Prescribing Information (in new labeling format)
Patient Package Insert |
CONTRAINDICATIONS
- Table 3: Drugs That Are Contraindicated with Reyataz
WARNINGS AND PRECAUTIONS
- Drug Interactions
- Cardiac Conduction Abnormalities
- Rash
- ...Toxic skin eruptions (added)
- Hepatotoxicity
ADVERSE REACTIONS
- Initial Section
- Clinical Trial Experience in Adults
- Treatment-Emergent Adverse Reactions in Treatment-Naive Patients
- Treatment-Emergent Adverse Reactions in Treatment-Experienced Patients
- Clinical Trial Experience in Pediatric Patients
- Postmarketing Experience
DRUG INTERACTIONS
- Potential for Reyataz to Affect Other Drugs
- Potential for Other Drugs to Affect Atazanavir
- Established and Other Potentially Significant Drug Interactions
- Drugs with No Observed or Predicted Interactions with Reyataz
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Pediatric Use
- Impaired Renal Function
- Impaired Hepatic Function
PATIENT COUNSELING INFORMATION
PATIENT PACKAGE INSERT
- Can children take Reyataz?
- What are the possible side effects of Reyataz?
- The following side effects have been reported with Reyataz...
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CONTRAINDICATIONS
Reyataz (atazanavir sulfate) is contraindicated:
- in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the
components of this product or to atazanavir.
- when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance...
See highlighted text, Table 3: Drugs That Are Contraindicated with Reyataz.
WARNINGS AND PRECAUTIONS
Cardiac Conduction Abnormalities
...Atazanavir in combination with diltiazem increased diltiazem plasma concentration by 2-fold with an additive effect on the PR interval. When used in combination with atazanavir, a dose reduction of diltiazem by one half should be considered and ECG monitoring is recommended...
Rash
...Reyataz should be discontinued if severe rash develops. Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions have been reported in patients receiving Reyataz...
Hepatotoxicity
...In these patients, appropriate laboratory testing should be conducted prior to initiating therapy with Reyataz and these patients should be monitored during
treatment... |
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Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension
Prescribing Information
See MedWatch Safety Alert posted 03/11/2008 for additional information on Long-Acting Hydrocodone-Containing Cough Product |
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
- Information for Patients
- Patients should be advised to measure Tussionex Pennkinetic Extended-Release Suspension with an accurate measuring device...
- Shake well before using.
- Pediatric Use
ADVERSE REACTIONS
- General Disorders and Administration Site Conditions (added)
- Respiratory, Thoracic and Mediastinal Disorders
- Dryness of the pharynx, occasional tightness of the chest, and respiratory depression...
- ...Use of Tussionex Pennkinetic Extended-Release Suspension in children less than 6 years of age has been associated with fatal respiratory depression...
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CONTRAINDICATIONS
The use of Tussionex Pennkinetic Extended-Release Suspension is contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.
WARNINGS
Pediatric Use
The use of Tussionex Pennkinetic Extended-Release Suspension is contraindicated in children less than 6 years of age...
In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering Tussionex Pennkinetic Extended-Release Suspension to pediatric patients 6 years of age and older. Overdose or concomitant administration of Tussionex Pennkinetic Extended-Release Suspension with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup)... |
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Vfend I.V.
(voriconazole) for Injection
Vfend Tablets
(voriconazole)
Vfend (voriconazole) for Oral Suspension
Prescribing Information
Patient Package Insert |
CONTRAINDICATIONS
PRECAUTIONS
- Drug Interactions
- Table 11: Effect of Other Drugs on Voriconazole Pharmacokinetics
- Monitoring of Pancreatic Function
- Pediatric Use
- There have been postmarketing reports of pancreatitis in pediatric patients
PATIENT PACKAGE INSERT
- Who should not take Vfend?
- St. John's Wort (herbal supplement)
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CONTRAINDICATIONS
Coadministration of Vfend with St. John's Wort is contraindicated...
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Back to Summary Page | Back to Top
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Aczone (dapsone) Gel, 5%
Prescribing Information (in new labeling format)
Patient Package Insert |
WARNINGS AND PRECAUTIONS
- Hematological Effects
- Peripheral Neuropathy
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
PATIENT PACKAGE INSERT
- What should I tell my doctor before using Aczone Gel?
- ...You and your doctor will need to decide if Aczone is right for you.
- What are the possible side effects of Aczone Gel?
- ...When the active ingredients of Aczone Gel (called dapsone) is taken orally as a pill...
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WARNINGS AND PRECAUTIONS
Hematological Effects
Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia...
Peripheral Neuropathy
Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical Aczone Gel, 5% treatment. |
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Advair HFA 45/21 (fluticasone propionate 45 mcg and salmeterol 21 mcg*) Inhalation Aerosol
Advair HFA 115/21 (fluticasone propionate 115 mcg and salmeterol 21 mcg*) Inhalation Aerosol
Advair HFA 230/21 (fluticasone propionate 230 mcg and salmeterol 21 mcg*) Inhalation Aerosol
*As salmeterol xinafoate salt 30.45 mcg, equivalent to salmeterol base 21 mcg
Prescribing Information
Medication Guide |
WARNINGS
- Potential drug interaction with CYP 3A4 inhibitors
PRECAUTIONS
- Drug Interactions
- Inhibitors of Cytochrome P450
- Salmeterol and Ketoconazole
MEDICATION GUIDE
- How do I use Advair HFA?
- While you are using Advair HFA twice a day, do not use other medicines that contain a long-acting beta2-agonist or LABA for any reason...
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WARNINGS
Potential drug interaction with CYP 3A4 inhibitors
Both fluticasone propionate and
salmeterol are substrates of CYP 3A4. |
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Amoxil (amoxicillin capsules, tablets, chewable tablets, and 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 Amoxil, 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 (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Chewable 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
(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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Depakote ER (divalproex sodium) Extended Release Tablets
Prescribing Information (in new labeling format)
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WARNINGS AND PRECAUTIONS
- Hypothermia
- Interaction with Carbapenem Antibiotics
- Suicidal Ideation
- Monitoring: Drug Plasma Concentration
- Effect on Ketone and Thyroid Function Tests
- Effect on HIV and CMV Viruses Replication
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Initial Paragraph
- Mania
- Migraine Prophylaxis
- Epilepsy
- Pediatric Safety
- Safety Studies - Mania
- Safety Study-Controlled Mania Trial
- Table 7
- Safety Study - Open Label Mania Safety Data
- Safety Study - Epilepsy (open label)
- Safety Studies - Migraine (controlled and open label)
- Prior Safety Experience
- Nonclinical Development Toxicology
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WARNINGS & PRECAUTIONS
Hypothermia
Hypothermia, defined as an unintentional drop in body core temperature to < 35° C (95° F), has been reported in association with valproate therapy both in conjunction with and in the absence of hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramate with valproate after starting topiramate treatment or after increasing the daily dose of topiramate...
Interaction with Carbapenem Antibiotics
Carbapenem antibiotics (ertapenem, imipenem, meropenem) may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop significantly or seizure control deteriorates...
Suicidal Ideation
Suicidal ideation may be a manifestation of certain psychiatric disorders, and may persist until significant remission of symptoms occurs. Close supervision of high risk patients should accompany initial drug therapy.
Monitoring: Drug Plasma Concentration
Since Depakote ER may interact with concurrently administered drugs which are capable of enzyme induction, periodic plasma
concentration determinations of valproate and concomitant drugs are recommended during the early course of therapy...
Effect on Ketone and Thyroid Function Tests
Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.
There have been reports of altered thyroid function tests associated with valproate. The clinical significance of these is unknown...
Effect on HIV and CMV Viruses Replication
There are in vitro studies that suggest valproate stimulates the replication of the HIV and CMV viruses under certain experimental conditions. The clinical consequence, if any, is not known. Additionally, the relevance of these in vitro findings is uncertain for patients receiving maximally suppressive antiretroviral therapy. Nevertheless, these data should be borne in mind when interpreting the results from regular monitoring of the viral load in HIV infected patients receiving valproate or when following CMV
infected patients clinically. |
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Depakote (divalproex sodium) Sprinkle Capsules
Prescribing Information (in new labeling format)
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WARNINGS AND PRECAUTIONS
- Hypothermia
- Interaction with Carbapenem Antibiotics
- Monitoring: Drug Plasma Concentration
- Effect on Ketone and Thyroid Function Tests
- Effect on HIV and CMV Viruses Replication
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Initial Section
- Pediatric Clinical Trials
- Nonclinical Developmental Toxicology
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WARNINGS AND PRECAUTIONS
Hypothermia
Hypothermia, defined as an unintentional drop in body core temperature to < 35°C (95°F), has been reported in association with valproate therapy both in conjunction with and in the absence of hyperammonemia. This adverse reaction can also occur in patients
using concomitant topiramate with valproate after starting topiramate treatment or after increasing the daily dose of topiramate...
Interaction with Carbapenem Antibiotics
Carbapenem antibiotics (ertapenem, imipenem, meropenem) may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop significantly or seizure control deteriorates...
Monitoring: Drug Plasma Concentration
Since Depakote may interact with concurrently administered drugs which are capable of enzyme induction, periodic plasma
concentration determinations of valproate and concomitant drugs are recommended during the early course of therapy...
Effect on Ketone and Thyroid Function Tests
Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.
There have been reports of altered thyroid function tests associated with valproate. The clinical significance of these is unknown...
Effect on HIV and CMV Viruses Replication
There are in vitro studies that suggest valproate stimulates the replication of the HIV and CMV viruses under certain experimental conditions. The clinical consequence, if any, is not known. Additionally, the relevance of these in vitro findings is uncertain for patients receiving maximally suppressive antiretroviral therapy. Nevertheless, these data should be borne in mind when interpreting the results from regular monitoring of the viral load in HIV infected patients receiving valproate or when following CMV
infected patients clinically. |
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Invanz (ertapenem for injection)
Prescribing Information
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WARNINGS
PRECAUTIONS
- Drug Interactions
- A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving carbapenem antibiotics and may result in loss of seizure control...
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WARNINGS: Seizure Potential
Seizures and other CNS adverse experiences have been reported during treatment with Invanz...
Carbapenems, including ertapenem, may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop below the therapeutic range or a seizure occurs... |
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Merrem I.V. (meropenem for injection) for Intravenous Use Only
Prescribing Information |
WARNINGS
- Seizure Potential
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Drug Interactions
- A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving carbapenem antibiotics and may result in loss of seizure control...
- Information for Patients
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued...
ADVERSE REACTIONS
- Postmarketing Experience
- Hematologic
- A positive direct or indirect
Coombs test
- Hemolytic Anemia
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WARNINGS: Seizure Potential
Seizures and other CNS adverse experiences have been reported during treatment with Merrem I.V....
Carbapenems, including meropenem, may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop below the therapeutic range or a seizure occurs...
WARNINGS: Clostridium difficile
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial
agents, including Merrem I.V., 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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Monurol (fosfomycin tromethamine) Sachet
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 Monurol, 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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NovoLog (insulin aspart [rDNA origin] injection) Solution for Subcutaneous Use
Prescribing Information (in new labeling format)
Patient Package Insert |
WARNINGS AND PRECAUTIONS
- Hypersensitivity and Allergic Reactions
ADVERSE REACTIONS
- Clinical Trial Experience
- Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 Diabetes Mellitus
- Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus
PATIENT PACKAGE INSERT
- How should I take NovoLog?
- Read the instructions for use that come with your NovoLog product...
- If you take too much NovoLog...
- If you forget to take your dose of NovoLog...
- What are the possible side effects of NovoLog?
- Serious allergic reaction (whole body reaction)...
- Call your doctor for medical advice about side effects...
PATIENT INSTRUCTIONS FOR USE:
- NovoLog FlexPen Prefilled Syringe
- NovoLog 3 mL PenFill Cartridge
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WARNINGS AND PRECAUTIONS
Hypersensitivity and Allergic Reactions
Systemic Reactions - Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin product, including NovoLog. Anaphylactic reactions with NovoLog have been reported post-approval. Generalized allergy to insulin may also cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis... |
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Penicillin G Potassium
Injection, USP
For Intravenous Use Only - GALAXY Container (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 Penicillin G Potassium 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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Premarin Intravenous (conjugated estrogens, USP) for Injection
Prescribing Information
Patient Package Insert |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Gastrointestinal
- Central Nervous System
- Possible growth potentiation of benign meningioma
PATIENT PACKAGE INSERT
- What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?
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WARNINGS
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). In the estrogen alone substudy of WHI, after an average of 7.1 years of followup, daily CE 0.625 mg was not associated with an increased risk of invasive breast cancer (relative risk [RR] 0.80, 95 percent nominal confidence interval [nCI] 0.62-1.04)... |
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Premarin (conjugated estrogens tablets, USP)
Prescribing Information
Patient Package Insert |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Gastrointestinal
- Central Nervous System
- Possible growth potentiation of benign meningioma
PATIENT PACKAGE INSERT
- What can I do to lower my chances of getting a serious side effect with Premarin?
- If you have a uterus, talk with your healthcare provider...
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WARNINGS
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). In the estrogen alone substudy of WHI, after an average of 7.1 years of follow-up, daily CE 0.625 mg was not associated with an increased risk of invasive breast cancer ( relative
risk [RR] 0.80, 95 percent nominal confidence interval [nCI] 0.62-1.04)... |
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Premarin (conjugated estrogens) Vaginal Cream in a nonliquefying base
Prescribing Information
Patient Package Insert |
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
- Gastrointestinal
- Central Nervous System
- Possible growth potentiation of benign meningioma
PATIENT PACKAGE INSERT
- What can I do to lower my chances of getting a serious side effect from Premarin Vaginal Cream?
- If you have a uterus, talk with your healthcare provider...
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WARNINGS
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). In the estrogen alone substudy of WHI, after an average of 7.1 years of followup, daily CE 0.625 mg was not associated with an increased risk of invasive breast cancer (relative risk [RR] 0.80, 95 percent nominal confidence interval [nCI] 0.62-1.04)... |
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Prempro
(conjugated estrogens/medroxyprogesterone acetate tablets)
Premphase
(conjugated estrogens/medroxyprogesterone acetate tablets)
Prescribing Information
Patient Package Insert
|
WARNINGS
PRECAUTIONS
- General
- Nursing Mothers
- ...Prempro and Premphase should not be used during lactation.
- Pediatric Use
- ...no clinicial data have been collected in children.
- Geriatric Use
ADVERSE REACTIONS
- Genitourinary System
- Central Nervous System (CNS)
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WARNINGS
Malignant Neoplasms: Breast Cancer
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 conjugated estrogens (CE 0.625 mg) plus medroxyprogesterone acetate (MPA 2.5 mg). In the estrogen plus
progestin substudy, after a mean follow-up of 5.6 years, the WHI substudy reported an increased
risk of breast cancer in women who took daily CE/MPA... |
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Prezista (darunavir) Tablets
Prescribing Information
Patient Package Insert
See MedWatch Safety Alert posted 03/12/2008 for additional information on Prezista. |
WARNINGS
PRECAUTIONS
- Patients with co-existing conditions
- Table 11
- HMG-CoA Reductase Inhibitors
ADVERSE REACTIONS
- Patients co-infected with hepatitis B and/or hepatitis C virus
PATIENT PACKAGE INSERT
- What should I tell my doctor before I take Prezista?
- have liver problems, including hepatitis B or C
- Can Prezista be taken with other medications?
- What are the possible side effects of Prezista?
- Your healthcare professional should do blood tests prior to initiating combination treatment including Prezista...
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WARNINGS: Hepatotoxicity
Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with Prezista/rtv. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with Prezista/rtv. Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe hepatic adverse events.
Postmarketing cases of liver injury, including some fatalities, have been reported. These have generally occurred in patients with advanced HIV-1 disease taking multiple concomitant medications, having co-morbidities including hepatitis B or C co-infection, and/or developing immune reconstitution syndrome. A causal relationship with Prezista/rtv therapy has not been established...
Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/rtv and patients should be monitored during treatment. Increased AST/ALT
monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of Prezista/rtv treatment... |
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Primaxin I.M.
(imipenem and cilastatin for injectable suspension)
For Intramuscular Injection Only
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 Primaxin I.M., 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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Primaxin I.V. (imipenem and cilastatin for injection)
For Intravenous Injection Only
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 Primaxin I.V., 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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Sandostatin LAR Depot (octreotide acetate for injectable suspension)
Prescribing Information (in new labeling format) |
WARNINGS AND PRECAUTIONS
- Cholelithiasis and Gallbladder Sludge
- Hyperglycemia and Hypoglycemia
- Thyroid Function Abnormalities
ADVERSE REACTIONS
- Clinical Studies Experience
- Acromegaly
- Carcinoid and VIPomas
- Postmarketing Experience
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WARNINGS AND PRECAUTIONS
Cholelithiasis and Gallbladder Sludge
Sandostatin may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge. Patients should be monitored periodically...
Hyperglycemia and Hypoglycemia
Octreotide alters the balance between the counter-regulatory hormones, insulin, glucagon, and growth hormone, which may result in hypoglycemia or hyperglycemia. Blood glucose levels should be monitored when Sandostatin LAR treatment is initiated, or when the dose is altered. Antidiabetic treatment should be adjusted accordingly...
Thyroid Function Abnormalities
Octreotide suppresses the secretion of thyroid stimulating hormone, which may result in hypothyroidism... |
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Serevent Diskus (salmeterol xinafoate inhalation powder)
Prescribing Information
Medication Guide
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WARNINGS
- Potential Drug Interactions
PRECAUTIONS
- Drug Interactions
- Inhibitors of Cytochrome P450
3A4
MEDICATION GUIDE
- How do I use Serevent Diskus?
- While you are using Serevent Diskus twice a day, do not use other medicines that contain a long-acting beta2-agonist or LABA for any reason...
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WARNINGS
Potential Drug Interactions
Because of the potential for drug interactions and the potential for increased risk of cardiovascular adverse events, the concomitant use of Servent Diskus with strong CYP 3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) is not recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Drug Interactions). |
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Zevalin (ibritumomab tiuxetan) Injection for Intravenous Use
Prescribing Information (in new labeling format) |
WARNINGS AND PRECAUTIONS
- Serious Infusion Reactions
ADVERSE REACTIONS
- Severe or life-threatening adverse reactions occuring...
- Infusion Reaction (1%)...
- Immunogenicity
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION |
WARNINGS AND PRECAUTIONS
Serious Infusion Reactions
Rituximab, alone or as a component of the Zevalin therapeutic regimen, can
cause severe including fatal infusiön reactions...
...Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions. Immediately stop rituximab, In-111 Zevalin, or Y-90 Zevalin administration for severe infusion reactions... |
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Brand
(Generic) Name
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Sections Modified |
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate (butalbital, acetaminophen, caffeine, and codeine Phosphate) Capsules
Prescribing Information |
PRECAUTIONS
- Ultra-rapid Metabolizers of Codeine
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Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
Prescribing Information |
PRECAUTIONS
- Ultra-rapid Metabolizers of Codeine
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Flolan (epoprostenol sodium) for Injection
Prescribing Information
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PRECAUTIONS
- General
- Flolan is a potent inhibitor of platelet aggregation. Therefore, an increased risk for hemorrhagic
complications should be considered, particularly for patients with other risk factors for bleeding...
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Pexeva (paroxetine mesylate) Tablets
Prescribing Information
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PRECAUTIONS
- General
- Information for Patients
- Drug Interactions
- Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, Warfarin)
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Ponstel (mefenamic acid capsules, USP)
Contact Sciele Pharma, Inc. at 1-800-461-3696 for current prescribing information.
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) |
PRECAUTIONS
- Information for Patients
- In late pregnancy, as with other NSAIDs, Ponstel should be avoided because it may cause premature closure of the ductus arteriosus.
MEDICATION GUIDE
- Table: NSAID that need a prescription - The following footnote was added after the table: *Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.
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Prozac (fluoxetine capsules, USP)
(fluoxetine oral solution, USP)
(fluoxetine delayed-release capsules, USP)
Prescribing Information
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PRECAUTIONS
- General
- Abnormal Bleeding
- Hyponatremia
- Information for Patients
- Drug Interactions
- Drugs that interfere with hemostasis (e.g., NSAIDs, Aspirin, Warfarin)
- Geriatric Use
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Septra I.V. Infusion (trimethoprim and sulfamethoxazole)
Contact King Pharmaceuticals, Inc. at 1-800-776-3637 for current prescribing information.
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PRECAUTIONS
- General
- Prescribing Septra in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.
- Information for Patients
- Patients should be counseled that antibacterial drugs, including Septra should only be used to treat bacterial infections...
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Septra Tablets (trimethoprim and sulfamethoxazole tablets)
Septra DS Tablets (trimethoprim and sulfamethoxazole double-strength tablets)
Septra Suspension (trimethoprim and sulfamethoxazole suspension)
Septra Grape Suspension
(trimethoprim and sulfamethoxazole grape suspension)
Prescribing Information
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PRECAUTIONS
- General
- Prescribing Septra in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.
- Information for Patients
- Patients should be counseled that antibacterial drugs, including Septra should only be used to treat bacterial infections...
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Symbyax (olanzapine and fluoxetine HCl capsules)
Prescribing Information |
PRECAUTIONS
- General
- Abnormal Bleeding
- Hyponatremia
- Information for Patients
- Drug Interactions
- Drugs that interfere with hemostasis (e.g., NSAIDs, Aspirin, Warfarin)
- Geriatric Use
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Tigan (trimethobenzamide hydrochloride)
Capsules
Prescribing Information |
PRECAUTIONS
- General
- Adjustment of Dose in Renal Failure
- Geriatric Use
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Urex (methenamine hippurate) Tablets
Prescribing Information |
PRECAUTIONS
- General
- Prescribing Urex in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
- Information for Patients
- Patients should be counseled that antibacterial drugs including Urex
should only be used to treat bacterial infections...
- Carcinogenesis, Mutagenesis, and Impairment of Fertility
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Ventolin HFA (albuterol sulfate) Inhalation Aerosol
Prescribing Information (in new labeling format) |
USE IN SPECIFIC POPULATIONS
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Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate
Prescribing Information
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PRECAUTIONS
- Abnormal Bleeding
- Information for Patients
- Drug Interactions
- Drugs That Interfere With Hemostasis (Non-selective NSAIDs, Aspirin, Warfarin, etc.)
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Zometa (zoledronic acid) Injection Concentrate for Intravenous Infusion
Prescribing Information (in new labeling format) |
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Zometa is not indicated for use in children...
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Brand
(Generic) Name
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Sections Modified |
Abilify (aripiprazole) Tablets and Oral Solution
Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets
Abilify (aripiprazole) Injection for Intramuscular Use Only
Prescribing Information (in new labeling format) |
ADVERSE REACTIONS
- Clinical Studies Experience
- Dose-Related Adverse Reactions
- Extrapyramidal Symptoms
- Dystonia - Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.......
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Avastin (bevacizumab) for Intravenous Use
Prescribing Information
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ADVERSE REACTIONS
- Other Serious Adverse Events
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Azmacort (triamcinolone acetonide) Inhalation Aerosol
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing
- ...very rare reports of bone mineral density loss and osteoporosis, especially with prolonged use, which may lead to an increased risk of fractures.
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Levitra (vardenafil HCl) Tablets
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing Experience
- Neurologic
- Seizure and seizure recurrence have been reported postmarketing in temporal association
with Levitra.
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PegIntron and Rebetol (peginterferon alfa-2b and ribavirin)
Prescribing Information
Medication Guide |
ADVERSE REACTIONS
- The adverse event profile in Study 3...
MEDICATION GUIDE
- The most serious possible side effects of Peglntron and PegIntron/Rebetol therapy include:
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Moban (molindone hydrochloride tablets, USP)
Prescribing Information
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ADVERSE REACTIONS
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Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules
Prescribing Information
See MedWatch Safety Alert posted 03/27/2008 for additional information on Singulair
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ADVERSE REACTIONS
- Postmarketing Experience
- Erythema Nodosum
- Suicidal Thinking and Behavior (Suicidality)
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Ventavis (iloprost) Inhalation Solution
Prescribing Information
Patient Package Insert |
ADVERSE REACTIONS
- Pre-marketing Experiences
- Postmarketing Experience (new subsection)
PATIENT PACKAGE INSERT
- What are the side effects with Ventavis?
- Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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