Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications and Warnings |
Definity (perflutren lipid microsphere) Injectable Suspension
Prescribing Information
|
BOXED WARNING
- WARNING: Serious Cardiopulmonary Reactions
WARNINGS
- Serious Cardiopulmonary Reactions
- Anaphylactoid Reactions
ADVERSE REACTIONS
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BOXED WARNING AND WARNINGS
Serious cardiopulmonary reactions, including fatalities, have occurred during or following
perflutren-containing microsphere administration.
BOXED WARNING
In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after Definity administration...
WARNINGS
Serious Cardiopulmonary Reactions
...In these patients, monitor vital signs, electrocardiography, and cutaneous oxygen saturation during and for at least 30 minutes after Definity administration. In the absence of these underlying conditions, observe patients closely during and following Definity administration.
In postmarketing use, uncommon but serious reactions observed during or shortly following
perflutren-containing microsphere administration included fatal cardiac or respiratory arrest...
Anaphylactoid Reactions
Post-marketing reports of acute anaphylactoid reactions including shock, bronchospasm, upper
airway swelling, loss of consciousness, urticaria and pruritus, have occurred in patients with no prior exposure to perflutren-containing microsphere products... |
Back to Summary Page | Back to Top
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Ambien (zolpidem tartrate) Tablets
Prescribing Information (in new labeling format)
Medication Guide |
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Abnormal thinking and behavioral changes
- Special populations
- Use in patients with concomitant illness
ADVERSE REACTIONS
- Clinical trials experience
- Adverse event incidence across the entire preapproval database
- Body as a whole
- Central and peripheral nervous system
- headache
- anxiety
- nervousness
- Gastrointestinal system
- dyspepsia
- nausea
- anorexia
- vomiting
- Immunologic system
- Musculoskeletal system
- Frequent
- Respiratory system
- upper respiratory infection (frequent)
- rhinitis
- Urogenital system
- urinary tract infection (frequent)
DRUG INTERACTIONS
- Drugs that affect drug metabolism via cytochrome P450
- Drug-laboratory test interactions
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Nursing mothers
- Pediatric use
- Geriatric use
PATIENT COUNSELING INFORMATION
- Severe anaphylactic and anaphylactoid reactions
- Sleep-driving and other complex behaviors
- Administration instructions
MEDICATION GUIDE |
CONTRAINDICATIONS
...Observed reactions include anaphylaxis and angioedema.
WARNINGS AND PRECAUTIONS
Abnormal thinking and behavioral changes
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem...
Special populations: Use in patients with concomitant illness
...Since sedative/hypnotics have the capacity to depress respiratory drive, precautions should be taken if Ambien is prescribed to patients with compromised respiratory function...
...Ambien should be used with caution in patients with sleep apnea syndrome or myasthenia gravis.
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Ceftriaxone for Injection and Dextrose Injection
Prescribing Information
See MedWatch Safety Alert for Rocephin posted 09/11/2007 and 07/05/2007 for additional safety information.
|
CONTRAINDICATIONS
WARNINGS
- Hypersensitivity
- Interaction with Calcium-Containing Products
- Clostridium difficile
PRECAUTIONS
- Pediatric Use
- ...Ceftriaxone for Injection and Dextrose Injection should not be administered...
ADVERSE REACTIONS
- Local Reactions
- Pain, induration and tenderness was 1% overall ...
- Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in neonates have been described...
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CONTRAINDICATIONS
Neonates (<28 days)
Hyperbilirubinemic neonates, especially prematures, should not be treated with Ceftriaxone for
Injection and Dextrose Injection. In vitro studies have shown that ceftriaxone can displace
bilirubin from its binding to serum albumin and bilirubin encephalopathy can possibly develop in these patients.
Ceftriaxone for Injection and Dextrose Injection must not be co-administered with calcium containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition, in neonates because of the risk of precipitation of ceftriaxone-calcium salt. Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in neonates have been described. In some cases the infusion lines and the times of administration of ceftriaxone and calcium-containing solutions differed.
WARNINGS
Interaction with Calcium-Containing Products
There are no reports to date of intravascular or pulmonary precipitations in patients, other
than neonates, treated with ceftriaxone and calcium-containing IV solutions. However, the theoretical possibility exists for an interaction between ceftriaxone and IV calcium-containing solutions in patients other than neonates. Therefore, Ceftriaxone for Injection and Dextrose Injection and calcium-containing solutions, including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. As a further theoretical consideration and based on 5 half-lives of ceftriaxone, Ceftriaxone for Injection and Dextrose Injection and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient...
No data are available on potential interaction between ceftriaxone and oral calcium-containing products
or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral). |
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Mirena (levonorgestrel-releasing intrauterine system)
Prescribing Information
Patient Package Insert
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CONTRAINDICATIONS
WARNINGS
- Ectopic Pregnancy
- Sepsis
- Perforation
- Ovarian Cysts
- Breast Cancer
PRECAUTIONS
- Continuation and Removal
- Mirena should be removed for the following reasons:
- Pelvic Infection
- Endometritis
- Drug Interactions
- Nursing Mothers
ADVERSE REACTIONS
- Other relevant reported adverse reactions occurring in less than 5% of subjects include:
- Postmarketing Experience
PATIENT PACKAGE INSERT
- What is Mirena?
- How does Mirena work?
- Who should not use Mirena?
- Tell your health care provider if you...
- How is Mirena placed?
- How can I check that Mirena is in place?
- Is it safe to breast-feed while using Mirena?
- What are the possible side effects of usine Mirena?
- When should I call my health care provider?
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CONTRAINDICATIONS
Mirena is contraindicated when one or more of the following conditions exist:
- Conditions associated with increased susceptibility to pelvic infections.
WARNINGS
Ectopic Pregnancy
...Up to half of pregnancies that occur with Mirena in place are ectopic. The incidence of ectopic pregnancy in clinical trials that excluded women with risk factors for ectopic pregnancy was about 1 ectopic pregnancy per 1000 users per year.
Tell women who choose Mirena about the risks of ectopic pregnancy, including the loss of fertility. Teach them to recognize and report to their physician promptly any symptoms of ectopic pregnancy...
Sepsis
...In some cases, severe pain
occurred within hours of insertion followed by sepsis within days...
Perforation
Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later...
Ovarian Cysts
...Surgical intervention is not usually required.
Breast Cancer
...Two observational studies have not provided evidence of an increased risk of breast cancer during the use of Mirena. |
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Noxafil (posaconazole) Oral Suspension
Prescribing Information
Patient Package Insert |
CONTRAINDICATIONS
PRECAUTIONS
- Information for Patients
- Drug Interactions
- Table 8
- Table 9
- Sirolimus
- Atazanavir
- Ritonavir
- Table 10
PATIENT PACKAGE INSERT
- Who should not take Noxafil?
- Can I take other medicines with Noxafil?
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CONTRAINDICATIONS
...Co-administration of Noxafil (posaconazole) with sirolimus is contraindicated ...
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Valium (diazepam) Tablets
Prescribing Information
|
CONTRAINDICATIONS
WARNINGS
- Initial Section
- Pregnancy
- Labor and Delivery (new subsection)
- Nursing Mothers (new subsection)
PRECAUTIONS
- General
- Information for Patients
- Drug Interactions
- Centrally Acting Agents
- Alcohol
- Antacids
- Compounds Which Inhibit Certain Hepatic Enzymes
- Phenytoin
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy: Category D
- Geriatric Use (new subsection)
- Hepatic Insufficiency (new subsection)
ADVERSE REACTIONS
- Initial Section
- Central Nervous System
- Gastrointestinal System
- Special Senses
- Cardiovascular System
- Psychiatric and Paradoxical Reactions
- Urogenital System
- Skin and Appendages
- Laboratories
- Other
- Antegrade Amnesia...
- Minor changes in EEG patterns...
|
Major revisions to labeling. See highlighted labeling for revised/new text.
CONTRAINDICATIONS
...Valium is also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome...
WARNINGS
Initial Section
...As with other agents that have anticonvulsant activity, when Valium is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of Valium in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.
Pregnancy
See section for new text.
Labor and Delivery
Special care must be taken when Valium is used during labor and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate respiratory depression in the neonates. With newborn infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).
Nursing Mothers
Diazepam passes into breast milk. Breastfeeding is therefore not recommended in patients receiving Valium. |
Back to Summary Page | Back to Top
Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Accolate (zafirlukast) Tablet, Film Coated
Prescribing Information
|
WARNINGS
|
WARNINGS
...In extremely rare post-marketing cases, no clinical symptoms or signs suggestive of liver dysfunction were reported to precede the latter observations. |
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Caduet (amlodipine besylate/atorvastatin calcium) Tablets
Prescribing Information
|
WARNINGS
PRECAUTIONS
- Drug Interactions
- Studies with Atorvastatin
- The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased...
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WARNINGS
Skeletal Muscle
The risk of myopathy during treatment with drugs in the HMG-CoA reductase inhibitor class is
increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin,
clarithromycin, combination of ritonavir plus saquinavir or lopinavir plus ritonavir, niacin, or azole antifungals... |
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CellCept
(mycophenolate mofetil capsules)
CellCept (mycophenolate mofetil tablets)
CellCept Oral Suspension
(mycophenolate mofetil for oral suspension)
CellCept Intravenous
(mycophenolate mofetil hydrochloride for injection)
Prescribing Information
See MedWatch Safety Alerts, most recently updated 6/26/2008, for additional safety information.
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WARNINGS
- Lymphoma and Malignancy
- Infections
- Progressive Multifocal Leukoencephalopathy (PML)
ADVERSE REACTIONS
- See highlighted text for revised labeling
- Postmarketing Experience
- Resistance Mechanism Disorders
- Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal...
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WARNINGS
Lymphoma and Malignancy
Lymphoproliferative disease or lymphoma developed in 0.4% to 1% of patients receiving
CellCept (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of renal,
cardiac, and hepatic transplant patients.
In pediatric patients, no other malignancies besides lymphoproliferative disorder (2/148 patients) have been observed.
Infections
Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections, and sepsis. In patients receiving CellCept (2 g or 3 g) in controlled studies for prevention of renal, cardiac or hepatic rejection, fatal infection/sepsis occurred in approximately 2% of renal and cardiac patients and in 5% of hepatic patients.
Progressive Multifocal Leukoencephalopathy (PML)
Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been
reported in patients treated with CellCept... |
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Chantix (varenicline) Tablets
Prescribing Information
Medication Guide
See MedWatch Safety Alert posted 5/16/2008 and 11/20/2007 for additional information. |
WARNINGS
- Neuropsychiatric Symptoms
PRECAUTIONS
- Information for Patients (see highlighted text for new information.)
MEDICATION GUIDE (new) |
WARNINGS
Neuropsychiatric Symptoms
Advise patients and caregivers that the patient should stop taking Chantix and contact a
healthcare provider immediately if agitation, depressed mood, or changes in behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. |
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Furadantin (nitrofurantoin) 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 Furadantin Oral Suspension, 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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Hepsera (adefovir dipivoxil) Tablets
Prescribing Information (in new labeling format)
|
WARNINGS AND PRECAUTIONS
- Clinical Resistance (new subsection)
ADVERSE REACTIONS
- Clinical Trials Experience
- For 65 patients who chose to continue Hepsera for up to 240 weeks in Study 437, 6 had a confirmed increase in serum creatinine of >0.5 mg/dL from baseline with 2 patients discontinuing from the study due to the elevated serum creatinine concentration.
- Postmarketing Experience (new subsection)
PATIENT COUNSELING INFORMATION
- Lamivudine-resistant patients should use Hepsera in combination with lamivudine and not as Hepsera monotherapy [See Warnings and
Precautions. (5.5)]
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WARNINGS AND PRECAUTIONS
Clinical Resistance
Resistance to adefovir dipivoxil can result in viral load rebound which may result in
exacerbation of hepatitis B and, in the setting of diminished hepatic function, lead to
liver decompensation and possible fatal outcome.
In order to reduce the risk of resistance in patients with lamivudine resistant HBV,
adefovir dipivoxil should be used in combination with lamivudine and not as adefovir dipivoxil monotherapy.
Long-term (144 week) data from Study 438 (n=124) show that patients with HBV DNA levels greater than 1000 copies/mL at Week 48 of treatment with Hepsera were at greater risk of developing resistance than patients with serum HBV DNA levels below 1000 copies/mL at Week 48 of therapy. |
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Herceptin (trastuzumab) Intravenous Infusion
Prescribing Information (in new labeling format)
See MedWatch Safety Alert posted 07/10/2008 for additional information. |
WARNINGS AND PRECAUTIONS
- Cardiomyopathy
- Cardiac Monitoring
- Table 1
- Table 2
ADVERSE REACTIONS
- Clinical Trials Experience
- Adjuvant Breast Cancer Studies
- Safety data from Study 4 ...
- Metastatic Breast Cancer Studies
- Cardiomyopathy
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WARNINGS AND PRECAUTIONS
Cardiac Monitoring
...In Study 4, a total of 2.9% (31/1056) patients in the TCH arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) patients in the AC-TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued Herceptin due to cardiac toxicity...
See highlighted prescribing information for additional new text. |
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Intron A (interferon alfa-2b, recombinant) For Injection
Prescribing Information
Medication Guide - Intron A Multidose Pen for Injection
Medication Guide - Intron A Solution for Injection
Medication Guide - Intron A Powder for Injection |
WARNINGS
MEDICATION GUIDE - Intron A Multidose Pen for Injection
- The most serious possible side effects of Intron A include:
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
MEDICATION GUIDE - Intron A Solution for Injection
- The most serious possible side effects of Intron A include:
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
- For Intramuscular Injection
- ...If after using a multidose vial (18 million IU or 25 million IU) there is enough solution...
MEDICATION GUIDE - Intron A Powder for Injection
- The most serious possible side effects of Intron A 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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WARNINGS
Cerebrovascular Disorders
Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha-based therapies, including Intron A. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alpha-based therapies and these events is difficult to establish. |
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Keflex (cephalexin) Capsules
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics...
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WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Keflex, 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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Keppra (levetiracetam) Injection for Intravenous Use
Prescribing Information (in new labeling format) |
WARNINGS AND PRECAUTIONS
- Neuropsychiatric Adverse Reactions
- Primary Generalized Tonic-Clonic Seizures
ADVERSE REACTIONS
- Clinical Studies Experience
- Primary Generalized Tonic-Clonic Seizures (located after Table 4)
- Table 5
- Discontinuation Or Dose Reduction In Well-Controlled Clinical Studies
- Primary Generalized Tonic-Clonic Seizures (located after Table 7)
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WARNINGS AND PRECAUTIONS
Neuropsychiatric Adverse Reactions: Primary Generalized Tonic-Clonic Seizures
...As in the partial seizure
patients, behavioral symptoms appeared to be associated
with Keppra treatment. Gait disorders and somnolence
were also described in the study in primary generalized seizures, but with no difference between placebo and Keppra treatment groups and no appreciable discontinuations...
In some patients experiencing primary generalized tonic-clonic
seizures, Keppra causes behavioral abnormalities.
In the double-blind, controlled trial in patients with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures, irritability was the most frequently reported psychiatric adverse event occurring in 6.3% of Keppra-treated patients compared to 2.4% of placebo patients...
Non-psychotic mood disorders (reported as anger, apathy,
depression, mood altered, mood swings, negativism, suicidal ideation, and tearfulness) occurred in 12.7% of
Keppra-treated patients compared to 8.3% of placebo
patients... |
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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
- Tendon Effects
- Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Inhalational Anthrax (Post-Exposure)
- Adverse Events
PATIENT COUNSELING INFORMATION
- Serious and Potentially Serious Adverse Reactions
- Musculoskeletal Disorders in Pediatric Patients
PATIENT PACKAGE INSERT
- Who should not take Levaquin?
- What if I have been prescribed Levaquin for possible anthrax exposure?
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WARNINGS AND PRECAUTIONS
Tendon Effects
...Postmarketing surveillance reports indicate that this
risk is increased in patients receiving concomitant corticosteroids and in patients over 65 years of age. Levaquin should be discontinued if the patient experiences pain,
inflammation, or rupture of a tendon...
Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals
Levaquin is indicated in pediatric patients (less than 18 years of age) only for the prevention of inhalational anthrax (post-exposure)... |
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Mycobutin (rifabutin capsules, USP)
Prescribing Information |
WARNINGS
- Clostridium difficile associated diarrhea (CDAD)
PRECAUTIONS
- Information for Patients
- Diarrhea is a common problem caused by antibiotics...
|
WARNINGS
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including Mycobutin (rifabutin capsules, 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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Myfortic (mycophenolic acid) Delayed-Release Tablets
Prescribing Information
See MedWatch Safety Alerts, most recently updated 05/16/2008, for additional safety information. |
WARNINGS
- Lymphoma and Other Malignancies
- Progressive Multifocal Leukoencephalopathy (PML)
ADVERSE REACTIONS
- Postmarketing Experience (new subsection)
- Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal...
- Congenital malformations have been reported in offspring of patients...
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WARNINGS
Lymphoma and Other Malignancies
...The rates for lymphoproliferative disease or lymphoma in Myfortic-treated patients were comparable
to the mycophenolate mofetil group in the de novo and maintenance studies. As usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Progressive Multifocal Leukoencephalopathy (PML)
Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with mycophenolate mofetil (MMF)...
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Primaxin I.M.
(imipenem and cilastatin for injectable suspension)
Prescribing Information |
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
Seizures and other CNS adverse experiences, such as myoclonic activity, have been reported during treatment with Primaxin I.M.
Carbapenems, including imipenem, 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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Primaxin I.V. (imipenem and cilastatin) For Injection
Prescribing Information |
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
Seizures and other CNS adverse experiences, such as confusional states and myoclonic activity, have been reported during treatment with Primaxin I.V.
Carbapenems, including imipenem, 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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Strattera (atomoxetine hydrochloride) Capsules
Prescribing Information (in new labeling format) |
WARNINGS AND PRECAUTIONS
- Effects on Blood Pressure and Heart Rate
- Effects on Urine Outflow from the Bladder
- Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients who are known to be CYP2D6 PMs
ADVERSE REACTIONS
- Clinical Trials Experience
- Child and Adolescent Clinical Trials
- Reasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trials
- Commonly observed adverse reactions in acute child and adolescent, placebo-controlled trials
- Table 1
- Table 2
- The following adverse reactions occurred in at least 2%...
- Adult Clinical Trials
- Reasons for discontinuation of treatment due to adverse reactions in acute adult placebo-controlled trials
- Commonly observed adverse reactions in acute adult placebo-controlled trials
- Postmarketing Spontaneous Reports
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WARNINGS AND PRECAUTIONS
Effects on Blood Pressure and Heart Rate
See highlighted text for revised labeling.
Effects on Urine Outflow from the Bladder
In adult ADHD controlled trials, the rates of urinary retention (1.7%, 9/540) and urinary hesitation (5.6%, 30/540) were increased among atomoxetine subjects compared with placebo subjects (0%, 0/402 ; 0.5%, 2/402, respectively)...
Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients who are known to be CYP2D6 PMs
Atomoxetine is primarily metabolized by the CYP2D6 pathway to 4-hydroxyatomoxetine. Dosage adjustment of Strattera may be necessary when coadministered with potent CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine) or when
administered to CYP2D6 PMs... |
Back to Summary Page | Back to Top
Brand
(Generic) Name
|
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) |
DRUG INTERACTIONS
- Drugs Having No Clinically Important Interactions with Abilify
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Aranesp (darbopoetin alfa) For Injection
Prescribing Information |
PRECAUTIONS
- Hematology
- Patients Transitioning to Dialysis
ADVERSE REACTIONS
- Chronic Renal Failure
Patients
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Argatroban Injection
Prescribing Information |
PRECAUTIONS
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Biaxin Filmtab (clarithromycin tablets, USP)
Biaxin XL Filmtab (clarithromycin extended-release tablets)
Biaxin Granules (clarithromycin for oral suspension, USP)
Prescribing Information
|
PRECAUTIONS
- General
- Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving clarithromycin therapy.
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Dexedrine (dextroamphetamine sulfate)
Spansule Sustained-Release Capsules
Prescribing Information
Medication Guide
|
PRECAUTIONS
- Pediatric Use
- Dexedrine is not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder with Hyperactivity...
MEDICATION GUIDE
- Who should not take Dexedrine?
- Dexedrine is not recommended for use in children less than 6 years old.
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E.E.S. (erythromycin ethylsuccinate)
Prescribing Information |
PRECAUTIONS
- General
- Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic
syndrome has been reported in patients receiving erythromycin therapy.
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Ery-Ped (erythromycin ethylsuccinate, USP)
Prescribing Information |
PRECAUTIONS
- General
- Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic
syndrome has been reported in patients receiving erythromycin therapy.
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Inderal (propranolol hydrochloride) Tablets
Prescribing Information |
PRECAUTIONS
- Drug Interactions
- Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
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Inspra (eplerenone) Tablets
Prescribing Information (in new labeling format) |
USE IN SPECIFIC POPULATIONS
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Lotensin (benazepril hydrochloride) Tablets
For current prescribing information, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682.
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PRECAUTIONS
- Drug Interactions
- Carcinogenesis, Mutagenesis, Impairment of Fertility
ADVERSE REACTIONS
- Other
- Frequent Urination
- The following adverse events of unknown frequency have been reported during post-marketing use of benazepril: small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, and neutropenia.
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Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide, USP)
For current prescribing information, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682. |
PRECAUTIONS
ADVERSE REACTIONS
- Unknown Frequency
- Small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, neutropenia.
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Malarone (atovaquone and proguanil hydrochloride) Tablets
Prescribing Information |
PRECAUTIONS
- Drug Interactions
- Proguanil may potentiate the anticoagulant effect of warfarin and other coumarin-based anticoagulants. The mechanism of this potential drug interaction has not been established. Caution is advised when initiating or withdrawing malaria prophylaxis or treatment with Malarone in patients on continuous treatment with coumarin-based anticoagulants. When these products are administered concomitantly, suitable coagulation tests should be closely monitored.
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Mepron (atovaquone) Suspension
Prescribing Information
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PRECAUTIONS
- General
- Rare cases of hepatitis, elevated liver function tests and one case of fatal liver failure have been
reported in patients treated with atovaquone. A causal relationship between atovaquone use and these events could not be established because of numerous confounding medical conditions and concomitant drug therapies...
ADVERSE REACTIONS
- Postmarketing Experience
- Blood and Lymphatic System Disorders
- Immune System Disorders: Hypersensitivity reactions including angioedema, bronchospasm, throat tightness, and urticaria.
- Eye Disorders
- Gastrointestinal Disorders: Pancreatitis
- Hepatobiliary Disorders: Rare cases of hepatitis and one case of fatal liver failure have been reported with atovaquone usage.
- Skin and Subcutaneous Tissue Disorders: ...Stevens-Johnson syndrome, and skin desquamation have been reported in patients receiving multiple drug therapy including atovaquone.
- Renal and Urinary Disorders
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PCE (erythromycin particles in tablets) Dispertabs Tablets
Prescribing Information |
PRECAUTIONS
- General
- Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic
syndrome has been reported in patients receiving erythromycin therapy.
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Sensipar (cinacalcet) Tablets
Prescribing Information |
PRECAUTIONS
- Drug Interactions and/or Drug/Laboratory Test Interactions
- Effect of Sensipar on other drugs
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Tekturna (aliskiren) Tablets
Prescribing Information
Patient Package Insert
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PRECAUTIONS
- Cyclosporine
- When aliskiren was given with cyclosporine, the blood concentrations of aliskiren were significantly increased. Concomitant use of aliskiren with cyclosporine is not recommended.
PATIENT PACKAGE INSERT
- Tell your doctor about all the medicines you take...
- cyclosporine (a medicine used to suppress the immune system).
- potassium-containing medicines, potassium supplements, or salt substitutes containing potassium.
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Timentin (ticarcillin disodium and clavulanate potassium) Injection
Galaxy (PL 2040) Plastic Container
Prescribing Information |
PRECAUTIONS
- Drug/Laboratory Test Interactions
- ...In common with other antibiotics, ticarcillin disodium/clavulanate potassium may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
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Timentin (sterile ticarcillin disodium and clavulanate potassium) for Intravenous Administration
(Pharmacy Bulk Package - Not for Direct Infusion)
Prescribing Information |
PRECAUTIONS
- Drug/Laboratory Test Interactions
- ...In common with other antibiotics, ticarcillin disodium/clavulanate potassium may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
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Vfend I.V. (voriconazole) for Injection
Vfend (voriconazole) Tablets
Vfend (voriconazole) for Oral Suspension
Prescribing Information |
PRECAUTIONS
- Drug Interactions
- Table 12: Effect of Voriconazole on Pharmacokinetics of Other Drugs
- Alfentanil (CYP3A4 Inhibition)
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Brand
(Generic) Name
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Sections Modified |
Effexor (venlafaxine hydrochloride) Tablets
Prescribing Information
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ADVERSE REACTIONS
- Postmarketing Reports
- Toxic Epidermal Necrolysis
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Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
Prescribing Information |
ADVERSE REACTIONS
- Postmarketing Reports
- Toxic Epidermal Necrolysis
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Emtriva (emtricitabine) Capsules and Oral Solution
Prescribing Information (in new labeling format) |
ADVERSE REACTIONS
- Adverse Reactions from Clinical Trials Experience
- Adult Patients
- Study 934 - Treatment Emergent Adverse Reactions
- Laboratory Abnormalities
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Geodon (ziprasidone HCl) Capsules
Geodon (ziprasidone mesylate) for Injection For IM Use Only
Prescribing Information |
ADVERSE REACTIONS
- Extrapyramidal Symptoms
(EPS)
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Haldol (brand of haloperidol injection)
For Immediate Release
Prescribing Information |
ADVERSE REACTIONS
- CNS Effects
- Extrapyramidal Symptoms
(EPS)
- Dystonia - Class Effect
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Haldol Decanoate (haloperidol) For IM Injection Only
Prescribing Information |
ADVERSE REACTIONS
- CNS Effects
- Extrapyramidal Symptoms
(EPS)
- Dystonia - Class Effect
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Invega (paliperidone) Extended-Release Tablets
Prescribing Information (in new labeling format) |
ADVERSE REACTIONS
- Extrapyramidal Symptoms
(EPS)
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Lariam (mefloquine hydrochloride) Tablets
Prescribing Information |
ADVERSE REACTIONS
- Postmarketing
- Other infrequent adverse events
- Respiratory Disorders
- Dyspnea
- Pneumonitis of possible allergic etiology
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Levitra (vardenafil hydrochloride) Tablets
Prescribing Information |
ADVERSE REACTIONS
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Seroquel (quetiapine fumarate) Tablets
Prescribing Information (in new labeling format)
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ADVERSE REACTIONS
- Clinical Study Experience
- Postmarketing Experience
- Anaphylactic Reaction
- Restless Legs
DRUG INTERACTIONS
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Seroquel XR (quetiapine fumarate) Extended-Release Tablets
Prescribing Information (in new labeling format) |
ADVERSE REACTIONS
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Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Prescribing Information (in new labeling format) |
ADVERSE REACTIONS
- Adverse Reactions from Clinical Trials Experience
- Study 934
- Laboratory Abnormalities
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Uroxatral (alfuzosin HCl extended-release tablets)
Prescribing Information |
ADVERSE REACTIONS
- Postmarketing Adverse Event Reports
- Hepatobiliary Disorders
- Hepatocellular and cholestatic liver injury (including cases with
jaundice leading to drug discontinuation)
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Viread (tenofovir disoproxil fumarate) Tablets
Prescribing Information (in new labeling format) |
ADVERSE REACTIONS
- Adverse Reactions from Clinical Trials Experience
- Treatment-Naive Patients
- Study 934 - Treatment Emergent Adverse Reactions
- Laboratory Abnormalities
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Brand (Generic) Name
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Sections Modified |
Actos (pioglitazone HCl) Tablets
Patient Package Insert
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PATIENT PACKAGE INSERT (new) |
Back to Summary Page | Back to Top
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