Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications and Warnings |
Optison
(Perflutren Protein -Type A Microspheres Injectable Suspension, USP)
Prescribing Information
See MedWatch Safety Alert posted 07/17/2008 for additional safety information. |
BOXED WARNING
- WARNING: Serious Cardiopulmonary Reactions
WARNINGS
- Serious Cardiopulmonary Reactions
|
BOXED WARNING
WARNING: Serious Cardiopulmonary Reactions
...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 Optison administration...
WARNINGS
Serious Cardiopulmonary Reactions
...The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation). In these patients, monitor vital signs, electrocardiography, and cutaneous oxygen saturation during and for at least 30 minutes after Optison administration... |
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Viramune (nevirapine) Tablets and Oral Suspension
Prescribing Information (in new labeling format)
Medication Guide
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BOXED WARNING
- Skin Reactions
- Monitoring
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Hepatotoxicity and Hepatic Impairment
- Skin Reactions
- Drug Interactions
ADVERSE REACTIONS
- Clinical Trials in Pediatrics
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Hepatic Impairment
PATIENT COUNSELING INFORMATION
- Hepatotoxicity and Skin Reactions
- ...Patients should be instructed that if any rash occurs during the two-week lead-in period, the Viramune dose should not be escalated until the rash resolves...
MEDICATION GUIDE
- Who should not take Viramune?
- Do not take Viramune if you have severe liver problems.
- How should I take Viramune?
- ...Therefore, it is important to strictly follow the once daily dose for the first 14 days. If you have a skin rash during the first 14 days immediately contact your doctor and do not increase your dose to Viramune twice a day. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen may need to be started...
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BOXED WARNING
Skin Reactions
...Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with Viramune 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed...
Monitoring
Patients must be monitored intensively during the first 18 weeks of therapy with Viramune to detect potentially life-threatening hepatotoxicity or skin reactions...
CONTRAINDICATIONS
Viramune is contraindicated in patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment...
WARNINGS AND PRECAUTIONS
Hepatotoxicity and Hepatic Impairment
...Transaminases should be checked immediately if a patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity reaction. Transaminases should also be checked immediately for all patients who develop a rash in the first 18 weeks of treatment...
...Nevirapine should not be administered to patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment...
Skin Reactions
...A patient experiencing a mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) should not have their Viramune dose increased until the rash has resolved. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought...
Drug Interactions
Concomitant use of St. John's wort (Hypericum perforatum) or St. John's wort containing products and Viramune is not recommended. Co-administration of St. John’s wort with non-nucleoside reverse transcriptase inhibitors (NNRTIs), including Viramune, is expected to substantially decrease NNRTI concentrations and may result in sub-optimal levels of Viramune and lead to loss of virologic response and possible resistance to Viramune or to the class of NNRTIs. |
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Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Aptivus (tipranavir) Capsules and Oral Solution
Prescribing Information (in new labeling format)
Patient Package Insert
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CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Effects on Platelet Aggregation and Coagulation
- Vitamin E Intake
- Rash
ADVERSE REACTIONS
- Clinical Trials in Pediatric Patients (new subsection)
DRUG INTERACTIONS
- Potential for Aptivus/ritonavir to Affect Other Drugs
- ...Aptivus oral solution co-administered with ritonavir capsules demonstrated similar effects as Aptivus capsules co-administrated with ritonavir...
- Potential for Other Drugs to Affect Tipranavir
- Table 4
- Benzodiazepines:
Parenterally administered midazolam
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
- Use of Vitamin E (new subsection)
- Administration
- ...Aptivus can be taken with or without food.
PATIENT PACKAGE INSERT
- Who should not take Aptivus?
- Do not take Aptivus if you take...
- Versed (midazolam) orally
- Tell your healthcare professional...
- If you are taking Aptivus oral solution, which contains vitamin E, you should not take additional vitamin E...
- How should I take Aptivus?
- What are the possible side effects of Aptivus?
- ...Rash was seen more frequently in children.
- How should I store Aptivus?
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CONTRAINDICATIONS
Drug Interactions: Oral midazolam
WARNINGS AND PRECAUTIONS
Effect on Platelet Aggregation and Coagulation
...In rats, tipranavir treatment alone induced dose-dependent changes in coagulation parameters, bleeding events and death. Co-administration with vitamin E significantly increased these effects [see Nonclinical Toxicology (13.2)]. However, analyses of stored plasma from adult patients treated with Aptivus capsules and pediatric patients treated with Aptivus oral solution (which contains a vitamin E derivative) showed no effect of Aptivus/ritonavir on vitamin K-dependent coagulation factors (Factor II and Factor VII), Factor V, or on prothrombin or activated partial thromboplastin times...
Vitamin E Intake
Patients taking Aptivus oral solution should be advised not to take supplemental vitamin E greater than a standard multivitamin as Aptivus oral solution contains 116 IU/mL of vitamin E which is higher than the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU).
Rash
...In the pediatric clinical trial, the frequency of rash (all grades, all causality) through 48 weeks of treatment was 21%. Overall, most of the pediatric patients had mild rash and 5 (5%) had moderate rash. Overall 3% of pediatric patients interrupted Aptivus treatment due to rash and the discontinuation rate for rash in pediatric patients was 0.9%... |
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Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert |
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Drug Interactions
- Nervous System Symptoms
ADVERSE REACTIONS
- Adverse Reactions from Clinical Trials Experience
- Laboratory Abnormalities
- Postmarketing Experience
- Tenofovir Disoproxil Fumarate
- Hepatobiliary Disorders
- Increased liver enzymes (most commonly AST, ALT, gamma GT)...
DRUG INTERACTIONS
- Emtricitabine and Tenofovir Disoproxil Fumarate
- Efavirenz Assay Interference
- Cannabinoid Test Interaction
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
- Lactic Acidosis/Severe Hepatomegaly with Steatosis
- Patients Coinfected with HIV-1 and HBV
- New Onset or Worsening Renal Impairment
- Decreases in Bone Mineral Density
- Dosing Instructions
PATIENT PACKAGE INSERT
- Medicines You Should Not Take With Atripla
- ...Reyataz is not recommended with Atripla...
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CONTRAINDICATIONS
See Table 1 in prescribing information.
WARNINGS AND PRECAUTIONS
Drug Interactions
Efavirenz plasma concentrations may be altered by substrates, inhibitors, or inducers of CYP3A. Likewise, efavirenz may alter plasma concentrations of drugs metabolized by CYP3A...
Nervous System Symptoms
Fifty-three percent (531/1008) of patients receiving efavirenz in controlled trials reported central nervous system symptoms (any grade, regardless of causality) compared to 25% (156/635) of patients receiving control regimens. These symptoms included dizziness (28.1% of the 1008 patients)...
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Avodart (dutasteride) Soft Gelatin Capsules
Prescribing Information (in new labeling format) |
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Evaluation for Other Urological Diseases
- Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection
ADVERSE REACTIONS
- Clinical Trials Experience
- Combination with Alpha-Blocker Therapy (CombAT)
- Table 2
DRUG INTERACTIONS
- Alpha-Adrenergic Blocking Agents
- ...The effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters has not
been evaluated.
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Hepatic Impairment
- ...in a clinical study where 60 subjects received 5 mg (10 times the therapeutic dose) daily for 24 weeks, no additional adverse events were observed compared with those observed at the therapeutic dose of 0.5 mg...
PATIENT COUNSELING INFORMATION
- Exposure of Women - Risk to Male Fetus
- ...Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a pregnant woman or woman of childbearing potential comes in contact with leaking Avodart Capsules, the contact area should be washed immediately with soap and water...
- Blood Donation
- ...Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends...
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CONTRAINDICATIONS
Pregnancy - Dutasteride inhibits the activity of 5α-reductase, which prevents conversion of
testosterone to dihydrotesterone, a hormone necessary for normal development of male genitalia. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, Avodart may cause fetal harm when administered to a pregnant woman. If Avodart is used during pregnancy or if the patient becomes pregnant while taking Avodart, the patient should be apprised of the potential hazard to the fetus...
WARNINGS AND PRECAUTIONS
Evaluation for Other Urological Diseases
...Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter...
Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection
Coadministration of tamsulosin with dutasteride resulted in similar changes to total PSA as dutasteride monotherapy. |
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Concerta (methylphenidate HCl) Extended-Release Tablets
Prescribing Information (in new labeling format)
Medication Guide
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CONTRAINDICATIONS
- Hypersensitivity to Methylphenidate
WARNINGS AND PRECAUTIONS
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Emergence of New Psychotic or Manic Symptoms
- Aggression
ADVERSE REACTIONS
- Initial Section
- Table 3
- Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials
- Children and Adolescents
- Adults
- Blood Pressure and Heart Rate Increases
- Postmarketing Experience
PATIENT COUNSELING INFORMATION
- Information for Patients
- Stimulants may impair the ability to operate potentially hazardous machinery...
MEDICATION GUIDE
- What are possible side effects of Concerta?
- Common side effects include...
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CONTRAINDICATIONS
Hypersensitivity to Methylphenidate
Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with Concerta. Therefore, Concerta is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product...
WARNINGS AND PRECAUTIONS
Psychiatric Adverse Events
Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder... |
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Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use
Kaletra (lopinavir and ritonavir) Solution for Oral Use
Prescribing Information (in new labeling format)
Patient Package Insert |
CONTRAINDICATIONS
- Initial Statement
- Table 3: Drugs That Are Contraindicated With Kaletra
ADVERSE REACTIONS
- Pediatric Patients - Clinical Trials Experience
DRUG INTERACTIONS
- Table 9
- Benzodiazepines:
Parenterally
Administered
Midazolam
USE IN SPECIFIC POPULATIONS
PATIENT PACKAGE INSERT
- What is Kaletra and how does it work?
- ...Kaletra is for adults and for children age 14 days and older.
- How should I take Kaletra?
- Dosing in children greater than 14 days of age...
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CONTRAINDICATIONS
Kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir.
Table 3: Drugs That Are Contraindicated With Kaletra
Sedative/Hyponotics:
- Orally Administered Midazolam (added)
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Reclast (zoledronic acid) Injection
Prescribing Information (in new labeling format)
Patient Package Insert
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CONTRAINDICATIONS
- Hypersensitivity to zoledronic acid or any components of Reclast
WARNINGS AND PRECAUTIONS
- Hypocalcemia and Mineral Metabolism
- Renal Impairment
- Musculoskeletal Pain
- Patients with Asthma
ADVERSE REACTIONS
- Clinical Studies Experience
- Treatment of Osteoporosis
- Table 1
- Renal Impairment
- Acute Phase Reaction
- Laboratory Findings
- Injection Site Reactions
- Osteonecrosis of the Jaw
- Atrial Fibrillation
- Ocular Adverse Events
- Postmarketing Experience (new subsection)
DRUG INTERACTIONS
- Initial Section
- Nephrotoxic Drugs
- ...such as nonsteroidal anti-inflammatory drugs.
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Geriatric Use
PATIENT COUNSELING INFORMATION
PATIENT PACKAGE INSERT
- What is the most important information I should know about Reclast?
- What is Reclast?
- What should I tell my doctor before getting Reclast?
- Tell your doctor about all the medicines you take...
- How will I receive Reclast?
- What are the possible side effects of Reclast?
- What is Osteoporosis?
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CONTRAINDICATIONS
Hypersensitivity to zoledronic acid or any components of Reclast
Hypersensitivity reactions including rare cases of urticaria, angioedema, and anaphylactic reaction/shock have been reported...
WARNINGS AND PRECAUTIONS
Hypocalcemia and Mineral Metabolism
...Clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended...
All osteoporosis patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels...
Renal Impairment
...Monitor serum creatinine before each Reclast dose. Transient increase in serum creatinine may be greater in patients with impaired renal function; consider interim monitoring of serum creatinine in at-risk patients.
Musculoskeletal Pain
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Reclast. The time to onset of symptoms varied from one day to several months after starting the drug. Consider withholding future Reclast treatment if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate...
Patients with Asthma
...Use Reclast with caution in aspirin-sensitive patients. |
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Zyvox (linezolid) Injection
Zyvox (linezolid) Tablets
Zyvox (linezolid) for Oral Suspension
Prescribing Information
|
CONTRAINDICATIONS
- Monoamine Oxidase Inhibitors
- Potential Interactions Producing Elevation of Blood Pressure
- Potential Serotonergic Interactions
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CONTRAINDICATIONS
Monoamine Oxidase Inhibitors
Linezolid should not be used in patients taking any medicinal product which inhibits monoamine
oxidases A or B (e.g. phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product.
Potential Interactions Producing Elevation of Blood Pressure
Unless patients are monitored for potential increases in blood pressure, linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following types of medications: directly and indirectly acting
sympathomimetic agents (e.g. pseudoephedrine), vasopressive agents (e.g. epinephrine, norepinephrine), dopaminergic agents (e.g. dopamine, dobutamine)...
Potential Serotonergic Interactions
Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome, linezolid should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone... |
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Brand (Generic) Name |
Sections Modified
|
Summary of Changes to Contraindications
and Warnings |
Advil Allergy Sinus Caplets (ibuprofen, pseudoephedrine HCl, chlorpheniramine maleate)
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845.
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WARNINGS |
WARNINGS
Ask a doctor before use if you have:
Do not use:
- in children under 12 years of age
Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin... |
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Advil Cold & Sinus (ibuprofen and pseudoephedrine HCl) Caplets
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
- Ask a doctor before use if you have:
- Do not use:
- in children under 12 years of age
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Advil Cold & Sinus Liqui-Gels (ibuprofen and pseudoephedrine HCl) Capsules
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
- Ask a doctor before use if you have:
- Do not use:
- in children under 12 years of age
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Advil Liqui-Gels (ibuprofen) Capsules
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
Ask a doctor before use if you have:
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Advil Migraine (ibuprofen) Capsules
Over-the-Counter
Prescribing Information |
WARNINGS
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WARNINGS
Ask a doctor before use if you have:
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Advil PM (ibuprofen, diphenhydramine citrate) Caplets
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
Ask a doctor before use if you have:
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Advil PM Liqui-Gels (ibuprofen, diphenhydramine HCl) Capsules
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
Ask a doctor before use if you have:
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Advil (ibuprofen) Tablets
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
Ask a doctor before use if you have:
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Agrylin (anagrelide hydrochloride) Capsules
Prescribing Information |
WARNINGS
- Interstitial Lung Diseases
PRECAUTIONS
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- In a two year rat carcinogenicity study a
higher incidence of uterine adenocarcinoma...
- Pregnancy
- ...There are however, no adequate and well controlled studies with anagrelide hydrochloride in pregnant women.
- Nonclinical Toxicology
ADVERSE REACTIONS
- Postmarketing Reports (new subsection)
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WARNINGS
Interstitial Lung Diseases
Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) have been reported to be associated with the use of anagrelide in post-marketing reports. Most cases presented with progressive dyspnea with lung infiltrations. The time of onset ranged from 1 week to several years after initiating anagrelide. In most cases, the symptoms improved after discontinuation of anagrelide... |
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Antara (fenofibrate) Capsules
Prescribing Information
|
WARNINGS
PRECAUTIONS
- Venothromboembolic Disease
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WARNINGS: Other Considerations
The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was a 5- year randomized, placebo-controlled study of 9795 patients with type 2 diabetes mellitus treated with fenofibrate. Fenofibrate demonstrated a non-significant 11 % relative reduction in the primary outcome of coronary heart disease events (hazard ratio (HR) 0.89, 95% CI 0.75-1.05, p=0.16) and a significant 11% reduction in the secondary outcome of total cardiovascular disease events (HR 0.89 (0.89-0.99), p=0.04). There was a non-significant 11 % (HR 1.11 (0.95, 1.29), p=0.18) and 19% (HR 1.19 (0.90, 1.57), p=0.22) increase in total and coronary heart disease mortality, respectively, with fenofibrate as compared to placebo. |
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Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate Injectable Suspension, USP)
Prescribing Information
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WARNINGS
|
WARNINGS
Neurologic
Results from one multicenter, randomized, placebo controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early
mortality (at 2 weeks) and late mortality (at 6 months) in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of corticosteroids, including Celestone Soluspan, should not be used for the treatment of traumatic brain injury. |
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Children’s Advil Chewables (50 ibuprofen) Chewable Tablets
Junior Strength Advil Chewables
(100 mg ibuprofen) Chewable Tablets
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
Ask a doctor before use if the child has:
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Children’s Advil (ibuprofen) Suspension
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
Ask a doctor before use if the child has:
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Clozaril (clozapine) Tablets
Prescribing Information
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WARNINGS
ADVERSE REACTIONS
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WARNINGS
Tardive Dyskinesia
...There are several reasons for predicting that Clozaril may be different from other antipsychotic drugs in its potential for inducing tardive dyskinesia, including the preclinical finding that it has a relatively weak dopamine-blocking effect and the clinical finding of a low incidence of certain acute extrapyramidal symptoms, e.g., dystonia... |
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Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules
Prescribing Information
(in new labeling format)
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WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
- Clinical Trial Data Sources
- Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials
- Fibromyalgia (new subsection)
- Adverse Reactions Occurring at an Incidence of 2% or More Among Duloxetine-Treated Patients in Placebo-Controlled Trials
- Fibromyalgia
(new subsection)
- Weight Changes
USE IN SPECIFIC POPULATIONS
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WARNINGS AND PRECAUTIONS
Hepatotoxicity
There have been reports of hepatic failure, sometimes fatal, in patients treated with Cymbalta...
...Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established..
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Infants' Advil (ibuprofen) Concentrated Drops
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS |
WARNINGS
Ask a doctor before use if child has:
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Junior Strength
Advil (ibuprofen) Tablets
Over-the-Counter
For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845. |
WARNINGS
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WARNINGS
Ask a doctor before use if the child has:
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Metvixia (methyl aminolevulinate) Cream, 16.8% For Topical Use Only
Prescribing Information
Patient Package Insert |
WARNINGS AND PRECAUTIONS
- Photosensitivity
- Aktilite Lamp
ADVERSE REACTIONS
- Dermal Safety Studies
- Clinical Studies Experience
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
PATIENT PACKAGE INSERT (to include use with the Aktilite CL 128 lamp)
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WARNINGS AND PRECAUTIONS
Photosensitivity
During the time period between the application of Metvixia Cream and exposure to Aktilite red light illumination, the treatment site will become photosensitive.
If for any reason the patient cannot have the Aktilite red light treatment after application of Metvixia Cream, the cream should be rinsed off, and the patient should protect the treated area from sunlight, prolonged or intense light for two days. Prolonged exposure for greater than 4 hours to Metvixia Cream should be avoided...
Aktilite Lamp
Before operating the Aktilite CL128 lamp, personnel should refer to the Operators Manual for specific warnings, cautions and instructions. Care should be exercised when positioning
and operating the lamp. During the red light illumination period, the patient, operator and other persons present should wear protective goggles that sufficiently screen out the appropriate spectrum of red light. The protective goggles or eye shields provided for the patient are dark or of metal to block visible light... |
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Potassium Chloride Extended Release Tablets, USP
Prescribing Information
|
WARNINGS
PRECAUTIONS
- Information for Patients
- Physicians should consider reminding the patient of the following...
- Geriatric Use
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WARNINGS
Gastrointestinal Lesion
...Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. |
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Pulmicort Flexhaler (budesonide inhalation powder) For Oral Inhalation Only
Prescribing Information |
WARNINGS
PRECAUTIONS
|
WARNINGS
...Chicken pox and measles, for example, can have a more
serious or even fatal course in susceptible children or adults
using corticosteroids. In such children or adults who have not
had these diseases or been properly immunized, particular care should be taken to avoid exposure...
... The immune responsiveness to varicella vaccine was evaluated in pediatric patients with asthma ages 12 months to 8 years with budesonide inhalation suspension...
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Synercid I.V.
(quinupristin and dalfopristin for injection)
Prescribing Information |
WARNINGS
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
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Synercid, 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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Vectibix (panitumumab) Injection for Intravenous Use
Prescribing Information (in new labeling format |
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
CLINICAL TRIALS EXPERIENCE
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Nursing Mothers
- Pediatric Use
PATIENT COUNSELING INFORMATION
- Advise patients to contact a healthcare professional for any of the following... (see highlighted section for changes)
- Advise patients of the need for... (see highlighted section for changes)
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WARNINGS AND PRECAUTIONS
...Withhold Vectibix for severe or life-threatening dermatologic toxicity... |
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Velcade (bortezomib) for Injection
Prescribing Information (in new labeling format)
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WARNINGS AND PRECAUTIONS
- Use in Pregnancy
- Peripheral Neuropathy
- Cardiac Disorders
- Gastrointestinal Adverse Events
- Thrombocytopenia/Neutropenia
ADVERSE REACTIONS
- Clinical Trials Safety Experience
- Summary of Clinical Trial in Patients with Previously Untreated Multiple Myeloma
(new subsection)
- Description of Selected Adverse Events from the Phase 2 and 3 Relapsed Multiple Myeloma and Phase 2 Mantle Cell Lymphoma Studies
DRUG INTERACTIONS
- Ketoconazole
- Melphalan-Prednisone
- Omeprazole
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Patients with Renal Impairment
PATIENT COUNSELING INFORMATION
- Dehydration/Hypotension
- Pregnancy/Nursing
- Concomitant Medications
- Diabetic Patients
- Peripheral Neuropathy
- Other
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WARNINGS AND PRECAUTIONS
Use in Pregnancy
...Bortezomib administered to rabbits during organogenesis caused post-implantation loss and a decreased number of live fetuses...
Peripheral Neuropathy
...Following dose adjustments, improvement in or resolution of peripheral neuropathy was reported in 51% of patients with >Grade 2 peripheral neuropathy in the relapsed multiple myeloma study...
Cardiac Disorders
...In the relapsed multiple myeloma study, the incidence of any treatment-emergent cardiac disorder was 15% and 13% in the Velcade and dexamethasone groups, respectively...
Gastrointestinal Adverse Events
...Ileus can occur...
Thrombocytopenia/Neutropenia
Velcade is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle...
...In the relapsed multiple myeloma study, the incidence of significant bleeding events (>Grade 3) was similar on both the Velcade (4%) and dexamethasone (5%) arms. Platelet count should be monitored prior to each dose of Velcade. Patients experiencing thrombocytopenia may require change in the dose and schedule of Velcade... |
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Brand
(Generic) Name
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Sections Modified |
Amoxicillin/Clavulanate Potassium Tablets
Prescribing Information |
PRECAUTIONS
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Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)
Prescribing Information
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PRECAUTIONS
- General
- A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with
mononucleosis.
- Drug Interactions
- ...reduced efficacy of combined oral estrogen/progesterone contraceptives.
ADVERSE REACTIONS
- Infections and Infestations
- Mucocutaneous Candidiasis
- Gastrointestinal
- Hypersensitivity Reactions
- Anaphylaxis (See WARNINGS)
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Doryx (doxycycline hyclate) Delayed-Release Tablets
Prescribing Information (in new labeling format)
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DRUG INTERACTIONS
- Antacids and Iron Preparations
USE IN SPECIFIC POPULATIONS
- Pediatric Use
- Geriatric Use
- Renal Impairment
PATIENT COUNSELING INFORMATION
- All patients taking doxycycline should be advised:
- that the absorption of tetracyclines is reduced when taken with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron containing preparations...
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Ganirelix Acetate Injection
Prescribing Information
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PRECAUTIONS
- General
- Cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported during post-marketing surveillance...
ADVERSE REACTIONS
- During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported...
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Levothyroxine Sodium Tablets, USP
Prescribing Information |
PRECAUTIONS
- Information for Patients
- ...It is very important that you take the tablet with a full glass of water.
- Agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine sodium tablets...
- Drug Interactions
- Table 2:
Drug-Thyroidal Axis Interactions
- Drugs that may decrease T4 absorption, which may result in hypothyroidism
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Ortho Micronor (norethindrone) Tablets
Prescribing Information |
PRECAUTIONS
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Sarafem
(fluoxetine hydrochloride)
Capsules
Prescribing Information |
PRECAUTIONS
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Brand
(Generic) Name
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Sections Modified |
Aciphex (rabeprazole sodium) Delayed Release Tablets
Prescribing Information (in new labeling format)
Patient Package Insert |
ADVERSE REACTIONS
- Clinical Studies Experience
- In a multicenter, open-label study of adolescent patients aged 12 to 16 years...
USE IN SPECIFIC POPULATIONS
PATIENT PACKAGE INSERT
- What is Aciphex?
- Aciphex is used in adolescents 12 years of age and above...
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Baraclude (entecavir) Tablets and Oral Solution
Prescribing Information
Patient Package Insert
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ADVERSE REACTIONS
- Postmarketing Experience
(new subsection)
- Skin and subcutaneous tissue disorders
PATIENT PACKAGE INSERT
- What are the possible side effects of Baraclude?
- There have also been occasional reports of rash (added)
- How should I store Baraclude?
- Keep Baraclude and all medicines out of the reach of children and pets at all times. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place Baraclude in an unrecognizable closed container in the household trash.
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Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
Prescribing Information
Patient Package Insert |
ADVERSE REACTIONS
- Postmarketing Reports
- Musculoskeletal and connective tissue disorders
- General disorders and administration site conditions
PATIENT PACKAGE INSERT
- What are the possible side effects of Gardasil?
- ...joint pain, aching muscles, unusual tiredness or weakness, and generally feeling unwell. (added)
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Genotropin (somatropin [rDNA origin] for injection)
Prescribing Information (in new labeling format)
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ADVERSE REACTIONS
- Clinical Trials Experience
- Clinical Trials in Children with Idiopathic Short Stature
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Mobic (meloxicam) Tablets and Oral Suspension
Prescribing Information
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ADVERSE REACTIONS
- Pediatrics
- Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)
- Psychiatric
- Alterations in mood (such as mood elevation)
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OxyContin (oxycodone HCl controlled-release) Tablets
Prescribing Information |
ADVERSE REACTIONS
- The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience. (The adverse reaction categories have been re- organized. The adverse events listed below include only the new reactions
added.)
- Cardiac Disorders
- Palpitations (in the context of withdrawal)
- Investigations
- Increased hepatic enzymes
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Spiriva HandiHaler (tiotropium bromide inhalation powder)
Prescribing Information
Patient Package Insert
See MedWatch Safety Alerts posted 03/18/2008 and 02/29/2008 for additional safety information. |
ADVERSE REACTIONS
- ...The following adverse reactions have been identified during worldwide post-approval use of Spiriva HandiHaler:
- application site irritation (glossitis, mouth ulceration, and pharyngolarygeal pain)
PATIENT PACKAGE INSERT
- The following statement was added on page 1, under drug name:
- Do Not Swallow Capsules.
For Use With HandiHaler Only.
- Removing a Spiriva Capsule (Figure 4):
- Do not swallow Spiriva Capsules.
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Vytorin (ezetimibe/simvastatin) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert
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ADVERSE REACTIONS
- Postmarketing Experience
- Vytorin or ezetimibe or simvastatin
USE IN SPECIFIC POPULATIONS
PATIENT PACKAGE INSERT
- What are the possible side effects of Vytorin?
- The following side effects have been reported in general use with Vytorin or with ezetimibe or simvastatin tablets (tablets that contain the active ingredients of Vytorin):
- Tingling Sensation (added)
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Zetia (ezetimibe) Tablets
Prescribing Information (in new labeling format)
Patient Package Insert
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ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONS
PATIENT PACKAGE INSERT
- What are the possible side effects of Zetia?
- Tingling Sensation (added)
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Brand (Generic) Name
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Sections Modified |
Byetta (exenatide) Injection
User Manual - 5 mcg Pen
User Manual - 10 mcg Pen |
PEN USER MANUALS (revised) |
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Forteo (teriparatide [rDNA origin]) Injection
Medication Guide
User Manual (for Forteo delivery device [pen]) |
MEDICATION GUIDE (revised)
USER MANUAL (new) |
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PegIntron/REBETOL Combo Pack containing:
PegIntron REDIPEN Single-dose Delivery System (peginterferon alfa-2b) and REBETOL (ribavirin, USP) Capsules
Medication Guide
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MEDICATION GUIDE (new) |
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