The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Actiq (fentanyl citrate) Oral Transmucosal Lozenge

Prescribing Information (in new labeling format)

BOXED WARNING

• Warnings: Importance of Proper Patient Selection and Potential for Abuse

CONTRAINDICATIONS

WARNINGS & PRECAUTIONS

• Patient/Caregiver Instructions
• Additive CNS Depressant Effects
• Effects on Ability to Drive and Use Machines

ADVERSE REACTIONS

• Clinical Studies Experience

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

• Pregnancy - Category C
• Labor and Delivery
• Nursing Mothers
• Pediatric Use
• Geriatric Use
• Patients with Renal or Hepatic Impairment
• Gender

PATIENT COUNSELING INFORMATION

• Dental Care
• Actiq Welcome Kit

BOXED WARNING

.....The concomitant use of Actiq with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.

CONTRAINDICATIONS

.....Anaphylaxis and hypersensitivity have been reported in association with the use of Actiq.

See prescribing information for extensive labeling revisions.

Prescribing Information

Patient Package Insert

BOXED WARNING

• Cardiovascular and Other Risks

WARNINGS

• Cardiovascular Disorders
  • Stroke
  • Coronary Heart Disease
  • Venous Thromboembolism (VTE)
• Malignant Neoplasms
  • Breast Cancer
• Dementia

PRECAUTIONS

• General
  • Addition of a Progestin when a Woman has not had a Hysterectomy
  • Exacerbation of Other Conditions
  • Toxic Shock Syndrome (TSS)
• Geriatric Use

ADVERSE REACTIONS

• Gastrointestinal
  • Nausea
  • Bloating

PATIENT PACKAGE INSERT

• What Is the most important information I should know about Femring (an estrogen product)?
• What is Femring?
• What are the possible side effects of vaginal rings?
• What can I do to lower my chances of a serious side effect with Femring?

BOXED WARNING: Cardiovascular and Other Risks

.....The estrogen-alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day relative to placebo.

The estrogen-plus-progestin substudy of WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment
with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.....

WARNINGS

See highlighted prescribing information for revised text.

Humira (adalimumab) Solution for Subcutaneous Injection

Prescribing Information (in new labeling format)

Patient Package Insert

BOXED WARNING

• Warning: Risk of Serious Infections

WARNINGS & PRECAUTIONS

• Serious Infections
• Malignancies
• Hepatitis B Virus Reactivation
• Immunizations

ADVERSE REACTIONS

• Clinical Studies Experience
  • Immunogenicity
  • Crohn's Disease Clinical Studies

DRUG INTERACTIONS

• Live Vaccines

PATIENT COUNSELING INFORMATION

• Patient Counseling
  • Immunosuppression
  • Allergic Reactions
  • Other Medical Conditions
  • Instruction on Injection Technique
• Patient Package Insert

BOXED WARNING

.....Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating Humira and during therapy.....

WARNINGS & PRECAUTIONS

See prescribing information for extensive labeling revisions.

Ketek (telithromycin) Tablets

Prescribing Information

Medication Guide

See MedWatch Safety Alert posted 2/12/2007 for additional information on Ketek labeling revisions.

BOXED WARNING (new)

CONTRAINDICATIONS

WARNINGS

• Hepatotoxicity
• QTc Prolongation
• Visual Disturbances
• Loss of Consciousness
• Pseudomembranous Colitis

PRECAUTIONS

• Information for Patients

ADVERSE REACTIONS

• Post-marketing Adverse Event Reports
  • Nervous System
    • Loss of consciousness

MEDICATION GUIDE (new)

BOXED WARNING

Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of Ketek.

CONTRAINDICATIONS

Ketek is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression.

Ketek is contraindicated in patients with a history of hypersensitivity to telithromycin and/or any components of Ketek tablets, or any macrolide antibiotic.

WARNINGS

See highlighted prescribing information for revised text.

Lotensin (benazepril hydrochloride) Tablets

Prescribing Information

See MedWatch Safety Alert posted 6/07/2006 for additional safety information.

BOXED WARNING (new)

• Use in Pregnancy

WARNINGS

• Fetal/Neonatal Morbidity and Mortality

PRECAUTIONS

• Information for Patients
  • Pregnancy
• Pregnancy Category D

BOXED WARNING: Use in Pregnancy

When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Lotensin should be discontinued as soon as possible.....

WARNINGS: Fetal/Neonatal Morbidity and Mortality

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, Lotensin should be discontinued as soon as possible and monitoring of the fetal development should be performed on a regular basis.

In addition, use of ACE inhibitors during the first trimester of pregnancy has been associated with a potentially increased risk of birth defects. In women planning to become pregnant, ACE inhibitors (including Lotensin) should not be used. Women of child-bearing age should be made aware of the potential risk and ACE inhibitors (including Lotensin).....

Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide, USP) Combination Tablets

Prescribing Information

See MedWatch Safety Alert posted 6/07/2006 for additional safety information.

BOXED WARNING (new)

• Use in Pregnancy

WARNINGS

• Fetal/Neonatal Morbidity and Mortality

PRECAUTIONS

• Information for Patients
  • Pregnancy
• Pregnancy Category D

BOXED WARNING: Use in Pregnancy

When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Lotensin HCT should be discontinued as soon as possible.....

WARNINGS: Fetal/Neonatal Morbidity and Mortality

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, Lotensin HCT should be discontinued as soon as possible and monitoring of the fetal development should be performed on a regular basis.

In addition, use of ACE inhibitors during the first trimester of pregnancy has been associated with a potentially increased risk of birth defects. In women planning to become pregnant, ACE inhibitors (including Lotensin HCT) should not be used. Women of child-bearing age should be made aware of the potential risk and ACE inhibitors (including Lotensin HCT) should only be given after careful counseling and consideration of individual risks and benefits.

Lotrel (amlodipine besylate and benazepril hydrochloride)

Prescribing Information

See MedWatch Safety Alert posted 6/07/2006 for additional safety information.

BOXED WARNING (new)

• Use in Pregnancy

WARNINGS

• Fetal/Neonatal Morbidity and Mortality

PRECAUTIONS

• Pregnancy
  • Pregnancy Category D

BOXED WARNING: Use in Pregnancy

When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Lotrel should be discontinued as soon as possible.....

WARNINGS: Fetal/Neonatal Morbidity and Mortality

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, Lotrel should be discontinued as soon as possible and monitoring of the fetal development should be performed on a regular basis.

In addition, use of ACE inhibitors during the first trimester of pregnancy has been associated with a potentially increased risk of birth defects. In women planning to become pregnant, ACE inhibitors (including Lotrel) should not be used. Women of child-bearing age should be made aware of the potential risk and ACE inhibitors (including Lotrel) should only be given after careful counseling and consideration of individual risks and benefits.

Rituxan (rituximab)

Prescribing Information

Patient Package Insert

BOXED WARNING

• Progressive Multifocal Leukoencephalopathy (PML)

WARNINGS

• Progressive Multifocal Leukoencephalopathy (PML)

ADVERSE REACTIONS

• Initial Section
• Infectious Events
• Post-marketing Reports
  • Infectious
    • Viral infections, including PML

PATIENT PACKAGE INSERT

• What is the most important safety information I should know about Rituxan?
• What are the possible side effects with Rituxan?

BOXED WARNING: Progressive Multifocal Leukoencephalopathy (PML)

JC virus infection resulting in PML and death has been reported in patients treated with Rituxan.....

WARNINGS: Progressive Multifocal Leukoencephalopathy (PML)

JC virus infection resulting in PML and death has been reported in Rituxan-treated patients with hematologic malignancies or with systemic lupus erythematosus (SLE), an indication for which Rituxan has not been approved. The majority of patients with hematologic malignancies diagnosed with PML have received Rituxan in combination with chemotherapy or as past of a hematopoietic stem cell transplant. Patients with SLE had a history of prior immunosuppressive therapy and were diagnosed with PML within 12 months of their last infusion of Rituxan.

Physicians treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. In patients who develop PML, Rituxan should be discontinued and reductions or discontinuation of any concomitant chemotherapy or immunosuppressive therapy should be considered.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Diprivan (propofol) Injectable Emulsion for IV Administration

Prescribing Information

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

• General
  • Adult and Pediatric Patients
• Intensive Care Unit Selection
• Adult Patients
• Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Carcinogenesis
  • Mutagenesis
  • Impairment of Fertility
• Geriatric Use
  • Initial Paragraph

CONTRAINDICATIONS

.....Diprivan Injectable Emulsion is contraindicated in patients with allergies to eggs, egg products, soybeans or soy products.

WARNINGS

Use of Diprivan Injectable Emulsion has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions......

.....Use of Diprivan Injectable Emulsion infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death.....

.....Abrupt discontinuation of Diprivan Injectable Emulsion prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation.....

Nardil (phenelzine sulfate tablets, USP)

Prescribing Information

CONTRAINDICATIONS

PRECAUTIONS

• Nardil should be used with caution in diabetes mellitus; increased insulin sensitivity may occur.....
• Drug Interactions
  • .....Administration of guanethidine to patients receiving an MAO inhibitor can produce moderate to severe hypertension due to release of catecholamines.....

CONTRAINDICATIONS

Nardil should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function tests.....

.....Concomitant use with meperidine is contraindicated.....

.....At least 14 days should elapse between the discontinuation of an MAO inhibitor and the start of a serotonin re-uptake inhibitor or vice-versa, with the exception of fluoxetine.....

Prescribing Information

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

• General
• Pediatric Patients
• Laboratory Tests
• Drug Interactions
• Geriatric Use
• Information for Patients

Nutropin (somatropin [rDNA origin] for injection)

Prescribing Information

CONTRAINDICATIONS

PRECAUTIONS

• General
• Pediatric Patients
• Adult Patients
• Information for Patients
• Laboratory Tests
• Drug Interactions
• Geriatric Usage

Nutropin AQ (somatropin [rDNA origin] injection)

Prescribing Information

CONTRAINDICATIONS

PRECAUTIONS

• General
• Pediatric Patients
• Adult Patients
• Information for Patients
• Laboratory Tests
• Drug Interactions
• Geriatric Usage

Tev-Tropin (somatropin [rDNA origin] for injection)

Prescribing Information

CONTRAINDICATIONS

PRECAUTIONS

• General
• Pediatric Patients
• Information for Patients
• Laboratory Tests
• Drug Interactions
• Geriatric Use

ADVERSE REACTIONS

• Initial Paragraph

Extensive labeling revisions. See highlighted prescribing information for revised text.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Actos (pioglitazone hydrochloride) Tablets

Prescribing Information

WARNINGS

• Cardiac Failure and Other Cardiac Effects
  • Prospective Pioglitazone Clinical Trial In MacroVascular Events (PROactive)

PRECAUTIONS

• Macular Edema
• Drug Interactions
  • An enzyme inhibitor of CYP2C8 (such as gemfibrozil) may significantly increase the AUC of pioglitazone and an enzyme inducer of CYP2C8 (such as rifampin) may significantly decrease the AUC of pioglitazone.....
• Carcinogenesis, Mutagenesis, Impairment of Fertility
  • In two 3-year studies in which pioglitazone was compared to placebo or glyburide, there were 16/3656 (0.44%) reports of bladder cancer in patients taking pioglitazone compared to 5/3679 (0.14%) in patients not taking pioglitazone.....

ADVERSE REACTIONS

• Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive)
  • Table 8
  • Postmarketing reports of new onset or worsening diabetic macular edema.....

WARNINGS: Cardiac Failure and Other Cardiac Effects

In PROactive, 5238 patients with type 2 diabetes and a prior history of macrovascular disease were treated with Actos (n=2605), force-titrated up to 45 mg once daily, or placebo (n=2633). The percentage of patients who had an event of serious heart failure was higher for patients treated with Actos (5.7%, n=149) than for patients treated with placebo (4.1%, n=108). The incidence of death subsequent to a report of serious heart failure was 1.5% (n=40) in patients treated with Actos and 1.4% (n=37) in placebo-treated patients.

Cymbalta (duloxetine hydrochloride) Delayed-release Capsules

Prescribing Information

WARNINGS

• Serotonin Syndrome

PRECAUTIONS

• General
  • Orthostatic Hypotension and Syncope
  • Effect on Blood Pressure
  • Hyponatremia
  • Use in Patients with Concomitant Illness
• Information for Patients
  • Orthostatic Hypotension and Syncope
• Drug Interactions
  • Serotonergic Drugs
• Nursing Mothers
• Geriatric Use

ADVERSE REACTIONS

• Adverse Events Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials
  • Generalized Anxiety Disorder
• Adverse Events Occurring at an Incidence of 2% or More Among Cymbalta- Treated Patients in Placebo-Controlled Trials
  • Generalized Anxiety Disorder
    • Table 3
• Other Adverse Events Observed During the Pre-marketing and Post-marketing Clnical Trial Evaluation of Duloxetine
• Post-marketing Spontaneous Reports

WARNINGS: Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including Cymbalta treatment, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs).....

Prescribing Information

WARNINGS

ADVERSE REACTIONS

• During post-marketing experience, central nervous system (CNS) depression, including obtunded feeling, non-arousable condition, unresponsiveness, confusion.....
• During post-marketing experience, severe respiratory depression, involving apnea or respiratory arrest, and cardiac arrest.....

WARNINGS

.....No clinical studies have evaluated the safety of administration of DepoDur into the intrathecal space. DepoDur is intended for administration by the epidural route only. However, cases of intrathecal administration of DepoDur have been reported during post-marketing experience. In all cases, signs of prolonged respiratory depression were observed requiring narcotic antagonist (naloxone) administration or ventilatory support.....

Extraneal (icodextrin) Peritoneal Dialysis Solution

Prescribing Information

Patient Package Insert

WARNINGS

PRECAUTIONS

• Information for Patients
  • .....patients should be instructed to use only glucose-specific glucose monitors and test strips.
• Drug/Laboratory Interactions
  • Blood Glucose

PATIENT PACKAGE INSERT

• If you monitor your blood glucose, you must use a glucose specific monitor and test strips. If your glucose monitor or test strips use a glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) or glucose-dye-oxidoreductase method, using Extraneal may cause a falsely high glucose reading or may mask a very low actual glucose reading.

WARNINGS

.....Blood glucose measurement in patients receiving Extraneal must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose, released from Extraneal. Glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) or glucose-dye-oxidoreductase based methods must not be used. If GDH-PQQ or glucose-dye-oxidoreductase based methods are used, using Extraneal may cause a falsely high glucose reading, which could result in the administration of more insulin than needed. This can cause hypoglycemia, which can result in loss of consciousness, coma, neurological damage and death. Additionally, falsely elevated blood glucose measurements due to maltose interference may mask true hypoglycemia and allow it to go untreated with similar consequences.

The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose results.....

Pravachol (pravastatin sodium) Tablets

Prescribing Information

WARNINGS

• Liver Enzymes

ADVERSE REACTIONS

• Post-marketing Experience
  • Laboratory Abnormalities
    • Liver Function Test

WARNINGS: Liver Enzymes

.....In a 320-patient placebo-controlled clinical trial, subjects with chronic (>6 months) stable liver disease, due primarily to hepatitis C or non-alcoholic fatty liver disease, were treated with 80 mg pravastatin or placebo for up to 9 months. The primary safety endpoint was the proportion of subjects with at least one ALT ≥2 times the upper limit of normal for those with normal ALT (≤ the upper limit of normal) at baseline or a doubling of the baseline ALT for those with elevated ALT (> the upper limit of normal) at baseline. By Week 36, 12 out of 160 (7.5%) subjects treated with pravastatin met the prespecified safety ALT endpoint compared to 20 out of 160 (12.5%) subjects receiving placebo.....

Prinivil (lisinopril) Tablets

Please contact Merck & Co., Inc. at 1-800-444-2080 for prescribing information.

See MedWatch Safety Alert posted 6/07/2006 for additional safety information.

WARNINGS

• Fetal/Neonatal Morbidity and Mortality

PRECAUTIONS

• Pregnancy
  • Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors during pregnancy. These patients should be asked to report pregnancies to their physicians as soon as possible.

WARNINGS: Fetal/Neonatal Morbidity and Mortality

.....In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor during their first trimester of pregnancy appeared to have an increased risk of major congenital malformations compared with infants whose mothers had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated.....

Prinzide (lisinopril-hydrochlorothiazide) Tablets

Please contact Merck & Co., Inc. at 1-800-444-2080 for prescribing information.

See MedWatch Safety Alert posted 6/07/2006 for additional safety information.

WARNINGS

• Fetal/Neonatal Morbidity and Mortality

PRECAUTIONS

• Pregnancy
  • Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors during pregnancy. These patients should be asked to report pregnancies to their physicians as soon as possible.

WARNINGS: Fetal/Neonatal Morbidity and Mortality

.....In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor during their first trimester of pregnancy appeared to have an increased risk of major congenital malformations compared with infants whose mothers had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated.....

Prescribing Information (in new labeling format)

Patient Package Insert

WARNINGS & PRECAUTIONS

• Left Ventricular Dysfunction
• QT Interval Prolongation and Torsade de Pointes
• Hypertension
• Hemorrhagic Events
• Hypothyroidism

ADVERSE REACTIONS

• Overview Section
• Adverse Reactions in the Treatment-Naïve MRCC Study
  • Table 3
• Venous Thromboembolic Events
• Pancreatic and Hepatic Function

USE IN SPECIFIC POPULATIONS

• Geriatric Use
• Hepatic Impairment

PATIENT COUNSELING INFORMATION

• Gastrointestinal Disorders
• Skin Effects
• Other Common Events
• Concomitant Medications

WARNINGS & PRECAUTIONS

Left Ventricular Dysfunction

.....In the treatment-naïve MRCC study, 78/375 (21%) and 44/360 (12%) patients on Sutent and IFN-α, respectively, had an LVEF value below the LLN. Thirteen patients on Sutent (4%) and four on IFN-α (1%) experienced declines in LVEF of >20% from baseline and to below 50%. Left ventricular dysfunction was reported in three patients (1%) and CHF in one patient (<1%) who received Sutent.

QT Interval Prolongation and Torsade de Pointes

See highlighted prescribing information for new text.

Hypertension

See highlighted prescribing information for revised text.

Hemorrhagic Events

In patients receiving Sutent for treatment-naïve MRCC, 112/375 patients (30%) had bleeding events compared with 27/360 patients (8%) receiving IFN-α.....

..... Most events in MRCC patients were Grade 1 or 2; there was one Grade 5 event of gastric bleed in a treatment-naïve patient.

Hypothyroidism

See highlighted prescribing information for revised text.

Bentyl (dicyclomine hydrochloride, USP) Capsules, Tablets, Syrup, and Injection

Prescribing Information

PRECAUTIONS

• Geriatric Use

Boniva (ibandronate sodium) Tablets

Prescribing Information and Patient Package Insert

PRECAUTIONS

• Information for Patients
  • Boniva should be taken at least 60 minutes before the first food or drink (other than water) of the day and before any oral medication or supplementation.....

PATIENT PACKAGE INSERT

• Tell your healthcare provider before using Boniva
• Tell your healthcare provider (including your dentist)
• What are the possible side effects of Boniva?

Duetact (pioglitazone hydrochloride and glimepiride) Tablets

Prescribing Information

Patient Package Insert

PRECAUTIONS

• General
  • Pioglitazone Hydrochloride
    • Macular Edema
• Drug Interactions
  • Pioglitazone Hydrochloride
    • An enzyme inhibitor of CYP2C8 (such as gemfibrozil) may significantly increase the AUC of pioglitazone and an enzyme inducer of CYP2C8 (such as rifampin) may significantly decrease the AUC of pioglitazone.....

ADVERSE REACTIONS

• Pioglitazone Hydrochloride
  • Post-marketing reports of new onset or worsening diabetic macular edema with decreased visual acuity.....

PATIENT PACKAGE INSERT

• What should I tell my doctor before taking Duetact?
• How should I store Duetact?

Prescribing Information

PRECAUTIONS

• General
  • Interstitial Lung Disease and Eosinophilic Pneumonia

Prescribing Information

PRECAUTIONS

• General
  • Interstitial Lung Disease and Eosinophilic Pneumonia

Flomax (tamsulosin hydrochloride) Capsules

Prescribing Information

Patient Package Insert

PRECAUTIONS

• General
  • Drug-Drug Interactions

PATIENT PACKAGE INSERT

• Why your doctor has prescribed Flomax Capsules?

Fortical (calcitonin-salmon [rDNA origin]) Nasal Spray

Prescribing Information

PRECAUTIONS

• Geriatric Use

Prescribing Information

PRECAUTIONS

• Drug Interactions
  • Alcohol, when used concomitantly with propranolol, may increase plasma levels of propranolol.

Prescribing Information

PRECAUTIONS

• Drug Interactions
  • Alcohol, when used concomitantly with propranolol, may increase plasma levels of propranolol.

Inderide (propranolol hydrochloride and hydrochlorothiazide)

Prescribing Information

PRECAUTIONS

• Drug-Drug Interactions
  • Propranolol Hydrochloride
    • Alcohol, when used concomitantly with propranolol, may increase plasma levels of propranolol.

Lexiva (fosamprenavir calcium) Tablets

Prescribing Information

PRECAUTIONS

• Carcinogenesis and Mutagenesis

Peganone (ethotoin tablets, USP)

Prescribing Information

PRECAUTIONS

• Pediatric Use
• Geriatric Use

Prescribing Information

Medication Guide

PRECAUTIONS

• Drug Interactions
  • Iloprost
  • Rifampicin

ADVERSE REACTIONS

• Post-marketing Experience
  • Thrombocytopenia

MEDICATION GUIDE

• Tell your doctor about all the medications you use.....

Vaprisol (conivapatan hydrochloride injection)

Prescribing Information

PRECAUTIONS

• Congestive Heart Failure
• Drug Interactions
• Geriatric Use

ADVERSE REACTIONS

• Overview Section
• Table 5
• Congestive Heart Failure

Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) [albumin-bound]

Prescribing Information

ADVERSE REACTIONS

• Adverse Event Experiences by Body System
  • Neurologic
    • Cranial nerve palsies have been reported.....
• Other Clinical Events
  • Skin Reactions

Baraclude (entecavir) Tablets and Oral Solution

Prescribing Information

ADVERSE REACTIONS

• Initial Section
• Clinical Adverse Events
  • Table 7
• Laboratory Abnormalities
  • Table 8
• Exacerbations of Hepatitis After Discontinuation of Treatment
  • Table 9

Cubicin (daptomycin for injection)

Prescribing Information

ADVERSE REACTIONS

• Post-marketing Experience
  • Immune System Disorders
    • Pulmonary Eosinophilia

Dostinex (cabergoline tablets)

Prescribing Information

ADVERSE REACTIONS

• Post-marketing Surveillance Data
  • .....cases of alopecia, aggression and psychotic disorder have been reported in patients taking Dostinex. Some of these reports have been patients who have had prior adverse reactions to dopamine agonist products.

Micardis (telmisartan) Tablets

Prescribing Information

ADVERSE REACTIONS

• Post-marketing Experience
  • .....bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, and increased CPK.

Prescribing Information

ADVERSE REACTIONS

• Post-marketing Experience
  • .....bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, and increased CPK.

Boniva (ibandronate sodium) Injection

Patient Package Insert

PATIENT PACKAGE INSERT

• What are the possible side effects of Boniva Injection?

Pulmicort Flexhaler (budesonide inhalation powder) for Oral Inhalation Only

Please contact AstraZeneca at 1-800-236-9933 for the Patient Package Insert.

Omacor (omega-3-acid ethyl esters) Capsules

Patient Package Insert

Vyvanse (lisdexamfetamine dimesylate)

Medication Guide

See MedWatch Safety Alert posted 2/21/2007 for additional on Attention Deficit Disorder (ADHD) Drug Products.

FDA/CDER/OCD/Safety Policy and Communication Staff
Web page last revised by jlw March 16, 2007