MedWatch - August 2005 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2005

The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The prescribing information may be accessed by clicking on the drug name.

Summary View

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Accutane (isotretinoin capsules) (click product name to read prescribing information)	CONTRAINDICATIONS & BOXED WARNING Special Prescribing Requirements Table 1: Monthly Required iPLEDGE Interactions PRECAUTIONS Initial Paragraph Wholesalers Prescribers All Patients Female Patients of Childbearing Potential Pharmacists Information for Patients MEDICATION GUIDE	CONTRAINDICATIONS & BOXED WARNING Because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. For additional details, see MedWatch 08/12/2005 Safety Alert.

Mobic (meloxicam) Tablets and Oral Suspension (click product name to read prescribing information)	CONTRAINDICATIONS BOXED WARNING Cardiovascular Risk Gastrointestinal Risk WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Skin Reactions PRECAUTIONS Hepatic Effects Hematological Effects Information for Patients Laboratory Tests Drug Interactions Furosemide Lithium Methotrexate Warfarin Pregnancy Teratogenic Effects: Pregnancy Category C. Nonteratogenic Effects Labor and Delivery Nursing Mothers ADVERSE REACTIONS Pediatrics Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA) Skin and Appendages Exfoliative Dermatitis MEDICATION GUIDE	CONTRAINDICATIONS Mobic is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. BOXED WARNING Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk..... Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. WARNINGS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal..... Hypertension NSAIDs, including Mobic, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs..... Congestive Heart Failure and Edema Fluid retention and edema have been observed in some patients taking NSAIDs. Mobic should be used with caution in patients with fluid retention, hypertension, or heart failure. Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation .....Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status..... Renal Effects Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Advanced Renal Disease No information is available from controlled clinical studies regarding the use of Mobic in patients with advanced renal disease. Therefore, treatment with Mobic is not recommended in these patients with advanced renal disease. If Mobic therapy must be initiated, close monitoring of the patient's renal function is advisable. Skin Reactions NSAIDs, including Mobic, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Adderall (mixed salts of a single-entity amphetamine product) Tablets (click product name to read prescribing information)	BOXED WARNING WARNINGS Sudden Death and Pre-existing Structural Cardiac Abnormalities ADVERSE REACTIONS Cardiovascular Sudden Death Myocardial Infarction Central Nervous System Depression Seizures Stroke	BOXED WARNING Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. WARNINGS Sudden death has been reported in association with amphetamine treatment at usual doses in children with structural cardiac abnormalities. Adderall generally should not be used in children or adults with structural cardiac abnormalities.

FazaClo (clozapine, USP) Orally Disintegrating Tablets (click product name to read prescribing information)	BOXED WARNING Increased Mortality in Elderly Patients with Dementia-related Psychosis WARNINGS Increased Mortality in Elderly Patients with Dementia-related Psychosis	BOXED WARNING Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo..... WARNINGS Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Fazaclo (clozapine, USP) is not approved for the treatment of patients with dementia-related psychosis.

Geodon (ziprasidone HCl) Capsules Geodon (ziprasidone mesylate) for Injection (click product name to read prescribing information)	BOXED WARNING Increased Mortality in Elderly Patients with Dementia-related Psychosis WARNINGS Increased Mortality in Elderly Patients with Dementia-related Psychosis	BOXED WARNING Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo..... .....Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Geodon (ziprasidone) is not approved for the treatment of patients with dementia-related psychosis. WARNINGS Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Geodon (ziprasidone) is not approved for the treatment of patients with dementia-related psychosis.

Premarin (conjugated estrogens, USP) for Injection (click product name to read prescribing information)	BOXED WARNING Women's Health Initiative Memory Study (WHIMS) WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke Venous Thromboembolism (VTE) Dementia PRECAUTIONS Geriatric Use ADVERSE REACTIONS Genitourinary System Vaginal Candidiasis Ovarian Cancer Endometrial Hyperplasia Endometrial Cancer Breasts Breast Cancer Cardiovascular Deep and Superficial Venous Thrombosis Thrombophlebitis Miscellaneous Urticaria Angioedema Increased Triglycerides	BOXED WARNING The Women's Health Initiative Memory Study (WHIMS), a sub-study of the Women's Health Initiative (WHI), reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with conjugated estrogens alone and during 4 years of treatment with conjugated estrogens combined with medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke In the estrogen alone sub-study of the WHI study, an increased risk of stroke was observed in women receiving Premarin (0.625 mg conjugated estrogens) per day compared to women receiving placebo (44 vs. 32 per 10,000 women-years). The increase in risk was observed in year one and persisted. Venous Thromboembolism (VTE) In the estrogen alone sub-study of the WHI study, an increased risk of deep vein thrombosis was observed in women receiving Premarin compared to placebo (21 vs. 15 per 10,000 women-years). The increase in VTE risk was observed during the first year. Dementia ..... In the estrogen alone sub-study, after an average follow-up of 5.2 years, 28 women in the estrogen alone group and 19 women in the placebo group were diagnosed with probable dementia..... .....In the estrogen plus progestin sub-study, after an average follow-up of 4 years, 40 women in the estrogen plus progestin group and 21 women in the placebo group were diagnosed with probable dementia.....

Premarin (conjugated estrogens) Vaginal Cream (click product name to read prescribing information)	BOXED WARNING Women's Health Initiative Memory Study (WHIMS) WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke Venous Thromboembolism (VTE) Dementia PRECAUTIONS Geriatric Use ADVERSE REACTIONS Genitourinary System Change in Vaginal Bleeding Pattern Increase in Size of Uterine Leiomyomata Cardiovascular Thrombophlebitis Miscellaneous Urticaria Angioedema	BOXED WARNING The Women's Health Initiative Memory Study (WHIMS), a sub-study of the Women's Health Initiative (WHI), reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with oral conjugated estrogens alone and during 4 years of treatment with conjugated estrogens combined with medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. WARNINGS Cardiovascular Disorders Coronary Heart Disease and Stroke In the estrogen alone sub-study of the WHI study, an increased risk of stroke was observed in women receiving Premarin compared to women receiving placebo (44 vs. 32 per 10,000 women-years). The increase in risk was observed in year one and persisted. Venous Thromboembolism (VTE) In the estrogen alone sub-study of the WHI study, an increased risk of deep vein thrombosis was observed in women receiving Premarin compared to placebo (21 vs. 15 per 10,000 women-years). The increase in VTE risk was observed during the first year. Dementia ..... In the estrogen alone sub-study, after an average follow-up of 5.2 years, 28 women in the estrogen alone group and 19 women in the placebo group were diagnosed with probable dementia..... .....In the estrogen plus progestin sub-study, after an average follow-up of 4 years, 40 women in the estrogen plus progestin group and 21 women in the placebo group were diagnosed with probable dementia.....

Risperdal Consta (risperidone) Long-Acting Injection (click product name to read prescribing information)	BOXED WARNING Increased Mortality in Elderly Patients with Dementia-related Psychosis WARNINGS Increased Mortality in Elderly Patients with Dementia-related Psychosis	BOXED WARNING Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo...... .....Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Risperdal Consta (risperidone) is not approved for the treatment of patients with dementia-related psychosis. WARNINGS Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Risperdal Consta (risperidone) is not approved for the treatment of dementia-related psychosis.

Risperdal (risperidone) Tablets and Oral Solution Risperdal M-Tab (risperidone) Orally Disintegrating Tablets (click product name to read prescribing information)	BOXED WARNING Increased Mortality in Elderly Patients with Dementia-related Psychosis WARNINGS Increased Mortality in Elderly Patients with Dementia-related Psychosis	BOXED WARNING Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo...... .....Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Risperdal (risperidone) is not approved for the treatment of patients with dementia-related psychosis. WARNINGS Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Risperdal (risperidone) is not approved for the treatment of dementia-related psychosis.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
AndroGel (testosterone gel) 1% (click product name to read prescribing information)	WARNINGS PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility Human Data ADVERSE REACTIONS See Table 3 and Text PATIENT PACKAGE INSERT	Increases in serum PSA from baseline values were seen in approximately 18% of individuals in an open label study of 162 hypogonadal men treated with AndroGel for up to 42 months. Most of these increases were seen within the first year of therapy.

Dianeal Low Calcium Peritoneal Dialysis Solution in Ambu-Flex III Container (click product name to read prescribing information)	WARNINGS PRECAUTIONS See information regarding the Proper Method for Heating Solution Prior to Administration	The use of 5 or 6 liters of dialysis solution is not indicated in a single exchange Do not use 6 liter product with Pac-X or Pac-Xtra hardware.

Dianeal Low Calcium Peritoneal Dialysis Solution UltraBag System (click product name to read prescribing information)	WARNINGS PRECAUTIONS General Carcinogenesis, Mutagenesis, Impairment of Fertility See information regarding the Proper Method for Heating Solution Prior to Administration.	.....Contamination of the patient connector may result in peritonitis. Excessive use of Dianeal Low Calcium peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient. After the pull ring has been removed from the outlet of the Luer lock system, check for broken connector frangible seal as evidenced by continuous fluid flow from port. A few drops of solution within the connector or protector cap may be present. If a continuous stream or droplets of fluid are noted with the Luer lock or Lineo connector systems, discard solution because sterility may be impaired. During solution drainage, fibrin strands may be observed in the solution and may become attached to the blue connector frangible closure of the Luer lock system. In occasional instances, partial or complete obstruction of draining may occur. Manipulation of the connector frangible closure in the tubing may free the fibrin obstruction.

Dianeal PD-1 Peritoneal Dialysis Solution in Ambu-Flex III Container (click product name to read prescribing information)	WARNINGS PRECAUTIONS See information regarding the Proper Method for Heating Solution Prior to Administration.	The use of 5 liters of dialysis solution is not indicated in a single exchange.

Dianeal PD-2 Peritoneal Dialysis Solution Ambu-Flex III Plastic Container (click product name to read prescribing information)	WARNINGS PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility See information regarding the Proper Method for Heating Solution Prior to Administration.	The use of 5 liters of dialysis solution is not indicated in a single exchange.

Dianiel PD-2 Peritoneal Dialysis Solution UltraBag System (click product name to read prescribing information)	WARNINGS PRECAUTIONS General Carcinogenesis, Mutagenesis, Impairment of Fertility See information regarding the Proper Method for Heating Solution Prior to Administration.	.....Contamination of the patient connector may result in peritonitis. Excessive use of Dianeal PD-2 peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient. After the pull ring has been removed from the outlet of the Luer lock system, check for broken connector frangible seal as evidenced by continuous fluid flow from port. A few drops of solution within the connector or protector cap may be present. If a continuous stream or droplets of fluid are noted with the Luer lock or Lineo connector systems, discard solution because sterility may be impaired. During solution drainage, fibrin strands may be observed in the solution and may become attached to the blue connector frangible closure of the Luer lock system. In occasional instances, partial or complete obstruction of draining may occur. Manipulation of the connector frangible closure in the tubing may free the fibrin obstruction.

Diovan (valsartan) Tablets (click product name to read prescribing information)	WARNINGS Hypotension PRECAUTIONS Impaired Renal Function Geriatric Use ADVERSE REACTIONS Post-Myocardial Infarction Post-Marketing Experience Rhabdomyolysis Clinical Laboratory Test Findings Creatinine PATIENT PACKAGE INSERT	Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction patients. Patients with heart failure or post-myocardial infarction patients given Diovan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients. In the Valsartan in Acute Myocardial Infarction Trial (VALIANT), hypotension in post-myocardial infarction patients led to permanent discontinuation of therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated patients.

Nubain (nalbuphine HCl) Injection (click product name to read prescribing information)	WARNINGS Use During Labor and Delivery ADVERSE REACTIONS Allergic Reactions Events Observed During Post-marketing Surveillance of Nubain	.....Fetal and neonatal adverse effects that have been reported following the administration of nalbuphine to the mother during labor include fetal bradycardia, respiratory depression at birth, apnea, cyanosis, and hypotonia. Some of these events may be life-threatening. Maternal administration of naloxone during labor has normalized these effects in some cases.....

Relafen (nabumetone) Tablets (click product name to read prescribing information)	WARNINGS Risk of GI Ulceration, Bleeding, and Perforation with NSAID Therapy PRECAUTIONS General Renal Effects	Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Except for a prior history of serious GI events and other risk factors known to be associated with peptic ulcer disease, such as alcoholism, smoking, other medications known to increase the risk of gastrointestinal ulcer (e.g., oral corticosteroids), etc., no risk factors (e.g., age, sex) have been associated with increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less well than other individuals and most spontaneous reports of fatal GI events are in this population.

Ventavis (iloprost) Inhalation Solution (click product name to read prescribing information)	WARNINGS PRECAUTIONS General Information for Patients ADVERSE REACTIONS "STEP" Clinical Trial	Ventavis is intended for inhalation administration only via either of two pulmonary drug delivery devices: the Ineb AAD System or the Prodose AAD System. Vital signs should be monitored while initiating Ventavis. In patients with low systemic blood pressure, care should be taken to avoid further hypotension.

Zocor (simvastatin) Tablets (click product name to read prescribing information)	WARNINGS Myopathy/Rhabdomyolysis HMG-CoA Reductase Inhibitors Potent Inhibitors of CYP3A4 Gemfibrozil, Particularly with Higher Doses of Simvastatin Other Lipid-Lowering Drugs (other Fibrates or ≥1 g/day of Niacin) Cyclosporine or Danazol, with Higher Doses of Simvastatin Amiodarone or Verapamil, with Higher Doses of Simvastatin Table 8: Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolys PRECAUTIONS Other Drug Interactions Cyclosporine or Danazol	As with other HMG-CoA reductase inhibitors, the risk of myopathy/rhabdomyolysis is dose related..... All patients starting therapy with simvastatin or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. Simvastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected..... The risk of myopathy/rhabdomyolysis is increased by concomitant use of simvastatin with the following: Potent inhibitors of CYP3A4 Gemfibrozil, particularly with higher doses of simvastatin Other lipid-lowering drugs (other fibrates or ≥1 g/day of niacin) Cyclosporine or Danazol, with higher doses of simvastatin Amiodarone or verapamil, with higher doses of simvastatin Please see prescribing information to review Table 8.

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Brand (Generic) Name	Sections Modified
Aldara (imiquimod) Cream, 5% (click product name to read prescribing information)	PRECAUTIONS General Pregnancy: Category C ADVERSE REACTIONS Post-marketing Adverse Events PATIENT PACKAGE INSERT

Augmentin (amoxicillin/clavulanate potassium) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Chloromycetin Sodium Succinate (chloramphenicol sodium succinate for injection, USP) Please contact King Pharmaceuticals Inc. at 1-800-776-3637 for prescribing information.	PRECAUTIONS Geriatric Use

Compazine (prochlorperazine) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Copegus (ribavirin, USP) Tablets (click product name to read prescribing information)	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility ADVERSE REACTIONS Thrombotic Thrombocytopenic Purpura

Cordarone (amiodarone HCl) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions CYP3A4 and p-glycoprotein Other Substances ADVERSE REACTIONS Post-marketing Reports Acute Renal Failure Renal Impairment Renal Insufficiency Agranulocytosis

Cosmegen (dactinomycin for Injection) for Injection [Actinomycin D] (click product name to read prescribing information)	PRECAUTIONS Veno-occlusive Disease ADVERSE REACTIONS Gastrointestinal Hepatic

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose injection, Type 1, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery

Dextrose and Sodium Chloride Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers Geriatric Use

Diuril (chlorothiazide) Oral Suspension Please contact Merck & Co., Inc. at 1-866-342-5683 for prescribing information.	PRECAUTIONS Geriatric Use

Lactated Ringer's Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers
Lactated Ringer's and 5% Dextrose Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery Geriatric Use

Lexxel (enalapril maleate-felodipine ER) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Micro-K LS Packets (potassium chloride) Extended Release Formulation for Liquid Suspension (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Osmitrol Injection (mannitol injection, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery

Pentetate Calcium Trisodium Injection For prescribing information, please contact Hameln Pharmaceuticals GmbH, c/o B & H Consulting Services Inc. at 1-908-704-1691.	PRECAUTIONS Patient Data Treatment Form now included in the PRECAUTIONS section.

Penetrate Zinc Trisodium For prescribing information, please contact Hameln Pharmaceuticals GmbH, c/o B & H Consulting Services Inc. at 1-908-704-1691.	PRECAUTIONS Patient Data Treatment Form now included in the PRECAUTIONS section.

Plasma-Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers

Plasma-Lyte 56 Injection (Multiple Electrolytes Injection, Type 1, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery Geriatric Use

Plasma-Lyte 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery Geriatric Use

Plasma-Lyte 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers

Plasma-Lyte 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery Geriatric Use

Plasma-Lyte M and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 2, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery Geriatric Use

Plasma-Lyte R Injection (Multiple Electrolytes Injection, Type 2, USP) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers Geriatric Use

Potassium Chloride in 5% Dextrose Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery Nursing Mothers

Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers

Potassium Chloride in Lactated Ringer's and 5% Dextrose Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery

Potassium Chloride in Sodium Chloride Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery

Ringer's Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers Geriatric Use

Ringer's and 5% Dextrose Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers

Sodium Chloride Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers

3% and 5% Sodium Chloride Injection, USP in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Carcinogenesis, mutagenesis, impairment of fertility Labor and Delivery Nursing Mothers

Sodium Lactate Injection, USP (M/6 Sodium Lactate) in Aviva Plastic Container (click product name to read prescribing information)	PRECAUTIONS General Laboratory Tests Drug Interactions Labor and Delivery Nursing Mothers Geriatric Use

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Brand (Generic) Name	Sections Modified
Aceon (perindopril erbumine) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Stable Coronary Artery Disease

Coreg (carvedilol) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Post-marketing Experience Severe Skin Reactions (Stevens-Johnson Syndrome) Toxic Epidermal Necrolysis Erythema Multiforme Urinary Incontinence in Women Interstitial Pneumonitis

Faslodex (fulvestrant) Injection (click product name to read prescribing information)	ADVERSE REACTIONS Hypersensitivity Reactions including Angioedema and Urticaria

Levaquin (levofloxacin) Tablets, Oral Solution and Injection Levaquin (levofloxacin in 5% dextrose) Injection (click product name to read prescribing information)	ADVERSE REACTIONS See information regarding Clinical Trial Data. Hearing and Vestibular Ear Disorder NOS Psychiatric Disorders Anxiety Resistance Mechanism Disorders Infection Respiratory System Disorders Respiratory Disorder Vascular (Extracardiac) Disorders Cerebrovascular Disorder White Cell and RES Disorders WBC Abnormal NOS

Persantine (dipyridamole USP) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Warfarin

Taxotere (docetaxel) for Injection Concentrate (click product name to read prescribing information)	ADVERSE REACTIONS Post-marketing Experiences Toxic Epidermal Necrolysis Severe Hand and Foot Syndrome

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