Contraindications and warnings August--2007.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. listed the following drugs and drug products as having had modifications to the Contraindications and/or Warnings/Boxed Warnings sections. For additional information or to read the full labeling of the drug products, visit: httg://www.fda.gov/medwatch/ Actos (pioglitazone hydrochloride pioglitazone hydrochloride Warning - High-alert drug! Actos Pharmacologic class: Thiazolidinedione Therapeutic class: Hypoglycemic Pregnancy risk category C ) Tablets BOXED WARNING: Congestive Heart Failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. Thiazolidinediones, including Actos, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of Actos, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea dyspnea /dysp·nea/ (disp-ne´ah) labored or difficult breathing.dyspne´ic paroxysmal nocturnal dyspnea , and/or edema edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts. ). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given . Furthermore, discontinuation or dose reduction of Actos must be considered. Actos is not recommended in patients with symptomatic heart failure. Initiation of Actos in patients with established New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Heart Association (NYHA NYHA New York Heart Association ) Class III or IV heart failure is contraindicated ... CONTRAINDICATIONS Initiation of Actos in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated ... WARNINGS: Cardiac Failure cardiac failure: see congestive heart failure. and Other Cardiac Effects ... If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Actos must be considered (see BOXED WARNING). Patients with NYHA Class III and IV cardiac status were not studied during pre-approval clinical trials and Actos is not recommended in these patients ... WARNINGS: Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) ... In patients treated with an insulin-containing regimen at baseline, the incidence of serious heart failure was 6.3% (n=54/864) with Actos and 5.2% (n=47/896) with placebo. For those patients treated with a sulfonylurea-containing regimen at baseline, the incidence of serious heart failure was 5.8% (n=94/1624) with Actos and 4.4% (n=71/1626) with placebo. Avandamet (rosiglitazone maleate rosiglitazone maleate Warning - High-alert drug! Avandia Pharmacologic class: Thiazolidinedione Therapeutic class: Hypoglycemic Pregnancy risk category C and metformin hydrochloride metformin hydrochloride Warning - High-alert drug! Apo-Metformin (CA), Fortamet, Glucophage, Glucophage XR, Glycon (CA), Metsol (UK), Novo-Metformin (CA), Riomet Pharmacologic class: ) Tablets BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Rosiglitazone maleate). After initiation of Avandamet, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandamet must be considered. Avandamet is not recommended in patients with symptomatic heart failure. Initiation of Avandamet in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated ... CONTRAINDICATIONS Initiation of Avandamet in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated ... WARNINGS: Rosiglitazone maleate/Cardiac Failure and Other Cardiac Effects ... If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING). Avandamet should be discontinued if any deterioration in cardiac status occurs ... Avandaryl (rosiglitazone maleate and glimepiride) Tablets BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Rosiglitazone). After initiation of Avandaryl, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandaryl must be considered. Avandaryl is not recommended in patients with symptomatic heart failure. Initiation of Avandaryl in patients with established NYHA Class III or IV heart failure is contraindicated ... CONTRAINDICATIONS Initiation of Avandaryl in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated (see BOXED WARNING) ... WARNINGS: Rosiglitazone/Cardiac Failure and Other Cardiac Effects ... If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING) ... Avandia (rosiglitazone maleate) Tablets BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of Avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandia must be considered. Avandia is not recommended in patients with symptomatic heart failure. Initiation of Avandia in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated ... CONTRAINDICATIONS Initiation of Avandia in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated (see BOXED WARNING) ... WARNINGS: Cardiac Failure and Other Cardiac Effects ... If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING) ... Celexa (citalopram hydrobromide ci·tal·o·pram hy·dro·bro·mide n. A drug of the SSRI class that is used primarily to treat depression. Citalopram hydrobromide Celexa; a SSRI that is highly specific for serotonin reuptake. ) Tablets and Oral Solution BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressant Drugs Definition Antidepressant drugs are medicines that relieve symptoms of depressive disorders. Purpose Depressive disorders may either be unipolar (depression alone) or bipolar (depression alternating with periods of Antidepressants Antidepressants Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder major depressive disorder (MDD MDD Major depressive disorder, see there ) and other psychiatric disorders. Anyone considering the use of Celexa or any other antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Cymbalta (duloxetine hydrochloride duloxetine hydrochloride Cymbalta Pharmacologic class: Selective serotonin and norepinephrine reuptake inhibitor Therapeutic class: Antidepressant Pregnancy risk category C ) Delayed-Release CapsulesBOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Diovan (valsartan) Tablets BOXED WARNING: Use in Pregnancy When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus ... WARNINGS: Fetal/Neonatal Morbidity and Mortality Morbidity and Mortality can refer to:
... In addition, first trimester use of ACE inhibitors, a specific class of drugs acting on the renin-angiotensin system, has been associated with a potential risk of birth defects in retrospective data. Healthcare professionals that prescribe drugs acting directly on the renin-angiotensin system should counsel women of childbearing potential about the potential risks of these agents during pregnancy ... Effexor (venlafaxine hydrochloride) Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor XR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Lexapro (escitalopram oxalate) Tablets and Oral Solution BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Limbitrol (chlordiazepoxide chlordiazepoxide /chlor·di·az·ep·ox·ide/ (klor?di-az?e-pok´sid) a benzodiazepine used as the base or hydrochloride salt in the treatment of anxiety disorders and short-term or preoperative anxiety, for alcohol withdrawal, and as an ) (amitriptyline HCl) DS (double strength) Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Marplan (isocarboxazid isocarboxazid /iso·car·box·a·zid/ (i?so-kahr-bok´sah-zid) a monoamine oxidase inhibitor used as an antidepressant and in the prophylaxis of migraine. ) Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Marplan or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk Contact Validus Pharmaceuticals for revised labeling. Nardil (phenelzine sulfate tablets, USP USP - unique sales point ) BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Nardil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Parnate (tranylcyTromine sulfate sulfate, chemical compound containing the sulfate (SO4) radical. Sulfates are salts or esters of sulfuric acid, H2SO4, formed by replacing one or both of the hydrogens with a metal (e.g., sodium) or a radical (e.g., ammonium or ethyl). ) Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Parnate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Paxil (paroxetine hydrochloride) Tablets and Oral Suspension BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil CR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Pexeva (paroxetine mesylate) Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Pexeva (paroxetine mesylate) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Prozac (fluoxetine fluoxetine /flu·ox·e·tine/ (floo-ok´se-ten) a selective serotonin reuptake inhibitor used as the hydrochloride salt in the treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder. capsules, USP, fluoxetine oral solution, USP, fluoxetine delayed-release capsules, USP) BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Prozac or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Sertraline Hydrochloride Tablets and Oral Concentrate BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS See highlighted prescribing information for revised text. Sinequan (doxepin HCl) Capsules and Oral Concentrate BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sinequan or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Surmontil (trimipramine maleate) BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Surmontil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Symbyax (olanzapine and fluoxetine HCl capsules) BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Symbyax or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Tekturna (aliskiren) Tablets BOXED WARNING: Use in Pregnancy When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus ... WARNINGS: Fetal/Neonatal Morbidity and Mortality ... In addition, first trimester use of ACE inhibitors, a specific class of drugs acting on the renin-angiotensin system, has been associated with a potential risk of birth defects in retrospective data. Healthcare professionals that prescribe drugs acting directly on the renin-angiotensin system should counsel women of childbearing potential about the potential risks of these agents during pregnancy ... Wellbutrin (bupropion hydrochloride) Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin SR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Wellbutrin XL (bupropion hydrochloride extended-release tablets) BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin XL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior ... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Zyban (bupropion hydrochloride) Sustained-Release Tablets BOXED WARNING: Suicidality and Antidepressant Drugs Although Zyban is not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications Wellbutrin, Wellbutrin SR, and Wellbutrin XL. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zyban or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text. Reclast (zoledronic acid) Injection CONTRAINDICATIONS: Hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to zoledronic acid or any components of Reclast Hypersensitivity reactions including rare cases of urticaria urticaria /ur·ti·ca·ria/ (ur?ti-kar´e-ah) hives; a vascular reaction of the upper dermis marked by transient appearance of slightly elevated patches (wheals) which are redder or paler than the surrounding skin and often attended by and angioedema, and very rare cases of anaphylactic anaphylactic /ana·phy·lac·tic/ (an?ah-fi-lak´tik) pertaining to anaphylaxis. anaphylactic (an´ reaction/shock have been reported. WARNINGS & PRECAUTIONS See highlighted prescribing information for revised text. Risperdal (risperidone) Tablets and Oral Solution Risperdal M-TAB (risperidone) Orally Disintegrating-Tablets CONTRAINDICATIONS Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone ... WARNINGS & PRECAUTIONS Orthostatic Hypotension ... Syncope syncope Effect of temporary impairment of blood circulation to a part of the body. It is often used as a synonym for fainting, which is loss of consciousness due to inadequate blood flow to the brain. was reported in 0.2% (6/2607) of Risperdal-treated patients in Phase 2 and 3 studies in adults with schizophrenia ... Seizures During premarketing testing in adult patients with schizophrenia, seizures occurred in 0.3% (9/2607) of Risperdal-treated patients, two in association with hyponatremia Hyponatremia Definition The normal concentration of sodium in the blood plasma is 136-145 mM. Hyponatremia occurs when sodium falls below 130 mM. Plasma sodium levels of 125 mM or less are dangerous and can result in seizures and coma. . Risperdal should be used cautiously in patients with a history of seizures. Tegretol (carbamazepine carbamazepine /car·ba·maz·e·pine/ (kahr?bah-maz´e-pen) an anticonvulsant and analgesic used in the treatment of pain associated with trigeminal neuralgia and in epilepsy manifested by certain types of seizures. , USP) Chewable Tablets and Suspension Tegretol-XR (carbamazepine extended-release tablets CONTRAINDICATIONS ... Co-administration of carbamazepine and nefazodone nefazodone /ne·fa·zo·done/ (ne-fa´zo-don) an antidepressant, used as the hydrochloride salt. ne·fa·zo·done n. may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Co-administration of carbamazepine with nefazodone is contraindicated. WARNINGS: Initial Section ... The use of Tegretol should be avoided in patients with a history of hepatic porphyria (e.g., acute intermittent porphyria acute intermittent porphyria n. See intermittent acute porphyria. Acute intermittent porphyria An inherited disease affecting the liver and bone marrow. , variegate porphyria, porphyria cutanea tarda porphyria cu·ta·ne·a tar·da n. Abbr. PCT Porphyria characterized by liver dysfunction and photosensitive cutaneous lesions, with hyperpigmentation and scleroderma-like changes in skin, neurologic manifestations, and porphyrinuria. ). Acute attacks have been reported in such patients receiving Tegretol therapy. Carbamazepine administration has also been demonstrated to increase porphyrin precursors in rodents, a presumed mechanism for the induction of acute attacks of porphyria Porphyria comes in a winter storm to show her devotion, and her lover strangles her with her own tresses. [Br. Poetry: Browning Porphyria’s Lover in Magill IV, 247] See : Love, Unrequited . As with all antiepileptic drugs, Tegretol should be withdrawn gradually to minimize the potential of increased seizure frequency. WARNINGS: Usage in Pregnancy ... There have also been reports that associate carbamazepine with developmental disorders and congenital anomalies (e.g., craniofacial craniofacial /cra·nio·fa·cial/ (kra?ne-o-fa´sh'l) pertaining to the cranium and the face. cra·ni·o·fa·cial adj. Of or involving both the cranium and the face. defects, cardiovascular malformations and anomalies involving various body systems). Developmental delays based on neurobehavioral assessments have been reported ... Ceftin Tablets (cefuroxime axetil tablets) Ceftin for Oral Suspension (cefuroxime axetil powder for oral suspension) WARNINGS Clostridium clostridium Any of the rod-shaped, usually gram-positive bacteria (see gram stain) that make up the genus Clostridium. They are found in soil, water, and the intestinal tracts of humans and other animals. Some species grow only in the complete absence of oxygen. d dle associated diarrhea (CDAD CDAD Clostridium Difficile-Associated Diarrhea CDAD Component Data Administrator ) has been reported with use of nearly all antibacterial agents, including Ceftin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to over-growth 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 colectomy /co·lec·to·my/ (ko-lek´tah-me) excision of the colon or of a portion of it. co·lec·to·my n. Surgical removal of part or all of the colon. . 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. NegGram Suspension (nalidixic acid, USP) Oral Suspension WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including NegGram, 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 overgrowth Rapid growth in the sales of a mutual fund's shares to the extent that the fund has difficulty finding promising new investments or it must take such large positions in individual investments that its trading flexibility is reduced. 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 MAD 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. Neoral Soft Gelatin gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid. Capsules (gyclosporine capsules, USP) MODIFIED Neoral Oral Solution (cyclosporine cyclosporine /cy·clo·spor·ine/ (-spor´en) a cyclic peptide from an extract of soil fungi that selectively inhibits T cell function; used as an immunosuppressant to prevent rejection in organ transplant recipients and to treat severe oral solution, USP) MODIFIED WARNINGS: Kidney, Liver and Heart Transplant ... Patients taking cyclosporine should be warned to avoid excess ultraviolet light exposure ... ... Transplant patients receiving cyclosporine are at increased risk for serious infection with fatal outcome ... Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets WARNINGS: Hypersensitivity Reactions ... Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin ciprofloxacin /cip·ro·flox·a·cin/ (sip?ro-flok´sah-sin) a synthetic antibacterial effective against many gram-positive and gram-negative bacteria; used as the hydrochloride salt. cip·ro·flox·a·cin n. . These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis Toxic Epidermal Necrolysis Definition Toxic epidermal necrolysis is a rare condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below. A reaction to a medication is the primary cause. , Stevens Johnson Syndrome); * vasculitis Vasculitis Definition Vasculitis refers to a varied group of disorders which all share a common underlying problem of inflammation of a blood vessel or blood vessels. The inflammation may affect any size blood vessel, anywhere in the body. , arthralgia arthralgia /ar·thral·gia/ (ahr-thral´jah) pain in a joint. ar·thral·gia n. Severe pain in a joint. Also called arthrodynia. , myalgia myalgia /my·al·gia/ (mi-al´jah) muscular pain.myal´gic epidemic myalgia see under pleurodynia. my·al·gia n. , serum sickness; * allergic pneumonitis pneumonitis /pneu·mo·ni·tis/ (noo?mo-ni´tis) inflammation of the lung; see also pneumonia. hypersensitivity pneumonitis ; * interstitial nephritis; acute renal insufficiency or failure; * hepatitis; jaundice jaundice (jôn`dĭs, jän`–), abnormal condition in which the body fluids and tissues, particularly the skin and eyes, take on a yellowish color as a result of an excess of bilirubin. ; acute hepatic necrosis or failure; * anemia, including hemolytic he·mo·lyt·ic adj. Destructive to red blood cells; hematolytic. Hemolytic Referring to the destruction of the cell membranes of red blood cells, resulting in the release of hemoglobin from the damaged cell. and aplastic a·plas·tic adj. 1. Unable to form or regenerate tissue. 2. Of, relating to, or characterized by aplasia. Aplastic Exhibiting incomplete or faulty development. ; thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. , including thrombotic thrombocytopenic purpura thrombotic thrombocytopenic purpura n. A disease of unknown origin, characterized by abnormally low levels of platelets in the blood, the formation of blood clots in the arterioles and capillaries of many organs, and neurological damage. ; leukopenia leukopenia /leu·ko·pe·nia/ (-pe´ne-ah) reduction of the number of leukocytes in the blood below about 5000 per cubic mm.leukope´nic basophilic leukopenia basophilopenia. ; agranulocytosis agranulocytosis (əgrăn'yəlōsītō`sis), disease in which the production of granulated white blood cells by the bone marrow is impaired. ; pancytopenia pancytopenia /pan·cy·to·pe·nia/ (-sit-ah-pe´ne-ah) abnormal depression of all the cellular elements of the blood. pan·cy·to·pe·ni·a n. ; and/or other hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. abnormalities. The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted ... Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Proquin XR, 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. Provigil (modafinil) Tablets WARNINGS: Serious Rash, including Stevens-Johnson Syndrome Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil. Modafinil is not approved for use in pediatric patients for any indication ... ... Rare cases of serious or life-threatening rash, including SJS SJS Stevens Johnson Syndrome (medical) SJS San Jose Sharks SJS St Joseph's School (Ifugao, Philippines) SJS Schwartz-Jampel Syndrome SJS San Jose Scale SJS Secretary, Joint Staff , Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia eosinophilia /eo·sin·o·phil·ia/ (e?o-sin?o-fil´e-ah) abnormally increased eosinophils in the blood. e·o·sin·o·phil·i·a n. An increase in the number of eosinophils in the blood. and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide postmarketing experience ... ... There are no factors that are known to predict the risk of occurrence or the severity of rash associated with modafinil. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation. However, isolated cases have been reported after prolonged treatment (e.g., 3 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash. WARNINGS: Angioedema and Anaphylactoid anaphylactoid /ana·phy·lac·toid/ (-fi-lak´toid) resembling anaphylaxis. an·a·phy·lac·toid adj. Of or resembling anaphylaxis. Reactions One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia dysphagia /dys·pha·gia/ (-fa´jah) difficulty in swallowing. dys·pha·gia or dys·pha·gy n. Difficulty in swallowing or inability to swallow. , and bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma. bron·cho·spasm n. ), were observed among 1,595 patients treated with armodafinil, the R enantiomer enantiomer /en·an·tio·mer/ (en-an´te-o?mer) one of a pair of compounds having a mirror image relationship. of modafinil (which is the racemic racemic /ra·ce·mic/ (ra-se´mik) optically inactive, being composed of equal amounts of dextrorotatory and levorotatory isomers. ra·ce·mic adj. Abbr. mixture). No such cases were observed in modafinil clinical trials. However, angioedema has been reported in postmarketing experience with modafinil. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis anaphylaxis (ăn'əfəlăk`sĭs), hypersensitive state that may develop after introduction of a foreign protein or other antigen into the body tissues. (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness). WARNINGS: Multi-organ Hypersensitivity Reactions Multi-organ hypersensitivity reactions, including at least one fatality in postmarketing experience, have occurred in close temporal association (median time to detection 13 days: range 4-33) to the initiation of modafinil ... ... If a multi-organ hypersensitivity reaction is suspected, Provigil should be discontinued. Although there are no case reports to indicate cross-sensitivity with other drugs that produce this syndrome, the experience with drugs associated with multi-organ hypersensitivity would indicate this to be a possibility. WARNINGS: Psychiatric Symptoms Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations Hallucinations Definition Hallucinations are false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even , and suicidal ideation, some resulting in hospitalization. Many, but not all, patients had a prior psychiatric history ... Pulmicort Turbuhaler (budesonide inhalation powder) for Oral Inhalation Only WARNINGS Patients requiring oral corticosteroids Corticosteroids Definition Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland. should be weaned slowly from systemic corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and use after transferring to Pulmicort Turbuhaler. Lung function (FEV FEV forced expiratory volume. FEV abbr. forced expiratory volume FEV forced expiratory volume. 1 or AM PEF PEF peak expiratory flow. ), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude lassitude /las·si·tude/ (las´i-tldbomacd) weakness; exhaustion. las·si·tude n. A state or feeling of weariness, diminished energy, or listlessness. , weakness, nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. , and hypotension hypotension or low blood pressure Condition in which blood pressure is abnormally low. It may result from reduced blood volume (e.g., from heavy bleeding or plasma loss after severe burns) or increased blood-vessel capacity (e.g., in syncope). . Transfer of patients from systemic corticosteroid therapy to Pulmicort Turbuhaler may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, eg, rhinitis Rhinitis Definition Rhinitis is inflammation of the mucous lining of the nose. Description Rhinitis is a nonspecific term that covers infections, allergies, and other disorders whose common feature is the location of their symptoms. , conjunctivitis conjunctivitis (kənjəngtəvī`təs), inflammation or infection of the mucosal membrane that covers the eyeball and lines the eyelid, usually acute, caused by a virus or, less often, by a bacillus, an allergic reaction, or an , arthritis, eosinophilic eosinophilic /eo·sin·o·phil·ic/ (-fil´ik) 1. readily stainable with eosin. 2. pertaining to eosinophils. 3. pertaining to or characterized by eosinophilia. conditions, and eczema ... Rituxan (rituximab) WARNINGS: Progressive Multifocal Leukoencephalopathy Progressive Multifocal Leukoencephalopathy Definition Progressive multifocal leukoencephalopathy (PML) is a rapidly progressive neuromuscular disease caused by opportunistic infection of brain cells (oligodendrocytes and astrocytes) by the JC virus (PML PML - Parallel ML. ["Synchronous Operations as First-Class Values", J.H. Reppy <jhr@research.att.com>, Proc SIGPLAN 88 Conf Prog Lang Design and Impl, June 1988, pp. 250-259]. ) JC virus infection resulting in PML and death has been reported in Rituxan-treated patients with hematologic malignancies or with autoimmune diseases for which Rituxan has not been approved. The majority of patients with hematologic malignancies diagnosed with PML received Rituxan in combination with chemotherapy or as part of a hematopoietic stem cell Hematopoietic stem cell A cell that can develop into any type of specialized blood cell. Mentioned in: Umbilical Cord Blood Banking transplant. The patients with autoimmune diseases had a history of prior, and may also have had concurrent, immunosuppressive therapy and were diagnosed with PML within 12 months of their last infusion of Rituxan ... Trileptal (oxcarbazapine) Tablets and Oral Suspension WARNINGS: Anaphylactic Reactions and Angioedema Rare cases of anaphylaxis and angioedema involving the larynx, glottis glottis /glot·tis/ (glot´is) pl. glot´tides [Gr.] the vocal apparatus of the larynx, consisting of the true vocal cords and the opening between them.glot´tal glot·tis n. pl. , lips and eyelids eyelids, n.pl a moveable fold of thin skin over the eye. The orbicularis oculi muscle and the oculomotor nerve control the opening and closing of the eyelid. have been reported in patients after taking the first or subsequent doses of Trileptal. Angioedema associated with laryngeal laryngeal /lar·yn·ge·al/ (lah-rin´je-al) pertaining to the larynx. la·ryn·geal or la·ryn·gal adj. Of, relating to, affecting, or near the larynx. edema can be fatal. If a patient develops any of these reactions after treatment with Trileptal, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug (see WARNINGS, Patients with a Past History of Hypersensitivity Reaction to Carbamazepine subsection). Tykerb (lapatinib) Tablets WARNINGS & PRECAUTIONS: Interstitial Lung Disease/Pneumonitis Lapatinib has been associated with interstitial lung disease Interstitial lung disease About 180 diseases fall into this category of breathing disorders. Injury or foreign substances in the lungs (such as asbestos fibers) as well as infections, cancers, or inherited disorders may cause the diseases. and pneumonitis in monotherapy or in combination with other chemotherapies [see Adverse Reactions (6.1)]. Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease or pneumonitis. Tykerb should be discontinued in patients who experience pulmonary symptoms indicative of interstitial lung disease/pneumonitis which are [greater than or equal to] Grade 3 (NCI See Liberate. CTCAE CTCAE Common Terminology Criteria for Adverse Events ). Viramune (nevirapine nevirapine /ne·vir·a·pine/ (ne-vir´ah-pen) a nonnucleoside inhibitor of HIV-1reverse transcriptase, used in combination with other antiretroviral agents in the treatment of HIV infection. ) Tablets and Oral Suspension WARNINGS: Hepatic Events ... Rhabdomyolysis rhabdomyolysis /rhab·do·my·ol·y·sis/ (-mi-ol´i-sis) disintegration of striated muscle fibers with excretion of myoglobin in the urine. rhab·do·my·ol·y·sis n. has been observed in some patients experiencing skin and/or liver reactions associated with Viramune use ... WARNINGS: Skin Reactions ... Rhabdomyolysis has been observed in some patients experiencing skin and/or liver reactions associated with Viramune use ... Clinoril (sulindac) Tablets PRECAUTIONS SLE SLE systemic lupus erythematosus. SLE abbr. systemic lupus erythematosus Systemic lupus erythematosus (SLE) and Mixed Connective Tissue Disease mixed connective tissue disease A connective tissue disease with features of SLE, dermatomyositis, rheumatoid arthritis Clinical Pleuritis, Raynaud's phenomenon, sclerodactyly, good response to steroids Lab MCTD has a unique speckled nucleolar pattern due to In patients with systemic lupus erythematosus Systemic Lupus Erythematosus Definition Systemic lupus erythematosus (also called lupus or SLE) is a disease where a person's immune system attacks and injures the body's own organs and tissues. Almost every system of the body can be affected by SLE. (SLE) and mixed connective tissue disease, there may be an increased risk of aseptic meningitis ... ADVERSE REACTIONS Nervous System Aseptic meningitis (especially in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease ... NSAID NSAID: see nonsteroidal anti-inflammatory drug. MEDICATION GUIDE Table: NSAID medicines that need a prescription Vicoprofen Vicoprofen contains the same dose of ibuprofen ibuprofen (ī`by  prō'fən), nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation. as over-the-counter
(OTC OTCSee: Over-the-counter. OTC See over-the-counter market (OTC). ) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. Coumadin Tablets (warfarin sodium tablets, USP) Crystalline Coumadin for Injection (warfarin sodium for injection USP PRECAUTIONS Drug/Drug and Drug/Disease Interactions Exogenous Factors (Table) Specific Drugs Reported Ezetimibe Botanical (Herbal) Medicines Table: Botanicals that contain coumarins with potential anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). effects Agrimony agrimony (ăg`rĭmō'nē), any plant of the genus Agrimonia, perennials of the family Rosaceae (rose family) native to north temperate zones, to Brazil, and to Africa. They are found wild in the N and central United States. (added to list) New footnote, #1: Contains coumarins, has antiplatelet an·ti·plate·let adj. Acting against or destroying blood platelets. antiplatelet directed against or destructive to blood platelets; inhibiting platelet function. properties, and may have coagulant coagulant /co·ag·u·lant/ (ko-ag´u-lint) promoting or accelerating coagulation of blood; an agent that so acts. co·ag·u·lant n. properties due to possible Vitamin K content. Considerations for Increased Bleeding Risk Coumadin is a narrow therapeutic range (index) drug, and additional caution should be observed when warfarin sodium is administered to certain patients ... ADVERSE REACTIONS Potential adverse reactions to Coumadin may include ... Adverse reactions reported infrequently include: hypersensitivity/allergic reactions, including anaphylactic reactions ... Diuril (chlorothiazide chlorothiazide /chlo·ro·thi·a·zide/ (klor?o-thi´ah-zid) a thiazide diuretic used in the form of the base or the sodium salt to treat hypertension and edema. ) Oral Suspension PRECAUTIONS Drug Interactions Non-steroidal Anti-inflammatory Drugs Non-steroidal anti-inflammatory drugs (NSAIDs) Aspirin, ibuprofen, naproxen, and many others. Mentioned in: Mastocytosis Including Selective Cyclooxygenase-2 (COX-2) Inhibitors Humalog (insulin lispro injection, USP [rDNA origin]), U-100 PRECAUTIONS Drug Interactions ... Insulin requirements may be decreased in the presence of drugs with hypoglycemic hypoglycemic /hy·po·gly·ce·mic/ (-gli-sem´ik) 1. pertaining to, characterized by, or causing hypoglycemia. 2. an agent that lowers blood glucose levels. activity, such as oral antidiabetic agents, salicylates Salicylates A group of drugs that includes aspirin and related compounds. Salicylates are used to relieve pain, reduce inflammation, and lower fever. , sulfa sul·fa adj. Of, relating to, or containing sulfanilamide or any sulfa drug. sulfa (sul´f antibiotics, certain antidepressants (monoamine oxidase inhibitors Monoamine Oxidase Inhibitors Definition Monoamine oxidase inhibitors (MAO inhibitors) are medicines that relieve certain types of mental depression. ), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia hypoglycemia: see diabetes. hypoglycemia Below-normal levels of blood glucose, quickly reversed by administration of oral or intravenous glucose. Even brief episodes can produce severe brain dysfunction. in some patients. PATIENT PACKAGE INSERT (updated) Humalog Mix 50/50 (50% insulin lispro protamine insulin lispro protamine, human Humalog Mix 50/50, Humalog Mix 75/25 Z Pharmacologic class: Pancreatic hormone Therapeutic class: Hypoglycemic Pregnancy risk category B Actionsuspension and 50% insulin lispro injection [rDNA origin]), U-100PRECAUTIONS Drug Interactions ... Insulin requirements may be decreased in the presence of drugs with hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients. PATIENT PACKAGE INSERT (updated) Humalog Mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection [rDNA origin]), U-100 PRECAUTIONS Drug Interactions ... Insulin requirements may be decreased in the presence of drugs with hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients. PATIENT PACKAGE INSERT (updated) Mycamine (micafungin sodium) for Injection Intravenous Infusion (not for IV bolus bolus /bo·lus/ (bo´lus) 1. a rounded mass of food or pharmaceutical preparation ready to swallow, or such a mass passing through the gastrointestinal tract. 2. a concentrated mass of pharmaceutical preparation, e. injection) PRECAUTIONS Carcinogenesis car·ci·no·gen·e·sis n. The production of cancer. carcinogenesis production of cancer. biological carcinogenesis viruses and some parasites are capable of initiating neoplasia. , Mutagenesis mutagenesis /mu·ta·gen·e·sis/ (mu?tah-jen´e-sis) 1. the production of change. 2. the induction of genetic mutation. mu·ta·gen·e·sis n. pl. and Impairment of Fertility Hepatic carcinomas and adenomas were observed in a 6-month intravenous toxicology study with an 18-month recovery period of micafungin sodium in rats designed to assess the reversibility of hepatocellular lesions ... Renagel (sevelamer hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. ) Tablets PRECAUTIONS General The safety and efficacy of Renagel in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility motility /mo·til·i·ty/ (mo-til´ite) the ability to move spontaneously.mo´tile Motility Motility is spontaneous movement. disorders including severe constipation, or major GI tract surgery have not been established ... ADVERSE REACTIONS ... and in very rare cases, intestinal obstruction and ileus Ileus Definition Ileus is a partial or complete non-mechanical blockage of the small and/or large intestine. The term "ileus" comes from the Latin word for colic. . Astelin (azelastine hydrochloride) Nasal Spray (for Intranasal in·tra·na·sal adj. Within the nose. Use Only) ADVERSE REACTIONS Postmarketing Experience Vasomotor Rhinitis Atrial Fibrillation Palpitations Elidel (pimecrolimus) Cream 1% ADVERSE REACTIONS Postmarketing Events General Skin Discoloration dis·col·or·a·tion n. 1. a. The act of discoloring. b. The condition of being discolored. 2. A discolored spot, smudge, or area; a stain. Noun 1. Arthrotec (diclofenac sodium/misoprostol) Tablets MEDICATION GUIDE: Non-Steroidal Anti-Inflammatory Drugs (NSAID) Table: NSAID medicines that need a prescription Vicoprofen Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. Coreg CR (carvedilol phosphate) Extended-Release Capsules PATIENT PACKAGE INSERT (new) Humulin 50/50 (50% human insulin isophane suspension and 50% human insulin injection [rDNA origin)), U-100 PATIENT PACKAGE INSERT (updated) Humulin 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]), U-100 PATIENT PACKAGE INSERT (updated) Humulin N NPH NPH 3-nitropropionic acid. isophane insulin suspension (NPH) and insulin injection (regular) Humulin 50/50 (50% isophane insulin and 50% insulin injection), Humulin 70/30 (70% isophane insulin and 30% insulin injection), Humulin 70/30 PenFill, (human insulin [rDNA origin] isophane suspension), U-100 PATIENT PACKAGE INSERT (updated) Humulin R Regular (insulin human injection, USP [rDNA origin]), U-100 PATIENT PACKAGE INSERT (updated) Nalfon (fenoprofen calcium capsules, USP) MEDICATION GUIDE: Non-Steroidal Anti-Inflammatory Drugs (NSAID) Table: NSAID medicines that need a prescription Vicoprofen Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. |
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