Matches in Nanopublications for { ?s <http://www.w3.org/2000/01/rdf-schema#label> ?o ?g. }
- association label "This involves also off-label prescription of the drug as hypnotic, which is high, and this has been attributed to the off-label promotion of its prescription by its manufacturers, who were also fined for this (Monasterio & McKean, 2011a, 2011b; McKean & Monasterio, 2012); this probably ensued in increased demand for other than indicated conditions (Monasterio & McKean, 2013a). " assertion.
- context label "Adults" assertion.
- association label "The on‐label indication for Brintellix is depression; we identified the following off‐label indications: schizophrenia, episodic mood disorders, anxiety disorders, personality disorders, bipolar depression, post‐traumatic stress disorder, and chronic pain." assertion.
- MONDO_0005090 label "schizophrenia" assertion.
- MONDO_0005090 label "schizophrenia" assertion.
- MONDO_0005090 label "schizophrenia" assertion.
- MONDO_0005090 label "schizophrenia" assertion.
- MONDO_0005090 label "Schizophrenia" assertion.
- MONDO_0005090 label "Manic bipolar affective disorder" assertion.
- context label "Adults" assertion.
- association label "The on‐label indication for Brintellix is depression; we identified the following off‐label indications: schizophrenia, episodic mood disorders, anxiety disorders, personality disorders, bipolar depression, post‐traumatic stress disorder, and chronic pain." assertion.
- association label "The on‐label indication for Brintellix is depression; we identified the following off‐label indications: schizophrenia, episodic mood disorders, anxiety disorders, personality disorders, bipolar depression, post‐traumatic stress disorder, and chronic pain." assertion.
- context label "Adults" assertion.
- context label "Adults" assertion.
- association label "The on‐label indication for Brintellix is depression; we identified the following off‐label indications: schizophrenia, episodic mood disorders, anxiety disorders, personality disorders, bipolar depression, post‐traumatic stress disorder, and chronic pain." assertion.
- context label "Adults" assertion.
- association label "In addition to neuropathic pain, bupropion has also shown some effectiveness in treating chronic pain that is caused by inflammatory bowel disease (IBD)" assertion.
- context label "Adults" assertion.
- association label "Emerging research assesses the utility of venlafaxine in the management of chronic neuropathic pain." assertion.
- association label "With regard to the use of specific SGAs in BD, off-label aripiprazole was considered appropriate for depressive episodes by 46% of the psychiatrists, followed by olanzapine which was considered appropriate by 33.7%." assertion.
- context label "Adults" assertion.
- context label "Adults" assertion.
- association label "Moreover, although the studies were uncontrolled, a significant body of literature has highlighted the potential benefit of clozapine in the treatment of acute mania, the depressive phase of BD, and in overall mood stabilization, with some evidence suggesting its use not only in treatment-resistant schizophrenia but also in treatment-refractory BD." assertion.
- context label "Adults" assertion.
- association label "When we asked about the long-term treatment of BD, after having excluded from the analyses the 3 SGAs with a European indication for maintenance BD treatment (aripiprazole, olanzapine, and quetiapine), asenapine was considered either “highly appropriate” or “appropriate” by 44.6% of the respondents, while other off-label SGAs (clozapine, paliperidone, risperidone, ziprasidone) were mostly considered inappro- priate for maintenance bipolar treatment" assertion.
- context label "Adults" assertion.
- association label "When we asked about the long-term treatment of BD, after having excluded from the analyses the 3 SGAs with a European indication for maintenance BD treatment (aripiprazole, olanzapine, and quetiapine), asenapine was considered either “highly appropriate” or “appropriate” by 44.6% of the respondents, while other off-label SGAs (clozapine, paliperidone, risperidone, ziprasidone) were mostly considered inappro- priate for maintenance bipolar treatment" assertion.
- context label "Adults" assertion.
- association label "When we asked about the long-term treatment of BD, after having excluded from the analyses the 3 SGAs with a European indication for maintenance BD treatment (aripiprazole, olanzapine, and quetiapine), asenapine was considered either “highly appropriate” or “appropriate” by 44.6% of the respondents, while other off-label SGAs (clozapine, paliperidone, risperidone, ziprasidone) were mostly considered inappro- priate for maintenance bipolar treatment" assertion.
- context label "Adults" assertion.
- association label "The off label antipsychotic treatments we considered were sulpiride, olanzapine, pimozide, quetiapine, risperidone, haloperidol, tiapride, chlorpromazine, and aripiprazole. We estimated the effect of antipsychotics as a group, and also estimated effects of certain individual antipsychotic chorea drugs (i.e. olanzapine, risperidone, and tiapride) commonly taken in our cohort." assertion.
- association label "The off label antipsychotic treatments we considered were sulpiride, olanzapine, pimozide, quetiapine, risperidone, haloperidol, tiapride, chlorpromazine, and aripiprazole. We estimated the effect of antipsychotics as a group, and also estimated effects of certain individual antipsychotic chorea drugs (i.e. olanzapine, risperidone, and tiapride) commonly taken in our cohort." assertion.
- context label "Adults" assertion.
- context label "Adults" assertion.
- association label "The off label antipsychotic treatments we considered were sulpiride, olanzapine, pimozide, quetiapine, risperidone, haloperidol, tiapride, chlorpromazine, and aripiprazole. We estimated the effect of antipsychotics as a group, and also estimated effects of certain individual antipsychotic chorea drugs (i.e. olanzapine, risperidone, and tiapride) commonly taken in our cohort." assertion.
- association label "The off label antipsychotic treatments we considered were sulpiride, olanzapine, pimozide, quetiapine, risperidone, haloperidol, tiapride, chlorpromazine, and aripiprazole. We estimated the effect of antipsychotics as a group, and also estimated effects of certain individual antipsychotic chorea drugs (i.e. olanzapine, risperidone, and tiapride) commonly taken in our cohort." assertion.
- context label "Adults" assertion.
- association label "Guidelines for the pharmacological treatment of chronic insomnia in adults recognize that trazodone and other off-label medications are commonly prescribed despite poor evidence." assertion.
- context label "Adults" assertion.
- association label ""1. Hepatic or severe renal dysfunction, including primary biliary cirrhosis. 2. Preexisting gallbladder disease (see WARNINGS 3. Hypersensitivity to gemfibrozil. 4. Combination therapy of gemfibrozil with simvastatin (see WARNINGS PRECAUTIONS 5. Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS 6. Combination therapy of gemfibrozil with dasabuvir (see PRECAUTIONS 7. Combination therapy of gemfibrozil with selexipag (see PRECAUTIONS"" assertion.
- association label ""Ocular or periocular infections ( 4.1 Glaucoma ( 4.2 Torn or ruptured posterior lens capsule ( 4.3 Hypersensitivity ( 4.4 OZURDEX (r) OZURDEX (r) OZURDEX (r) OZURDEX (r) OZURDEX (r) [see Adverse Reactions ( 6 )]"" assertion.
- association label ""Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age , nursing mothers , and in patients with: [see Use in Specific Populations ( )] 8.4 [see Use in Specific Populations ( )] 8.3 unstable cardiovascular status in acute hemorrhage myasthenia gravis [see Warnings and Precautions ( )] 5.4 glaucoma [see Adverse Reactions ( ) and Drug Interactions ( )] 6.3 7.1 obstructive uropathy [see Warnings and Precautions ( )] 5.8 obstructive disease of the gastrointestinal tract [see Warnings and Precautions ( )] 5.5 severe ulcerative colitis [see Warnings and Precautions ( )] 5.7 reflux esophagitis Infants less than 6 months of age ( ) 4 Nursing mothers ( ) 4 Unstable cardiovascular status in acute hemorrhage ( ) 4 Myasthenia gravis ( ) 4 Glaucoma ( ) 4 Obstructive uropathy ( ) 4 Obstructive disease of the gastrointestinal tract ( ) 4 Severe ulcerative colitis ( ) 4 Reflux esophagitis ( ) 4"" assertion.
- association label ""Fenofibric acid delayed-release capsules are contraindicated in: patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology ( 12.3 patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions ( 5.3 patients with preexisting gallbladder disease [see Warnings and Precautions ( 5.5 nursing mothers [see Use in Specific Populations ( 8.2 patients with hypersensitivity to fenofibric acid or fenofibrate [see Warnings and Precautions ( 5.9 Severe renal dysfunction, including patients receiving dialysis ( 4 , 12.3 ). Active liver disease ( 4 , 5.3 ). Gallbladder disease ( 4 , 5.5 ). Lactation ( 4 , 8.2 ). Known hypersensitivity to fenofibric acid or fenofibrate ( 4 , 5.9 )."" assertion.
- association label ""Y Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. Known hypersensitivity to product components. ( 4 Severe bradycardia. ( 4 Heart block greater than first degree. ( 4 Cardiogenic shock. ( 4 Decompensated cadiac failure. ( 4 Sick sinus syndrome without a pacemaker. ( 4"" assertion.
- association label ""Benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse. Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine hydrochloride should not be used concomitantly with other CNS stimulants. Benzphetamine hydrochloride may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine hydrochloride is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions. Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime. Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly. Efficacy of benzphetamine hydrochloride tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems. Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine hydrochloride should not be used concomitantly with other CNS stimulants. Amphetamines may decrease the hypotensive effect of antihypertensives. Amphetamines may enhance the effects of tricyclic antidepressants. Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying agents decrease blood levels and increase excretion of amphetamines. Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed. Pregnancy Category X (see CONTRAINDICATIONS Section). Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing. Safety and effectiveness in pediatric patients have not been established. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age. Clinical studies of benzphetamine hydrochloride tablets did not include sufficient numbers of subjects aged 65 and over to establish safety and efficacy in this population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."" assertion.
- association label ""Clindamycin Phosphate Foam, 1% is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). Clindamycin Phosphate Foam, 1% is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis, (including pseudomembranous colitis). ( 4"" assertion.
- association label "Sotalol hydrochloride tablets are contraindicated in patients with bronchial asthma, sinus bradycardia, second and third degree AV block, unless a functioning pacemaker is present, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled congestive heart failure and previous evidence of hypersensitivity to sotalol hydrochloride tablets." assertion.
- association label ""Diltiazem hydrochloride injection is contraindicated in: Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. Patients with second- or third-degree AV block except in the presence of functioning ventricular pacemaker. Patients with severe hypotension or cardiogenic shock. Patients who have demonstrated hypersensitivity to the drug. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome. As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (eg, verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with diltiazem hydrochloride injection. As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscitation capabilities, including DC cardioversion/defibrillation, are present (see OVERDOSAGE Patients with ventricular tachycardia. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS >= 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. It is important that an accurate pretreatment diagnosis distinguish wide complex QRS tachycardia of supraventricular origin from that of ventricular origin prior to administration of diltiazem hydrochloride injection."" assertion.
- association label ""Ezetimibe Tablet is contraindicated in the following conditions: The combination of Ezetimibe Tablets with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels. Women who are pregnant or may become pregnant. Because statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Ezetimibe Tablets in combination with a statin may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy, and safety in pregnant women has not been established. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy. [See Use in Specific Populations ( 8.1 Nursing mothers. Because statins may pass into breast milk, and because statins have the potential to cause serious adverse reactions in nursing infants, women who require Ezetimibe Tablets treatment in combination with a statin should be advised not to nurse their infants [see Use in Specific Populations ( 8.3 Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria have been reported with Ezetimibe Tablets [see Adverse Reactions ( 6.2 * Statin contraindications apply when Ezetimibe Tablet is used with a statin: Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4 5.2 Women who are pregnant or may become pregnant ( 4 8.1 Nursing mothers ( 4 8.3 Known hypersensitivity to product components ( 4 6.2"" assertion.
- association label ""Nebivolol Tablets are contraindicated in the following conditions: * Severe bradycardia * Heart block greater than first degree * Patients with cardiogenic shock * Decompensated cardiac failure * Sick sinus syndrome (unless a permanent pacemaker is in place) * Patients with severe hepatic impairment (Child-Pugh >B) * Patients who are hypersensitive to any component of this product * Severe bradycardia (4) * Heart block greater than first degree (4) * Patients with cardiogenic shock (4) * Decompensated cardiac failure (4) * Sick sinus syndrome (unless a permanent pacemaker is in place) (4) * Patients with severe hepatic impairment (Child-Pugh >B) (4) * Hypersensitive to any component of this product (4)"" assertion.
- association label ""Warfarin sodium is contraindicated in: Pregnancy Warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [ see Warnings and Precautions (5.7) Use in Specific Populations (8.1 see Use in Specific Populations (8.1) Warfarin sodium is contraindicated in patients with: Hemorrhagic tendencies or blood dyscrasias Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [ see Warnings and Precautions (5.8) Bleeding tendencies associated with: - Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract - Central nervous system hemorrhage - Cerebral aneurysms, dissecting aorta - Pericarditis and pericardial effusions - Bacterial endocarditis Threatened abortion, eclampsia, and preeclampsia Unsupervised patients with conditions associated with potential high level of non-compliance Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) [ see Adverse Reactions (6) Major regional or lumbar block anesthesia Malignant hypertension Pregnancy, except in women with mechanical heart valves. ( 4 5.7 8.1 Hemorrhagic tendencies or blood dyscrasias. ( 4 Recent or contemplated surgery of the central nervous system (CNS) or eye, or traumatic surgery resulting in large open surfaces. ( 4, 5.8) Bleeding tendencies associated with certain conditions. ( 4 Threatened abortion, eclampsia, and preeclampsia. ( 4 Unsupervised patients with potential high levels of non-compliance. ( 4 Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding. ( 4 Hypersensitivity to warfarin or any component of the product. ( 4 Major regional or lumbar block anesthesia. ( 4 Malignant hypertension. ( 4"" assertion.
- association label ""Seizure disorder. ( 4 5.3 Current or prior diagnosis of bulimia or anorexia nervosa ( 4 5.3 Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. ( 4 5.3 Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion hydrochloride extended-release tablets (XL) or within 14 days of stopping treatment with bupropion hydrochloride extended-release tablets (XL). Do not use bupropion hydrochloride extended-release tablets (XL) within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrochloride extended-release tablets (XL) in a patient who is being treated with linezolid or intravenous methylene blue. ( 4 7.6 Known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL) ( 4 5.8 Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride extended-release tablets (XL) [ see Warnings and Precautions (5.3) Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [ see Warnings and Precautions (5.3) Drug Interactions (7.3) The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (XL) is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (XL) within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting bupropion hydrochloride extended-release tablets (XL) in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [ see Dosage and Administration (2.9) Warnings and Precautions (5.4) Drug Interactions (7.6) Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL). Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported [ see Warnings and Precautions (5.8)"" assertion.
- association label ""WARNINGS Anaphylactoid Reactions, PRECAUTIONS Preexisting Asthma WARNINGS WARNINGS for correction of volume depletion WARNINGS PRECAUTIONS"" assertion.
- association label ""* When co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. Table 2. Drugs that are Contraindicated with Ritonavir Drug Class Drugs Within Class That Are Contraindicated With Ritonavir ** Clinical Comments Alpha 1 Alfuzosin HCL Potential for hypotension. Antianginal Ranolazine Potential for serious and/or life-threatening reactions. Antiarrhythmic Amiodarone,dronedarone, flecainide, propafenone, Potential for cardiac arrhythmias. Antifungal Voriconazole Voriconazole is contraindicated with ritonavir doses of 400 mg every 12 hours or greaterdue to the potential for loss of antifungal response. Anti-gout Colchicine a Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment. Antipsychotics Lurasidone Potential for serious and/or life-threatening reactions. Ergot Derivatives Dihydroergotamine, Potential for acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system. GI Motility Agent Cisapride Potential for cardiac arrhythmias. Herbal Products St. John's Wort (hypericum perforatum) May lead to loss of virologic response and possible resistance to ritonavir or to the class of protease inhibitors. HMG-CoA Reductase Inhibitors: Lovastatin, simvastatin Potential for myopathy including rhabdomyolysis. PDE5 inhibitor Sildenafil b (r) Potential for sildenafil-associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope. Sedative/hypnotics Oral midazolam c Prolonged or increased sedation or respiratory depression. a 7 Table 5 b 7 Table 5 c ( 7 Table 5 * Ritonavir is contraindicated in patients with known hypersensitivity to ritonavir (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome) or any of its ingredients (4)"" assertion.
- association label ""Benazepril hydrochloride tablets are contraindicated in patients: who are hypersensitive to benazepril or to any other ACE inhibitor with a history of angioedema with or without previous ACE inhibitor treatment Benazepril hydrochloride tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2) Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including benazepril hydrochloride tablets in patients with diabetes [see Drug Interactions (7.4) Angioedema or history of hereditary or idiopathic angioedema ( 4 Hypersensitivity ( 4 Coadministration with aliskiren in patients with diabetes ( 4"" assertion.
- association label ""IONSYS is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions ( 5.1 Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.1 Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.13 Hypersensitivity to fentanyl, cetylpyridinium chloride (e.g., Cepacol(r)), or any components of IONSYS [see Adverse Reactions ( 6.1 6.2 Significant respiratory depression. ( 4 Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 Hypersensitivity to fentanyl, cetylpyridinium chloride (e.g., Cepacol (r) 4"" assertion.
- association label ""Fentanyl transdermal system is contraindicated in the following patients and situations: in patients who are not opioid-tolerant. in patients who have or are suspected of having paralytic ileus. in patients with known hypersensitivity to fentanyl or any components of the transdermal system. Severe hypersensitivity reactions, including anaphylaxis have been observed with fentanyl transdermal system [see Adverse Reactions (6.2) Opioid non-tolerant patients. ( 4 Acute or intermittent pain, postoperative pain, mild pain. ( 4 Respiratory compromise, acute or severe asthma. ( 4 Paralytic ileus. ( 4 Known hypersensitivity to fentanyl or any of the components of the transdermal system. ( 4"" assertion.
- association label ""Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. Known hypersensitivity or idiosyncrasy to amphetamine. In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine sulfate extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products ( see ADVERSE REACTIONS Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis ( see WARNINGS and Drug Interactions"" assertion.
- association label ""Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncratic reaction to sympathomimetic amines, glaucoma Agitated states Patients with a history of drug abuse During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) [ See Drug Interactions (7.3) Advanced arteriosclerosis ( 4 Symptomatic cardiovascular disease ( 4 Moderate to severe hypertension ( 4 Hyperthyroidism ( 4 Known hypersensitivity or idiosyncrasy to sympathomimetic amines ( 4 Glaucoma ( 4 Agitated states ( 4 History of drug abuse ( 4 During or within 14 days following the administration of monoamine oxidase inhibitors (MAOI) ( 4 7.3"" assertion.
- association label ""FOSAMAX is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1) Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.6) Warnings and Precautions (5.1) Do not administer FOSAMAX oral solution to patients at increased risk of aspiration. Hypocalcemia [see Warnings and Precautions (5.2) Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see Adverse Reactions (6.2) Abnormalities of the esophagus which delay emptying such as stricture or achalasia ( 4 5.1 Inability to stand/sit upright for at least 30 minutes ( 2.6 4 5.1 Do not administer FOSAMAX oral solution to patients at increased risk of aspiration. ( 4 Hypocalcemia ( 4 5.2 Hypersensitivity to any component of this product ( 4 6.2"" assertion.
- association label "Clonazepam tablets should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma." assertion.
- association label ""Captopril tablets are contraindicated in patients who are hypersensitive to this product or any other angiotensin-converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer aliskiren with captopril tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions Captopril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer captopril tablet within 36 hours of switching to or from sacubitril/valsartan, a nepriltsin inhibitor ( see PRECAUTIONS, Drug Interactions"" assertion.
- association label ""Sumatriptan succinate tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see Warnings and Precautions ( )] 5.1 Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( )] 5.2 History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke ee [s Warnings and Precautions ( )] 5.4 Peripheral vascular disease [see Warnings and Precautions ( )] 5.5 Ischemic bowel disease [see Warnings and Precautions ( )] 5.5 Uncontrolled hypertension [see Warnings and Precautions ( )] 5.8 Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT ) agonist 1 [see Drug Interactions ( , )] 7.1 7.3 Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions ( ) and Clinical Pharmacology ( )] 7.2 12.3 Hypersensitivity to sumatriptan succinate tablets (angioedema and anaphylaxis seen) [see Warnings and Precautions ( )] 5.9 Severe hepatic impairment [see Use in Specific Populations ( ) and Clinical Pharmacology ( )] 8.6 12.3 History of coronary artery disease or coronary artery vasospasm ( ) 4 Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( ) 4 History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( ) 4 Peripheral vascular disease ( ) 4 Ischemic bowel disease ( ) Uncontrolled hypertension ( ) 4 4 Recent (within 24 hours) use of another 5-HT agonist (e.g., another triptan) or of an ergotamine-containing medication. ( ) 1 4 Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor. ( ) 4 Hypersensitivity to sumatriptan succinate tablets (angioedema and anaphylaxis seen). ( ) 4 Severe hepatic impairment. ( ) 4"" assertion.
- association label ""Sumatriptan succinate tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive sumatriptan succinate tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see WARNINGS). Because sumatriptan succinate tablets may increase blood pressure, they should not be given to patients with uncontrolled hypertension. Concurrent administration of MAO-A inhibitors or use within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated (see CLINICAL PHARMACOLOGY, Drug Interactions and PRECAUTIONS, Drug Interactions). Sumatriptan succinate tablets should not be administered to patients with hemiplegic or basilar migraine. Sumatriptan succinate tablets and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should sumatriptan succinate tablets and another 5-HT 1 Sumatriptan succinate tablets are contraindicated in patients with hypersensitivity to sumatriptan or any of their components. Sumatriptan succinate tablets are contraindicated in patients with severe hepatic impairment."" assertion.
- association label ""Griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. Griseofulvin may cause fetal harm when administered to a pregnant woman. Two published cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy, therefore, griseofulvin is contraindicated in women who are or may become pregnant during treatment. Women taking estrogen-containing oral contraceptives may be at increased risk of becoming pregnant while on griseofulvin (see also PRECAUTIONS, Drug Interactions Note: The Maximum Recommend Human Dose (MRHD) was set at 500 mg/day for the multiple of human exposure calculations performed in this label. If higher doses than 500 mg/day were used clinically, then the multiple of human exposure would be correspondingly reduced for that dose. For example, if a 1000 mg/day dose was administered to an individual, then the multiple of human exposure would be reduced by a factor of 2. Griseofulvin has been shown to be embryotoxic and teratogenic in pregnant rats when given at a daily oral dose of 250 mg/kg/day [4X the Maximum Recommended Human Dose (MRHD) based on a Body Surface Area (BSA)]. Griseofulvin also has been shown to be embryotoxic and teratogenic in pregnant cats treated weekly with griseofulvin at doses of 500 to 1000 mg/week. There are reports of teratogenicity in a Golden Retriever when doses of 750 mg/day [1.2X the MRHD based on BSA] were administered for four weeks prior to and throughout the pregnancy, and in a study in which beagles were administered 35 mg/kg/day [1.9X the MRHD based on BSA] for intervals from one week up to the entire gestation period. Teratogenicity was also seen in mice when griseofulvin was administered in doses equivalent to 5g/kg/day [40X the MRHD based on BSA] for 2 consecutive days at various stages of the pregnancy."" assertion.
- association label "Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone." assertion.
- association label ""Quinidine is contraindicated in patients who are known to be allergic to it, or who have a history of immune thrombocytopenia or have developed thrombocytopenic purpura during prior therapy with quinidine or quinine (see WARNINGS In the absence of a functioning artificial pacemaker, quinidine is also contraindicated in any patient whose cardiac rhythm is dependent upon a junctional or idioventricular pacemaker, including patients in complete atrioventricular block. Quinidine is also contraindicated in patients who, like those with myasthenia gravis, might be adversely affected by an anticholinergic agent."" assertion.
- association label ""Eletriptan hydrobromide tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see Warnings and Precautions ( 5.1 )] Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 )] History of stroke, transient ischemic attack (TIA), or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4 )] Peripheral vascular disease [see Warnings and Precautions ( 5.5 )] Ischemic bowel disease [see Warnings and Precautions ( 5.5 )] Uncontrolled hypertension [see Warnings and Precautions ( 5.8 )] Recent use (i.e., within 24 hours) of another 5-hydroxytryptamine 1 1 [see Drug Interactions ( 7.1 )] Hypersensitivity to eletriptan hydrobromide tablets (angioedema and anaphylaxis seen) [see Warnings and Precautions ( 5.9 )] Recent use (i.e., within at least 72 hours) of the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir [see Drug Interactions ( 7.2 ) and Clinical Pharmacology ( 12.3 )] History of coronary artery disease (CAD) or coronary artery vasospasm ( 4 Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 History of stroke, transient ischemic attack, or history or current evidence of hemiplegic or basilar migraine ( 4 Peripheral vascular disease ( 4 Ischemic bowel disease ( 4 Uncontrolled hypertension ( 4 Within 24 hours of treatment with another 5-HT 1 4 Hypersensitivity to eletriptan hydrobromide tablets (angioedema and anaphylaxis seen) ( 4 Within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir ( 4"" assertion.
- association label ""Aranesp is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] Serious allergic reactions to Aranesp [see Warnings and Precautions ( 5.7 )] Uncontrolled hypertension ( 4 Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs ( 4 Serious allergic reactions to Aranesp ( 4"" assertion.
- association label ""Zolmitriptan is contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or c Warnings and Precautions ( 5.1 Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4 Peripheral vascular disease (PVD) [see Warnings and Precautions ( 5.5 Ischemic bowel disease [see Warnings and Precautions ( 5.5 Uncontrolled hypertension [see Warnings and Precautions ( 5.8 Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions ( 7.1 7.3 Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent use of a MAO-A inhibitor (that is within 2 weeks) [see Drug Interactions ( 7.2 Clinical Pharmacology ( 12.3 Known hypersensitivity to zolmitriptan (angioedema and anaphylaxis seen) [see Adverse Reactions ( 6.2 History of coronary artery disease (CAD) or coronary vasospasm ( 4 Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 Peripheral vascular disease ( 4 Ischemic bowel disease ( 4 Uncontrolled hypertension ( 4 Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan), or an ergotamine-containing medication ( 4 Monamine oxidase (MAO)-A inhibitor used in past 2 weeks ( 4 Known hypersensitivity to zolmitriptan ( 4"" assertion.
- association label ""Ocular or periocular infections (4.1) Glaucoma (4.2) Hypersensitivity (4.3) ILUVIEN ILUVIEN ILUVIEN"" assertion.
- association label ""Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria, marked impairment of liver functions or with severe respiratory distress where dyspnea or obstruction is evident. Large doses are contraindicated in nephritic subjects. Barbiturates should not be administered to persons with known previous addiction to the sedative-hypnotic group since ordinary doses may be ineffectual and may contribute to further addiction. Intraarterial administration is contraindicated. Its consequences vary from transient pain to gangrene. Subcutaneous administration produces tissue irritation, ranging from tenderness and redness to necrosis and is not recommended. (See DOSAGE AND ADMINISTRATION, Treatment of Adverse Effects Due to Inadvertent Error in Administration"" assertion.
- association label "Anuria. Known hypersensitivity to indapamide or to other sulfonamide-derived drugs." assertion.
- association label ""Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age. Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals)are also contraindicated in those patients with known hypersensitivity to nitrofurantoin."" assertion.
- association label ""TYSABRI is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [ see Warnings and Precautions ( 5.1 TYSABRI is contraindicated in patients who have had a hypersensitivity reaction to TYSABRI. Observed reactions range from urticaria to anaphylaxis [ see Warnings and Precautions ( 5.5 Patients who have or have had PML ( 4 Patients who have had a hypersensitivity reaction to TYSABRI ( 4 5.3"" assertion.
- association label ""* [see Drug Interactions ( 7 12.3 * LEXIVA is contraindicated when coadministered with the following drugs: o Alpha 1-adrenoreceptor antagonist: Alfuzosin o Antiarrhythmics: Flecainide (with ritonavir), propafenone (with ritonavir) o Antimycobacterial: Rifampin o Antipsychotic: Lurasidone (with ritonavir), pimozide o Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine o GI motility agent: Cisapride o Herbal product: St. John's wort ( Hypericum perforatum o Lipid modifying agents: Lomitapide, lovastatin, simvastatin o Non-nucleoside reverse transcriptase inhibitor: Delavirdine o PDE5 inhibitor: Sildenafil (REVATIO) (for treatment of pulmonary arterial hypertension) o Sedative/hypnotics: Midazolam, triazolam * 4 * 4 * 4"" assertion.
- association label ""* Active pathological bleeding ( 4.1 4.2 4.3 Prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions ( 5.1 6.1 Prasugrel tablets is contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke. In TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel), patients with a history of TIA or ischemic stroke (>3 months prior to enrollment) had a higher rate of stroke on Prasugrel tablets (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ICH]) than on clopidogrel (1.2%; all thrombotic). In patients without such a history, the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with Prasugrel tablets and clopidogrel, respectively. Patients with a history of ischemic stroke within 3 months of screening and patients with a history of hemorrhagic stroke at any time were excluded from TRITON-TIMI 38. Patients who experience a stroke or TIA while on Prasugrel tablets generally should have therapy discontinued [see Adverse Reactions ( 6.1 14 Prasugrel tablets is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see Adverse Reactions ( 6.2"" assertion.
- association label ""Indomethacin for Injection is contraindicated in neonates: With proven or suspected infection that is untreated Who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding With thrombocytopenia or coagulation defects With or who are suspected of having necrotizing enterocolitis With significant impairment of renal function With congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta). Indomethacin for Injection is contraindicated in neonates: With proven or suspected infection that is untreated Who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding With thrombocytopenia or coagulation defects Suspected of having necrotizing enterocolitis With significant impairment of renal function With congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow. ( 4"" assertion.
- association label ""Quinine sulfate is contraindicated in patients with the following: Prolongation of QT interval ( 4 Glucose-6-phosphate dehydrogenase (G6PD) deficiency ( 4 Myasthenia gravis ( 4 Known hypersensitivity to quinine, mefloquine, or quinidine ( 4 Optic neuritis ( 4 Quinine sulfate is contraindicated in patients with the following: * Prolonged QT interval. One case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P. falciparum [see WARNINGS AND PRECAUTIONS ( 5.3 * Glucose-6-phosphate dehydrogenase (G6PD) deficiency. * Hemolysis can occur in patients with G6PD deficiency receiving quinine. * Known hypersensitivity reactions to quinine. * These include, but are not limited to, the following [see WARNINGS AND PRECAUTIONS ( 5.6 * Thrombocytopenia * Idiopathic thrombocytopenia purpura (ITP) and Thrombotic thrombocytopenic purpura (TTP) * Hemolytic uremic syndrome (HUS) * Blackwater fever (acute intravascular hemolysis, hemoglobinuria, and hemoglobinemia) * Known hypersensitivity to mefloquine or quinidine: cross-sensitivity to quinine has been documented [see WARNINGS AND PRECAUTIONS ( 5.6 * Myasthenia gravis. Quinine has neuromuscular blocking activity, and may exacerbate muscle weakness. * Optic neuritis. Quinine may exacerbate active optic neuritis [see ADVERSE REACTIONS ( 6"" assertion.
- association label ""Anuria. Severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis. Severe hepatic disease. Hypersensitivity to the drug or any of its components. Triamterene capsules should not be used in patients with pre-existing elevated serum potassium, as is sometimes seen in patients with impaired renal function or azotemia, or in patients who develop hyperkalemia while on the drug. Patients should not be placed on dietary potassium supplements, potassium salts or potassium-containing salt substitutes in conjunction with triamterene capsules. Triamterene capsules should not be given to patients receiving other potassium-sparing agents, such as spironolactone, amiloride hydrochloride, or other formulations containing triamterene. Two deaths have been reported in patients receiving concomitant spironolactone and triamterene capsules or Dyazide (r) Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including triamterene capsules. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving triamterene capsules, when dosages are changed or with any illness that may influence renal function."" assertion.
- association label ""Nitroglycerin in 5% Dextrose Injection is contraindicated in patients who are allergic to it. In patients with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, cardiac output is dependent upon venous return. Intravenous nitroglycerin is contraindicated in patients with these conditions. Nitroglycerin is also contraindicated in patients with increased intracranial pressure. Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors) such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension."" assertion.
- association label ""Newborn or Premature Infants: Nursing Mothers: Other Conditions: Monoamine oxidase inhibitor therapy (see DRUG INTERACTIONS) Angle-closure glaucoma Stenosing peptic ulcer Symptomatic prostatic hypertropy Bladder neck obstruction Pyloroduodenal obstruction Elderly, debilitated patients"" assertion.
- association label ""Do not initiate in patients with constipation ( 4.1 History of chronic or severe constipation or sequelae from constipation; intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; ischemic colitis; impaired intestinal circulation, thrombophlebitis, or hypercoagulable state; Crohn's disease or ulcerative colitis; diverticulitis; severe hepatic impairment ( 4.2 Concomitant use of fluvoxamine ( 4.3 Alosetron hydrochloride tablets should not be initiated [see Warnings and Precautions ( 5.1 Alosetron hydrochloride tablets are contraindicated in patients with a history of the following: chronic or severe constipation or sequelae from constipation intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions ischemic colitis, impaired intestinal circulation, thrombophlebitis, or hypercoagulable state Crohn's disease or ulcerative colitis diverticulitis severe hepatic impairment Concomitant administration of alosetron hydrochloride tablets with fluvoxamine is contraindicated. Fluvoxamine, a known strong inhibitor of CYP1A2, has been shown to increase mean alosetron plasma concentrations (AUC) approximately 6-fold and prolong the half-life by approximately 3-fold [see Drug Interactions ( 7.1"" assertion.
- association label ""Carvedilol tablets are contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of carvedilol tablets. Second- or third-degree AV block Sick sinus syndrome Severe bradycardia (unless a permanent pacemaker is in place) Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating carvedilol tablets. Patients with severe hepatic impairment Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. Bronchial asthma or related bronchospastic conditions ( ) 4 Second- or third-degree AV block ( ) 4 Sick sinus syndrome ( ) 4 Severe bradycardia (unless permanent pacemaker in place) ( ) 4 Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy. ( ) 4 Severe hepatic impairment ( , ) 2.4 4 History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. ( ) 4"" assertion.
- association label ""Carisoprodol Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. * Acute intermittent porphyria ( 4 * Hypersensitivity reactions to a carbamate such as meprobamate ( 4"" assertion.
- association label ""The use of Heparin Sodium in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection is contraindicated in patients with the following conditions: History of Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) [see Warnings and Precautions ( 5.3 Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions ( 6.1 In whom suitable blood coagulation tests -- e.g., the whole blood clotting time, partial thromboplastin time, etc., -- cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin) [see Warnings and Precautions ( 5.5 An uncontrolled bleeding state [see Warnings and Precautions ( 5.2 History of Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) ( 4 Known hypersensitivity to heparin or pork products ( 4 In whom suitable blood coagulation tests cannot be performed at appropriate intervals ( 4"" assertion.
- association label ""ZELNORM is contraindicated in patients with: A history of myocardial infarction (MI), stroke, transient ischemic attack (TIA), or angina [see Warnings and Precautions (5.1) A history of ischemic colitis or other forms of intestinal ischemia [see Warnings and Precautions (5.2) Severe renal impairment (eGFR< 15 mL/min/1.73 m 2 [see Use in Specific Populations (8.6) Moderate and severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7) A history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions [see Adverse Reactions (6.2) Hypersensitivity to tegaserod [see Adverse Reactions (6.2) ZELNORM is contraindicated in patients with: A history of myocardial infarction, stroke, transient ischemic attack, or angina. ( 4 5.1 A history of ischemic colitis or other forms of intestinal ischemia. ( 4 5.2 Severe renal impairment (eGFR< 15 mL/min/1.73 m 2 4 8.6 Moderate or severe hepatic impairment (Child-Pugh B or C). ( 4 8.7 A history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions. ( 4 Hypersensitivity to tegaserod. ( 4"" assertion.
- association label ""Fosinopril sodium tablets are contraindicated in patients who are hypersensitive to this product or to any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced angioedema with any other ACE inhibitor therapy). Do not co-administer fosinopril sodium tablets with aliskiren in patients with diabetes."" assertion.
- association label "Methyclothiazide tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to this compound or other sulfonamide-derived drugs." assertion.
- association label ""Ibandronate sodium is contraindicated in patients with the following conditions: * Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see Warnings and Precautions [ 5.1 * Inability to stand or sit upright for at least 60 minutes (see Dosage and Administration [2.2], and Warnings and Precautions [ 5.1 * Hypocalcemia (see Warnings and Precautions [ 5.2 * Known hypersensitivity to ibandronate sodium tablets or to any of its excipients. Cases of anaphylaxis have been reported. (see Adverse Reactions [6.2]) * Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia ( 4 5.1 * Inability to stand or sit upright for at least 60 minutes ( 4 5.1 * Hypocalcemia ( 4 * Hypersensitivity to ibandronate sodium ( 4"" assertion.
- association label ""ENDOMETRIN is contraindicated in individuals with any of the following conditions: Previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN [ see Description (11) see Description (11) Undiagnosed vaginal bleeding Undiagnosed vaginal bleeding Known missed abortion or ectopic pregnancyKnown missed abortion or ectopic pregnancy Liver diseaseLiver disease Known or suspected malignancy of the breast or genital organsKnown or suspected malignancy of the breast or genital organs Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these eventsActive arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events Previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN Vaginal Insert ( 4 Undiagnosed vaginal bleeding ( 4 Known missed abortion or ectopic pregnancy ( 4 Liver disease ( 4 Known or suspected malignancy of the breast or genital organs ( 4 Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events ( 4"" assertion.
- association label ""1. Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy. 2. Liver dysfunction or disease. 3. Known or suspected malignancy of breast or genital organs. 4. Undiagnosed vaginal bleeding. 5. Missed abortion. 6. Known sensitivity to progesterone injection."" assertion.
- association label "Bumetanide is contraindicated in anuria. Although bumetanide tablets can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide tablets. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug." assertion.
- association label ""* Medullary Thyroid Carcinoma VICTOZA is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). * Hypersensitivity VICTOZA is contraindicated in patients with a prior serious hypersensitivity reaction to VICTOZA or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with VICTOZA [see Warnings and Precautions 5.6 VICTOZA is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4) VICTOZA is contraindicated in patients with a prior serious hypersensitivity reaction to VICTOZA or any of the product components (4)"" assertion.
- association label "Paliperidone is FDA-approved for schizophrenia aged 12-17. However, the pharmacologic portfolio, extrapolation from adult studies, and the long track record of the parent drug, risperidone in child/adolescent psychiatric (CAP) population might expand its therapeutic potential. An 8-week open-label study [9] examined paliperidone monotherapy for acute mania, mixed, or hypomanic episode in pediatric patients (n = 15, 6–17 years of age) with bipolar spectrum disorders. At the end of follow-up period, 11 subjects (73%) completed the study; treatment with paliperidone was associated with a 60% response rate (50% decrease in the Young Mania Rating Scale) and 40% remission (YMRS <12)" assertion.
- context label "Children and adolescents (6-17 years)" assertion.
- context label "Children and adolescents (mean age 13.4 years)" assertion.
- association label "Fernandez-Mayoralas et al. [12] have conducted a prospective 16-week open-label study of paliperidone in 18 patients (mean age, 13.4 years) with severe and excessive irritability in the context of generalized developmental disorders or ADHD." assertion.
- context label "Adolescents (15-17)" assertion.
- association label "Similarly, De Cos Milas et al. [6] described their clinical experience with paliperidone in adolescents. They presented 3 males and 2 females, age between 15 and 17 years. Diagnoses were autism, borderline personality disorder, schizotypal personality disorder, personality disorder not otherwise specified, and schizophrenia. Prescribed dose was 3–9 mg/day, and actual mean time of treatment duration is 5.8 months. In 4 cases, paliperidone was initiated as a change from other antipsychotic. There were no adverse effects that required discontinuation and in all cases symptoms improved." assertion.