Tikosyn Clinical Studies

Black Box Warnings - Adverse Drug Events And Black Box Warnings
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder Patients who are started on therapy should be observed closely for clinical worsening, ... Read Article

An Overview Of Drug Transporters In ADME, Safety, And Efficacy
Clinical pharmacology studies. • Classification of CYP inhibitors and substrates can aid in study design and labeling. – Substrate (25% metabolism) Tikosyn (420 mL/min) + cimetidine + probenecid. Narrow TDI: 40% Çin AUC; CLR È33%; QTc Ç17-19 ms. No effect. Oseltamivir +cimetidine ... Read Full Source

Itraconazole - Wikipedia, The Free Encyclopedia
Clinical data; Trade names: Sporanox: AHFS/Drugs.com: MedlinePlus: dofetilide (Tikosyn); nisoldipine (Sular); pimozide (Orap); quinidine (Quinaglute, Quinidex, Quin-Release); lovastatin (Altocor, Altoprev, Mevacor) or simvastatin (Zocor); ... Read Article

ARON FARREL STEIN, Ph.D.
Products including DOXIL for ovarian cancer, VIAGRA, TIKOSYN, and multiple Served as Study Director conducting toxicology GLP studies in support of new therapeutics entering clinical trials. ... Access Document

REMS Webinar 12-15-10 - FINALcorrection 12-22
Approval use studies of clinical outcomes Focus studies on safety concerns Go beyond stapling a computer generated handout to a paper bag Continue to focus Committee sponsored use studies on safety concerns Its about Time! Dofetilide (Tikosyn ... Visit Document

2011 An Overview Of Drug Transporters In ADME & Drug Action
Dofetilide (Tikosyn™) > Concomitant administration OCT inhibitors increase potential for cardiac toxicity Cidofovir (Vistide™) Clinical Studies and DDI Potential Drug (CL R) Results (Bedside) Mirapex (400 mL/min) + cimetidine + probenecid ... Read Here

Haloperidol And Cardiovascular Concerns Reports Of ...
Recommended that manufacturers conduct clinical studies to investigate the frequency of complex sleep-related (Tikosyn®) – Restricted to 6WSD nursing unit requiring continuous telemetry monitoring and approved by TIP® registered ... View This Document

CODING GUIDELINES AND POLICY UPDATE COMPENDIUM
Studies and the consistency of the results are considered in evaluating the evidence. Studies are Dofetilide (Tikosyn®) in clinical situations in which the following criteria are met: ... Fetch Full Source

In clinical studies, patients with creatinine clearance 45mL/min required no dose adjustments other than those recommended for all patients. Insufficient numbers of patients with creatinine clearance below 45mL/min have been treated to make dosage ... Fetch Doc

Global Regulatory Perspectives On Drug Safety
Clinical trial databases vs. post-marketing Acute vs. long-term effects Large, simple (?) safety studies Baraclude (entecavir) in hepatitis B Dofetilide Tikosyn Eculizumab Soliris Fentanyl PCA Ionsys3 Fentanyl citrate Actiq ... Read Full Source

MATERIAL SAFETY DATA SHEET
Effects similar to those seen in clinical use. however, those with preexisting cardiovascular illnesses may be at increased risk from exposure. Long Term: Repeat-dose studies in animals have shown a potential to cause adverse Tikosyn (Dofetilide) capsules - 0.125 mg, 0.25 mg, 0.50 mg ... Fetch This Document

Medical Policy And Clinical Guideline Updates
Medical Policy and Clinical Guideline Updates RAD.00046 Cerebral Perfusion Studies using Diffusion and Perfusion Magnetic Resonance Imaging Dofetilide, Tikosyn™ Toolkit - Dolasetron, Anzemet® Toolkit - Doxorubicin, Adriamycin®, ... Read Content

Medical Professional Education And Consultation Services
• Cardiovascular imaging studies with contrast and no identified risk factors, e.g. arteriogram, cardiac catheterization • Clinical lab tests requiring arterial puncture • Skin biopsies • Rest • Gargles • Elastic bandages ... Retrieve Full Source

The Weekly Mortar & Pestle
CPA = Clinical Prior Authorization MUE = Medication Use Evaluation PIT = Place in Therapy SPA ▪ Among 74 studies reviewed by the FDA, 38 were deemed to have positive results, ▪ Tikosyn 0.25 mg and 0.5 mg capsules are available ... Retrieve Here

Histamine H2-Receptor Antagonists
Clinical studies document a maximum treatment duration of 56 days (eight weeks) for anti-ulcer therapy in the treatment of acute duodenal ulcer and gastric ulcer. (Tikosyn®) [clinical significance level - 1 (DIF); contraindicated (DrugReax); 3 (Hansten & Horn] ... Visit Document

TABLE OF CONTENTS 1-2 2-3 3-4 - Drug Information Group
2004 due to post-marketing studies that demonstrated an increase in cardiovascular events. Dofetilide Tikosyn Eculizumab Soliris Fentanyl PCA Ionsys Fentanyl citrate Actiq during both clinical development and post-approval phases through REMS. ... Read Here

*** Warning ***
The studies were performed in order to better understand the clinical impact studies reported in the 1960s also favor the use of anticoagulation prior to direct current cardioversion. In http://www.tikosyn.com/pdf/ ... Access Full Source

What Clinicians Should Know About The QT Interval
CLINICAL CARDIOLOGY CLINICIAN’S CORNER The Pfizer Tikosyn program specifies that while the QTc should be no more than 440 millisec-onds Although inadequate clinical studies preclude prediction of abso-lute risk for individual patients, par- ... Retrieve Doc

HIGHLIGHTS OF PRESCRIBING INFORMATION ...
14 CLINICAL STUDIES 14.1 Clinical Efficacy in Adults with HIV-1 Infection 14.2 Clinical Efficacy in Adults with Chronic Hepatitis B 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information ... Document Viewer

Emerging Regulatory Changes In Post-Approval Safety And Risk ...
• Epidemiological studies and clinical trials • Risk management • Summary of selected FDAAA activities • Risk communication • Looking to the future. 4 Some Recent Trends. 5 Goals of Drug Safety Surveillance Tikosyn. Tysabri. 32 Medication Guides and REMS ... Fetch Doc