Hospital Pharmacy - February 2018 - 21
Current FDA-Related Drug Information
21
CONZIP (TRAMADOL HYDROCHLORIDE) (NDA 022370)
ULTRAM (TRAMADOL HYDROCHLORIDE) (NDA 020281)
ULTRACET (ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE) (NDA 021123)
Edited Boxed Warning
(additions underlined)
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION;
ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR
LIFE- THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL
SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
...
Ultra-Rapid Metabolism Of Tramadol And Other Risk Factors For Life-Threatening Respiratory Depression In Children
Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the
reported cases followed tonsillectomy and/or adenoidectomy; and at least one case, the child had evidence of being an
ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism (see WARNINGS). ULTRAM is contraindicated
in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or
adenoidectomy (see CONTRAINDICATIONS). Avoid the use of ULTRAM in adolescents 12 to 18 years of age who
have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
ULTRAM ER (TRAMADOL HYDROCHLORIDE) (NDA 21692)
Edited Boxed Warning
(additions underlined)
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION;
ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR
LIFE- THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL
SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
...
Ultra-Rapid Metabolism Of Tramadol And Other Risk Factors For Life-Threatening Respiratory Depression In
Children
Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of
the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of
being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. ULTRAM ER is contraindicated in
children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or
adenoidectomy. Avoid the use of ULTRAM ER in adolescents 12 to 18 years of age who have other risk factors that
may increase their sensitivity to the respiratory depressant effects of tramadol.
...
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including
alcohol, may result in profound sedation, respiratory depression, coma, and death.
** Reserve concomitant prescribing of ULTRAM ER Injection and benzodiazepines or other CNS depressants for use
in patients for whom alternative treatment options are inadequate.
** Limit dosages and durations to the minimum required.
** Follow patients for signs and symptoms of respiratory depression and sedation.
DEMEROL (MEPERIDINE HYDROCHLORIDE) (NDA 005010)
Edited Boxed Warning
Addition of or Oral Solution to DEMEROL Tablets throughout this section
Addition of the following:
Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering DEMEROL Oral Solution. Dosing errors due to
confusion between mg and mL, and other Meperidine Hydrochloride Oral Solutions of different concentrations can
result in accidental overdose and death.
Table of Contents for the Digital Edition of Hospital Pharmacy - February 2018
Ed Board
TOC
Editorial
The Evolving Frontier of Digital Health: Opportunities for Pharmacists on the Horizon
Letter to the Editor
Immediate Attention Required: Another Shortage
ISMP Adverse Drug Reactions
ISMP Adverse Drug Reactions
Current FDA-Related Drug Information
Summaries of Safety Labeling Changes Approved By FDA: Boxed Warnings Highlights July-September 2017
ISMP Medication Error Report Analysis
Common Missteps With Medication Safety: Rolling a Single Dice, Ineffective Strategies, and Unexecuted Action Plans
Formulary Drug Reviews
Betrixaban
Pharmaceutical Pipeline Update
Antibiotics in Development for the Treatment of Resistant Bacterial Disease
Articles
Evaluation of the Incidence of Ibuprofen Administration in Alcohol and Opioid Detoxification Patients With Concomitant Thrombocytopenia
Antimicrobial Utilization Pattern in Pediatric Patients in Tertiary Care Hospital, Eastern Ethiopia: The Need for Antimicrobial Stewardship
Acute Hepatocellular Jaundice After Dofetilide Initiation: A Case Report
Outcomes From a Pharmacist: Led Proton Pump Inhibitor Stewardship Program at a Single Institution
Corrigendum
Hospital Pharmacy - February 2018 - Cover1
Hospital Pharmacy - February 2018 - Cover2
Hospital Pharmacy - February 2018 - 1
Hospital Pharmacy - February 2018 - 2
Hospital Pharmacy - February 2018 - 3
Hospital Pharmacy - February 2018 - Ed Board
Hospital Pharmacy - February 2018 - TOC
Hospital Pharmacy - February 2018 - Editorial
Hospital Pharmacy - February 2018 - The Evolving Frontier of Digital Health: Opportunities for Pharmacists on the Horizon
Hospital Pharmacy - February 2018 - 8
Hospital Pharmacy - February 2018 - 9
Hospital Pharmacy - February 2018 - 10
Hospital Pharmacy - February 2018 - Letter to the Editor
Hospital Pharmacy - February 2018 - Immediate Attention Required: Another Shortage
Hospital Pharmacy - February 2018 - 13
Hospital Pharmacy - February 2018 - ISMP Adverse Drug Reactions
Hospital Pharmacy - February 2018 - ISMP Adverse Drug Reactions
Hospital Pharmacy - February 2018 - 16
Hospital Pharmacy - February 2018 - Current FDA-Related Drug Information
Hospital Pharmacy - February 2018 - Summaries of Safety Labeling Changes Approved By FDA: Boxed Warnings Highlights July-September 2017
Hospital Pharmacy - February 2018 - 19
Hospital Pharmacy - February 2018 - 20
Hospital Pharmacy - February 2018 - 21
Hospital Pharmacy - February 2018 - 22
Hospital Pharmacy - February 2018 - 23
Hospital Pharmacy - February 2018 - ISMP Medication Error Report Analysis
Hospital Pharmacy - February 2018 - Common Missteps With Medication Safety: Rolling a Single Dice, Ineffective Strategies, and Unexecuted Action Plans
Hospital Pharmacy - February 2018 - 26
Hospital Pharmacy - February 2018 - 27
Hospital Pharmacy - February 2018 - Formulary Drug Reviews
Hospital Pharmacy - February 2018 - Betrixaban
Hospital Pharmacy - February 2018 - 30
Hospital Pharmacy - February 2018 - 31
Hospital Pharmacy - February 2018 - 32
Hospital Pharmacy - February 2018 - 33
Hospital Pharmacy - February 2018 - 34
Hospital Pharmacy - February 2018 - 35
Hospital Pharmacy - February 2018 - 36
Hospital Pharmacy - February 2018 - Pharmaceutical Pipeline Update
Hospital Pharmacy - February 2018 - Antibiotics in Development for the Treatment of Resistant Bacterial Disease
Hospital Pharmacy - February 2018 - 39
Hospital Pharmacy - February 2018 - Articles
Hospital Pharmacy - February 2018 - Evaluation of the Incidence of Ibuprofen Administration in Alcohol and Opioid Detoxification Patients With Concomitant Thrombocytopenia
Hospital Pharmacy - February 2018 - 42
Hospital Pharmacy - February 2018 - 43
Hospital Pharmacy - February 2018 - Antimicrobial Utilization Pattern in Pediatric Patients in Tertiary Care Hospital, Eastern Ethiopia: The Need for Antimicrobial Stewardship
Hospital Pharmacy - February 2018 - 45
Hospital Pharmacy - February 2018 - 46
Hospital Pharmacy - February 2018 - 47
Hospital Pharmacy - February 2018 - 48
Hospital Pharmacy - February 2018 - 49
Hospital Pharmacy - February 2018 - 50
Hospital Pharmacy - February 2018 - 51
Hospital Pharmacy - February 2018 - 52
Hospital Pharmacy - February 2018 - 53
Hospital Pharmacy - February 2018 - 54
Hospital Pharmacy - February 2018 - Acute Hepatocellular Jaundice After Dofetilide Initiation: A Case Report
Hospital Pharmacy - February 2018 - 56
Hospital Pharmacy - February 2018 - 57
Hospital Pharmacy - February 2018 - 58
Hospital Pharmacy - February 2018 - Outcomes From a Pharmacist: Led Proton Pump Inhibitor Stewardship Program at a Single Institution
Hospital Pharmacy - February 2018 - 60
Hospital Pharmacy - February 2018 - 61
Hospital Pharmacy - February 2018 - 62
Hospital Pharmacy - February 2018 - 63
Hospital Pharmacy - February 2018 - 64
Hospital Pharmacy - February 2018 - 65
Hospital Pharmacy - February 2018 - 66
Hospital Pharmacy - February 2018 - 67
Hospital Pharmacy - February 2018 - Corrigendum
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