Hospital Pharmacy - July/August 2018 - 224

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Hospital Pharmacy 53(4)

Dolophine Hydrochloride (NDA-006134) (METHADONE HYDROCHLORIDE)
Edited Boxed Warning
(Additions and/or revisions are underlined)
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 DOLOPHINE Tablets and benzodiazepines or other CNS depressants for use in patients for whom
alternatives to benzodiazepines or other CNS depressants are inadequate.
Limit dosages and durations to the minimum required for patients being treated for pain.
Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of
sedation, and consider delaying or omitting the daily methadone dose.

Ocaliva (NDA-207999) (OBETICHOLIC ACID)
New Boxed Warning
(Newly added section)
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS
B OR C OR DECOMPENSATED CIRRHOSIS
In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with primary biliary
cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more
frequently than recommended.
The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a
prior decompensation event.

Aquamephyton (NDA-012223) (PHYTONADIONE)
Edited Boxed Warning
(Additions and/or revisions are underlined)
WARNING-HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE
Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR
injection of AquaMEPHYTON. Reactions have occurred despite dilution to avoid rapid infusion and upon first dose. Avoid the intravenous
and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified.

Parnate (NDA-012342) (TRANYLCYPROMINE SULFATE)
Edited Boxed Warning
(Physician Labeling Rule (PLR conversion); additions and/or revisions underlined)
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE
Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely
monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. PARNATE is
not approved for use in pediatric patients.
Hypertensive Crisis with Significant Tyramine Use
Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with PARNATE or after
PARNATE discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between
administration of PARNATE and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content.

1

Search of Drug Safety Labeling Changes (SLC) database 1/1/18-3/31/18.
Drug Safety Labeling Changes are available at: http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdel
ivery&utm_medium=email&utm_source=govdelivery
2

Shannon Thor, PharmD, MS, Health Programs Coordinator
US Food and Drug Administration, Office of Health and Constituent Affairs
http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdelivery&utm_medium=email&utm_source=govdelivery http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdelivery&utm_medium=email&utm_source=govdelivery
Table of Contents for the Digital Edition of Hospital Pharmacy - July/August 2018
