Revisions

To ensure that we are providing our clients with the industry's best and most current clinical information, we complete a "post-publication" process and receive feedback regarding opportunities to add additional information or, in rare cases, make revisions.

Below is information on revisions, corrections, or modifications to existing monographs that have been identified in the past 12 months.

Ribociclib – September 2019

Revision in the Dosing: Adjustment for Toxicity: Adult field of the Ribociclib monograph in the Lexi-Drugs database, available online and in mobile apps, as well as the following publications: Drug Information Handbook 28th edition, Drug Information Handbook with International Trade Names Index 27th edition, and Drug Information Handbook for Oncology 16th edition.

The monograph previously read:

Dosing: Adjustment for Toxicity: Adult (only portion of field impacted is presented):

Nonhematologic toxicity:

Cardiovascular: QT prolongation:

QTcF >480 msec: Interrupt treatment; when QTcF resolves to <481 msec, may resume ribociclib at the same dose level. If QTcF ≥481 msec recurs, interrupt treatment until QTcF resolves to <481 msec and resume ribociclib at the next lower dose level.

It has been revised to read:

Dosing: Adjustment for Toxicity: Adult (only portion of field impacted is presented):

Nonhematologic toxicity:

Cardiovascular: QT prolongation:

QTcF >480 msec: Interrupt treatment; when QTcF resolves to <481 msec, may resume ribociclib at the next lower dose level. If QTcF ≥481 msec recurs, interrupt treatment until QTcF resolves to <481 msec and resume ribociclib at the next lower dose level.

These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.

Ribociclib Oral – September 2019

Revision in the Dosing: Adult field of the Ribociclib Oral monograph in the Drug Facts & Comparisons database.

The monograph previously read:

Dosage: Adult (only portion of field impacted is presented):

Ribociclib Dose Modification and Management for QT Prolongation(1)

ECGs with QTcF >480 msec

Interrupt ribociclib treatment

If QTcF prolongation resolves to <481 msec, resume ribociclib treatment at the same dose level;

If QTcF ≥481 msec recurs, interrupt dose until QTcF resolves to <481 msec; then resume ribociclib at next lower dose level.

ECGs with QTcF >500 msec

Interrupt ribociclib treatment if QTcF >500 msec.

If QTcF prolongation resolves to <481 msec, resume ribociclib treatment at the next lower dose level.

Permanently discontinue ribociclib if QTcF interval prolongation is either >500 msec or >60 msec change from baseline AND associated with any of the following: torsades de pointes, polymorphic ventricular tachycardia, unexplained syncope, or signs/symptoms of serious arrhythmia.

It has been revised to read:

Dosage: Adult (only portion of field impacted is presented):

Ribociclib Dose Modification and Management for QT Prolongation(1)

ECGs with QTcF >480 msec

Interrupt ribociclib treatment

If QTcF prolongation resolves to <481 msec, resume ribociclib treatment at the next lower dose level;

If QTcF ≥481 msec recurs, interrupt dose until QTcF resolves to <481 msec; then resume ribociclib at next lower dose level.

ECGs with QTcF >500 msec

Interrupt ribociclib treatment if QTcF >500 msec.

If QTcF prolongation resolves to <481 msec, resume ribociclib treatment at the next lower dose level.

Permanently discontinue ribociclib if QTcF interval prolongation is either >500 msec or >60 msec change from baseline AND associated with any of the following: torsades de pointes, polymorphic ventricular tachycardia, unexplained syncope, or signs/symptoms of serious arrhythmia.

These changes have been automatically posted online.

Lenograstim – June 2019

Revision in the Dosing: Adult field of the Lenograstim monograph in the Lexi-Drugs Multinational database, available online and in mobile apps.

The monograph previously read:

Dosing: Adult (only portion of field impacted is presented):

Peripheral blood progenitor cell (PBPC) transplantation, mobilization: Adults ≤60 years:

Following chemotherapy: SubQ: 150 mcg/m2 or 5 mcg/kg once or twice daily, initiate within 1 to 5 days after chemotherapy. Maximum daily dose: 10 mcg/kg daily. May adjust dose based on clinical response. Discontinue treatment after the expected nadir and the neutrophil count normalizes, after the last leukopheresis, or if during treatment the WBC count exceeds 75,000/mm3.

Lenograstim monotherapy without chemotherapy or PBPC mobilization in healthy donors: SubQ: 10 mcg/kg daily for 4 to 6 days; some manufacturers also recommend up to 10 mcg/kg twice daily. May adjust dose based on clinical response. Discontinue if during treatment the WBC count exceeds 75,000/mm3.

It has been revised to read:

Dosing: Adult (only portion of field impacted is presented):

Peripheral blood progenitor cell (PBPC) transplantation, mobilization: Adults ≤60 years:

Following chemotherapy: SubQ: 150 mcg/m2 or 5 mcg/kg daily, initiate within 1 to 5 days after chemotherapy. Maximum daily dose: 10 mcg/kg daily. May adjust dose based on clinical response. Discontinue treatment after the expected nadir and the neutrophil count normalizes, after the last leukopheresis, or if during treatment the WBC count exceeds 75,000/mm3.

Lenograstim monotherapy without chemotherapy or PBPC mobilization in healthy donors: SubQ: 10 mcg/kg daily for 4 to 6 days. May adjust dose based on clinical response. Discontinue if during treatment the WBC count exceeds 75,000/mm3.

These changes have been automatically posted to online and mobile app databases. Please update your mobile application to get the updated monograph.

Ampicillin and Sulbactam – April 2019

Revision in the Dosing: Adult field of the Ampicillin and Sulbactam monograph in the Lexi-Drugs database, available online and in mobile apps.

The monograph previously read:

Field Name (only portion of field impacted is presented):

Peritonitis associated with CAPD:

Intraperitoneal:

Intermittent: 3 g added to one exchange every 12 hours; allow to dwell for at least 6 hours (Blackwell 1990; Li 2010)

Continuous: Loading dose: 1.5 g per liter of dialysate; maintenance dose: 150 mg per liter of dialysate (Li 2010)

It has been revised to read:

Field Name (only portion of field impacted is presented):

Peritonitis associated with CAPD:

Intraperitoneal:

Intermittent: 3 g added to one exchange every 12 hours; allow to dwell for at least 6 hours (Blackwell 1990; ISPD [Li 2016])

Continuous: Loading dose: 750 mg to 1 g per liter of dialysate; maintenance dose: 100 mg per liter of dialysate (ISPD [Li 2016]; Lam 2008)

These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.

Risperidone – December 2018

Revision in the Maximum Dose field of the Risperidone Injection monograph in the Drug Facts and Comparisons database, available online.

The monograph previously read:

Maximum Dose (only portion of field impacted is presented):

Schizophrenia

IM

50 mg IM every 2 weeks for the treatment of schizophrenia according to the prescribing information. There is no well-established maximum dose for the other approved indication according to the prescribing information.

Subcutaneous

120 mg once weekly according to the prescribing information.

It has been revised to read:

Maximum Dose (only portion of field impacted is presented):

Schizophrenia

IM

50 mg IM every 2 weeks for the treatment of schizophrenia according to the prescribing information. There is no well-established maximum dose for the other approved indication according to the prescribing information.

Subcutaneous

120 mg once monthly according to the prescribing information.

These changes have been automatically posted online.

Hemorrhagic Fevers – December 2018

Revision in the Treatment: Pharmacologic Supportive Therapy field of the Hemorrhagic Fevers monograph in the Lexi-Tox database, available online and in mobile apps.

The monograph previously read:

Treatment: Pharmacologic Supportive Therapy (only portion of field impacted is presented):

Ribavirin: Hemorrhagic viral fever (off-label use): Oral:

Children: Loading dose: 300 mg/kg (maximum: 2,000 mg), followed by 400 mg in AM and 600 mg in PM (weight ≤75 kg). If weight >75 kg, then 600 mg in AM and 600 mg in PM

It has been revised to read:

Treatment: Pharmacologic Supportive Therapy (only portion of field impacted is presented):

Ribavirin: Hemorrhagic viral fever (off-label use): Oral:

Children: Loading dose: 30 mg/kg (maximum: 2,000 mg), followed by 400 mg in AM and 600 mg in PM (weight ≤75 kg). If weight >75 kg, then 600 mg in AM and 600 mg in PM

These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.

Amoxicillin and Clavulanate – December 2018

Revision in the Dosing: Pediatric field of the Amoxicillin and Clavulanate monograph in the Pediatric and Neonatal Lexi-Drugs database, available online and in mobile apps.

The monograph previously read:

Dosing: Pediatric (only portion of field impacted is presented):

Rhinosinusitis, acute bacterial:

Infants ≥3 months: Oral: 45 mg amoxicillin/kg/day divided every 12 hours or 40 mg/kg/day divided every 8 hours

Children and Adolescents: Oral:

Standard dose: 45 mg amoxicillin/kg/day divided every 12 hours for 10 to 14 days; maximum daily dose: 875 mg amoxicillin/day (IDSA [Chow 2012])

It has been revised to read:

Dosing: Pediatric (only portion of field impacted is presented):

Rhinosinusitis, acute bacterial:

Infants ≥3 months: Oral: 45 mg amoxicillin/kg/day divided every 12 hours or 40 mg/kg/day divided every 8 hours

Children and Adolescents: Oral:

Standard dose: 45 mg amoxicillin/kg/day divided every 12 hours for 10 to 14 days; Usual adult dose: 875 mg amoxicillin/dose (IDSA [Chow 2012])

These changes have been automatically posted to online and mobile app databases. Please update your mobile Pediatric and Neonatal Lexi-Drugs application to get the updated monograph.

Acyclovir (Systemic) – November 2018

Revision in the Dosing: Adult field of the Acyclovir (Systemic) monograph in the Lexi-Drugs database, available online and in mobile apps.

The monograph previously read:

Dosing: Adult (only portion of field impacted is presented):

Herpes zoster (shingles), treatment:

Immunocompromised patients: Oral: 800 mg 5 times daily for 7 days (Pott Junior 2018; Shafran 2004). Initiate at earliest sign or symptom (most effective when initiated ≤48 hours of rash onset); may initiate treatment >72 hours after rash onset if new lesions are continuing to appear (Cohen 1999).

It has been revised to read:

Dosing: Adult (only portion of field impacted is presented):

Herpes zoster (shingles), treatment:

Immunocompetent patients: Oral: 800 mg 5 times daily for 7 days (Pott Junior 2018; Shafran 2004). Initiate at earliest sign or symptom (most effective when initiated ≤48 hours of rash onset); may initiate treatment >72 hours after rash onset if new lesions are continuing to appear (Cohen 1999).

These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.

Sodium Phenylbutyrate – November 2018

Revision in the Dosing: Pediatric field of the Sodium Phenylbutyrate monograph in the Pediatric and Neonatal Lexi-Drugs database, available online and in mobile apps, as well as the following print publications: Pediatric & Neonatal Dosage Handbook 24th edition and Pediatric & Neonatal Dosage Handbook with International Trade Name Index 24th edition

The monograph previously read:

Dosing: Pediatric (only portion of field impacted is presented):

Urea Cycle Disorder, chronic management: Note: The use of sodium phenylbutyrate tablets in children weighing ≤20 kg is not recommended.

Infants and Children <20 kg: Oral: 450 to 600 mg/kg/day in divided doses with meals/feedings 3 to 6 times daily; minimum daily dose: 20 g/day

Children ≥20 kg and Adolescents: Oral: 9.9 to 13 g/m2/day in divided doses with meals 3 to 6 times daily; maximum daily dose: 20 g/day

It has been revised to read:

Dosing: Pediatric (only portion of field impacted is presented):

Urea Cycle Disorder, chronic management: Note: The use of sodium phenylbutyrate tablets in children weighing ≤20 kg is not recommended.

Infants and Children <20 kg: Oral: 450 to 600 mg/kg/day in divided doses with meals/feedings 3 to 6 times daily; maximum daily dose: 20 g/day

Children ≥20 kg and Adolescents: Oral: 9.9 to 13 g/m2/day in divided doses with meals 3 to 6 times daily; maximum daily dose: 20 g/day

These changes have been automatically posted to online and mobile app databases. Please update your mobile Pediatric and Neonatal Lexi-Drugs application to get the updated monograph.

Fat Emulsion (Fish Oil Based) – November 2018

Revision in the Administration field of the Fat Emulsion (Fish Oil Based) monograph in the Pediatric and Neonatal Lexi-Drugs database, available online and in mobile apps.

The monograph previously read:

Administration (only portion of field impacted is presented):

IV: Administer by IV infusion via peripheral line or central venous infusion using DEHP-free administration sets and lines. All fat emulsion infusions should be filtered whether part of an admixture or infused separately using a 1.2-micron in-line filter only (ISMP 2016). May be simultaneously infused with amino acid and dextrose mixtures by means of Y-connector located near infusion site (flow rates of each solution should be controlled separately by infusion pumps). When administered with dextrose and amino acids as an admixture, the choice of a central or peripheral infusion depends on the osmolarity of the final infusate (osmolarity ≥900 mOsm/L must be infused through a central vein). Use a vented infusion set when infused from the bottle, avoid multiple connections, do not connect multiple medications in series, and turn off pump before the bottle runs dry.

Rate: Initial rate of infusion should not exceed 0.5 mL/minute for the first 15 to 30 minutes; gradually increase until reaching the required rate after 30 minutes as tolerated. Do not exceed a rate of 1.5 mL/kg/hour. Infusion should be completed within 12 hours when using a Y-connector and within 24 hours when used as part of an admixture.

It has been revised to read:

Administration (only portion of field impacted is presented):

IV: Administer by IV infusion via peripheral line or central venous infusion using DEHP-free administration sets and lines. All fat emulsion infusions should be filtered whether part of an admixture or infused separately using a 1.2-micron in-line filter only (ISMP 2016). May be simultaneously infused with amino acid and dextrose mixtures by means of Y-connector located near infusion site (flow rates of each solution should be controlled separately by infusion pumps). When administered with dextrose and amino acids as an admixture, the choice of a central or peripheral infusion depends on the osmolarity of the final infusate (osmolarity ≥900 mOsm/L must be infused through a central vein). Use a vented infusion set when infused from the bottle, avoid multiple connections, do not connect multiple medications in series, and turn off pump before the bottle runs dry.

Rate: Initial rate of infusion should not exceed 0.05 mL/minute for the first 15 to 30 minutes; gradually increase until reaching the required rate after 30 minutes as tolerated. Do not exceed a rate of 1.5 mL/kg/hour. Infusion should be completed within 12 hours when using a Y-connector and within 24 hours when used as part of an admixture.

These changes have been automatically posted to online and mobile app databases. Please update your mobile Pediatric and Neonatal Lexi-Drugs application to get the updated monograph.

Digoxin Oral – October 2018

Revision in the Dosing: Pediatric field of the Digoxin Oral monograph in the Facts & Comparisons eAnswers database, available online.

The monograph previously read:

Dosage: Pediatric (only portion of field impacted is presented):

Heart failure

Oral solution

Loading dose

If a loading dose is needed, it can be administered with roughly half the total given as the first dose. Additional fractions of this planned total dose may be given at 4- to 8-hour intervals, with careful assessment of clinical response before each additional dose. If the patient's clinical response necessitates a change from the calculated loading dose of digoxin, then calculation of the maintenance dose should be based on the amount actually given as the loading dose.2

Digoxin Oral Solution Estimated Loading Dose2

Age

Oral loading dose

Premature

20 to 30 mcg/kg

Full-term

25 to 35 mcg/kg

1 to 24 mo of age

35 to 60 mcg/kg

2 to 5 y of age

30 to 45 mcg/kg

5 to 10 y of age

20 to 45 mcg/kg

> 10 y of age

10 to 15 mcg/kg

It has been revised to read:

Dosage: Pediatric (only portion of field impacted is presented):

Heart failure

Oral solution

Loading dose

If a loading dose is needed, it can be administered with roughly half the total given as the first dose. Additional fractions of this planned total dose may be given at 4- to 8-hour intervals, with careful assessment of clinical response before each additional dose. If the patient's clinical response necessitates a change from the calculated loading dose of digoxin, then calculation of the maintenance dose should be based on the amount actually given as the loading dose.2

Digoxin Oral Solution Estimated Loading Dose2

Age

Oral loading dose

Premature

20 to 30 mcg/kg

Full-term

25 to 35 mcg/kg

1 to 24 mo of age

35 to 60 mcg/kg

2 to 5 y of age

30 to 45 mcg/kg

5 to 10 y of age

20 to 35 mcg/kg

> 10 y of age

10 to 15 mcg/kg

These changes have been automatically posted online.