Loperamide Hcl

Loperamide Hcl Manufacturers

• Mckesson
  

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  Loperamide Hcl | Mckesson

  

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  drink plenty of clear fluids to help prevent dehydration caused by diarrhea not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

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• Chain Drug Consortium, Llc
  

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  Loperamide Hcl | Chain Drug Consortium, Llc

  

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  drink plenty of clear fluids to help prevent dehydration caused by diarrhea not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

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• Target Corporation
  

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  Loperamide Hcl | E.r. Squibb & Sons, L.l.c.

  

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  2.1 Recommended Dosage for Melanoma • The recommended dose of OPDIVO administered as a single agent is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. • The recommended dose of OPDIVO is 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for 4 doses [see Clinical Studies (14.1)]. The recommended subsequent dose of OPDIVO, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.  
  Review the Full Prescribing Information for ipilimumab prior to initiation. 2.2 Recommended Dosage for NSCLC

  The recommended dose of OPDIVO is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

  2.3 Dose Modifications

  Guidelines for treatment modifications are provided in Table 1.

  There are no recommended dose modifications for hypothyroidism or hyperthyroidism.

  Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Discontinue OPDIVO in patients with severe or life-threatening infusion reactions.

  Table 1: Recommended Dose Modifications for OPDIVO a  Resume treatment when adverse reaction returns to Grade 0 or 1.

  Adverse Reaction

  Severity

  Dose Modification

  Colitis

  Grade 2 diarrhea or colitis

  Withhold dosea

  Grade 3 diarrhea or colitis

       Single-agent OPDIVO

  Withhold dosea

       OPDIVO, in combination with ipilimumab

  Permanently discontinue

  Grade 4 diarrhea or colitis

  Permanently discontinue

  Pneumonitis

  Grade 2 pneumonitis

  Withhold dosea

  Grade 3 or 4 pneumonitis

  Permanently discontinue

  Hepatitis

  Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal

  Withhold dosea

  AST or ALT more than 5 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal

  Permanently discontinue

  Hypophysitis

  Grade 2 or 3 hypophysitis

  Withhold dosea

  Grade 4 hypophysitis

  Permanently discontinue

  Adrenal Insufficiency

  Grade 2 adrenal insufficiency

  Withhold dosea

  Grade 3 or 4 adrenal insufficiency

  Permanently discontinue

  Nephritis and Renal Dysfunction

  Serum creatinine more than 1.5 and up to 6 times the upper limit of normal

  Withhold dosea

  Serum creatinine more than 6 times the upper limit of normal

  Permanently discontinue

  Rash

  Grade 3 rash

  Withhold dosea

  Grade 4 rash

  Permanently discontinue

  Encephalitis

  New onset moderate or severe neurologic signs or symptoms

  Withhold dosea

  Immune-mediated encephalitis

  Permanently discontinue

  Other

  Other Grade 3 adverse reaction

       First occurrence

  Withhold dosea

       Recurrence of same Grade 3 adverse reactions

  Permanently discontinue

  Life-threatening or Grade 4 adverse reaction

  Permanently discontinue

  Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks

  Permanently discontinue

  Persistent Grade 2 or 3 adverse reactions lasting 12 weeks or longer

  Permanently discontinue

  When OPDIVO is administered in combination with ipilimumab, if OPDIVO is withheld, ipilimumab should also be withheld.

  2.4 Preparation and Administration

  Visually inspect drug product solution for particulate matter and discoloration prior to administration. OPDIVO is a clear to opalescent, colorless to pale-yellow solution. Discard the vial if the solution is cloudy, discolored, or contains extraneous particulate matter other than a few translucent-to-white, proteinaceous particles. Do not shake the vial.

  Preparation • Withdraw the required volume of OPDIVO and transfer into an intravenous container. • Dilute OPDIVO with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare an infusion with a final concentration ranging from 1 mg/mL to 10 mg/mL. • Mix diluted solution by gentle inversion. Do not shake. • Discard partially used vials or empty vials of OPDIVO. Storage of Infusion

  The product does not contain a preservative.

  After preparation, store the OPDIVO infusion either:

  • at room temperature for no more than 4 hours from the time of preparation. This includes room temperature storage of the infusion in the IV container and time for administration of the infusion or • under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of infusion preparation.

  Do not freeze.

  Administration

  Administer the infusion over 60 minutes through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micrometer to 1.2 micrometer).

  Do not coadminister other drugs through the same intravenous line.

  Flush the intravenous line at end of infusion.

  When administered in combination with ipilimumab, infuse OPDIVO first followed by ipilimumab on the same day. Use separate infusion bags and filters for each infusion.

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