Transcript Handbook on injectable drugs

• Drug oriented, topic specific reference.
• Published by AHFS services.
• It display a summary of all of the primary
published literature on drug stability &
compatibility.
• The monographs are arranged alphabetically
by nonproprietary name.
• The names of the drugs follow the style of
USAN & the USP Dictionary of Drug
Names.
• Each monograph contain the following
information:
• Products:
– Lists many of the sizes, strengths, volumes,
and forms in which the drug is supplied.
– Instructions for constitution (when applicable).
– pH of the drug products.
– osmotic value of the drug.
– other miscellaneous product information.
• Administration:
– Routes.
– Rates of infusion (when applicable), and other
related administration details.
• Stability:
– Describes the drug’s stability and storage
requirements according to USP.
– In addition, pH effects, the effects of freezing and
exposure to light, and the sorption and filtration
characteristics of the drug are presented.
• Compatibility Information:
– Tabulates the results of published reports from primary
reference sources of compatibility testing of the subject
drug with infusion solutions and other drugs.
– The various citations are listed alphabetically by solution or
drug name; the information is completely cross-referenced
among the monographs .
– Four types of tables are utilized to present the available
information, depending on the kind of test being reported.
•
Compatible, if the results of original article
indicate one or more of the following criteria
were met:
1. Physical or visual compatibility of the combination
was reported (no detection of particulate formation,
ppt., color change or gas evolution).
2. Stability of the components for at least 24 hrs in an
admixture under the specified conditions was reported
(decomposition of 10% or less)
3. Stability of the components for the entire test period.
•
Incompatible, if the results of original article indicate
either or both of the following criteria were met:
1.
A physical or visual compatibility was reported (detection of
particulate formation, ppt., color change or gas evolution)
2.
Greater than 10% decomposition of one or more components
in 24 hrs or less under the specified condition was reported.
•
The compatibility of Injectable solution will be
discussed in case of:
1.
Dilution of drug (or reconstitution) with infusion solution e.g.
NS, D5W.(Solution Compatibility).
2.
Mixing of 2 or more drugs in the
Same IV solution.(additive compatbility).
3.
Withdrawing of 2 or more drugs by the
same syringe.(syringe compatbility).
4.
Administration of 2 drug solution by Y-site injection.
Manufacturer
of the solution
Solution in which the
test was conducted
Conc. of
the drug(m)
Manufacturer
of the drug(m)
Primary reference
Description of the
Results of the test
C: compatible
I: incompatible
Conc. of the
T. drug
Test drug
Conc. of the
Drug(m)
Manufacturer Manufacturer Infusion solution
of the T. drug of the drug(m)
of the test
Actual Amount
of the T. drug
Test drug
Manufacturer
of the T. drug
Actual Amount
of the drug(m)
Manufacturer
of the drug(m)
Conc. of the Drug(m)
prior to mixing at Y-site
Test drug
Conc. of the T. Drug prior to
mixing at Y-site
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