1: Parenteralia Flashcards
parenteral articles must meet requirements for
sterility pyrogens particulate matter other contaminants inhibitors of microorganism growth
parenteral route is used when
rapid action
oral dose can’t be used
when something is not effective except as an injection
rate these from fastest to slowest peak
-IM, IV, SC
IV, SC, IM
T or F: IV is only small volumes
F- can also be large volumes
SC and intracutaneous is _____ amounts for ____ and ____
small amounts only
diagnostic and immunization
4 advantages to parenteral admin
alternative to poorly absorbed drugs
fast and predictable
for uncooperative, unconscious, or can’t take it orally
for localized drug therapy
disadvantages of parenteral
Expensive
Must be sterile
Administration requires skilled or trained personnel
May be difficult to remove if adverse or toxic reaction
Thrombus (clot) or embolism (blocking vessel)
5 categories of injections
Solutions ready for injection
Dry, soluble products ready to be combined with solvents
Suspensions ready for injection
Dry, insoluble products ready to be combined with solvents
Emulsions
Official types of injections
- Solutions of meds (injection)
- Dry solids (for injection)
- Emulsion (injectable emulsion)
- Suspensions (injectable suspension)
- Dry solids (for injectable SUSPENSION)
can suspensions be given IV
no- interferes with clotting system
Aqueous vehicles must meet requirements for _____ or ______, whichever is specified
Pyrogen test or Bacterial Endotoxin Test
what to add to IV to make isotonic
NaCl
who can’t use bacteriostatic water for injection
neonates
nonaqueous injection vehicles are
fixed oils of vegetable origin only
requirements for fixed oils
liquid at room temp clear at 10C antioxidants free of acids odourless non-irritating, active, or toxic non-pharmacologically active/ interacting
Use caution for __ addition of added substances to IVs
> 5mL
Maximums for added substances:
____ for agents containing mercury and cationic, surface active compounds
_____for chlorobutanol, cresol, phenol, and similar
_____ for sulfur dioxide or equivalent amount of sulfite, bisulfite, or metabisulfite of potassium or sodium
- 01%
- 5%
- 2%
substance(s) to prevent growth of microorganisms must be added for______________, regardless of method of sterilization
multiple dose containers
when do multiple dose containers not require addition of anti-microbials
different directions in individual monograph
substance contains radionuclide with physical half life of <24h
active ingredients themselves are antimicrobial
list 3 types of solutes
Drugs
Isotonic agents like NaCl, dextrose, and other materials to adjust tonicity
Buffer agents to prevent chemical degradation
Antimicrobial agents like thiomersal, benzoyl alcohol
Antioxidants like sodium bisulfate or ascorbic acid (both aq)
Preservatives
Solubilizers
Thickeners
______: hermetic container with sterile drug intended for single dose
- give an example
Single dose
Ex- ampoules sealed by fusion
___________: hermetic container that permits withdrawal of successive portions of the contents without changing strength, quality, or purity of remaining portion
- give an example
Multiple dose
Ex- vial with elastomer seal
multiple dose products should not see change in ___, ____, or ____ of remaining portion
strength, purity, quality
Sufficient area of container must remain uncovered for _____ or _______ to permit inspection of contents
full length or circumference
