Chapter 15 - Parenterals Part 1 Flashcards
name 5 types of parenteral medications
- small and large volume injectable preparations
- Irrigation fluid (to bathe body wounds or surgical openings)
- Dialysis Solutions
- Biological preparations (vaccines, toxoids, antitoxins)
- Blood replenishment products
name 4 disadvantages of using parenteral medications
- Difficult to make; high cost
- specific equipment needed
- hard to retrieve – once in circulation you can’t get it out
- causes pain
name 6 advantages of parenteral medications
-if the person is unconscious (coma), we can still give them medication through IV
-not active when taken orally - no swallowing required
-rapid acting – placed directly into body. fastest onset time of any dosage form
-if someone in hospital cant eat, we can still give parenteral medications to maintain their essential nutrients
-drug depots – releases the drug slowly over time for less frequent administration
-implantable pumps – also consistent and controlled way of delivering drug
name 3 requirements for injections
-STERILE (free from all microorganisms)
-Pyrogen-free
-administered parenterally by health professionals (with the exception of insulin)
explain why injections must be pyrogen free
a small concenteration of pyrogen is okay.
however, pyrogen is a metabolic byproduct of gram negative bacteria. they are fever-producing organic substances
come about due to microbial contamination
name 4 parenteral routes of administration
-intravenous
-intramuscular
-subcutaneous
-intradermal
the intravenous route of parenteral administration is delivered where into the body?
directly into circulation
differentiate between the effect of IV administration vs IM (intramuscular)
intramuscular provides LESS RAPID effects but last longer than IV
why are intramuscular injections most commonly delivered? what is an important factor to consider when determining this?
muscle mass is important in determining this.
for example, intramuscular injections are most commonly administered into the upper outer quadrant of the gluteus maximus for adults.
HOWEVER, in infants and young children, this area is composed primarily of fat and not muscle. Therefore, the muscles of the mid-deltoid area are preferred for younger children and infants.
IM injections must be administered into skeletal muscles and not fat. as to be as far away as possible from major nerves and blood vessels
between the 4 parenteral routes of administration (IV, IM, subQ, intradermal) which goes in the deepest to most superficial?
DEEPEST – intramuscular
intravenous
subcutaneous
MOST SUPERFICIAL – intradermal
where are subcutaneous injections administered?
in the subcutaneous tissue (LOOSE) beneath the skin layers
frequently administered in the arm or thigh
where are intradermal injections administered to? give an example of when intradermal injections are used
just beneath the most superficial layer of the skin
used during allergy tests
is it a good thing if blood comes out after giving an IM injection?
NO – VERY BAD. this means you hit a capillary. IM injections must be administered into skeletal muscles
name the 3 ways in which IV injections can be administered
- bolus
- infusion
- aqueous solutions
what is a bolus? through which parenteral route is it administered?
a bolus is a single, small-volume injection. given through IV
explain what an infusion is.
through which parenteral route is it administered?
infusion is a SLOW, LARGE-volume injection (opposite of bolus)
administered intravenously
true or false
all infusions are continuous
false – can be continuous or intermittent
which parenteral route is used for blood transfusions?
intravenous
should drugs administered intravenously be aqueous or fat emulsion?
aqueous is preferred because they will mix with the blood in circulation and not precipitate, leading to a blockage of blood flow
however, IV fat emulsions (fatty acids) have gained acceptance to be used as a caloric source (vs glucose)
why are intramuscular injections administered?
what should be avoided?
administered deep into skeletal muscles (gluteal or lumbar)
administered in places with a deep muscle mass to minimize hitting a nerve or a blood vessel
can intravenous drugs be administered as suspensions?
NO
if a drug precipitates after injection, what can it cause?
emboli - blockage of a blood vessel. disrupts blood flow
can suspensions be administered intramuscularly?
YES
suspensions, or aqueous or oleaginous solutions
which are more rapidly absorbed – drugs in solution or drugs in suspension?
in solution
rank the following according to their rate of absorption, from fastest to slowest
oleaginous solutions
aqueous solutions
suspension
fastest – aqueous solutions
oleaginous solutions
slowest - suspension
a suspension of penicillin G benzathine is given through which route of administration?
how long is the effect?
given IM (intramuscular)
7-10 days of effect
low drug solubility gives longer or shorter duration of action?
longer (sustained drug action)
parenteral drugs given via the subcutaneous route are delivered where and at what volume?
delivered into LOOSE SUBCUTANEOUS TISSUE of the upper arm, forearm, or thigh
very small volume –2mL or less
injections given via subcutaneous route can be…..
aqueous solutions, suspensions, and pellets
(i think non aqueous too??? not sure)
how are subcutaneous suspensions administered?
through a drug depot or repository to give prolonged effects
how are subcutaneous pellets administered?
via implantation
where are intradermal injections administered?
at what volume?
in the corium (aka dermis) of the skin in the ARM or the BACK
VERY SMALL VOLUME —- ~0.1mL
which parenteral route of administration is used for tuberculin testing and allergy testing?
intradermal route
define Injection and give a specific example of an Injection product
INJECTION – liquid preparations that are drug substances or solutions thereof
Insulin Injection, USP
define “for injection” and give an example of a specific product
“for injection” – dry solids that, upon the addition of suitable vehicles, yield solutions that conform, in all respects, to the requirements for injections
Cefuroxime for Injection, USP
define Injectable Emulsion and give a specific example of a product
injectable emulsion = liquid preparation of a drug substance dissolved or dispersed in a suitable emulsion medium
Propofol, USP
define injectable suspension and give an example of a specific product
liquid preparation of a solid suspended in a suitable liquid medium
Methylprednisolone Acetate Suspension, USP
define “for injectable suspension” and give a specific example of a product
“for injectable suspension” = dry solid that, upon the addition of a suitable vehicle, yields preparation conforming in all respects to the requirements for injectable suspensions
Imipenem and Cilastatin for Injectable Suspension
what is an emulsion?
2 phases – oil and water
name the 5 OFFICIAL TYPES OF INJECTIONS
Injection
For injection
Injectable emulsion
Injectable suspension
For injectable suspension
name the 5 GENERAL categories for 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
differentiate between
“Sterile Dexamethasone Acetate Suspension, USP”
and
“Sterile Ampicillin for Suspension, USP”
the dexamethasone is READY FOR INJECTION – insoluble components are already suspended in the solvent
the ampicillin is a dry, insoluble powder that is ready to be combined with solvents
true or false
there usually is no issue with adding coloring agents to parenteral injections
FALSE – it is strictly prohibited
what can you say about the use of buffers, stabilizers, and antimicrobial preservatives in parenteral injections
these are added substances that fall under very specific guidelines and are restricted in certain parenteral products
true or false
solvents/vehicles for parenteral injections must meet special purity and other standards, ensuring their safety by injection
TRUE
True or false
parenteral products are always sterile, with very few exceptions
FALSE — ALWAYS STERILIZED AND MUST MEET STERILITY STANDARDS
parenteral injections must not exceed allowable ____ limits
endotoxin limits (ELs)
parenteral _____ must meet compendial standards for ____ matter
parenteral SOLUTIONS, particulate (amt of particles not dissolved)
parenteral products must be prepared in what areas?
in environmentally controlled areas under STRICT SANITATION standards and by personnel that are trained and clothed to maintain these sanitation standards
what does hermetic mean
airtight
explain how parenteral products must be packaged
in special hermetic (airtight) containers of specific and high quality.
quality control procedures are in place to ensure the hermetic seal and sterile condition
explain how high injection containers are filled and why
filled slightly higher than the labeled volume to be withdrawn
makes it easier to withdraw and administer the labeled volume
are there specific labeling regulations that apply only to injections?
yes
is there any restriction on if an injection can be contained in a single or multidose container?
yes
if multi-dose is allowed, there is a restricted volume. sometimes only single dose is allowed for certain injections
STERILE POWDERS intended for solution or suspension immediately prior to being injected are packaged how?
they are lypophilized (AKA freeze dried) to permit ease of solution or suspension when the solvent or vehicle is added
extemporaneously prepared (impromptu) parenteral preparations must be compounded in what kind of facility?
USP <797> compliant
what is the most frequently used solvent in the large-scale manufacturer of injections
Water for Injection, USP
explain how Water for Injection, USP is prepared
through distillation or reverse osmosis.
meets the same standards of Purified Water, USP
what are the requirements for “Water for Injection, USP”
when is it intended to be used?
does NOT have to be sterile, but DOES have to be pyrogen free
meets the same standards as Purified Water, USP (not more than 1mg/100mL of total solids)
intended to be used in the manufacture of injectable products to be sterilized AFTER PREPARATION
Name 3 water products used for solvents in injections
-Water for Injection, USP
-Sterile Water for Injection, USP
-Bacteriostatic Water for Injection, USP
true or false
Sterile Water for Injection, USP is required to be antimicrobial free, while Water for Injection, USP is not
true
true or false
Sterile Water for Injection, USP must be pyrogen free
TRUE
Explain the difference between Bacteriostatic Water for Injection, USP and Sterile Water for Injection, USP
Bacteriostatic Water, USP is the same as Sterile Water, USP except that it has one or more antimicrobial agents
is Bacteriostatic Water for Injection, USP used in large volumes? why or why not?
NO because of the antimicrobial agents (preservatives). toxic if administered in large amounts
Is Sodium Chloride Injection, USP sterile?
yes
Does Sodium Chloride Injection, USP have preservatives?
NO – it is a sterile, isotonic solution of sodium chloride in sterile water (Sterile Water for Injection, USP)
explain the difference between Sodium Chloride, for Injection, USP and Bacteriostatic Sodium Chloride for Injection, USP
Bacteriostatic Sodium Chloride Injection, USP is also a sterile isotonic solution of sodium chloride, but it has 1 or more antimicrobial agents
What is Ringer’s Injection, USP
(also state if it’s sterile or not)
a STERILE solution of sodium chloride, potassium chloride, and calcium chloride in water for injection
the 3 agents (NaCl, KCl, CaCl2) are present in concentrations similar to physiological fluids
explain the difference between Ringer’s Injection, USP and Lactated Ringer’s Injection, USP
Lactated Ringer’s Injection, USP has different quantities of the 3 salts (NaCl, KCl, CaCl2) and also contains sodium lactate
What is the purpose of Lactated Ringer’s Injection, USP
a fluid and electrolyte replenisher and systemic alkanizer
name 4 solvents and vehicles for injections
water (Water for Injection, Sterile Water for Injection, Bacteriostatic Water for Injection)
Sodium Chloride (Sodium Chloride Injection, USP, Bacteriostatic Sodium Chloride Injection, USP
Ringer’s Injection, USP, Lactated Ringer’s Injection, USP
Dextrose
