Chapter 15: Parenterals

Parenteral The term parenteral derived from the Greek words: para (outside) and
enteron, (intestine) denotes routes of administration other than oral route refe
rs to the injectable routes administration sterile Parenteral Injections pyrogen
free preparations intended to be administered parenterally. Based on the route
of administration, sterile products are classified into: 1. Parenteral preparati
ons 2. Ophthalmic preparations - for the eye 3. Otic preparations - for the ear
4. Nasal preparations - for the nose & throat 5. Irrigating solutions - for wash
ing wounds or abraded mucous membrane Parenteral Routes of Administration 1. Int
ra-articular joints 2. Intraspinal spinal column 3. Intra-arterial arteries 4. I
ntravenous veins 5. Intradermal shin 6. Intrasynovial joint fluid 7. Intrathecal
spinal fluid 8. Intracardiac heart 9. Intramuscular muscles 10. Subcutaneous un
der the skin
Physician's assistant Nurse Parenterals are administered at: Hospitals Clinics Ext
ended care facilities Antirheumatic injectables Brand Name: Enbrel Generic name:
Etanercept Manufacture: Immunex Form: Injectable Recommended initial dose: 25mg
(1 vial) twice a week injected subcutaneously Botulinum toxin Brand name: Botox
Generic name: Clostridium botulinum ( type A neurotoxin complex) Form: Powder f
or solution for injection Botulinum toxin Brand name: Myobloc Generic name: Botu
linum toxin Type B Form: Injection, solution [single-dose vial]: 5000 units/mL (
0.5 mL, 1 mL, 2 mL) [contains albumin 0.05%] Intravenous Route (IV) Advantage: M
ay be a life-saving procedure because of the placement of the drug directly into
the circulation and the prompt actions which ensues. Disadvantage: Once the dru
g administered, it cannot be retrieved. In the case of adverse reaction to the d
rug, for instance, the drug cannot be easily removed from the circulation. Preca
utions: Strict aseptic precautions must be taken at all times to avoid risk of i
nfection. The syringes and needles used must be sterilized and to the point of e
ntrance must be disinfected to reduce chance of carrying bacteria from the skin
into the blood via the needle Flow Rates: Generally, the flow rates of IV are ex
pressed in mL/hour, Range from 42 to 150 mL/hour. Lower rates are used for keep-
open (KO, KVO) Great care must be taken to prevent overdosing or underdosing. Ex
ample: Metoprolol (beta blocker) 3 bolus injections of 5 mg each at about 2 minu
te intervals oral dosing (100 mg/day) NOTE: Not only are the injectable solution
s sterile, syringes, needles must also be disinfected to reduce the chance of ca
rrying bacteria
Parenterals are administered by: Physician
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A backflow of blood into the administration set or syringe indicates proper plac
ement of the needle in the vein Intravenous drugs ordinarily must be aqueous sol
ution They must mix with the circulating blood and not precipitate from solution
. Such an event can lead to pulmonary micropillary occlusion and blockage of blo
od flow.
4. 5.
6. 7. 8. 9.

Intravenous fat emulsions Intralipid, 10,20,30% Clintec Liposyn 11,10, 20% Abott
Liposyn 111, 10,20,30% as a source of calories and essential fatty acids for pa
tients requiring parenteral nutrition for extended period, usually more than 5 d
ays. The product contains up to: 30% soybean oil emulsified with eggyolk phospho
lipids in a vehicle of glycerin in water injection
Example: WalkMed PCA Ability to provide constant and uniform analgesia Can preve
nt pharmacokinetics and pharmacodynamic differences between patients from interf
ering with the effectiveness of analgesia Also permits patients to medicate them
selves when there is breakthrough pain Minimizes various side effects PCA device
s can be used for IV, SC or epidural administration These devices are either, de
mand dosing (fixed dose of drug is injected intermittently) or constant-rate inf
usion plus demand dosing
Different lengths of needles
Hazard of Intravenous Injection The possibility of thrombus formation induced by
the touching of the wall of the vein by the catheter or needle. Thrombus is a b
lood clot formed within the blood vessel (or heart) due usually to a slowing of
the circulation or to an alteration of the blood or vessel wall. Once such a blo
t circulates, it becomes an Embolus carried by the blood stream until it lodges
in a blood vessel, obstructing it, and resulting in blockage or occlusion referr
ed to as an Embolism. Example: Automated IV delivery system - Self administratio
n analgesics Advantages: 1. Patient Controlled Analgesia (PCA) used to control p
ain 2. Allows greater degree of ambulation and independence 3. Typical PCA conta
ins analgesic drug, syringe and programmable electromechanical unit, which might
be compact enough to be worn on a belt or carried in a pocket
Intramuscular (IM) Intramuscular injections of drugs provide effects that are le
ss rapid, but generally of greater duration than those obtained from intravenous
administration IM are performed deep into the skeletal muscles. The point of in
jection should be as far as possible from major nerves and blood vessels. Injuri
es to patients from IM injection usually are related to the point at which the n
eedle entered and where the medication was deposited. Such injuries include: 1.
Paralysis resulting from neural damage 2. Abscesses 3. Cysts 4. Embolism 5. Hema
toma 6. Sloughing of the skin 7. Scar formation Adult upper outer quadrant of th
e gluteus maximus Infants gluteal area is small, composed primarily fats not musc
le, so not recommended Infants and Young children deltoid, muscles of the upper
arm or the midlateral muscles of the thigh Volume of Administration: limited : 5
mL in the gluteal region 2 mL in the deltoid of the arm Injection is 2 to 3 inc
hes deep 20 to 22 gauge needle. To avoid staining: it must be injected only into
the muscle mass of the upper outer quadrant of the buttock. The skin is displac
ed laterally, then needle inserted and syringe aspirated, and injection performe
d slowly & smoothly. The needle is then withdrawn and the skin release. This cre
ates a Z pattern that blocks infiltration of medication into subcutaneous tissue.
The Z-Track Injection technique is useful for IM injections of medications that
stain upper tissue. Examples: Iron dextran injection irritate tissues Diazepam (V
alium) by sealing in the lower muscle Subcutaneous Route (SC)
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May be utilized for the injection of small amounts of medication or of drugs ben
eath the surface of the skin of the 1. upper arm 2. the anterior surface of the
thigh, and the 3. lower portion of the abdomen. The site of injection is usually
rotated when injections are frequently given, as with daily insulin injection.
The maximum amount of drug given SC is about 1.3 mL Amounts greater than 2 mL wi
ll most likely cause painful pressure Syringes: up to 3 mL capacities Utilizing
needles: 24 to 26 gauges SC insulin needles: gauge between 25 to 30 needle lengt
h between 5-16 to 5-8 inch. Upon insertion, if blood appears in the syringe, a n
ew site should be selected. Irritating drugs and those in thick suspension may p
roduce induration, sloughing, or abscess and may be painful. Such preparations a
re not suitable for subcutaneous injection

Intradermal Route Substances may be effectively injected into the corium, the mo
re vascular layer of the skin just beneath the epidermis. These substances inclu
de: diagnostic determinations, desensitization, or immunization. Usual site: ant
erior surface of the forearm. Needle: A short (3-8 inch) and narrow gauge (23 to
26). is inserted horizontally into the skin with the bevel facing upward. The i
njection is made when the bevel just disappears into the corium. Volume: Usually
about 0.1 mL Specialized Access Devices that provide continued access and reduc
e pain associated with administration (Repeated injections over time) Several ca
theters of central venous are used for a variety of parenteral medications. Exam
ple: cancer chemotherapy, long term antibiotic, therapy,TPN solutions The use of
indwelling plastic catheters reduces the need for multiple punctures during int
ravenous therapy. Composed of polyvinyl chloride Teflon Polyethylene these should
be radiopaque to ensure that they are visible on radiographs. Usually, these mu
st be removed within 48 hours after insertion.
The choice of catheter depends on several factors 1. Length of time of the infus
ion 2. Purpose of the infusion 3. Condition and availability of the veins Types
of Catheter 1. Plain plastic 2. Catheter over needle or outside needle 3. Cathet
er inside needle Official Types of Injections 1. Drug Injection Liquid preparati
ons that are drug substances or solutions thereof Ex.: Insulin Injection, USP 2.
Drug for Injection Dry solids that, upon the addition of suitable vehicles, yie
ld solutions conforming in all respects to the requirement for Injections Ex.: C
efamandole Sodium for Injection 3. Drug Injectable Emulsion Liquid preparations
of drug substances dissolved or dispersed in a suitable emulsion medium Ex.: Pro
pofol 4. Drug Injectable Suspension Liquid preparations of solids suspended in a
suitable liquid medium Ex.: Methylprednisolone Acetate Suspension 5. Drug Injec
table Suspension Dry solids that, upon the preparations conforming in all respec
ts to the requirements for Injectable Suspensions Ex.: Imipenem, Cilastatin for
Injection Suspension, USP a. b. c. INSULIN INJECTION, USP PROPOFOL METHYLPREDNIS
OLONE ACETATE SUSPENSION
Injections Generally, if a drug is unstable in solution, it may be prepared as a
dry powder intended for reconstitution with the proper solvent at the time of a
dministration If the drug is unstable in water, the solvent may be replaced in p
art or totally by a solvent in which the drug is insoluble If the drug is insolu
ble in water, an injection may be prepared as an aqueous suspension or as soluti
on in a suitable nonaqueous solvent, such as a vegetable oil If an aqueous solut
ion is desired, a water soluble salt form of the insoluble drug is frequently pr
epared Aqueous or blood miscible solutions may be injected directly into the blo
od stream Blood immiscible liquids, such asoleaginous injections and suspensions
can interrupt the normal flow of blood, and their use is generally restricted t
o other than intravenous administration Often times long action is desired to re
duce the frequency of injections.
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These long acting injections are called respiratory or depot preparations Follow
ing differences with other preparations 1. Solvents or vehicles used must meet s
pecial purity and other standards assuring their safety by injection 2. The use
of added substances, as buffers, stabilizers, and antimicrobial preservatives, f
all under specific guidelines of use and are restricted in certain parenteral pr
oducts. The use coloring agents is strictly prohibited. 3. Parenteral products a
re always sterilized and meet sterility standards and must be pyrogen free. ympt
oms of potassium loss :weak pulse, faint heart sounds, falling blood pressures &
generalized weakness Excess potassium is not good either : Hyperkalemia can cau
se kidney failure
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*
Symptoms : diarrhea, irritability, muscle cramps, and pain 2. Sodium is vital to
maintain normal extracellular fluids. Average daily intake of sodium: 135 to 17
0 mEq (8 to 10 g of Sodium chloride) Sodium loss/deficit: 3 to 5 g sodium chlori
de (51 to 85 mEq of sodium) is administered daily Symptoms: excessive sweating,
fatigue, muscle weakness, convulsions Symptoms (excess): Dry, sticky mucous memb
ranes, flushed skin, elevated body temperature, lack of tears, and thirst 3. Chl
oride the principal anion of the extracellular fluid usually paired with sodium.
Chloride is also important for muscle contraction, balancing the fluid levels i
nside and outside the cells & maintaining the acid-base balance of the extracell
ular fluid. Caloric Requirements : Basic caloric requirements may be estimated b
y body weight; in the fasting state, the average daily loss of body proteins is
approximately 80g/day for a 70 kg man. Daily ingestion of at least 100 g of gluc
ose reduces this loss by half. Generally patients requiring parenteral fluids ar
e given 5% dextrose to reduce caloric deficit Parenteral hyperalimentation This
is the infusion of large amounts of basic nutrients sufficient to achieve active
tissue synthesis and growth. It is employed with a long term intravenous feedin
g of protein solutions containing high concentration of dextrose (approximately
20%), electrolytes, vitamins, and sometimes insulin.

Niacin 40 mg Vitamin B2 3.6 to 4.93 mg Vitamin B1 3 to 3.35 mg Vitamin B6 4 to

.86 mg Pantothenic Acid 15 mg Folic Acid 400 mcg Vitamin B12 5 mcg Biotin 60 m
Amino Acids: Essential Amino Acids 1. L - Isoleucine..590 mg 2. L - Leucine .770 m
Lysine acetate..870 mg (free base.620 mg) 4. L - Methionine 450 mg 5. L - Threon
- Tryptophan 130 mg 7. L - Valine .560 mg 8. L - Phenylalanine ..480 mg Noness
ds 1. L - Alanine ..600 mg 2. L - Arginine .810 mg 3. L - Histidine .240 mg 4.
L - Serine .500 mg 6. Aminoacetic acid 1.19 g
Enteral Nutrition Enteral nutrition products may be administered orally, via nas
ogastric tube, via feeding gastronomy, or via needle-catheter jejunostomy. These
products are formulated to contain vitamins, minerals, carbohydrates, proteins,
fats and caloric requirements to meet specific needs of the patient. The formul
a diets may be monomeric or oligomeric (amino acids or peptides and simple carbo
hydrates) or polymeric (more complex protein and carbohydrates sources. Ex.: Pro
tein - ProMod Powder, Propac Powder Carbohydrates - Moducal Powder Fat - Lipomul
Liquid Fewer calories- Ensure HN, Sustacal, & Osmolite HN Intravenous Infusion
Devices Advances in infusion technology and computer technology have resulted in
devices with extremely sophisticated drug-delivery capabilities Ex.: Multiple-r
ate programming, pump or controller operation) Special Considerations Associated
with Parenteral Therapy Adsorption Of Drugs - Some drugs are adsorbed onto the
inner lining of IV containers and tubing or administration sets. Ex.: 1. Chorpro
mazine HCl 2. Insulin 3. Promethazine HCl 4. Trifluoperazine HCl 5. Thioridazine
HCl 6. Diazepam 7. Promazine HCl
Components of Parenteral Nutrition Solutions Electrolytes 1. Sodium. 25 mEq 2. Potas
sium ... 20 mEq 3. Magnesium ..5 mEq 4. Calcium .5 mEq 5. Chloride .. 30 mEq 6. Ace
mEq 7. Phosphate ..18 mM Vitamins Vitamin A 3300 I.U. Vitamin D 200 I.U. Vitamin
10 I.U. Vitamin C 100 mg
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8. 9.
Thiopental sodium Warfarin sodium

Another Example: Nitroglycerin should always be prepared in glass containers, an

d is adsorbed (40 to 80% of total dose) to polyvinylchloride (PVC), a plastic co
mmonly used in administration components and some infusion containers, therefore
, it should be packaged with special non-PVC tubing to avoid loss <5% of the dru
g into the tubing during administration. Selected Infusion Devices Used in Paren
teral Nutrition Support 1. Volumetric Infusion Pumps - AVI 2000 #200: Flo-Gard 8
100; IMED 2. Multiple-rate Programmable Pumps CADD-TPN 3. Volumetric Infusion Pu
mps - Provider one; Quest 521 Intelligent 4. Multiple-solution Programmable Pump
s - Gemini PC 2; Life Care 5000 Plum;Omni-Flow 4000 5. Others- Breeze Lifecare 17
5, Coleague 3, Horozon Nxt, Sabratek 600 NOTE: All these devices have their own
features like: safety alarm, flow rate error, alarm for air in line, door open,
low battery, occlusion, malfunction, invalid rates and others Handling/Disposal
of Chemotherapeuticc Agents for Cancer In theory, correct and perfect preparation
and handling techniques will prevent drug particles or droplets from escaping f
rom their containers while they are being manipulated. Basic Steps in handling Ch
emotherapeutic Agents 1. Utilizing vertical laminar flow hoods (or bacteriologic
al gloves boxes) for the preparation and reconstitution of cytotoxic drugs. 2. W
earing protective gloves and mask during product preparation 3. Handling and dis
posing of cytotoxic drugs centrally utilizing specially designed waste container
s and incineration. 4. Periodic monitoring of personnel involved with handling a
dmixtures of cytotoxic drugs (CBC, blood chemistry screen, differential cell cou
nt) 5. Informing personnel handling cytotoxic drugs that a potential risk to the
ir health exists. 6. Instituting specialized labeling of containers to ensure pr
oper handling and disposal of the cytotoxic agent. Other Injectable Products Pel
lets or Implants are sterile, small, usually cylindrical-shaped solid objects ab
out 3.2 mm in diameter and 8 mm in length, prepared by compression and intended
to be implanted subcutaneously for the purpose of providing the continuous relea
se of medication over prolonged period of time The pellets - implanted under the
skin (thigh or abdomen) with special injector or by surgical incision used for
potent hormones.

The implanted pellets, which might contain 100 times the amount of drug. Ex.: (d
esoxycorticosterone, estradiol, testosterone) given other routes are release slo
wly into general circulation Pellets were formulated with no binders, diluents,
or excipients, to permit total dissolution and absorption of the pellets. Ex.: L
evonorgestrel
Levonorgestrel Implants These are a set of six flexible, closed capsules of a di
methylsiloxane/methylvinylsiloxane copolymer, each containing 36 mg of the proge
stin levonorgestrel These are found in an insertion fit to facilitate surgical s
ubdermal implantation through a 2 mm incision in the mid-portion of the upper ar
m about 8 to 10 cm above the elbow crease. These are implanted in a fan like pat
tern, about 150 apart, for a total of 750. Removal after the end of the 5th year
. The dose of levonergestrel is about 85 mcg/day by 9 months and to about 35 mcg
/day by 18 months, with a further decline thereafter to about 30 mcg/day. Irriga
tion and Dialysis Solutions Solutions for irrigation of body tissues and dor dia
lysis resemble parenteral solutions in that they are subject to the same stringe
nt standards. These solutions are not injected into the vein, but employed outsi
de of the circulatory system. Irrigation Solutions Irrigation solutions are inte
nded to bathe or wash wounds, surgical incisions, or body tissues. Ex.: 1. Aceti
c acid Irrigation, USP - This solution is employed topically to the bladder as a
0.25% solution for irrigation. It is administered to wash blood and surgical de
bris away while maintaining suitable conditions for the tissue. 2. Neomycin and
Polymixin B Sulfate Solution for Irrigation, USP - Employed as a topical antibac
terial in the continuous irrigation of the bladder. 3. Ringer's Irrigation, USP -
It is used topically as an irrigation and must be labeled not for injection. The s
olution is sterile and pyrogen free. 4. Sodium Chloride Irrigation, USP - This s
olution is employed topically to wash wounds and into body cavities where absorp
tion into the blood is not likely. The solution also employed rectally as an ene
ma for simple evacuation and also for colonic flush. 5. Sterile Water for Irriga
tion, USP - The label designations for irrigation only and not for injection must ap
pear prominently on the label. The water must not contain any antimicrobial or o
ther added agent.
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Dialysis Solutions May be defined as a process whereby substances may be separat
ed from one another in solution by taking advantage of their differing diffusibi
lity through membranes Peritoneal Dialysis Solutions allowed to flow into the pe
ritoneal cavity, are used to remove toxic substances normally excreted by the ki
dney The solutions are made to be hypertonic (with dextrose) to plasma to avoid
absorption of water from the dialysis solution into the circulation Hemodialysis
Is employed to remove toxins from the blood. In this method, the arterial blood
is shunted through a polyethylene catheter through an artificial dialyzing memb
rane bathed in an electrolyte solution. Following the dialysis, the blood is ret
urned to the body circulation through a vein.
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