Chapter 15: Parenterals  Physician’s assistant

 Nurse
Parenterals are administered at:
Parenteral  Hospitals
 The term parenteral derived from the Greek words:  Clinics
para (outside) and enteron, (intestine)  Extended care facilities
 denotes routes of administration other than oral route
 refers to the injectable routes administration Antirheumatic injectables
 sterile Brand Name: Enbrel
Generic name: Etanercept
Parenteral Injections
Manufacture: Immunex
 pyrogen free preparations
Form: Injectable
 intended to be administered parenterally.
Recommended initial dose: 25mg (1 vial) twice a week injected
subcutaneously
Based on the route of administration, sterile products are
classified into:
Botulinum toxin
1. Parenteral preparations
Brand name: Botox
2. Ophthalmic preparations - for the eye
Generic name: Clostridium botulinum ( type A neurotoxin
3. Otic preparations - for the ear
complex)
4. Nasal preparations - for the nose & throat
Form: Powder for solution for injection
5. Irrigating solutions - for washing wounds or abraded
mucous membrane
Botulinum toxin
Brand name: Myobloc
Parenteral Routes of Administration
Generic name: Botulinum toxin Type B
1. Intra-articular – joints
Form: Injection, solution [single-dose vial]: 5000 units/mL (0.5 mL, 1
2. Intraspinal – spinal column
mL, 2 mL) [contains albumin 0.05%]
3. Intra-arterial – arteries
4. Intravenous – veins
Intravenous Route (IV)
5. Intradermal – shin
 Advantage:
6. Intrasynovial – joint fluid
 May be a life-saving procedure because of the
7. Intrathecal – spinal fluid
placement of the drug directly into the circulation
8. Intracardiac – heart
and the prompt actions which ensues.
9. Intramuscular – muscles
 Disadvantage:
10. Subcutaneous – under the skin
 Once the drug administered, it cannot be
retrieved.
 In the case of adverse reaction to the drug, for
instance, the drug cannot be easily removed from
the circulation.
 Precautions:
 Strict aseptic precautions must be taken at all
times to avoid risk of infection.
 The syringes and needles used must be sterilized
and to the point of entrance 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 expressed 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.
 Example:
 Metoprolol (beta blocker)
– 3 bolus injections of 5 mg each at about
2 minute intervals
– oral dosing (100 mg/day)
 NOTE:
 Not only are the injectable solutions sterile,
syringes, needles must also be disinfected to
Parenterals are administered by: reduce the chance of carrying bacteria
 Physician

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  A backflow of blood into the administration set or
syringe indicates proper placement of the needle
in the vein
 Intravenous drugs ordinarily must be aqueous
solution
 They must mix with the circulating blood and not
precipitate from solution. Such an event can lead
to pulmonary micropillary occlusion and blockage
of blood flow.
 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
patients requiring parenteral nutrition for extended
period, usually more than 5 days.
 The product contains up to: 30% soybean oil
emulsified with eggyolk phospholipids in a vehicle
of glycerin in water injection
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 blood 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 blot 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 referred to as an
Embolism.
Example: Automated IV delivery system - Self administration
analgesics
Advantages:
1. Patient Controlled Analgesia (PCA) used to control
pain
2. Allows greater degree of ambulation and
independence
3. Typical PCA contains analgesic drug, syringe and
programmable electromechanical unit, which might
be compact enough to be worn on a belt or carried in
a pocket
Example: WalkMed PCA
4. Ability to provide constant and uniform analgesia
5. Can prevent pharmacokinetics and
pharmacodynamic differences between patients from
interfering with the effectiveness of analgesia
6. Also permits patients to medicate themselves when
there is breakthrough pain
7. Minimizes various side effects
8. PCA devices can be used for IV, SC or epidural
administration
9. These devices are either, demand dosing (fixed dose of
drug is injected intermittently) or constant-rate infusion
plus demand dosing
Intramuscular (IM)
 Intramuscular injections of drugs provide effects that
are less rapid, but generally of greater duration than
those obtained from intravenous administration
 IM are performed deep into the skeletal muscles.
 The point of injection should be as far as possible from
major nerves and blood vessels.
 Injuries to patients from IM injection usually are related
to the point at which the needle entered and where
the medication was deposited.
 Such injuries include:
1. Paralysis resulting from neural damage
2. Abscesses
3. Cysts
4. Embolism
5. Hematoma
6. Sloughing of the skin
7. Scar formation
 Adult – upper outer quadrant of the gluteus
maximus
 Infants– gluteal area is small, composed
primarily fats not muscle, 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 inches 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 displaced laterally, then needle inserted and
syringe aspirated, and injection performed slowly &
smoothly. The needle is then withdrawn and the skin
release. This creates 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 (Valium) – 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 beneath 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 will 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 length between 5-16 to 5-8 inch.
 Upon insertion, if blood appears in the syringe, a new
site should be selected.
 Irritating drugs and those in thick suspension may
produce
 induration, sloughing, or abscess and may be
painful. Such preparations are not suitable for
subcutaneous injection
Intradermal Route
 Substances may be effectively injected into the corium,
the more vascular layer of the skin just beneath the
epidermis.
 These substances include:
 diagnostic determinations, desensitization, or
immunization.
 Usual site: anterior 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 injection is made
when the bevel just disappears into the
corium.
 Volume: Usually about 0.1 mL
Specialized Access
 Devices that provide continued access and reduce
pain associated with administration (Repeated
injections over time)
 Several catheters of central venous are used for a
variety of parenteral medications.
 Example: cancer chemotherapy, long term antibiotic,
therapy,TPN solutions
 The use of indwelling plastic catheters reduces the
need for multiple punctures during intravenous therapy.
 Composed of
 polyvinyl chloride
 Teflon
 Polyethylene
these should be radiopaque to ensure that they are
visible on radiographs.
 Usually, these must be removed within 48 hours after
insertion.
 The choice of catheter depends on several factors
1. Length of time of the infusion
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. Catheter inside needle
 Official Types of Injections
1. Drug Injection
 Liquid preparations that are drug
substances or solutions thereof
 Ex.: Insulin Injection, USP
2. Drug for Injection
 Dry solids that, upon the addition of
suitable vehicles, yield solutions
conforming in all respects to the
requirement for Injections
 Ex.: Cefamandole Sodium for Injection
3. Drug Injectable Emulsion
 Liquid preparations of drug substances
dissolved or dispersed in a suitable
emulsion medium
 Ex.: Propofol
4. Drug Injectable Suspension
 Liquid preparations of solids suspended in
a suitable liquid medium
 Ex.: Methylprednisolone Acetate
Suspension
5. Drug Injectable Suspension
 Dry solids that, upon the preparations
conforming in all respects to the
requirements for Injectable Suspensions
 Ex.: Imipenem, Cilastatin for Injection
Suspension, USP
a. INSULIN INJECTION, USP
b. PROPOFOL
c. METHYLPREDNISOLONE 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 administration
 If the drug is unstable in water, the solvent may be
replaced in part or totally by a solvent in which the
drug is insoluble
 If the drug is insoluble in water, an injection may be
prepared as an aqueous suspension or as solution in a
suitable nonaqueous solvent, such as a vegetable oil
 If an aqueous solution is desired, a water soluble salt
form of the insoluble drug is frequently prepared
 Aqueous or blood miscible solutions may be injected
directly into the blood stream
 Blood immiscible liquids, such asoleaginous injections
and suspensions can interrupt the normal flow of blood,
and their use is generally restricted to other than
intravenous administration
 Often times long action is desired to reduce the
frequency of injections.
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 These long acting injections are called respiratory or
depot preparations
 Following differences with other preparations
1. Solvents or vehicles used must meet special
purity and other standards assuring their safety
by injection
2. The use of added substances, as buffers,
stabilizers, and antimicrobial preservatives, fall
under specific guidelines of use and are
restricted in certain parenteral products. The
use coloring agents is strictly prohibited.
3. Parenteral products are always sterilized and
meet sterility standards and must be pyrogen
free.
4. Parenteral solutions must meet compendial
standard for particulate matter.
5. Parenteral products are packaged in special
hermetic containers of specific and highly
quality.
6. Each container of an injection is filled to a
volume in slight excess of the labeled “size” or
volume to be withdrawn. This overfill permits
the ease of withdrawal and administration of
the labeled volumes
7. Parenteral products must be prepared in
environmentally controlled areas, under strict
sanitation standards, and by personnel
especially trained and clothed to maintain
the sanitation standards.
8. There are restrictions over the volume of
injection permitted in multiple-dose containers
and also a limitation over the types of
containers (single-dose or multiple- dose)
which may be used for certain Injections.
9. Specific powders intended for solution or
suspension immediately prior to injection are
frequently packaged as lyophilized or freeze-
dried powders to permit ease of solution or
suspension upon the addition of the solvent or
vehicle.
 Solvents and Vehicles for Injections
1. Water for Injection, USP
 This water is purified by distillation or
by reverse osmosis.
 Water for Injection is not required to
be sterilized, it must be pyrogen free.
2. Purified water, USP
 may not contain other substances
 meets standard for the presence of
total solids
3. Sterile Water for Injection, USP
 is water for injection which has been
sterilized and packaged in single-
dose containers of not greater than
IL size
 as water for Injection, it must be
pyrogen free and may not contain
an anti-microbial agent or other
added substance.
4. Bacteriostatic Water for Injection, USP
 is sterile water for injection
containing one or more suitable anti-
microbial agents.
 it is packaged in pre-filled syringes or
in vials containing not more than 30
mL of the water. Label must state,
“Not for Use in Newborns”.
 Ex.: benzyl alcohol - not good for
neonates and the toxicity of the
bacteriostat.
5. Sodium Chloride Injection, USP
 a sterile isotonic solution of sodium
chloride in Water for Injection.
 It contains no anti-microbial agents
6. Bacteriostatic Sodium Chloride Injection
 is a sterile isotonic solution of sodium
chloride in Water for Injection. It
contains one or more suitable
antimicrobial agents which must be
specified in the label.
 Sodium chloride concentration is
0.9% to render isotonic solution. It is
also used to flush a catheter or IV
line to maintain its patency.. “Not for
Use in Newborns”.
7. Ringer’s Injection, USP
 is a sterile solution of sodium chloride,
potassium chloride, and calcium
chloride in water for injection.
 It is used as electrolyte replenisher
and a systemic alkalizer.
 Lactated R = Na lactate
Characteristics Of Components used in Compounding
1. Therapeutically effective when used as the active
ingredients
2. Provide maximum safety
3. Function efficiently (when used as excipient)
4. Free from contamination
5. Physically and chemically stable even after thermal
sterilization
6. Produce little or no tissue irritation at site of
administration
Nonaqueous Vehicles Selected Vehicles must be:
1. Nonirritating
2. Non toxic in the amounts administered
3. Nonsensitizing
4. It must not exert a pharmacologic activity
5. May not adversely affect the activity of the medicinal
agent
Other Considerations Of Selecting Nonaqueous Solvents
1. Physical and chemical stability
2. Its viscosity (syringeability) and its fluidity
3. Its boiling point (it should be high to permit heat
sterilization)
4. Its miscibility with body fluids
5. Its low vapor pressure to avoid problems during heat
sterilization
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 6. Constant purity or ease of purification & Antioxidants
standardization  Oxidation is one of the pathways of degradation which
Examples of Nonaqueous Solvents can be accelerated during thermal sterilization.
1. Fixed vegetable oils  To protect a therapeutic agent susceptible to this
2. Glycerin reaction, antioxidants are required.
3. Polyethylene glycols  Ex.: Sulfur dioxide - 0.2%
4. Propylene glycol  Classification of Antioxidants used in Sterile products:
5. Ethyl oleate 1. Reducing agents - antioxidants which functions
6. Isopropyl myristate by being preferentially oxidized
7. Methylacetamide Ex.: ascorbic acid, sodium bisulfate,
8. Alcohol metabisulfite, thiourea, sodium formaldehyde,
sulfoxylate
Nonaqueous Vehicles… 2. Blocking agents - antioxidants which block an
Examples of Fixed Oils Commonly Used in Injections oxidative chain reaction in which they are not
1. Corn Oil usually consumed
2. Cottonseed seed Oil Ex.: ascorbic acid esters, butyl hydroxytoluene
3. Peanut Oil (BHT), tocopherols
4. Sesame Oil 3. Synergists - compounds increase the
5. Castor Oil and Olive Oil (occasion) effectiveness of antioxidants, particularly those
blocking oxidative reactions
SOLVENTS AND VEHICLE FOR INJECTIONS Ex.: ascorbic acid, citraconic acid,
Water for Injection phosphoric acid, citric acid, tartaric acid
 solvent 4. Chelating agents - those that complex with
 purified by distillation or by reverse osmosis catalysts which otherwise would accelerate the
 stored in tight container with temperature below or oxidative reaction
above the range of microbial growth Ex.: ethylenediaminetetraacetic acid salts
 must be pyrogen free 5. Inert gases like nitrogen and carbon dioxide
have been used to displace oxygen from a
Added Substances solution and reduce the possibility of oxidative
 Additives are essential for almost every product to changes in the formulation
enhance its stability. They must exhibit the following
characteristics: Buffers
1. Perform its function throughout the useful life of  added to maintain the required pH for many products;
the product a change in pH may cause significant alterations in the
2. Must be non-toxic and non-irritating rate of degradation reactions.
3. Must not exert any adverse effect on the product  Changes in pH may occur during storage as a result of:
4. Must be compatible in all components of the 1. Dissolving of glass constituents in the product
formulation 2. Release of constituents from rubber closures or
5. Must not interfere with: plastic components in contact with the product
a. Therapeutic efficacy 3. Dissolving of gases and vapors from the air
b. Assay of the active therapeutic space in the container or by diffusion through
compound the rubber or plastic component.
4. Reactions within the product
Such substances include:  The principal buffer systems used to stabilize pH are the
1. Solubilizers 1. Acetates
2. Chelating agents 2. Citrates
3. Anti-microbial agents 3. Phosphates
4. Hydrolysis Inhibitors  Tonicity Contributors
5. Antioxidants  Compounds contributing to the isotonicity of a
6. Buffers product reduce the pain of injection in areas
7. Tonicity contributors with nerve endings
8. Antifoaming agents  Buffers may serve as tonicity contributors as well
as as stabilizers for the___?___
Antifungal/Antibacterial
 must be present in adequate concentration at the time Containers
of use to prevent the multiplication of microorganism.  Containers for sterile products are made of glass or
 Ex.: agents containing mercury and the cationic, plastic.
surface active compounds - 0.01%; for agents like  Glass is still preferred for injectable products.
chlorobutanol, cresol, and phenol - 0.5%  Glass is composed principally of the:
 silicon dioxide tetrahedron

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  modified physicochemically by such oxides as  2 MAIN DIVISIONS OF STERILIZATION
those of sodium, potassium, calcium, 1. Physical Processes of Sterilization
magnesium, aluminum, boron and iron. A. Thermal Method
 Two general types of glass i. Microorganisms are killed by heat
1. soda-lime by what is thought to be
2. borosilicate coagulation of the protein of a
 Based on its chemical resistance, glass compounds are living cell. The lethal
classified into 4 types: effectiveness of heat is
1. Type I - highly resistant borosilicate glass dependent on:
2. Type II - treated soda-lime glass  The degree of heat
3. Type III - soda lime glass  The exposure period
4. NP (nonparenteral) - general purpose soda-  The moisture present
lime glass ii. Steam sterilization is conducted
***Glass containers like ampule cartridges and vials in an autoclave and employs
may be manufactured from glass tubings or blow steam under pressure
molding. iii. The usual steam pressures, the
 Rubber closures are used to seal the openings of temperatures obtainable under
catridges, vials and bottles, providing a material soft these pressures, and the
and elastic enough to permit entry and withdrawal of a approximate length of time
hypodermic needle without loss of the integrity of the required after the system reaches
sealed container. Accessories used in conjunction with the indicated temperatures are
closures are aluminum caps with or without flif-off seals. as follows:
 10 pounds pressure
Examples of Some Injections in Oil (115.50C), for 30 min.
 15 pounds pressure
(121.50C), for 20 min.
 20 pounds pressure
(126.50C), for 15 min.
iv. Dry-Heat Sterilization usually
carried out in sterilizing ovens
specifically designed for this
purpose. The ovens may be
heated either gas or electricity
and generally thermostatically
controlled. It is conducted at
temperatures of 1600C to 1700C
for periods not less than 2 hours.
B. Nonthermal Methods
i. Ultraviolet light
- is commonly employed to aid in the
METHODS OF STERILIZATION
reduction of airborne contamination and
Sterilization
to attempt to sterilize surfaces within the
 defined as the complete destruction or elimination of
processing environment. The germicidal
microbial life
light produced by mercury vapor lamps is
 The choice of the most effective sterilization procedure
emitted at a wavelength of 2537
is dependent on:
Angstrom units (253.7 millimicrons)
1. Compatibility of the process with the
- The lethal mechanism of UV light works
preparation; (sterilization process must not have
when this energy is absorbed by orbital
significant adverse effect upon the preparation)
electrons within the molecules of the
2. The successful validation of the process (the
microorganisms or of their essential
parameters must prove to be lethal to the most
metabolites causing excitation and
resistant spores of microorganism normally
alteration of activity. Thus the organism
encountered)
dies or is unable to reproduce.
 5 general methods:
ii. Ionizing Radiations - are highly
1. Steam distillation
radiations emitted from
2. Dry-heat sterilization
radioactive isotopes such as
3. Sterilization by filtration
cobalt-60 (gamma rays) or
4. Gas sterilization
produced by mechanical
5. Sterilization by ionizing radiation
acceleration of electrons to very
high velocities and energies
(cathode rays, beta rays).
Ionizing radiations destroy

A. Uy | Page 6 of 14
 microorganisms by stopping
reproduction as a result of lethal
mutations.
iii. Filtration
- This is a nonthermal method for the
sterilization of select solutions by
removing microorganisms from the
solution while permitting the passage of
all the desired components of the
solution and imparting no undesirable
components from the filter.
- They are available in pore sizes from 14 to
0.025 um.
- The size of the smallest particle visible to
the naked eye is about 40 um, a red
blood cell is about 6.5 um, the smallest
bacteria, about 0.2 um, and a polio virus,
about 0.025 um
2. Chemical Processes of Sterilization
A. Gas Sterilization
– Ethylene oxide believed to exert
its lethal effect upon
microorganisms by alkylating
essential metabolites, affecting
particularly the reproductive
process. Ethylene dioxide
sterilization is the acceptable
practical method for sterilizing
plastic. Other gases used are
beta propiolactone,
formaldehyde & sulfur dioxide
B. Surface Disinfection
– Disinfectants do not sterilize a
surface. However, as adjuncts
to thoroughly cleaning of
surfaces, disinfectants properly
used may be expected to
provide an aseptic condition of
the surfaces involved
Validation of Sterility
 Regardless of the method of sterilization employed,
Pharmacutical preparations must undergo sterility tests
to confirm the absence of microorganisms.
 A biologic indicator is characterized preparation of
specific microorganisms resistant to a particular
sterilization process
2 main forms
1. Spores are added to a carrier, as a strip of filter paper,
packaged to maintain physical integrity while allowing the
sterilization effect.
2. The spores are added to representative units of the product
being sterilized, with sterilization assessed based on these
samples
In moist heat (steam) - Bacillus stearothermophilus
In dry heat - Bacillus subtilis
In ionizing radiation - Bacillus pumilus, stearothermophilus, subtilis
Pyrogens and Pyrogen Testing
 Pyrogens are fever producing organic substances
arising from microbial contamination and responsible
for many of the febrile reactions which occur in
patients following injections.
 Are lipid substances associated with a carrier molecule
which is usually a polysaccharide but may be a protein.
2 Official Tests for Detecting and Measuring Pyrogens
1. Bacterial Endotoxins Test
– Using Limulus Amebocyte Lysate (LAL) which
has been obtained from aqueous extracts of
the circulating amebocytes of the horseshoe
crab, Limulus polyphemus, and which has
been prepared & characterized for use as an
LAL reagent for gel-clot formation
– The procedure include incubation for a
preselected time of reacting endotoxins and
control solutions with LAL Reagent and
reading of the spectrophotometer light
absorbance at suitable wavelength
2. Pyrogen Test
– The test involves measuring the rise in
temperature of rabbits following the
intravenous injection of a test solution and is
designed for products that can be tolerated
by the test rabbit in a dose not to exceed 10
mL per Kg injected intravenously within a
period of not more than 10 minutes
– If no rabbit shows an individual rise in
temperature 0.60C or more above its
respective control temperature, and if the
sum of the 3 individual maximum temperature
rises does not exceed 1.400 C, the product
meets the requirements for the absence of
pyrogens.
Depyrogenation Method are as follows:
1. Adequate washing with detergent treatment followed
by dry heat sterilization is recommended for glasswares
and equipment. Optimum temperature is 2500C for 45
minutes.
2. Distillation is the most reliable method of eliminating
pyrogens from water. Pyrogenic substances are not
volatile and thus will remain in the distilland.
3. Removal of pyrogens by select adsorbents has limited
use because of the concurrent phenomenon of
adsorption of solute ions of molecules. It is of interest in
the production of antibiotics where heavy pyrogen
contamination results from fermentation.
PRODUCTION of a sterile preparation
 consists of the following steps:
1. Compounding
- Processing of sterile preparations follow
normal manufacturing procedures which
must be done in aseptic condition. All
equipment and materials used whenever
possible must be sterile
2. Filtration
- Membrane filters are used for clarification
when a highly polished solution is desired.
The process removes particulates matter
down to at least 3 microns in size.
Sterilization by filtration is achieved when
A. Uy | Page 7 of 14
 viable microorganisms and spores of
approximately 0.3 microns are removed.
Membranes with porosity ratings of 0.22
or 0.45 microns are usually specified for
sterile filtration.
3. Filling
- Bulk preparations are subdivided into unit
dose containers during filling. This process
forces a measured volume of the
preparation through the orifices of a
delivery tube designed to enter the
constricted opening of a container by
means of gravity, vacuum or with the aid
of a pressure pump.
4. Sealing
- Sealing will retain the contents of a sterile
product and will assure a tamper-proof
presentation
5. Sterilization
Containers
 should be sealed in an aseptic area adjacent to the
filling machine. Ampuls are sealed by heating with a
high temperature gas-oxygen flame to form
1. Tip-seals: those made by melting sufficient
glass at the tip of the ampul neck to form a
bead of glass and close the opening
2. Pull-seals: those made by heating the neck of
a rotating ampul below the lip, then pulling
away the tip to form a small, twisted capillary
just prior to being melted closed.
A leakers test
 is a useful method for evaluating the efficiency of the
sealing process.
 the test consists of immersing completely the sterile
sealed ampuls in an aqueous dye bath (0.5 to 1.0% of
methylene blue) within a vacuum chamber.
 ss negative pressure of 27 inches Hg or more is created,
a tiny drop of dye solution can penetrate an opening
of an incompletely sealed ampul.
 the colored ampuls are sorted out during washing and
100% inspection that follows after.
Examples of Sterile Drugs prepared and packaged without the
presence of phamaceutical additives as buffers, preservatives,
stabilizers, tonicity agents, and other substances
1. Sterile Ampicillin Sodium
2. Sterile Ceftazidime Sodium
3. Sterile Kanamycin Sulfate
4. Sterile Penicillin G Banzathine
5. Sterile Tobramycin Sulfate
6. Sterile Ceftizoxime Sodium
7. Sterile Cefuroxime Sodium
8. Sterile Nafcillin Sodium
9. Sterile Streptomycin Sulfate
Examples of Sterile Drugs prepared and packaged with the
presence of phamaceutical additives as buffers, preservatives,
stabilizers, tonicity agents, and other substances
1. Cephradine for Injection
2. Dactinomycin for Injection
3. Erythromycin Lactobionate for Injection
4. Oxytetracycline Hydrochloride Injection
5. Nafcillin Sodium for Injection
6. Hydrocortisone Sodium Succinate for Injection
7. Cyclophosphamide for Injection
8. Hyaluronidase for Injection
9. Mitomycin for Injection
10. Penicillin G Potassium for Injection
11. Vinblastine Sulfate for Injection
Containers…
1. Mix-O-Vial - that incorporates the cover as part of the
plunger. Once mixed, the small circle of plastic that
covers the injection site is removed. This reduces the
touch contamination
2. Add-Vantage System IVPH - is other example of ready-
to-mix sterile IV product designed for intermittent IV
administration of potent drugs that do not have long
term stability in solution. Two components:
a. A flexible plastic IV container partially filled
with diluents
b. Glass vial of powdered or liquid drug
 The vials containing the medication and the
piggybacks (50-250 mL of Dextrose 5% in Water
Injection) or Normal Saline Solution are specially
designed to be used together.
 The ADD-Vantage System can be used within 30
days from the date that the diluent container was
removed from the overwrap.
3. Monovial Safety Guard
- This is new system integrated device
(drug transfer mechanism) with a
protective shield surrounding the
attached transfer needle. The
reconstitution and transfer of the drug
into an infusion bag is accomplished
safely, quickly, and necessitates fewer
materials. The needle is inserted into the
port of the infusion bag and then the
transfer set is pushed down toward the
vial until a “Click” is heard. With Monovial
upright, the infusion bag is squeeze
several times to transfer liquid into the
Monovial. The Monovial is then shaken to
reconstitute the drug. It is then inverted,
the minibag is squeezed and release to
transfer the drug back into the infusion
bag. This process is repeated until the
vial is empty
- Packaging, Labeling, and Storage of
Injections - Containers for injections,
including closures, must not interact
physically and chemically with the
preparation
- Single-dose container - A single dose
container is a hermetic container holding
a quantity of sterile drug intended for
parenteral administration as a single
dose, and which when opened cannot
be re-sealed with assurance that sterility
has been maintained.
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 - Multiple-dose container - A multiple-dose
container is a hermetic container that
permits withdrawal of successive portions
of thecontents without changing the
strengths, quality, or purity of the
remaining portion.
- Note: Recall type I,II,III containers
The Labels on containers of parenteral products must state:
1. The name of the preparation
2. For liquid preparation, the percentage content of the
drug or amount of the drug; for dry preparation - the
amount of the active ingredient present and the
volume of liquid to be added to the dry preparation to
prepare a solution or suspensions.
3. The route of administration
4. Statement of storage conditions and expiration
5. The name of the manufacturer and distributor
6. The identifying lot number
General Precautions required with the use of microwave ovens
for thawing frozen premixed products include
1. Being aware that the possibility of radiation leakage
does exist. However, manufacturers of microwave
ovens are required by law to comply with federal
standards
2. Safeguarding pharmacy personnel who are exposed to
these ovens, especially those with cardiac
pacemakers.
3. The possible leaching of rubbers material when the
rubber material on the container is exposed to
microwave heating.
4. A possible explosion that may result from the increase in
internal pressure as a result of placing a closed or
sealed container into the microwave oven.
5. Developing protocols to ensure that the final solution
temperature does not exceed room temperature
Examples of some Injections Usually Package and Administered
in Small Volume
1. Butorphanol Tartrate Injection - Narcotic Agonist-
Antagonist Analgesic
2. Chlorpromazine HCl Injection - Antipsychotic drug with
antiemtic
3. Cimetidine HCl Injection - Histamine H2 antagonist
4. Dalteparin Sodium Injection- Prophylaxis against deep
vein thrombosis
5. Dexamethasone Sodium Phosphate Injection -
Glucocorticoids
6. Digoxin Injection – Cardiotonic
7. Dihydroergotamine Mesylate Injection - Alpha-
adrenergic blocking agent
8. Diphenhydramine HCl Injection - An ethanolamine, non
selective antihistamine
9. Furosemide Injection - Loop diuretic
10. Granisetron HCl Injection - Prevention of nausea &
vomiting
11. Heparin Sodium Injection - Anticoagulant (IV or SubQ)
12. Hydromorphone HCl Injection - Narcotic analgesic
13. Ibutilide Fumarate Injection - An antiarrhythmic drug
14. Iron Dextran Injection- Hematinic agent
15. Isoproterenol HCl Injection - Adrenergic
(bronchodilator)
16. Ketorolac Tromethamine Injection - NSAID
17. Lidocaine HCl Injection - Cardiac depressant as an
antiarrhythmic
18. Magnesium Sulfate Injection -
Anticonvulsant/Electrolyte
19. Meperidine HCl Injection - Narcotic analgesic
20. Metoclopramide Monohydrochloride Injection-
Gastrointestinal stimulant
21. Midazolam HCl - Short acting benzodiazepine CNS
depressant
22. Morphine Sulfate injection - Narcotic analgesic
23. Naloxone HCl Injection - Narcotic antagonist
24. Nalbuphine HCl Injection - Narcotic Agonist-Antagonist
Analgesic
25. Oxytocin Injection- Oxytoxic
26. Phenytoin Sodium Injection - Anticonvulsant
27. Phytonadione Injection - Vitamin K (prothrombogenic)
28. Procaine Penicillin G Injection - Anti-infective
29. Prochlorperazine Edisylate Injection - Antidopaminergic
30. Propranolol HCl Injection - Beta adrenergic receptor
blocking agent
31. Sodium Bicarbonate Injection- Electrolyte
32. Sumatriptan Succinate injection - treat acute migraine
attacks
33. Verapamil HCl Injection - Calcium channel blocking
agent
INSULIN
1. Insulin Injection (regular)
 Insulin Injection is a sterile aqueous solution of
insulin. It is prepared from beef or pork pancreas
or both or through biosynthetic means (Human
Insulin). With apH of 2.8 to 3.5. Insulin Injection is
prepared to contain 100 or 500 USP Insulin Units in
each mL.
Expiration: Not to be later than 24 months
after the date of distribution.
Preservative: Glycerin (1.4 to 1.8) for stability,
Phenol or Cresol (0.1 to 0.25%)
Storage: Cold place, preferably the
refrigerator
2. Human Insulin
 It is produced by utilizing a special nondisease-
forming laboratory strain of Escherichia coli and
recombinant DNA technology.
 Two formulations:
A. Neutral Regular Human Insulin (Humulin R) -
consists of Zinc-insulin crystals in solution. It has
a rapid onset of action and relatively short
duration of action (6 to 8 hours)
B. NPH Human Insulin (Humulin N) - is a turbid
preparation that is intermediate acting, with a
slower onset of action and longer duration of
action (slightly less than 24 hours) than regular
insulin
3. Lispro Insulin Solution
 Insulin solution consists of Zinc-insulin lispro
crystals dissolved in a clear aqueous fluid. It is
created when the amino acids at positions 28
and 29 on the Insulin B-chain are reversed
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  Compared to regular insulin, however, peak
serum levels of lispro insulin occur earlier,
(within 0.5 to 1.5 hours) are higher, and are
shorter acting ( 6 to 8 hours)
 Lispro insulin are administered fifteen minutes
before meals has decreased the risk of
hypoglycemic episodes and improve
postprandial glucose excursions when
compared to conventional regular insulin.
 Storage: Refrigerator; room temperature - 28
days
 Note: If accidentally frozen, it should not be
used
4. Isophane Insulin Suspension (NPH Insulin)
 Is a sterile suspension, in an aqueous vehicle
buffered with dibasic sodium phosphate to
between pH 7.1 and 7.4, of insulin prepared
from zinc-insulin crystals modified by the
addition of protamine so that the solid phase
of the suspension consists of crystals
composed of insulin, zinc, and protamine.
 Protamine is prepared from the sperm or the
mature testes of fish belonging to the genus
Oncorhynchus.
 Expiration date: 24 months
 Dosage: dosage range subcutaneously is 10
to 80 USP Units
 NPH used in some product names stands for
“Neutral Protamine Hagedorn”; the pH is 7.2
and developed by Hagedorn. The term
“isophane” is based on the Greek: iso and
phane, meaning “equal” and “appearance”
and refers to equivalent balance between
the protamine and insulin.
5. Isophane Insulin Suspension and Insulin Injection
 A premixed formulation of of isophane insulin
suspension and Insulin injection.
 2 Formulations:
A. Humulin 70/30 - combination that
consists of 70% isophane insulin
suspension and 30% insulin injection
B. Humulin 50/50 - combination that
consists of 50% isophane insulin
suspension and 50% insulin injection
 They contain zinc of 0.01 to 0.04 mg/100 units.
Neutral in pH and phosphate buffered
 Preservatives: m-cresol and phenol
6. Insulin Zinc Suspension
 modified by the addition of zinc chloride so
that the suspended particles consists of a
mixture of crystalline and amorphous insulin
 in a ratio of approximately 7 parts of crystals
to 3 parts of amorphous material.
 Buffered to pH 7.2 to 7.5 with sodium acetate:
0.7% sodium chloride for tonicity; 0.10%
methylparaben as preservatives
 Expiration: 24 months after the immediate
container was filled.
 Storage: Refrigerator with freezing being
avoided
7. Extended Insulin Zinc Suspension
 Is a sterile suspension of zinc insulin crystals in
an aqueous medium buffered to between pH
7.2 and 7.5 with sodium acetate.
 Present also are 0.7% sodium chloride for
tonicity & 0.1% methylparaben as
preservatives
 Dosage: The usual dosage range is 10 to 80
USP Units
 Expiration: 24 months after the immediate
container was filled
8. Prompt Insulin Zinc Suspension
 The sterile suspension of insulin in Prompt Insulin
Zinc Suspension is modified by the addition of
Zinc chloride so that the solid phase of the
suspension is amorphous
 The suspension is available in 100 USP Insulin
Units per mL in vials of 10 mL
 Expiration: not more 24 months
9. Insulin Infusion Pumps
 Insulin infusion pumps allow the patients to
achieve and maintain blood glucose at near-
normal levels on a constant basis.
 The main objective of pump therapy is the
strict control of the blood glucose level
between 70 to 140 mg/dL
 These systems utilize microcomputers to
regulate the flow of insulin from a syringe
attached to a catheter (usually 18 gauge)
connected to a 27 to 28 gauge needle
inserted in the patient.
 The insulin may be delivered SubQ, IV, IP
 Patients who used infusion pumps for the
continuous subcutaneous administration of
insulin may develop hard nodules at the site
of injection
10. Humalog Mix
 Manufactured premix insulin consisting lispro
and neutral protamine lispro (NPL) in afixed
ratio
 Humalol Mix 50/50 consists of 50% insulin NPL
suspension and 50% insulin lispro injection
 Humalog Mix 75/25 contains 75% insulin NPL
suspension and 25% insulin lispro injection
 It is estimated that these premixed
combinations are used by more than 40% of
diabetes patients who inject insulin twice daily
11. Insulin Glargine
 It is a long acting (up to 24 hours) basal insulin
preparation intended for once daily
subcutaneous administration at bedtime in
the treatment of type 1 diabetes mellitus in
adult and children
 In can be used by adults with type 2 diabetes
who require long-acting insulin
 It is created when the amino acids at position
21a of human insulin are placed by glycine
and 2 arginines are added to the C terminus
of the B chain
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Types of Insulin: Approximate effect/action * several days, simple solutions
providing adequate amounts of
Characteristics Onset Peak Duration water, dextrose and small amounts
sodium and potassium generally
suffice.
5 - 30
Short/Fast-Acting (clear) 1 - 3 hrs 4 - 8 hrs – Total Nutrient Admixtures also may
mins
be given (TNA) include all substrate
4 - 12 16 - 24 necessary for nutritional support (
Intermediate-Acting (milky) 1 - 2 hrs carbohydrates, protein, fat,
hrs hrs
electrolytes, trace elements and
Premixed (Short & 2 - 12 16 - 24 others).
1/2 hr
Intermediate) hrs hrs – These admixtures are very useful for
patients undergoing chemotherapy,
8 - 24 28 - 36 and for gastrointestinal patients, and
Long-Acting (milky) 4 hrs
Ins ulin Activity Prof iles and Comp at ib ility hrs hrs anorexic patients
Insulin Preparat ions Onset (hr) Peak (hr) Duration (hr) Compatible 2. Utilized as Replacement therapy in patients who
mixed with
Rapid acting
have suffered a heavy loss of fluid and
Insulin I nj (reg ular) 0.5 to 1 8 to 12 all Lente Prompt electrolytes.
Insulin Z inc 1 to 1.5 5 to 10 12 to 16
 Replacement Therapy
Suspension(semilente)
– given to the patient in which there is
Lispro Ins ulin Sol’n 0.25 0.5 to 1.5 6 to 8 Ultralente, NPH
Intermediate heavy loss of water and electrolytes, as in
Isophane Insulin 1 to 1.5 4 to 12 24 regular severe diarrhea or vomiting, greater than
Suspension (NPH) usual amounts of these materials may be
Insulin Zinc Suspension(lente) 1to 2.5 7 to 15 24 regular, semilente initially administered and maintenance
Long acting
therapy provided. Patients with Crohn’s
PZI (Protamine Zinc Insulin) 4 to 8 14 to 24 36 regular
Extended Insulin Zinc 4 to 8 10 to 30 >36 regular, semilente
disease, AIDS, burn patients, or those
Isophane Ins ulin Suspensio n experiencing trauma are candidates for
Premixed 50% and Insulin Inj 50% replacement therapy.
insulin Isophane Ins ulin Susp. 0.5 2 to 12 18 to 24 regular, NPH  Water Requirement
70% and Insulin Inj, 30%
– The daily water requirement is that
amount needed to replace normal and
expected losses. Normal requirement
Examples of Some Injections Administered in Large Volume by IV t hat may be Administered
adult -25 to 40 mL/kg of body weight or
in Volumes of 1 Liter or More, Alone, or With Other Drugs Added
an average of about 2,000 mL per square
Injection Usual Content Category/Comments
meter of body surface area
– Estimate guidelines in normal daily
Amino Acid Injection 3.5,5,5.5,7,8.5,10% crystalline amino
acids with or without varying
Fluid /Nutrient replenishe r requirement for water
concentrations of electrolytes or glycerin 1. <10 kg: 100 mL/kg/day
Dextrose Injection,USP 2.5,5,10,20% dextrose, other strengths Fluid/Nutrient replenishe r
2. 10-20kg: 1000 mL plus 50 mL/kg/day
Dextrose and sodium Dextrose varying from 2.5 to 10% and F luid/Nutrient/Electrolyte
chloride Injection,USP sodium chloride from 0.11 (19 mEq Na) electrolyte for weight over 10 kg
to 0.9% (154 mEq sodium)
Mannitol Injection, USP 5,10,15,20 and 25% mannitol Diagnostic aid in renal 3. >20 kg to maximum of 80 kg: 1500
f unction determinatio ns;
diuret ic. Fluid/Nut rient mL Plus 20 mL/kg/day for weight
Ringers’ Injection, USP 147 mEq sodium, 4 mEq potassium Fluid/electrolyte over 20 kg
calcium, and 156 mEq chloride/ liter
Lactated Ringer’s 2.7 mEq calcium, 4 mEq potassium, Systemic alkalinizer; Injectio n,
 Electrolyte Requirement
USP 130 mEq sodium and 28 mEq
lactate per liter replenisher
f luid and electro lyte
1. Potassium
Sodium Chloride 0.9% sodium Chloride Fluid and electrolyte Injection,  important for cardiac and skeletal
USP replenisher, isotonic
vehicle muscle function. The usual daily intake
Large Volume Parenterals (LVPs) is about 100 mEq and the usual daily
 These solutions are usually administered by IV infusion to loss is about 40 mEq
replenish body fluids, electrolytes, or to provide  Potassium can be lost through:
nutrition. They are usually administered in volumes of excessive perspiration, repeated enemas,
100 mL to liter amounts and more per day by slow trauma (such as severe burns), uncontrolled
intravenous infusion with or without controlled-rate diarrhea, diseases of intestinal tract, surgical
infusion systems operations and others
 USES:  Low potassium levels - Hypokalemia,
1. Employed as Maintenance therapy for the can lead to death
patient entering or recovering from surgery, or for  Symptoms of potassium loss :weak
the patient who is unconscious and unable to pulse, faint heart sounds, falling blood
obtain fluids, electrolytes, and nutrition orally. pressures & generalized weakness
 Maintenance Therapy  Excess potassium is not good either :
– given to the patient being Hyperkalemia can cause kidney
maintained on parenteral fluids only failure

A. Uy | Page 11 of 14
  Symptoms : diarrhea, irritability, muscle
cramps, and pain
2. Sodium
 is vital to maintain normal extracellular
fluids.
 Average daily intake of sodium:
 135 to 170 mEq (8 to 10 g of Sodium
chloride)
 Sodium loss/deficit: 3 to 5 g sodium
chloride (51 to 85 mEq of sodium) is
administered daily
 Symptoms: excessive sweating,
fatigue, muscle weakness, convulsions
 Symptoms (excess): Dry, sticky mucous
membranes, flushed skin, elevated
body temperature, lack of tears, and
thirst
3. Chloride
 the principal anion of the extracellular
fluid usually paired with sodium.
 Chloride is also important for muscle
contraction, balancing the fluid levels
inside and outside the cells &
maintaining the acid-base balance of
the extracellular fluid.
 Caloric Requirements :
– Basic caloric requirements
may be estimated by 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 glucose reduces
this loss by half.
– Generally patients requiring
parenteral fluids are 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 feeding of
protein solutions containing high concentration of
dextrose (approximately 20%), electrolytes, vitamins,
and sometimes insulin.
Components of Parenteral Nutrition Solutions
 Electrolytes
1. Sodium…………. 25 mEq
2. Potassium ……... 20 mEq
3. Magnesium ……..5 mEq
4. Calcium …….……5 mEq
5. Chloride ……….. 30 mEq
6. Acetate …..…… 25 mEq
7. Phosphate ……..18 mM
 Vitamins
 Vitamin A – 3300 I.U.
 Vitamin D – 200 I.U.
 Vitamin E – 10 I.U.
 Vitamin C – 100 mg
 Niacin – 40 mg
 Vitamin B2 – 3.6 to 4.93 mg
 Vitamin B1 – 3 to 3.35 mg
 Vitamin B6 – 4 to 4.86 mg
 Pantothenic Acid – 15 mg
 Folic Acid – 400 mcg
 Vitamin B12 – 5 mcg
 Biotin – 60 mcg
 Amino Acids: Essential Amino Acids
1. L - Isoleucine……………..590 mg
2. L - Leucine ……………….770 mg
3. L - Lysine acetate………..870 mg
(free base…………….620 mg)
4. L - Methionine ……………450 mg
5. L - Threonine ……………..340 mg
6. L - Tryptophan ……………130 mg
7. L - Valine ………………….560 mg
8. L - Phenylalanine ………..480 mg
 Nonessential Amino Acids
1. L - Alanine ……………..600 mg
2. L - Arginine …………….810 mg
3. L - Histidine …………….240 mg
4. L - Proline ………………950 mg
5. L - Serine ……………….500 mg
6. Aminoacetic acid ………1.19 g
Enteral Nutrition
 Enteral nutrition products may be administered orally,
via nasogastric 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 formula diets may be monomeric or oligomeric
(amino acids or peptides and simple carbohydrates) or
polymeric (more complex protein and carbohydrates
sources.
 Ex.:
Protein - 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-rate 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. Chorpromazine HCl
2. Insulin
3. Promethazine HCl
4. Trifluoperazine HCl
5. Thioridazine HCl
6. Diazepam
7. Promazine HCl
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 8. Thiopental sodium
9. Warfarin sodium
Another Example:
Nitroglycerin
 should always be prepared in glass containers, and is
adsorbed (40 to 80% of total dose) to polyvinylchloride
(PVC), a plastic commonly used in administration
components and some infusion containers, therefore, it
should be packaged with special non-PVC tubing to
avoid loss <5% of the drug into the tubing during
administration.
Selected Infusion Devices Used in Parenteral Nutrition Support
1. Volumetric Infusion Pumps - AVI 2000 #200: Flo-Gard
8100; IMED
2. Multiple-rate Programmable Pumps – CADD-TPN
3. Volumetric Infusion Pumps - Provider one; Quest 521
Intelligent
4. Multiple-solution Programmable Pumps - Gemini PC –2;
Life Care 5000 Plum;Omni-Flow 4000
5. Others- Breeze Lifecare 175, 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 from their containers while they
are being manipulated”.
 Basic Steps in handling Chemotherapeutic Agents
1. Utilizing vertical laminar flow hoods (or
bacteriological gloves boxes) for the
preparation and reconstitution of cytotoxic
drugs.
2. Wearing protective gloves and mask during
product preparation
3. Handling and disposing of cytotoxic drugs
centrally utilizing specially designed waste
containers and incineration.
4. Periodic monitoring of personnel involved with
handling admixtures of cytotoxic drugs (CBC,
blood chemistry screen, differential cell count)
5. Informing personnel handling cytotoxic drugs
that a potential risk to their health exists.
6. Instituting specialized labeling of containers to
ensure proper handling and disposal of the
cytotoxic agent.
Other Injectable Products
Pellets or Implants
 are sterile, small, usually cylindrical-shaped solid objects
 about 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 release 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.: (desoxycorticosterone, estradiol, testosterone)
given other routes are release slowly into general
circulation
 Pellets were formulated with no binders, diluents, or
excipients, to permit total dissolution and absorption of
the pellets.
Ex.: Levonorgestrel
Levonorgestrel Implants
 These are a set of six flexible, closed capsules of a
dimethylsiloxane/methylvinylsiloxane copolymer, each
containing 36 mg of the progestin levonorgestrel
 These are found in an insertion fit to facilitate surgical
subdermal implantation through a 2 mm incision in the
mid-portion of the upper arm about 8 to 10 cm above
the elbow crease.
 These are implanted in a fan like pattern, 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.
Irrigation and Dialysis Solutions
 Solutions for irrigation of body tissues and dor dialysis
resemble parenteral solutions in that they are subject to
the same stringent standards.
 These solutions are not injected into the vein, but
employed outside of the circulatory system.
Irrigation Solutions
 Irrigation solutions are intended to bathe or wash
wounds, surgical incisions, or body tissues.
 Ex.:
1. Acetic 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 debris away while
maintaining suitable conditions for the tissue.
2. Neomycin and Polymixin B Sulfate Solution for
Irrigation, USP - Employed as a topical
antibacterial 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 solution is sterile and pyrogen
free.
4. Sodium Chloride Irrigation, USP - This solution is
employed topically to wash wounds and into
body cavities where absorption into the blood is
not likely. The solution also employed rectally as
an enema for simple evacuation and also for
colonic flush.
5. Sterile Water for Irrigation, USP - The label
designations “for irrigation only” and “not for
injection” must appear prominently on the label.
The water must not contain any antimicrobial or
other added agent.
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Dialysis Solutions
 May be defined as a process whereby substances may
be separated from one another in solution by taking
advantage of their differing diffusibility through
membranes

Peritoneal Dialysis
 Solutions allowed to flow into the peritoneal cavity, are
used to remove toxic substances normally excreted by
the kidney
 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
membrane bathed in an electrolyte solution. Following
the dialysis, the blood is returned to the body
circulation through a vein.

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