Secundum

Artem
VOLUME 13 NUMBER 1
Current & Practical Compounding
Information for the Pharmacist.
INTRODUCTION
Ear problems have been common throughout history and various med-
ications have been administered to the ear for a local effect. Early otic
preparations were applied by soaking materials, such as cloth, wood, or
plants, in various oils or extracts from plants or animals and placing the
soaked materials into the ear. More recently, administration of medica-
tions to the ear involve placing a liquid in the ear and inserting a cotton
plug to keep the medication from draining out. This method is still used
today, along with the use of ear irrigants, which clean debris from the
ear. This debris can be the cause of many otic infections.
Otic (aural) preparations may consist of solutions, suspensions, oint-
ments, gels and powders. Liquid ear preparations are usually placed
in the ear canal by drops or in small amounts for the removal of exces-
sive cerumen (ear wax) or for the treatment of ear infections,
inflammation, or pain. Because the outer ear is a skin-covered struc-
ture and susceptible to the same dermatologic conditions as other
parts of the body's surface, skin conditions which arise are treated
using a variety of topical dermatological preparations.
ANATOMY AND PHYSIOLOGY
The external ear is made up of the pinna (auricle) and the external audi-
tory canal. Terminating the end of the external auditory canal is the
tympanic membrane, which forms the beginning of the middle ear. The
auricle consists of a thin layer of highly vascular skin firmly attached to
cartilage. There is generally no fatty tissue or subcutaneous tissue in the
auricle, except for the ear lobe, which is composed primarily of fatty tis-
sue with fewer blood vessels than the rest of the auricle.
1,2
Starting from the exterior and moving along into the external audito-
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GOALS AND OBJECTIVES
Goal: To provide information on the anatomy, physiology and common disorders of the ear and some examples of
compounded drugs and dosage forms used in their treatment.
Objectives: After reading and studying the article, the reader will be able to:
1. Discuss the physiology of the ear and the function of the different parts of the ear.
2. List at least four disorders of the ear, their causes and differential diagnosis.
3. Discuss common drugs and their dosage forms used in treating otic disorders.
4. Counsel a patient on the proper use of otic preparations.
COMPOUNDING FOR
OTIC DISORDERS
Loyd V. Allen, Jr., Ph.D., R.Ph., Professor Emeritus,
University of Oklahoma, HSC College of Pharmacy,
Oklahoma City, OK 73190
ry canal, the first one-third to one-half is the outer cartilaginous portion
followed by the inner body or osseous portion. The end of the ear canal
ends in a cul-de-sac. The external auditory canal of adults tends to be
S shaped and that of children tends to be shorter and straighter.
1,2
The auricle is susceptible to bleeding when scratched because it is more
rigid and lacks the flexibility normally provided by a subcutaneous
layer of fat. The auricle area contains many nerves which can cause
enhanced pain sensations when inflamed. Moving further into the
external auditory canal, the skin becomes thicker and contains both
apocrine and exocrine glands along with hair follicles. The skin lining
the external auditory canal is continuous with that forming the tym-
panic membrane outer layer.
Cerumen is produced as a part of the bodys normal defensive mecha-
nisms. Cerumen is formed when the oily secretions from the exocrine
glands mixes with the milky, fatty fluid from the apocrine glands. The
cerumen serves to lubricate the canal and entrap dust and foreign
materials; it also provides a waxy, waterproof barrier to the entry of
pathogens. Under normal conditions, bacterial growth is inhibited
because the cerumen contains lysozymes and an acidic pH. Normal
skin growth results in a continuous shedding of the external layer
including the ear canal. The shed skin cells are continually mixed with
the cerumen. This mixture normally moves outward to the external
opening of the ear when the jaw moves, such as in talking or chewing.
The ear canal is usually self-cleaning. The cerumen may progress from
an oily and pastelike appearance to that of being dry and flaky. The
color ranges from light gray to orange or brown and may darken upon
exposure to the air.
1,2
CE No Longer
Avai l abl e f or
Thi s i ssue
TREATMENT OF OTIC DISORDERS
Cerumen
There are a number of methods of breaking up the cerumen and aid-
ing its removal from the ear, including preparations containing
carbamide peroxide, glycerin, hydrogen peroxide and olive oil. The
carbamide peroxide and hydrogen peroxide contribute a mechanical
bubbling action that can serve to soften and break up dried cerumen
and move the pieces of ear wax towards the outer portion of the ear
canal; they also have anti-infective properties. Glycerin is hygroscopic
and can absorb some moisture from the environment and serve to soft-
en the cerumen. The olive oil can also serve as a softening agent for the
cerumen so it can be easily removed. These liquids are viscous and will
tend to stay in the ear canal if a small piece of cotton is placed at the
entrance to the ear.
Recently, solutions of synthetic surfactants have been developed for
their cerumenolytic activity in the removal of ear wax. One of these
agents, triethanolamine polypeptide oleate-condensate, commercially
formulated in propylene glycol, is used to emulsify the cerumen there-
by facilitating its removal.
The procedure for removing cerumen usually involves placing the otic
solution in the ear canal with the patient's head tilted at a 45 angle,
inserting a cotton plug to retain the medication in the ear for 15 to 30
minutes. This is followed by gentle flushing of the ear canal with luke-
warm water using a soft rubber ear syringe.
Water Clogged Ears
Preparations used to treat water-clogged ears (otitis externa, swim-
mers ear) include isopropyl alcohol, glycerin, boric acid,
hydrocortisone, ethyl alcohol and acetic acid. Also effective, when
infection occurs, are otic drops containing a mixture of aminoglycoside
antibiotics and anti-inflammatory corticosteroids in an acidic vehicle.
The alcohols aid in reducing surface tension mixing with the water to
aid in its removal through the ear canal. Glycerin also will aid in
absorbing the water. Acetic acid will reduce the pH in the ear canal
minimizing bacterial growth. Hydrocortisone will assist in reducing
inflammation and the antibiotics will help reduce infection.
In addition to the antibiotic-steroid combinations that are often used to
treat otitis externa, a combination of acetic acid (2%) in aluminum
acetate solution and boric acid (2.75%) in isopropyl alcohol is used.
These drugs help to re-acidify the ear canal and the vehicles serve to
dry the ear canal. By drying the ear canal, the growth medium for the
offending microorganisms, usually Pseudomonas aeruginosa, is kept in
check. Pharmacists may also be called on to extemporaneously prepare
a solution of acetic acid, 2 to 2.5% in rubbing alcohol (70% isopropyl
alcohol or ethanol), propylene glycol or anhydrous glycerin. The
source of the acetic acid can be glacial acetic acid USP or acetic acid NF.
Boric acid, 2 to 5%, dissolved in either ethanol or propylene glycol has
also been recommended for use in the ear. This substance, however,
may be absorbed from broken skin and be toxic. Thus, its use is usual-
ly limited and should be avoided in treating children with burst ear
drums.
Skin Disorders of the Ear
Topical treatment of ear infections is frequently considered adjunctive,
with concomitant systemic treatment of orally administered antibiotics
also undertaken.
Liquid ear preparations of the anti-inflammatory agents hydrocorti-
sone, triamcinolone and dexamethasone sodium phosphate are
prescribed for their effects against the swelling and inflammation
which frequently accompany allergic and irritative manifestations of
the ear, as well as for the inflammation and pruritus which sometimes
follow treatment of ear infections. In the latter instance, some physi-
cians prefer the use of corticosteroids in ointment form packaged in
ophthalmic tubes. This packaging allows the placement of small
amounts of ointment in the ear canal with a minimum of waste. Some
of the commercially available products used in this manner are labeled
"eye-ear" to indicate their dual use.
COMMON OTIC DISORDERS
Under certain circumstances, the external auditory canal forms an ideal
environment for bacterial growth. The canal, if moisture accumulates,
will form a dark, warm, moist environment that can support bacterial
growth. The protective layer of skin can be challenged and traumatized
by fingernails, cotton-tipped swabs, hair pins, or any other object insert-
ed into the ear in attempts at cleaning. Once the integrity of the skin is
penetrated, pathogenic organisms can enter and initiate an infection.
Other injuries can result from burns, sporting accidents, ear piercing,
and improperly fitted ear molds or hearing aids.
Ear complaints affect patients of all ages and range from simple condi-
tions such as excessive ear wax to more complex painful ear infections.
Impacted Cerumen
Ear wax impaction may be experienced by up to about 6% of the gen-
eral population; this is one of the most common ear problems presented
to physicians.
2
Some individuals are more prone to impacted cerumen;
especially those with narrow or mis-shaped ear canals and those with
excessive hair growth in the canal. Others with a greater than average
tendency for impacted cerumen are those with overactive glands, those
wearing hearing aids as well as those using ear plugs to prevent water
from entering the ear and to muffle loud noises. If cerumen is prevent-
ed from its natural migration outward to the opening of the ear canal,
it may build up and dry out, forming a plug. As cerumen becomes dry,
it is more difficult to remove from the ear. Impacted cerumen buildup
is experienced by the patient as a sense of fullness or pressure within
the ear, some associated with a dull pain.
It is obvious from this discussion that any object placed in the ear may
tend to compress the cerumen and alter the normal flow of the cerumen
from the ear. In fact, cotton-tipped swabs can result in pushing the ceru-
men back deeper into the ear.
Water-Clogged Ears
If cerumen builds up in an ear and the ear is exposed to water, as in tak-
ing a shower or going swimming, water may get in behind the cerumen
in contact with the tympanic membrane. The presence of this moisture
may result in maceration of the skin lining the ear and the tympanic
membrane contributing to inflammation and infection of the external
auditory canal; a condition known as swimmers ear. This situation can
also result from excessive sweating in humid environments as well as
from the improper use of aqueous products to clean the ear.
Symptoms of water-clogged ears include a feeling of fullness and wet-
ness of the ear; this may be accompanied by some gradual loss of
hearing. As the condition progresses, it can result in tissue maceration
leading to itching, pain, inflammation and/or infection.
Disorders of the Skin of the Ear
Disorders of the skin of the ear can include contact dermatitis, sebor-
rhea, psoriasis and boils.
Contact dermatitis may result from either an allergy or an irritant. It
may present as maculopapular rash and vesicles. The rash may be asso-
ciated with pruritus, erythema and/or edema. Mild irritants include
soaps and detergents and can cause an inflammatory response similar
to allergic contact dermatitis.
Seborrhea affecting the ear is presented with visible drying and flaking
of the skin, with or without fissuring of the skin.
Psoriatic lesions present as thickened, erythematous, silvery scales that
occur most frequently on the knees, elbows, torso and scalp, including
the ear.
Boils
Localized infections of hair follicles can result in boils, or furuncles.The
causative organism often is a Staphylococcus species. The boil general-
ly begins as a red papule and develops into a superficial pustule with a
core of pus and a reddened area around the base. The lesion slowly
enlarges and becomes firm prior to softening and opening in a couple
of weeks discharging its contents. Pain can be caused by the swelling
and tight skin.
Contact dermatitis can be treated with a 2.5% aluminum acetate solu-
tion which has antipruritic, anti-inflammatory and some antibacterial
properties. This astringent precipitates proteins and dries the affected
area. It can also reduce the pH of the area inhibiting bacterial and fun-
gal growth.
The associated itching of seborrhea can be treated with topical hydro-
cortisone-containing preparations.
Psoriatic lesions can be treated with routine medications used to treat
psoriasis as well as hydrocortisone-containing preparations for the
discomfort.
Boils are generally self-limiting. Treatment can include warm compresses
and topical antibiotics, as previously listed.
In the event of an excessively dry ear canal skin, the application of miner-
al oil or olive oil (sweet oil) may help to counteract dryness and repel
moisture.
Ear Pain
Pain in the ear frequently accompanies ear infection or inflamed or
swollen ear tissue. Frequently, the pain is far out of proportion to the
actual condition. Because the ear canal is so narrow, even a slight
inflammation can cause intense pain and discomfort for the patient.
Topical analgesic agents generally are employed together with inter-
nally administered analgesics, as aspirin, and other agents, such as
anti-infectives, to combat the cause of the problem.
Topical analgesics for the ear are usually solutions and frequently
contain the analgesic antipyrine and the local anesthetic benzocaine in
a vehicle of propylene glycol or anhydrous glycerin. The hygroscopic
vehicles reduce the swelling of tissues (and thus some pain) and the
growth of microorganisms by drawing moisture from the swollen tis-
sues into the vehicle. These preparations are commonly employed to
relieve the symptoms of acute otitis media.
DRUGS USED IN TREATING OTIC DISORDERS
Categories of medications commonly used in the ear include local
anesthetics, cleansing agents (peroxides), anti-infectives, and antifun-
gals. Also included are liquids for cleaning, warming, or drying the
external ear and for removing any fluids that may be entrapped by a
local waxy buildup.
Anti-infective agents include drugs such as chloramphenicol,
ciprofloxacin, colistin sulfate, gentamicin sulfate, neomycin and
polymyxin B sulfate. For fungal infections, nystatin, ketoconazole,
amphotericin and clotrimazole are used. These agents are formulated
into ear drops (solutions or suspensions) in a vehicle of anhydrous
glycerin or propylene glycol. These viscous vehicles permit maximum
contact time between the medication and the tissues of the ear. In
addition, their hygroscopicity causes them to draw moisture from the
tissues thereby reducing inflammation and diminishing the moisture
available for the life process of the microorganisms present. To assist
in relieving the pain which frequently accompanies ear infections, a
number of anti-infective otic preparations also contain analgesic
agents such as antipyrine and local anesthetics such as lidocaine,
dibucaine, and benzocaine.
DOSAGE FORMS USED IN TREATING OTIC DISORDERS
Otic preparations can be in liquid, ointment, gel or powder dosage
forms. Both otic solutions and suspensions, the liquid dosage forms, are
prepared for instillation into the ear. Solutions are also used for irri-
gating the ear. Otic irrigating solutions, which may consist of
surfactants, weak sodium bicarbonate, boric acid (0.5%1%), or alu-
minum acetate solutions, may be warmed to about 37 C before
instillation into the ear. These irrigating solutions may be used to
remove ear wax, purulent discharges of infection, and foreign bodies
from the ear canal.
Otic suspensions can be used when a long duration of drug effect is
desired or when the drug is not soluble in the vehicles commonly used
in otic preparations. Pharmacists must be aware that there may be sub-
tle differences in the formulation of some otic suspensions that could
be potentially bothersome to the patient. This is especially so as it
relates to inactive or inert ingredient differences between formulations
from manufacturers which are considered equivalent on the basis of active
ingredient(s) and strength. For example, several suspension combinations
of polymyxin B sulfate, neomycin sulfate and hydrocortisone have been
shown to be more acidic, i.e., pH 3.0 to 3.5, compared to commercial prod-
ucts, which possesses a higher pH range, i.e., 4.8 to 5.1. Consequently, there
is a risk that a burning and stinging sensation can occur when the drops are
introduced into the ear of young children, especially those with tympanos-
tomies. Further, it has been demonstrated that with time, the pH of some of
these formulations, including commercial products, becomes more acidic,
e.g., pH 3.0. Thus, if stored for a period of time, it is conceivable that if used
again, the acidity could cause irritation to the ear canal.
Otic ointments and gels are semisolid preparations that are applied to the
exterior of the ear. Otic ointments are actually seldom used. Any ointment
base can be used in their preparation. They may include antibacterial, anti-
fungal, or corticosteroid ingredients. These ointments are applied directly
to the exterior portions of the ear.
Insufflations are preparations made of finely divided powders that are
administered to the ear canal. Insufflating a powder into the ear canal is
not too common because the ear lacks fluids and a powderwax buildup
may occur. Fine powders used as insufflations may contain an antibacter-
ial and/or an antifungal agent that will create a repository for the drug. A
small rubber or plastic bulb insufflator (powder blower, puffer) can be
used to blow, or insufflate, the powder into the ear.
Physicochemical Considerations
Physicochemical considerations in developing otic preparations include
solubility, viscosity, tonicity, surfactant properties, and preservatives.
Although sterility is not generally a consideration, the products need to be
clean.
Many drugs are soluble in the vehicles commonly used in these prepara-
tions. If a drug is insoluble in these vehicles, the preparation can be
prepared as a suspension. Because most of these vehicles are relatively vis-
cous agents, the addition of suspending agents may not be necessary.
The viscosity of the preparation is important in keeping the medication in
the ear canal. If the preparation is too thin, the medication will drain out
of the ear. On the other hand, if the medication is too thick, it may not
reach the inner recesses of the ear.
Tonicity and hygroscopicity are important in the products ability to aid in
withdrawing fluids from the immediate area of the ear. If the product is
hypertonic, some fluid may be withdrawn from the ear, thereby releasing
some of the pressure. If the product is hypotonic, however, some fluid
may flow into the area.
Because many ear conditions are related to the difficulty in cleaning the
ear, the presence of a surfactant in the preparation helps the medication
spread out and aids in breaking up ear wax. This action makes it easier to
remove any foreign material.
Many otic preparations are self-preserving because of the high concentra-
tion of glycerin, propylene glycol, and the like. If these agents are not
present, it may be wise to add a preservative to minimize the chance of
introducing bacteria that might grow in an unpreserved product. As deter-
mined on an individual product basis, some liquid otic preparations
require preservation against microbial growth. When preservation is
required, such agents as chlorobutanol (0.5%), thimerosal (0.01%), and
combinations of the parabens are commonly used. Antioxidants, as sodi-
um bisulfite, and other stabilizers are also included in otic formulations, as
required. Ear preparations are usually packaged in small (5 to 15 mL) glass
or plastic containers with a dropper.
Vehicles
Vehicles used most often in otic preparations are glycerin, propylene glycol,
and the lower molecular weight polyethylene glycols (PEGs), especially PEG
300. These vehicles are viscous and will adhere to the ear canal. Water and
alcohol (ethanol and isopropyl) can be used as vehicles and solvents for some
medications; however, they are used primarily for irrigation, since one of the
therapeutic aims of these preparations is to keep the ear canal dry to mini-
mize bacterial/fungal growth. Alcohol can be used full strength. Vegetable
oils, especially olive oil, are also good vehicles. Mineral oil has been used as
a vehicle for some antibiotics and anti-inflammatory medications. Otic oint-
ments primarily contain petrolatum as a vehicle, whereas otic powders may
contain talc or lactose as a vehicle.
QUALITY CONTROL
The compounding pharmacist should follow standard quality con-
trol procedures. These include checking the volume/weight, pH,
viscosity, appearance, and odor of these products.
PACKAGING, STORAGE AND LABELING
Otic preparations should be packaged in dropper containers, puffers,
syringes (without needles) or tubes as appropriate for the product
and method of administration. Generally, otic preparations should
be stored at either room or refrigerated temperatures. They should
not be frozen. These preparations should be labeled For the Ear,
Discard after [appropriate date], and Use Only as Directed and
Keep Out of Reach of Children.
STABILITY AND BEYOND-USE DATES FOR OTIC
PREPARATIONS
The following beyond-use recommendations can be exceeded if
there is valid scientific information to support the stability of the
product.
Beyond-use dates for water-containing formulations are no later
than 14 days, when stored at cold temperatures, for products pre-
pared from ingredients in solid form. If nonaqueous liquids are
prepared using a manufactured product, the beyond-use recom-
mendation is no later than 25% of the time remaining on the
products expiration date or 6 months, whichever is earlier and six
months if prepared from ingredients with a USP-NF monograph.
For all other products, the beyond-use recommendation is the
intended duration of therapy or 30 days, whichever is earlier.
PROPER ADMINISTRATION AND USE OF OTIC DROPS
Patients should be instructed on how to apply drops to the ear from
dropper bottles. They should also be told to place a cotton or gauze
pad in the ear to keep the liquid from escaping.
When ear drops are prescribed, it is important for the pharmacist to
first determine how the drops are to be used. For example, ear wax
removal drops should be instilled and then removed by the patient
with an ear syringe. Alternatively, drops intended to treat external
otitis infection are intended to be instilled and left in the ear.
The pharmacist should make sure the patient or parent understands
that administration is intended for the ear and the frequency of appli-
cation. To facilitate patient acceptance, the pharmacist should point
out that the bottle or container of medication should first be warmed
in the hands, and if the product is a suspension, shaken well prior to
withdrawal into the dropper. The pharmacist should also explain the
need to store the medication in a safe place out of the reach of chil-
dren and away from extremes of temperature.
When instilled into the ear, to allow the drops to run in deeper, the
earlobe should be held up and back. For a child, the earlobe should
be held down and back. For convenience it is probably easier to
have someone other than the patient to administer the drops.
Some ear drops by virtue of their formulation, i.e., low pH, may
cause stinging upon administration. Thus, parents and children
should be forewarned especially if a child, for example, has tympa-
nostomy tubes in the ear. The patient should also understand the
length, in days, to use the product. For antibiotic ear drops, it is not
necessary to finish the entire bottle because therapy could last 20 to
30 days depending upon the dosage regimen. Therefore, patients
should be instructed to continue using the drops for 3 days beyond
the time ear symptoms disappear. Products for swimmers ear or
otitis externa may take up to 7 to 10 days to demonstrate efficacy.
If a child is prone to develop ear infections as a result of swimming
or showering, it might be advisable to recommend the parents to
consult a physician for prophylactic medication to use during
swimming season, and consider using form-fitting ear plugs that fit
snugly in the ear when swimming or showering. Further, after the
child emerges from the water or shower, the parents can be advised
to use a home hair blow dryer on a low setting to dry out the ear. It
will dry out the ear quickly without trauma. The dryer should not
be placed too close to the child's ear.
FORMULATIONS FOR TREATING OTIC DISORDERS
Formulations for Removing Cerumen
Rx Urea and Hydrogen Peroxide Otic Solution
Carbamide peroxide 6.5 g
Glycerin qs 100 mL
Dissolve the carbamide peroxide in sufficient glycerin to volume,
package and label. A beyond-use date of up to six months can be
used for this preparation.
Formulations for Treating Water-Clogged Ears
Rx Boric acid 2% in Isopropyl Alcohol
Boric acid 2 g
Isopropyl alcohol 70% qs 100 mL
Dissolve the boric acid in sufficient isopropyl alcohol 70% to vol-
ume, package and label. A beyond use date of up to six months
can be used for this preparation.
Formulations for Treating Disorders of the Skin of the Ear
Rx Aluminum Acetate Otic Solution
Aluminum subacetate topical solution 54.4 mL
Glacial acetic acid 1.5 mL
Purified water qs 100 mL
Slowly and with stirring add the glacial acetic acid to the alu-
minum subacetate topical solution. Add sufficient purified water
to volume and mix well. Package and label. A beyond use date of
up to six months can be used for this preparation.
Rx Hydrocortisone and Acetic Acid Otic Solution
Hydrocortisone 1 g
Glacial acetic acid 2 mL
Propylene glycol qs 100 mL
Add the hydrocortisone and glacial acetic acid to sufficient
propylene glycol to volume and mix well. It will slowly dissolve.
Gentle heat can be used if required. Package and label. A beyond
use date of up to six months can be used for this preparation.
Rx Acetic Acid and Glycerin Otic Solution
Glacial acetic acid 0.5 mL
Glycerin 20 mL
Purified water qs 100 mL
Mix the glacial acetic acid and glycerin. Add sufficient purified
water to volume and mix well. Package and label. A beyond use
date of up to six months can be used for this preparation.
REFERENCES
1. Jacker RK and Kaplan MJ. Ear, Nose & Throat. In Tierney LM Jr,
McPhee SJ, Papadakis MA. Current Medical Diagnosis & Treat-
ment 2003, 42nd Ed. New York. Lange Medical
Books/McGraw-Hill,2002, pp 178-192.
2. Krypel L. Otic Disorders, Chapter 24. In Handbook of Nonpre-
scription Drugs, 12th Ed., Washington DC, American
Pharmaceutical Association, 2000, pp 541-557.
Rx Neomycin Sulfate, Polymyxin B Sulfate, Triamcinolone
and Nystatin Otic Suspension
Neomycin sulfate 350 mg
Polymyxin B sulfate 1,000,000 units
Triamcinolone 100 mg
Nystatin 10,000,000 units
Propylene glycol qs 100 mL
Blend the powders with sufficient propylene glycol to volume
and mix well. Package and label. A beyond use date of up to 30
days can be used for this preparation.
Rx Clotrimazole and Gentamicin Sulfate Otic Liquid
Clotrimazole 1 g
Gentamicin sulfate 300 mg
Polyethylene glycol 300 qs 100 mL
Add the clotrimazole and gentamicin sulfate to sufficient poly-
ethylene glycol 300 to volume and mix well. Low heat can be
used if needed to effect solution. Package and label. A beyond
use date of up to 6 months can be used for this preparation.
Rx Triamcinolone 0.1% Otic Solution
Triamcinolone 100 mg
Propylene glycol 50 mL
Glycerin qs 100 mL
Add the triamcinolone to the propylene glycol. Add sufficient
glycerin to volume and mix well. Package and label. A beyond
use date of up to six months can be used for this preparation.
Formulations for Treating Pain in the Ear
Rx Lidocaine Hydrochloride 0.5% Otic Solution
Lidocaine hydrochloride 500 mg
Glycerin 50 mL
Propylene glycol qs 100 mL
Add the lidocaine hydrochloride to the glycerin and sufficient propy-
lene glycol to volume and mix well. Package and label. A beyond use
date of up to six months can be used for this preparation.
Rx Antipyrine and Benzocaine Otic Solution
Antipyrine 810 mg
Benzocaine 210 mg
Glycerin qs 15 mL
Add the antipyrine and benzocaine to sufficient glycerin to vol-
ume, mix well and allow to set until all dissolved. Package and
label. A beyond-use date of up to six months can be used for this
preparation. Note: As an option, 0.25% phenylephrine
hydrochloride can be added to this preparation. A beyond-use
date of only 14 days could be used for this modified formulation,
when stored in a refrigerator.
Rx Tetracaine 30% Otic Solution
Tetracaine 30 g
Propylene glycol qs 100 mL
Add the tetracaine to sufficient propylene glycol to volume and
mix well. Package and label. A beyond use date of 30 days can be
used for this preparation.
Rx Gentamicin Sulfate 0.1% Otic Solution
Gentamicin sulfate 100 mg (equivalent activity)
Glycerin qs 100 mL
Add the gentamicin sulfate to sufficient glycerin to volume and
mix well. Package and label. A beyond use date of up to six
months can be used for this preparation.
Rx Nystatin 100,000 units/mL Otic Suspension
Nystatin 10,000,000 units
Propylene glycol 25 mL
Glycerin qs 100 mL
Add the nystatin to the propylene glycol and mix well. Add suffi-
cient glycerin to volume and mix well. Package and label. A beyond
use date of up to six months can be used for this preparation.
Rx Ciprofloxacin 1% Otic Drop
Ciprofloxacin 1 g
Propylene glycol 50 mL
Glycerin qs 100 mL
Pulverize sufficient ciprofloxacin tablets to a very fine powder.
Add the propylene glycol slowly and mix well. Add sufficient
glycerin to volume and mix well. Package and label. A beyond
use date of 14 days can be used for this preparation.