Otic and Opthalmic Agents

Enrichment Program Community Pharmacy Internship

Otic Preparations

Common Ear Disorders

•1. Excessive/Impacted Earwax

A. Function of cerumen:

(1) Lubrication of the lining of the ear canal(2) Aiding in the removal of organisms and debris by its

outward movement (ceruminokinesis), which is caused by movement of the jaw during chewing or talking. The healthy ear is “self-cleaning” through this process.

(3) Helping to protect the ear canal through its bacteriostatic and possibly fungistatic properties.

• B. Four Reasons Why Earwax Accumulates

(1) Overactive ceruminous glands, which are rare(2) An anatomically narrowed ear canal(3) A large amount of hair in the canal, which occurs often during

elderly(4) Inefficient or insufficient chewing or talking, which may also occur

in the elderly

C. Improper Removal Methods

Attempts should not be made to remove earwax by using cotton-tipped applicators, match sticks, or hairpins as this usually pushes the earwax down farther in the canal and makes it more difficult to remove and may contribute to the development of infection.

“ never put anything in your ear smaller than your elbow”

Earwax-softening Agents(Ceruminolytics)

•Auralgan Otic – antipyrine 54mg, benzocaine 14mg

•Cleaners – Mineral Oil, phytosqualan, spearmint oil

•Otosol – Docusate sodium

2. Altitude and Ear Pressure • During situations such as airplane descent when there are rapid

changes in air pressure, the eustachian tubes may not function properly. Travelling from low atmospheric pressure to a higher air pressure causes a vacuum to form in the middle ear. As a result, the eardrum retracts and cannot vibrate, which creates a muffled sound and some pain. Patients with cold or allergy might be more susceptible to this problem.

• The act of swallowing (chewing gums) activates the muscles that pull open the euastachian tubes and helps to unblock the ears.

• Yawning is also effective in opening the eustachian tubes.• Pinching the nostrils , and using the cheek and throat muscles,

forcing the air back of the nose as if trying to blow off the thumb and fingers from the nostrils.

3. Otitis Externa• is an inflammation of the external ear canal. The most

common form is acute diffuse otitis externa ( Swimmer’s ear or hot weather ear)

• Pathophysiology

Typically, this condition develops when water accumulates in the external ear canal after swimming. The combination of heat and humidity results in softening and swelling of the ear wax, which interferes with the normal protective function of the ear wax. The pH in this area then increases and sets the stage for bacterial invasion.

• The Resulting itching makes affected patients scratch the area which further interferes with the integrity of the ear canal.

• Microorganisms involves is -Pseudomonas aeruginosa ( in more than 50% of cases)

- Staphylococcus-Bacillus- Proteus

Symptoms

• Itching• Pain that is accentuated by moving the ear• A fluid discharge from the ear canal• A decrease or loss of hearing

• Treatment

• There is no OTC treatment for this condition• Prescription treatment usually includes an

antibiotic/steriod combination such as:

- Neomycin- Polymyxin- Hydrocortisone ( Cortisporin Otic)- Ofloxacin ( Inoflox Otic)- Ciprofloxacin/hydrocortisone- Acetic acid and Hydrocortisone

4. Boils• Furuncles

• Are infected hair follicles in the ear canal that usually involve the organism Staphyloccocus aureus.

• This condition is usally self-limiting and is best treated by the application of warm compress.

5. Otitis media (OM)• Is an infection of the middle ear.• There are four types :

- Myringitis- Acute otitis media (AOM)- Chronic supporative OM - OM with effusion

S. pneumoniae, Haemophilus influenzae and Moraxella catarrhalis- are the most frequent organism encountered for AOM

Symptoms- Pain in the ear- Fever- Fluid discharge from the ear - Decreased hearing

Treatment

- Oral antibiotics

Administration of Otic Preparation Inform / Counsel the patient to:

Shake the bottle well before using.

When using for the first time, pump the spray a few times until you obtain a fine spray/drops.

• When administering the ear drops, pull the earlobe up and back to straighten the canal for adults and down and back to straighten in children.

• Avoid touching the ear dropper tip to the ear; this prevent recontamination of the external ear.

• If using bulb syringe for ear irrigation, direct the solution up against the upper portion of the ear canal and not directly against tympanic membrane

• Spray directly into the affected ear(s) at fixed intervals as directed by the doctor.

• Tilt the head sideways with the affected ear upward when applying the drops.

• Do not use for a longer period of time than advised by your doctor. Always wash your hands after using the spray.

• If the patient stop using this for more than one week, inform him that he will need to pump the spray/drops again a few times until a fine spray/drops is obtained before you can use it.

• Spray the missed dose as soon as you remember. DO NOT double a dose to make up for a missed dose.

• Alert your doctor if your condition worsens or does not improve.

• Do not spray this into your nose. Ensure that this medicine does not enter your eyes.

• Do not share your otic drops or spray with anyone else, even if they seem to have the same problem as you have.

• Store in a cool, dry place away from the reach of children

• Throw this away one month after opening or when you have completed the required number of days of treatment as directed by the doctor.

Otic Medications

• Must be at room temperature or body temperature▫ heated drops may cause rupturing of the

eardrum▫ cold drops can cause vertigo and discomfort

• Old medication should be removed along with any drainage before applying fresh medication

• Alcohol causes pain and burning sensation ▫ should not be used if the patient has a ruptured

tympanic membrane (eardrum)

Otic Medications

• Tilt head to side with ear facing up▫ 2 to 5 minutes

• Cotton swabs placed in the ear after administration of drops will prevent excess medication from dripping out of the ear ▫ swabs will not reduce drug

absorption

Patients under 3 should have lobes pulled down and back.

Patients over 3 should should have lobes pulled up and back

Nasal Medications

• Applied by: ▫ drops (instillation)▫ sprays▫ aerosol (spray under pressure)

• Used for:▫ relief of nasal congestion or allergy symptoms▫ administration of flu vaccine

Nasal Medications

• Patient should:▫ tilt head back▫ insert dropper or spray or aerosol tip into the

nostril pointed toward the eyes▫ apply prescribed number of drops or sprays in

each nostril• Breathing should be through mouth to

avoid sniffing medication into the sinuses • Important not to overuse nasal

decongestants ▫ follow label instructions carefully

Opthalmic Preparation

Common Eye Disorder

• 1. Condition affecting the eyelid

--- include irritation, inflammation, and infections

• A. Stye --- a localized, purulent, inflammatory infection of one or more sebaceous glands of the eyelid.

Symptoms: pain, tenderness , redness , and swelling.

It cannot be treated with OTC medications. Some patients may require treatment with an antibiotic.

Hot compress applied four times a day are helpful.

• B. Inflammation of the eyelid (blepharitis)

--- can be detected by redness of the lids and burning, tiching, and scaly skin.

--- underlying problem (e.g. Seborrheic dermatitis, S. Aureus) should be treated, which often requires antibiotic.

C. Black Eyes

--- may be treated with cold compress for the first 24 hours, then with warm compress. Damage to the eyelid itself should be reffered to a physician.

• 2. External ocular disorder

--- include chemical burns, conjuctivitis, and lacrimal sysytem disorders.

a. Chemical burns --- should not be self-treated with OTC products. Patients should be referred to a physician immediately.

b. Conjuctivitis --- is caused either by virus ( most common), allergies,bacteria, or chlamydia.

--- symptoms : redness, itching,discharge

(1) Viral conjunctivitis

–-- “pink eye” is a contagious form. Treatment is aimed at symptom relief. Artifical tears and topical decongestant can be used. Patients should be counseled to wash hands thoroughly, to share towels with others and to dispose of tissues properly.

(2) Allergic conjunctivitis

--- commonly caused by animal dandler, pollen , or topical eye preparations. Itching is considered the hallmark of this form of conjunctivitis. Removal and avoidance of the offending sunstances is recommended. However, cold compress, oral or topical antihistamines or decongestants may be used.

(3) Bacterial and Chlamydial conjuctivitis

---- require treatment with prescription antibiotic

d. Dacryoadenitis

--- swelling of the lacrimal gland--- should be referred to a physician.--- symptoms include red, burning eyes and the

sensation of a foreign body in the eye.

e. Insufficient tearing

--- can be side effect of many medications, especially those with anticholinergic activity. Treatment for dry eyes should include an evaluation of the current medications and use of artificial tears. A chronic condition where insufficient tearing occurs is generally successfully treated with artificial tear products. The use of pilocarpine is also used when artificial tears are ineffective .

•3. Internal ocular disorder--- glaucoma--- cataracts--- uveitis

These internal ailments should be diagnosed and treated by a physician.

Opthalmic products

1. Antioxidants and stabilizers--- are used to delay or prevent deterioration of the drug.--- ex. Edetic acid

sodium bisulfitesodium metabisulfitesodium thiosulfatethiourea

2. Buffers --- are designed to keep products within the appropriate pH range, which is 6.0-8.0 (tears are 7.4)

Buffers include: acetic acidboric acidhydrochloric acidphosphoric acidpotassium bicarbonatepotassium boratepotassium citrate

Potassium phosphatesPotassium tetraborateSodium acetateSodium bicarbonateSodium biphosphateSodium borateSodium carbonateSodium citrateSodium hydroxideSodium phosphate

3. Clarifying or wetting agents

Reduce tension of the lens

Ex. Polysorbate 20 Polysorbate 80 Poloxamer 282 Tyloxapol

4. Preservatives-- destroy or inhibit the development of

microorganism.Ex. Benzalkonium chloride benzethonium chloride

5. Tonicity adjusters--- dextrose glycerine (1%)

potassium chloride propylene gylcol (1%) sodium chloride

• Agents considered to be isotonic should equal 0.9%-60.2% sodium chloride. When applied to the eye, these agents pull water from the middle of the cornea. Nonisotonic agents used in the eye may produce excessive blinking or cause damage cornea.

• 6. Viscosity-increasing agents--- are used to increase the retention time for

opthalmic medications.

Ex. Cellulose derivatives Dextran 70

Gelatin (0.01%) Liquid polyols

Medicinal agents• There are no FDA-approved anti-infective products for

OTC opthalmic use. The following compounds are medicinal agents used fo opthalmic therapy.

• 1. Astringents.

-- The only FDA-approved astringent is zinc sulfate (0.25%). This agent is relatively mild but still provides some relief from eye irritation because it decreases inflammation. The recommended dose is 1-2 drops four times a day

(Oculosan) zinc sulfate 200mcg + naphazoline nitrate 50mcg.

• 2. Demulcents -- are relatively free from side effects and are used to

protect and lubricate the eye from dryness and irritation from sun exposure. It includes:- carboxymethylcellulose sodium (Cellufresh)- dextran 70 (tears naturale II)- gelatin- glycerin- hydroxyethyl cellulose- hydroxypropyl methylcellulose (tears naturale)- methylcellulose- polyethylene glycol 300- polyethylene glycol 400- polysorbate 80- polyvinyl alcohol- povidone- propylene glycol ( systane)

• 3. Decongestants and Vasoconstictors

Mechanism of action.-- these agents work by producing a temporary

constriction of the blood vessels located in the conjunctiva.

Products:- naphazoline hydrochloride (Optazoline)- phenylephrine hydrochloride (Mydfrin)- tetrahydrozoline hydrochloride (visine)- oxymetazoline hydrochloride

Combination decongestant and antihistamine products include:

- Naphazoline Plus solution, - Naphcon-A, Opcon-A.

Rebound congestion --- can occur with a long duration of use.

Contraindication--- the available OTC agents are useful in

relieving eye redness and irriration and are contraindicated in anlge-close glaucoma patients.

4. Hypertonic agents ( sodium chloride 2%-5%) are used for the relief of corneal swelling. Although they are available as nonprescription products, these products should be used under the supervision of a physician beacuse of their concentration.

•5. Artificial tears (combination of hypertonic agent, buffer,

viscosity agent, and preservative)--- are used to lubricate the eye for relief of

dry eyes or irritation. Preservative-free (PF) products are also available for single or unit dose use.

E. Home remedies--- should be avoided. --- These homemade remedies have not been

proven safe or effective. There are also risk due to nonsterilization of placing these products into one’s eye.

General patient information

• 1. Patients should be counselled regarding administration of individual products. They also should be told to wash hands thoroughly before applying these products.

• 2. If a patient presents with a headache or vision abnormalities, has had symptoms persisting for more than 3 days, or if recommended OTC products has not abated symptoms during this time. A physician should be contacted. In general OTC opthalmic products should not be used for more than 3 days without physician supervision.

• 3. Proper administration technique is important when using these agents. The tip of the container should never come in contact with the eye itself. Suspensions should be shaken before being administered. Any agent that has changed color should be discarded immediately.

• 4. Systemic absorption may occur; therefore, patients should be instructed to compress the lacrimal sac for 1-2 min during and following instillation of drops.

• 5. If more than one opthalmic product is being used, an interval of at least 5 minutes should be allowed before administering the next product.

• 6. Opthalmic ointments may blur vision during waking hours. Use with caution in conditions where visual clarity is critical.

Ophthalmic Medications

• Must be at room temperature or body temperature before application

• Should be stored according to package information ▫ reduces bacterial growth▫ ensures stability

• Considered sterile products▫ only preparations with preservatives can be

repeatedly used

Ophthalmic Medications

• Unused medication should be discarded 30 days after the container is opened.

• Manufacturer expirations do not apply once a patient has opened the medication.

Ophthalmic Medications

• Before application, patient should wash hands ▫ prevents contamination of application site

• Tube or dropper should not touch the application site▫ medication may become contaminated

• Only sterile ophthalmic solutions or suspensions should be used in the eye▫ not preparations intended for other uses (e.g., otic)

• Some products are unit of use▫ to be used for one administration only and then

discarded

Ophthalmic Medications

Ear drops can never be used in the eye, but eye drops can be used in the ear.

Ophthalmic Medications

• Previously applied medications should be cleaned away▫ also any drainage from the eye

• Intended location is the conjunctiva • Poorly administered eye drops could result

in loss of medication through the tear duct• Poorly placed ointments may be

distributed over the eyelids and lashes

Ophthalmic Medications

• Patient’s head should be tilted back• After administration, the patient should

place a finger in the corner of the eye, next to the nose to close the lacrimal gently ▫ prevents loss of medication through tear duct

• Patient should also keep the eyes closed for 1or 2 minutes after application

Ophthalmic Medications

• When multiple drops of more than one medication are to be administered, the patient should wait 5 minutes between different medications▫ the first drop may be washed away

• If an ointment and a drop are used together, the drop is used first ▫ wait 10 minutes before applying the ointment

Ophthalmic Medications

• Ointments are generally applied at night▫ drug form of choice when extended contact with

the medication is desired▫ remind patient that some temporary blurring of

vision may occur after application