throbber
Blunt Trauma Drama, p. 114
`
`Part 1 of 2
`
`www.revoptom.com
`
`~0~~ ~li MLW~
`
`When to Call a
`Compounding Pharmacist, p. 30
`
`/
`
`ALSO INSIDE:
`consider Ortho-K for Myopia Control, p. 38
`
`181h ANNUAL GLAUCOMJI. REPORT
`
`New Thoughts on the Newly Diagnosed
`Glaucoma Patient, p. 53
`
`Earn 2 CE Credits:
`Optic Neuropathies: Glaucomatous vs.
`Non-glaucomatous, p. 58
`
`PROPERTY OF THE
`NATIONAL
`LIBRARY OF
`MEDICINE
`
`This material wasm,pcied
`at the t~ LM and may Ire
`~uhjen US Copyright Laws
`
`APOTEX 1046, pg. 1
`
`

`


`
`.
`
`.
`
`.
`
`IX ..
`
`When to Call a Compounding Pharmacist
`Most medications that we require are readily available. But when they aren't, it's time
`to get creative. By Jill C. Autry, R.Ph., D.O.
`
`i he roots of medicinal com(cid:173)
`
`pounding trace back to
`antiquity. In that era, copper
`compounds were concocted
`to treat headaches and a mixture of
`diluted snake venom was applied
`topically to stop bleeding.
`The mixing and making of
`medications evolved from the first
`"healer," who compounded plant(cid:173)
`based and herbal remedies around
`4,000 B.C., to the multitasking
`professional we know today as
`a pharmacist. In fact, until mass
`drug manufacturing became com(cid:173)
`monplace in the 1950s, the neigh(cid:173)
`borhood pharmacist mixed and
`molded almost all prescriptions
`made in the United States.
`Today, although the need for
`compounding is far less common,
`there arc still several situations
`when a compounded product may
`be your preferred choice. What do
`they offer that off-the-shelf prod(cid:173)
`ucts lack? At least four worthwhile
`variations:
`• Different strength. The most
`common need for a compounded
`drug: The prescribed agent is not
`manufactured in a strength deemed
`necessary for the patient's concli(cid:173)
`tion, so the doctor needs a higher
`or lower concentration than what
`
`The neighborhood pharmacist of the 1950s mixed and molded almost all prescriptions.
`Today, we still need compounded drugs when manufactured ones won't do.
`
`can be found in stock. For example,
`a terminally ill patient may need
`a medication delivered at half the
`typically prescribed strength, or a
`psoriasis patient may need a cream
`that is twice as strong as those
`made commercially. In such cases,
`the compounding pharmacist can
`purchase the raw materials and
`make the medication to match the
`needs of the patient.
`• Different fonn. Another cause
`
`for calling upon a compounding
`pharmacist is when the prescribed
`medication does not come in the
`dosage form needed by the patient.
`This is common when making adult
`medications into suspensions for
`children or for a cancer patient
`who ca~not swallow a pill or cap(cid:173)
`sule. The mixing of oral and intra(cid:173)
`venous medications into alternate
`dosage forms is also co~mon in
`making ocular preparatwns, rectal
`
`30 REVIEW OF OPTOMETRY JULY 15, 2012
`
`This material was~a.pied
`at the N LM and may b-e
`5u bj.ect US Copyright Laws
`
`APOTEX 1046, pg. 2
`
`

`

`RESTASIS 0
`(cyclosporine ophthalmic emulsion) 0.05%
`Sterile, Preservative-Free
`INDICATIONS AND USAGE
`RESTASts·~ ophthalmic emulsion is indicated to increase tear production in patients whose tear
`production is presumed to be suppressed due to ocular mflammat1on assoc1ated Wlthkeratocon]unctlvltls
`sicca. Increased tear production was not seen 1n pat1ents currently takmg top1cal antunflammatory drugs
`or using puncta! plugs.
`CONTRAINDICATIONS
`RESTASIS" is contraindicated in patients with active ocular infections and in patients with known or
`suspected hypersensitivity to any of the ingredients in the formulation.
`WARNING
`RESTASIS 0 ophthalmic emulsion has not been studied in patients with a history of herpes keratitis.
`PRECAUTIONS
`General: For ophthalmic use only.
`Information for Patients
`The emulsion from one individual single-use vial is to be used immediately after opening for administration
`to one or both eyes, and the remaining contents should be discarded immediately after administration.
`Do not allow the tip of the vial to touch the eye or any surtace, as this may contaminate the emulsion.
`RESTASIS'~ should not be administered while wearing contact lenses. Patients with decreased
`tear production typically should not wear contact lenses. If contact lenses are worn, they should be
`removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following
`administration of RESTASIS~ ophthalmic emulsion.
`Carcinogenesis, Mutagenesis, and Impairment of Fertility
`Systemic carcinogenicity studies were carried out in male and female mice and rats .. In the 78-week oral
`(diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, ev1dence of a stat1st1cally s1gn1f1cant trend was
`found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose
`males significantly exceeded the control value.
`In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas
`significantly exceeded the control rate in the low dose level. The hepatocellular carcinomas and pancreatic
`islet cell adenomas were not dose related. The low doses m m1ce and rats are approximately 1000 and
`500 times greater, respectively, than the daily human dose of one drop (28 ~L of 0.05% RESTASIS" BID
`into each eye of a 60 kg person (0.001 mg/kg/day), assummg that the ent1re dose 1s absorbed.
`Cyclosporine has not been found mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the
`micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster
`bone-marrow the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. A
`study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes
`in vitro gave indication of a positive effect (i.e., induction of SCE).
`No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of
`cyclosporine up to 15 mg/kg/day (approximately 15,000 t1mes the human dally dose of 0.001 mg/kg/day)
`for 9 weeks (male) and 2 weeks (female) prior to mating.
`Pregnancy· Teratogenic Effects
`Pregnancy category C.
`Teratogenic Effects: No evidence of teratogenicity was observed in rats or rabbits receiving oral
`doses of cyclosporine up to 300 mg/kg/day during organogenesis. These doses in rats and rabbits are
`approximately 300,000 times greater than the daily human dose of one drop (28 ~L)0.05% RESTAStsw
`BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed.
`Non-Teratogenic Effects: Adverse effects were seen in reproduction studies in rats and rabbits only at dose
`levels toxic to dams. Attoxic doses (rats at 30 mg/kg/day and rabbits at1 00 mg/kg/day), cyclosporine oral
`solution, USP, was embryo· and fetotoxic as indicated by 1ncreased pre· and postnatal mortality and reduced
`fetal weight together with related skeletal retardations. These doses are 30,000 and 100,000 times greater,
`respectively than the daily human dose of one drop(28 ~L)of 0.05% RESTASIS' BID into each eye of a
`60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal
`toxicity was observed in rats or rabbits receiving cyclosporine at oral doses up to17mg/kg/day or 30 mg/
`kg/day, respectively, during organogenesis. These doses in rats and rabbits are approximately 17,000 and
`30,000 times greater, respectively, than the daily human dose.
`Offspring of rats receiving a 45 mg/kg/day oral dose of cyclosporine from Day 15 of pregnancy until
`Day 21 postpartum, a maternally toxic level, exhibited an increase in postnatal mortal1ty; this dose is
`45,000 times greater than the daily human topical dose, 0.001 mg/kg/day, assuming that the entire dose
`is absorbed. No adverse events were observed at oral doses up to 15 mg/kg/day (15,000 times greater than
`the daily human dose).
`There are no adequate and well-controlled studies of RESTASIS~ in pregnant women. RESTASIS 0 should
`be administered to a pregnant woman only if clearly needed.
`Nursing Mothers
`Cyclosporine is known to be excreted in human milk following systemic administration but excretion
`in human milk after topical treatment has not been investigated. Although blood concentrations are
`undetectable after topical administration of RESTASIS' ophthalmic emulsion, caution should be exercised
`wl1en RESTASIS'' is administered to a nursing woman.
`Pediatric Use
`The safety and efficacy of RESTASIS' ophthalmic emulsion have not been established in pediatric
`patients below the age of 16.
`Geriatric Use
`No overall difference in safely or effectiveness has been observed between elderly and younger patients.
`ADVERSE REACTIONS
`The most common adverse event following the use of RESTASIS'" was ocular burning (17%).
`Other events reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye
`pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
`Rx Only
`~.OALLERGAN
`Based on package insert 71876US14B Revised February 2010
`102010 Allergan,lnc., Irvine, CA 92612, U.S.A.
`''marks owned by Allergan, Inc. APC74CS12
`U.S. Patent 5,474 979
`Made in the u.s.A.
`
`This material wasuJ~ie<l
`at the NLM and m y bel!
`Subje<t USC<J~yri ht Laws
`
`or vaginal suppositories, topical creams and lotions,
`or oral rinses.
`• Different ingredients. Some instances require
`the compounding pharmacist to remove or change
`the manufactured formulation. Inactive ingredients,
`such as preservatives or buffers, may cause toxicity
`or allergy in susceptible individuals. In this case, the
`pharmacist uses the active ingredient in the dosage
`required but removes the offending agent from the
`preparation without altering the pharmacological pro(cid:173)
`file of the medication.
`• Different fonnulation. Some compounds are even
`formulated to ease administration or promote compli(cid:173)
`ance. This is an option when two or more medica(cid:173)
`tions are mixed together into a single dosage form.
`The most common of these combinations include
`dermatological preparations, which are usually pre(cid:173)
`scribed separately but are more effective when applied
`together.
`In ocular disease, many of the same reasons prompt
`an eye care practitioner to call the local compound(cid:173)
`ing pharmacist for help. This article reviews the most
`commonly compounded ophthalmic preparations for
`specific conditions, the appropriate designations for
`usc, and helpful hints forfinding the right pharmacist
`nearby to put it all together.
`
`Dry Eye
`In its mildest form, dry eye causes episodic symp(cid:173)
`toms of burning, tearing, foreign body sensation and
`intermittent blur. For these patients, artificial tears
`and/or environmental changes may be all they need
`to relieve their symptoms. For patients with moder(cid:173)
`ate dry eye, treatments such as Restasis (cyclosporine
`0.05%, Allergan), puncta! plugs, topical steroids and
`doxycycline are often added.
`When we exhaust these more conventional treat(cid:173)
`ments for a patient with moderate to severe dry eye,
`we can look to additional therapeutic options that
`need to be compounded:
`• Cyclosporine ophthalmic ointnzent. This oint(cid:173)
`ment, applied q.h.s. in severe dry eye patients, typi(cid:173)
`cally is used to supplement Restasis topical emulsion.
`It can be formulated as a 0.1% to 2% concentration.
`In severely damaged, low vision and/or phthisical
`eyes, the ointment may be substituted for the topi(cid:173)
`cal cyclosporine drop b.i.d. to q.i.d. for more contact
`time without the concern of associated blur.
`• Autologous senmz. This is used in severe aqueous(cid:173)
`deficient dry eye to provide patient-specific protein(cid:173)
`based protection to the ocular surface. Serum and
`
`APOTEX 1046, pg. 3
`
`

`

`normal tears have many of the
`same components, including vita(cid:173)
`min A, various growth factors and
`proteins (such as lactoferrin and
`lysoszyme). To create the serum,
`the patient must make three to four
`blood donations a year; most clini(cid:173)
`cians ask for a 20% diluted serum
`to be instilled q.i.d. or more. Inves(cid:173)
`tigators also have tested this treat(cid:173)
`ment for persistent corneal defects. 1
`• Albumin drops. Although
`not the preferred autologous
`serum-based derivative described
`above, albumin 5% artificial tears
`may be a suitable alternative tear
`supplement for several reasons.
`For one, it is easier to compound
`than autologous serum. Also, it
`avoids the need for the patient to
`make a blood donation. Last but
`not least, it's much cheaper than
`autologous serum.
`Albumin may improve the
`tear film by providing mucin-
`like protection as well as anti(cid:173)
`inflammatory action. Research
`on patients with Sjogren's syn(cid:173)
`drome found that albumin therapy
`inhibited the apoptotic enzyme cas(cid:173)
`pase-3, and improved fluorescein
`and rose bengal scores in just four
`weeks. 2 (However, it was not statis(cid:173)
`tically significant for tear break-up
`time or subjective symptoms.)
`• Trausdennal testosterone
`cream. Androgens play a role in
`dry eye through receptor activity in
`the lacrimal glands, the meibomian
`glands and the conjunctiva. Because
`androgen production decreases in
`older men and women as well as
`in autoimmune patients, clinicians
`are increasingly using topical, trans(cid:173)
`dermal testosterone in a vanishing
`cream as a treatment for refractive
`dry eye in these patient populations.
`Various clinicians recommend a
`3% to 5% concentration applied
`to the upper eyelids b.i.d. initially,
`then q.h.s. 3 Investigators also are
`
`testing compounded testosterone
`solution applied directly to the eye. 4
`• Preservative-free steroids.
`Many commercially available
`products for dry eye are available
`without preservatives, such as arti(cid:173)
`ficial tears and Restasis. Steroids
`are often an unavoidable part of
`our treatment regimen for dry eye,
`but unfortunately do not come in a
`preservative-free preparation.
`
`Would your patient like
`a preservative-free
`steroid? Call your
`compounding pharmacist.
`
`.•. .-····"
`
`Dexamethasone)
`Topical Solu~
`"*NOTF0~1i
`lot:05232012~
`GreenPark Co(l'l
`i
`
`For patients
`who cannot toler(cid:173)
`ate preservatives,
`or if preservative(cid:173)
`containing medica(cid:173)
`tions exacerbate
`their dry eye, the
`compounding phar-
`macist can make
`preservative-free
`products, such as
`1% methylpredniso-
`lone ophthalmic drops.
`When necessary, other chronic
`medications, such as glaucoma
`drops or allergy treatments, can
`also be prepared preservative-free
`through compounding.
`• Acetylcysteille solutioll. In
`various chronic ocular conditions(cid:173)
`most notably severe dry eye(cid:173)
`mucous filaments can form and
`attach to the cornea. This results
`in pain, foreign body sensation,
`photophobia and decreased vision.
`Initial treatment is to remove the
`filaments with forceps and, if neces(cid:173)
`sary, apply bandage contact lenses.
`Next, aggressively treat the under(cid:173)
`lying dry eye and consider an oph(cid:173)
`thalmic solution of acetylcysteine
`drops. Mucomyst (acetylcysteine,
`Bristol-Myers Squibb) is used in
`patients with pulmonary conditions
`
`to reduce excess bronchial mucus.
`The compounding pharmacist
`can convert it into a 5% or 10%
`ophthalmic solution, which can be
`helpful in treating and preventing
`recurrences when used q.i.d.
`
`Corneal Bacterial Keratitis
`Within the first year of practice,
`most eye-care practitioners will
`encounter a bacterial keratitis that
`is so large, so central or so vision
`threatening that normal empirical
`treatment with topical fluoroquino(cid:173)
`lones does not meet the standard of
`care. The majority of these corneal
`ulcers are contact-lens related and,
`although we tend to think Pseudo(cid:173)
`monas in these cases, they can be
`caused by either gram-positive or
`gram-negative organisms.
`In these cases, first culture the
`ulcer and then initiate fortified topi(cid:173)
`cal antibiotic therapy with one of
`the following:
`• Vancomycin 2Smg!ml. This
`covers a wide range of gram(cid:173)
`positive organisms, including
`methicillin-resistant Staphylococcus
`aureus (MRSA). It should be alter(cid:173)
`nated every half-hour or hour with
`a gram-negative medication, such
`as ceftazidime or tobramycin.
`• Cefazolin SOmghnl. Like
`vancomycin, this first-generation
`cephalosporin also covers a wide
`range of gram-positive organisms,
`but is not effective against MRSA.
`It is well tolerated and is a good
`choice for pregnant patients who
`need intense antibiotic therapy
`(because fluoroquinolones are
`contraindicated).
`• Tobramycin 14mg!ml.
`Although generally considered a
`medication that is active against
`gram-negative species, this amino(cid:173)
`glycoside also works well against
`gram-positive organisms. It is often
`paired with vancomycin or cefazo(cid:173)
`lin for comprehensive coverage.
`
`This material was ccpie<l
`atthe NLMand maybe
`~ubje<:t US Copyright Laws
`
`REVIEW OF OPTOMETRY JULY 15, 2012 33
`
`APOTEX 1046, pg. 4
`
`

`

`~'<i'c:>';,"\: ~;:,::; 11{
`
`Ophthalmic II•
`
`;,.,,,,'
`
`,.,~,
`
`>
`
`I ~~
`
`How io Find a Compounding Pharmacist
`Find a compounding pharmacist and develop a relationship before a unique case occurs so
`you'll be prepared if-or more likely when-the patient presents to your practice,
`So, how do you find one?
`• Ask your local dermatologist, oncologist or local retail pharmacist where they send
`compound prescriptions.
`• Check professional websites, such as those for the Professional Compounding Centers
`of America (www.pccaruom) or the International Academy of Compounding Pharmacists
`(www.iacprx.org), where you can enter your city/state/zip code to find a compounding
`pharmacist near you.
`• When you do locate one, don't forget to make sure the compounding pharmacist
`makes ocular preparations; many are willing to mix common creams, ointments and oral
`dosage forms, but may decline to make the more involved ophthalmic preparations, which
`must meet more stringent guidelines.
`
`Also, it is FDA Pregnancy Category
`B (no known risk to the fetus), so it
`can be compounded for the treat(cid:173)
`ment of severe corneal infections in
`pregnant patients.
`• Ceftazidime 50mglml. This
`third-generation cephalosporin
`is known for outstanding gram(cid:173)
`negative coverage. Like tobramycin,
`ceftazidime is paired with gram(cid:173)
`positive vancomycin or cefazolin
`and is alternated every 30 minutes to
`an hour for initial treatment.
`The aforementioned are just a few
`of the most common fortified antibi(cid:173)
`otics. Other choices include amika(cid:173)
`cin, gentamicin and ceftriaxone.
`
`Amoebic Keratitis
`Acanthamoeba, one of the more
`formidable causes of keratitis,
`often results in the need for cor(cid:173)
`neal transplantation. The infec(cid:173)
`tion is almost exclusive to contact
`lens wearers. Its diagnosis is often
`delayed because it can mimic bacte(cid:173)
`rial, fungal or, more commonly,
`herpetic keratitis. Keep in mind
`that the amoeba can be resistant
`to treatment. This is why therapy
`definitely requires a compounding
`pharmacist, because the current
`recommended preparations are
`not commercially available in the
`
`U.S. Often, treatment involves a
`combined approach, including the
`use of a biguanide (either poly(cid:173)
`hexamethylene biguanide 0.02%
`or chlorhexidine 0.02%) combined
`with a diamidine (either hexamidine
`0.1% or propamidine 0.1 %).5,6
`
`Band Keratopathy
`This ocular degeneration is char(cid:173)
`acterized by a 3 o'clock to 9 o'clock
`band deposition of calcium across
`the cornea. The calcium is found
`just under the epithelial surface,
`and tends to be concentrated in the
`intrapalpebral area due to increased
`tear tonicity and evaporation in this
`area. Band keratopathy can occur
`due to a variety of etiologies, but is
`most often seen in chronic inflam(cid:173)
`matory conditions, both systemic
`and ocular. The calcium band can
`cause visual acuity loss as well as
`chronic foreign body sensation,
`depending on its severity.
`Treatment involves an ophthal(cid:173)
`mic solution of ethylenediaminetet(cid:173)
`raacetic acid (EDT A), an effective
`treatment due to its chelating effect
`on calcium and other metal ions.?
`Therapy starts with first debriding
`the epithelium and then applying a
`2 'X, EDT A compounded solution
`to the cornea for three to five min-
`
`34 REVIEW OF OPTOMETRY JULY 15, 2012
`
`This materia I was ~o ~ied
`at the NLM and
`~uhje~t US Copyright Laws
`
`utes. Lastly, the calcium deposits
`are scraped away with a spatula
`and then a bandage contact lens
`is applied. Depending on severity,
`multiple applications and scrapings
`may be necessary over time to con(cid:173)
`trol the keratopathy.
`
`lntravitreal Injections
`Although intravitreal injections
`for macular degeneration are com(cid:173)
`monplace today, compounding
`pharmacists have been supplying
`various preparations of antibiotics
`and steroids for intraocular injec(cid:173)
`tion for years.
`Today, the off-label use of the
`anti-VEGF Avastin (bevacizumab,
`Genentech), a systemic cancer
`therapy reformulated for intra(cid:173)
`ocular use, is the most commonly
`compounded intravitreal prepara(cid:173)
`tion. It continues to be prescribed in
`lieu of the FDA-approved Lucentis
`(ranibizumab, Genentech) due to
`the extreme cost difference between
`the two products. (A single Lucen(cid:173)
`tis injection costs approximately
`$2,000 while a shot of Avastin is
`closer to $50.)
`A 2011 outbreak of endophthal(cid:173)
`mitis cases in Avastin-treated
`patients was traced to a single com(cid:173)
`pounding pharmacy; this serves as
`an object lesson on the importance
`of demanding strict adherence
`to sterility protocols from your
`compounding pharmacies. (See
`"Compounding Pharmacists Keep
`it Clean, " page 3 6.)
`A new entrant to the anti-VEGF
`market, Eylea (aflibercept, Regen(cid:173)
`eron Pharmaceuticals), offers com(cid:173)
`parable efficacy to Lucentis but
`with less frequent dosing, especially
`in the first year of therapy. Depend(cid:173)
`ing on its cost, Eylea's reduced
`treatment regimen and manufactur(cid:173)
`ing safeguards may temper enthusi(cid:173)
`asm for reformulated A vas tin used
`off-label.
`
`APOTEX 1046, pg. 5
`
`

`

`solution of 0.02% to 0.05% con(cid:173)
`centration and apply it directly to
`the surgical site for 20 seconds to
`five minutes, depending on the sur(cid:173)
`gical or clinical situation. 10
`11
`•
`
`Corneal Collagen Crosslinking
`Riboflavin (vitamin B2 ) 0.1%
`drops are compounded and used
`in conjunction with an application
`of UV -A light during a procedure
`known as corneal crosslinking.
`Although not yet FDA approved in
`the United States, this technique is
`now being used off-label in the U.S.
`and is used routinely in many other
`countries for the treatment of kera(cid:173)
`toconus, corneal ectasia and even
`some cases of bacterial keratitis.
`The riboflavin acts as a photo(cid:173)
`sensitizer that strengthens the colla(cid:173)
`gen fibers. It is applied topically five
`minutes before UV-A light exposure
`and every five minutes thereafter
`during the 30-minute ultraviolet
`light exposure. 12-14
`
`In-Office Compounding
`In-office dilutions are off-label
`and anecdotal. But that doesn't
`mean off-label is off limits.
`One of the more popular exam(cid:173)
`ples in eye care: diluting a sample
`bottle of brimonidinc with artificial
`tears for a quick red eye remedy.
`Practitioners who report success
`with this compound most often usc
`a ratio of two drops of brimonidine
`per 1 ml of artificial tears, using
`the mixture b.i.d. until the sample
`is empty. Any concentration of
`brimonidine will work; however,
`samples of Alphagan P (brimoni(cid:173)
`dine 0.1 %, Allergan) are the most
`common. Six drops are placed in
`a 3ml sample bottle of Allergan's
`Optive artificial tears (because the
`top easily pops on and off).
`Be aware that long-term use can
`result in rebound hyperemia, which
`is typical with alpha-agonists. Also,
`
`Compounding Pharmacists Keep it Clean
`Despite recent reports of tainted Avastin, be assured that problems with compounded
`medications are rare. Ophthalmic preparations must be made under sterile conditions fol(cid:173)
`lowing the U.S. Pharmacopeia Chapter 797 guidelines. Pharmacists and technicians must
`use aseptic techniques to preserve sterility when preparing these products and keep cur(cid:173)
`rent on the techniques they have learned.
`Further, the medications must be prepared in a clean room inside a laminar flow hood to
`avoid contaminants or bacteria, and then sterilized by using a micron filter or autoclave to
`ensure a quality product. The clean room and laminar flow hood must be tested regularly
`by an outside source for bacteria and endotoxins.
`
`Watch for the use of intravitreal
`injections to become even more
`commonplace in the future as they
`bypass topical administration con(cid:173)
`ccms, take compliance issues out of
`the hands of patients, and are direct
`to the intended target site.
`Currently, the usc of anti-VEGF
`treatments is increasing as both
`on-label and off-label indications
`expand beyond age-related macular
`degeneration. For chronic disease
`states, such as glaucoma or diabetic
`retinopathy, novel intravitrcal injec(cid:173)
`tions could someday replace and/
`or supplement current standard(cid:173)
`of-care ropica I medications or laser
`treatments. For instance, a brimo-
`
`nidine inrravitreal implant is now
`in two Phase II studies-one for
`glaucomatous optic neuropathy and
`one for the treatment of geographic
`atrophy due to AMD.x.'J
`
`Antifibrosis
`Mitomycin-C is an antitumor
`antibiotic used in cancer chemo(cid:173)
`therapy. It is also commonly
`employed in various ophthalmo(cid:173)
`logical surgical procedures-such as
`pterygium removal, trabeculcctomy
`and photorefractive keratectomy(cid:173)
`to prevent vascularization, scar for(cid:173)
`mation and haze.
`Most physicians ask a com(cid:173)
`pounding pharmacist to make a
`
`36 REVIEW OF OPTOMETRY .JIJL'f J:,, ?0 12
`
`This materia I was copied
`at the N LM and may tie
`5u bje~t US Cop~Tight Laws
`
`APOTEX 1046, pg. 6
`
`

`

`don't use it on post-LAS II( patients because it might
`cause slippage of the flap. 15
`Another in-office dilution: adding 1 0 to 20 drops of
`a topical anesthetic, such as proparacaine, to a sample
`bottle of artificial tears. This very weak amount of
`anesthetic is useful following refractive surgery, such
`as PRK, in order to provide pain relief for 24 to 48
`hours. 16 Take note that this dilution should never be
`used for pathologic pain, such as infectious keratitis
`or corneal abrasions associated with contact lens wear
`or of unknown etiology.
`
`In short, don't neglect to offer unconventional
`pharmaceutical options. These tips should make pre(cid:173)
`scribing a compounded ophthalmic preparation a suc(cid:173)
`cessful venture for both you and your patient. As we
`know, one size does not fit all. a
`Dr. Autry fJractices in a referral center in Hous(cid:173)
`ton. She 1naintains a phannacist license, and lectures
`extensively 011 pharnzaceutical and ocular disease
`tofJics. She thanks co1npozmding pharmacists Ken
`Hughes, R.Ph., in Bellaire, Texas, and Tim Clark,
`R.Ph., in Southern Pines, N.C., for their assistance
`with this article.
`
`1. Poon AC, Geerling G, Dart JK, el al. Autologous serum eyedrops for dry eyes and epithe(cid:173)
`lial defects: clinical and in vHro toxicity studies. Br J Oplilhalmol. 2001 Oct;85(10):1188-97.
`2. Shimmura S, Ueno R, Matsumoto Y, el al. Albumin as a tear supplement inll1e treatment
`of severe dry eye. Br J Ophthalmol. 2003 Oc!;87(10):1279-83.
`3. Connor CG. Treatment of dry eye wi!l1 a lransdermal 3% testosterone cream. Invest Oph(cid:173)
`!lmlmol Vis Sci. 2004;45: E-Abstracl3899.
`4. Clinicallrials.gov. A single-center, double-masked, randomized, vehicle controlled study
`to evaluate the safely and efficacy of testosterone 0.03% ophthalmic solution compared to
`vel1icle for the treatment of meibomian gland dysfunction. Bethesda, MD: National Library
`of Med1cine. Available at: hllpli\:linicaltrials govlcl2/show/NCT00755183 (accessed June
`18, 2012).
`5. Kumar R, Lloyd D. Recent advances in the treatment of Acant11amocba keratitis. Clinlnfcct
`Dis. 2002 Aug 15;35(4)434-41.
`6. Seal DV. Acan!lmmoeba keratitis update-incidence, molecular epidemiology and new
`drugs for treatment. Eye (Land). 2003 Nov;17(8):893-905.
`7. Najjar DM, Cohen EJ, Rapuano CJ, Laibson PR. EDTA chelation for calcific band kera(cid:173)
`topatlly: results and long-term follow-up. Am J Ophthalmol. 2004 Jun;137(6):105G-G4.
`8. Clinicallrials.gov. Safely and efficacy of brimonidine intravilreal implant in patients with
`geographic atrophy due to age-related macular degeneration (AMD). Bethesda, MD: National
`Library of Medicine. Available at htlp'//clinicaltriols aov/ci?(Show/NCT00658619 (accessed
`June 13, 2012)
`9. Clinicallrials.gov. Safety and effects of brimonidine intravilreal implant in patients with
`glaucomatous optic neuropathy. Bct11esda, MD: National Library of Medicine. Available at:
`http Uctinical!rials.govlct2/show/study/NCT0069348~. (accessed June 13, 2012).
`10. Hast10mi H, Tal1eri SM, Fotouhi A, Klleiltasli A. Evaluation of !l1e propliylactic use of
`milornycin-C to inliibilllaze formation after ptwtorefraclive keratectomy in l1igli myopia: a
`prospective clinical study. BMC Ophlhalmol. 2004 Sop 14;4:12.
`11. Bindlish R, Condon GP, Schlosser JD, et at. Eflicacy and safety of mitomycin-C in pri(cid:173)
`mary trabeculectomy: five-year follow-up. Opli!IJalmology. 2002 Jut; 109(7):1336-41.
`12. Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet A induced collagen crosslinking
`for the treatment of keratoconus. Am J Opli!llalrnol. 2003 May;135(5):620-7.
`13. Spoerl E, Mrochen M, Sliney D. et al. Safely of UVA riboflavin cross-linking of the cor(cid:173)
`nea. Cornea. 2007 May;26(4):385-9.
`14. lseli HP, Thiel MA, Hafezi F, et at. Ultraviolet A/riboflavin corneal cross-linking for infec(cid:173)
`tious keratitis associated will! corneal melts. Cornea. 2008 Jun;27(5):590-4.
`15. Munoz G, Albarran-Diego C, Sakla HF, Javaloy J Increased risk for flap dislocation with
`perioperalive brirnonidine use in femtosecond laser in situ keratomileusis. J Cataract Refract
`Surg 2009 Aug;35(8):1338-42.
`16. Be!11ke W. Secrets to beller surface procedures. Rev Opli!llalmol. 2011 Jut; 18(7):64-6.
`
`APOTEX 1046, pg. 7
`
`

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