eview of o tometry
`5 149 no. £(July 15 2012)
`General Collection
`W1 CH739
`2012-08—22 09:13:12
`
`Blunt Trauma Drama, p. 114
`
`
`
`
`
`
`
`yxxwf
`
`
`
`www.revoptom.com
`
`
` MM. 1
`w
`
`When to Call a
`Compounding Pharmacrst p. 30
`
` PROPERTY OF THE
`
`MR NATIONAL
`
`mm LIBRARY or
`
`WEEK“. MEDICINE
`
`.
`
`ALSO INSIDE:
`
`Consider Ortho-Klor Myopia Control, p. 38
`
`18"‘ANNUALGLAUGUMAREPORT
`
`New Thoughts on the Newly Diagnosed
`Glaucoma Patient, p. 53
`
`k
`
`Earn 2 CE Credits:
`Optic Neuropathies: Glaucomatous vs.
`Non-glaucomatous, p. 58
`
`This mama-rial wastapiled
`acme NLM and may he
`Subjefl U5 Copy right Laws
`
`M331
`
`APOTEX 1046 pg. 1
`
`APOTEX 1046, pg. 1
`
`

`

`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`
`
`
`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, B.Ph., 0.0.
`
`
`
`
`
`‘llcl'lzl"Cl'fl"JUN(lll'35710k'd
`
`
`
`he roots of medicinal com-
`
`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-
`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-
`monplace in the 19503, the neigl -
`borhood pharmacist mixed and
`molded almost all prescriptions
`made in the United States.
`Today, although the need for
`compounding is far less common,
`there are still several situations
`when a compounded product may
`be your preferred choice. What do
`they offer that off—the—shelf prod-
`ucts lack? At least four worthwhile
`variations:
`
`0 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 concil-
`tion, so the doctor needs a higher
`or lower concentration than what
`
`The neighborhood pharmacist ol the 19505 mlxed 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
`
`for calling upon a compounding
`pharmacist is when the prescribed
`medication does not come in 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 form. Another cause
`
`dosage form needed by the patient.
`This is common when making adult
`medications into suspensions for
`children, or for a cancer patient
`who cannot swallow a pill or CEIP'
`sule. The mixing of oral and intra—
`venous medications into alternate
`dosage forms is also common in
`making ocular preparations, rectal
`
`30 REVIEW OF OPTOMETRY JULY li;. 2012
`
`Th is material was {carried
`at the N LM and may be
`Subject US Supyright Laws
`
`APOTEX 1046, pg. 2
`
`

`

`I
`RESTASIS'k
`gcyclosporine ophthalmic emulston) 0.05%
`terile, Preservative-Free
`I
`I
`I
`.
`INDICATIONS AND USAGE
`RESTASIS‘J" ophthalmic emulsion is Indicated to increase tear production in patients whoseItear
`production is presumed to be suppressed due to ocular inflammation associated WithIIkeratoconiunctiwtis
`sicca. Increased tear production was not seen in patients currently taking topical antiinflammatory drugs
`or using punctal plugs.
`I
`.
`I
`I
`.
`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
`II
`I
`I
`,
`RESTASIS‘D ophthalmic emulsion has not been studied in patents With a history of herpes keratitis.
`PRECAUTIONS
`General: For ophthalmic use only.
`.
`.
`,
`_
`_
`I
`I
`Information lorPatients
`Theemulsionlrom oneindividualsingle-usevialistobeusedimmediatelyafteropeningforadmiInistrIation
`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 surface, as this may contaminate the emulsion.
`RESTASIS’D should not be administered while wearing contact
`lenses. Patients with decreased
`tear production typically should not wear contact lenses.
`It contact lenses are worh,Ilhey shouldIbe
`removed prior to the administration of the emulsion, Lenses may be reinserted 15 minutes follovving
`administration of RESTASIS’3 ophthalmic emulsion.
`I
`Carcinogenesis, Mutagenesis, and Impairment oi Fertility
`Systemic carcinogenicity studies were carried out in male and female mice and raisin the 78-week oral
`Idiot) mouse study, at doses of 1, 4, and 16 mg/kg/day,IeVidence of a statistically Significant trend was
`ound for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose
`males signticantly exceeded the control value.
`In the 24-month oral édiet) rat study, conducted at0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas
`significantl exceede the control rate in the low dose level. The hepatoce lular carcinomas and pancreatic
`islet cell a enemas were not dose related. The low doses in mice and rats are approximately 1000 and
`500 times greater, respectively than the daily human dose of one drop (20 uL 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.
`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 theIDNA-repair test in sperm from treated mice. A
`study analyzing sister chromatid exchange (SCIE) induction by cyclosporine usrng human lymphocytes
`in vitro gave indication of a positive effect (to, induction of SUE).
`No impairment in fertility was demonstrated in studies in male and IemaleIrats receiving oral doses of
`cyclosporine up to 15 mg/kg/day (approximately 15,000 times the human daily dose oi 0.001 mg/kg/day
`for 9 weeks (male) and 2 weeks (female) prior to mating.
`Pregnancy-Teralogenic Effects
`Pregnancy category C.
`Teratogenli: Ellecis: No evidence of teratogenicity was observed in rats or Irabbits receiving ora
`doses of cyclosporine up to 300 mg/kg/day during orgarrogenesis, These doses in rats and rabbits are
`approximately 300,000 times greater than the daily human dose of one drop (28 uL)0,I05% RESTASIS”
`BID into each eye of a 60 kg person (0,001 mg/ltg/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. At toxic doses (rats at 30 mg/kg/day and rabbits at100 rng/kg/dayl, cyIclosporine ora
`solution, USP, was cmb o- and fetotoxlc as indicated by increased pre- and postnatal mortalityand reduced
`fetal weight together wit
`related skeletal retardations. These doses are 30,000 and 100,000 times greater,
`respectively than the daily human dose of one drop(28I uLlot 0.05% RESTASIS’” RID into each eye of a
`60 kg person (0,001 mg/ g/day), assumingIthat the entire dose is absorbed. No evrdence of embryofeta
`toxicity was observed in rats or rabbits receivrng cyclosporine at oral doses up toi7mg/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 cyclosperine from Day 15 of pregnancy unti
`Day 2f postpartum, a maternally toxic level, exhibited an increase in postnatal mortality; this dose is
`45,000 times greater than the daily human topical dose, 0.001 mg/kg/day, assuming that the entire dose
`isabsorbedtlo adverse events were observed at oral doses up to 15 mg/kg/day (15,000 times greaterthar
`the daily human dose)
`There are no adequate and well-controlled studies of RESTASIS‘” in pregnant women, RESTASISg shoult
`be administered to a pregnant women only it clearly needed,
`I
`I
`.
`I
`Nursing Mothers
`I
`Cyclosporino is known to be excreted in human milinollowing systemic administration but excretion
`in human milk alter topical
`treatment has not been investigated. Although blood concentrations are
`undetectable after topical administration of RESTASIS" ophthalmic emulsion, caution should be exercised
`when RESTASIS‘” is administered to a nursing woman.
`Pediatric Use
`The safety and elficacy of RESTASIS‘V ophthalmic emulsion have not been established in pediatric
`patients below the ago 0116.
`Geriatric Use
`No overall difference in safety or effectiveness has been observed between elderly and younger patients.
`ADVERSE REACTIONS
`.
`The most common adverse event following the use of RESTASIS‘u was ocular burning (t 7%),
`Other events reported in 1% to 5%I of patients included coniunctival hyperemia, discharge, epiphora, eye
`pain, loreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
`Rx Only
`{5;} ALLERGAN
`Based on package insert 71 B76USI4B Revised February 2010
`©2010 Allergen, nc., Irvine, CA 9261 2, U SA.
`Vmarks owned by Allergan, Inc. APC74CSlZ
`US. Patent 5,474,979
`Made in the USA.
`
`
`
`‘
`
` Ophthalmic
`
`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-
`file of the medication.
`
`0 Different formulation. Some compounds are even
`formulated to case administration or promote compli-
`ance. This is an option when two or more medica-
`tions are mixed together into a single dosage form.
`The most common of these combinations include
`
`dermatological preparations, which are usually pre-
`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-
`ing pharmacist for help. This article reviews the most
`commonly compounded ophthalmic preparations for
`specific conditions, the appropriate designations for
`use, and helpful hints forfinding the right pharmacist
`nearby to put it all together.
`
`Dry Eye
`In its mildcst form, dry eye causes episodic symp-
`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—
`ate dry eye, treatments such as Restasis (cyclosporine
`0.05%, Allergen), punctal plugs, topical steroids and
`doxycycline are often added.
`When we exhaust these more conventional treat-
`ments for a patient with moderate to severe dry eye,
`we can look to additional therapeutic options that
`need to be compounded:
`° Cyclosporine ophthalmic oinmrzent. This oint-
`ment, applied q.h.s. in severe dry eye patients, typi-
`cally is used to supplement Rcstasis 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—
`cal cyclosporinc drop b.i.d. to q.i.cl. for more contact
`time without the concern of associated blur.
`
`0 Autologous serum. This is used in severe aqueous—
`deficicnt dry eye to provide patient-specific protein-
`buscd protection to the ocular surface. Serum and
`
`This material was copied
`
`Subject US-Cc-pyri ht: Laws
`acme NList 5”Id mgr be
`
`APOTEX 1046. pg. 3
`
`APOTEX 1046, pg. 3
`
`

`

`normal tears have many of the
`same components, including vita-
`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-
`cians ask for a 20% diluted serum
`
`to be instilled q.i.d. or more. Inves—
`tigators also have tested this treat-
`ment for persistent corneal defects.l
`. Albumin drops. Although
`not the preferred autologous
`scrum—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 mncin—
`like protection as well as anti-
`inflammatory action. Research
`on patients with Sjogren’s syn-
`drome found that albumin therapy
`inhibited the apoptotic enzyme cas-
`pase-3, and improved fluorescein
`and rose bengal scores in just four
`weeks.Z (However, it was not statis-
`tically significant for tear break-up
`time or subjective symptoms.)
`- Trmzsdemml 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-
`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.“
`- Preservatiue—free steroids.
`Many commercially available
`products for dry eye are available
`without preservatives, such as arti-
`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.
`
`‘1‘:
`
`.
`
`LA..._ .
`E .
`
`‘
`
`.
`
`, Would your patientllke
`f
`a preservative-tree
`f
`steroid? Call your
`compounding pharmaclst.
`
`.1
`
`i.
`ilr
`
`"
`
`For patients
`who cannot toler-
`ate preservatives,
`I or if preservative-
`Dexamelhasqnel
`containing medica-
`Topical Soluu‘fi}
`tions exacerbate
`“NOT FOR jl'
`their dry eye the
`.
`L0t205232012€d
`d-
`’
`GifienPark com ;,
`compoun ing phar-
`.
`.
`,. mac1st can make
`j" 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.
`0 Acetylcysteine solution. In
`various chronic ocular conditions——
`most notably severe dry eye—
`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-
`sary, apply bandage contact lenses.
`Next, aggressively treat the under-
`lying dry eye and consider an oph-
`thalmic solution of acetylcysteine
`drops. Mucomyst (acctylcysteine,
`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—
`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-
`momzs 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-
`cal antibiotic therapy with one of
`the following:
`_
`° Vancomycin ZSIrzg/ml. This
`covers a wide range of gram—
`positive organisms, including
`methicillin-resistant Staphylococcus
`aureus (MRSA). It should be alter-
`nated every half-hour or hour with
`a gram-negative medication, such
`as ceftazidime or tobramycin.
`' Ccfazolin 50mg/ml. 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 Ming/ml.
`Although generally considered a
`medication that is active against
`gram-negative species, this amino-
`glycoside also works well against
`gram-positive organisms. It is often
`paired with vancomycin or cefazo-
`lin for comprehensive coverage.
`
`This material was copied
`at the N LM 5 rid may tre-
`Eu'bjeet Ugo-Copyright Laws
`
`REVIEW OF OPTOMETRY JULY 15, 2012 33
`
`APOTEX 1046. pg. 4
`
`
`
`
`
`APOTEX 1046, pg. 4
`
`

`

`OphthalmlCDrusr.
`
`.
`_
`How to 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?
`0 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.pccarx.com) or the international Academy at Compounding Pharmacists
`(wwwiacprxorg), 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
`13 (no known risk to the fetus), so it
`can be compounded for the treat~
`ment of severe corneal infections in
`pregnant patients.
`0 Ceftazidime 5Omg/ml. This
`third-generation cephalosporin
`is known for outstanding grain-
`negative COVerage. Like tobramycin,
`ceftazidime is paired with grain-
`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-
`otics. Other choices include amika-
`
`cin, gentamicin and ceftriaxone.
`
`Amoebic Keratitis
`Acrmlbamoebo, one of the more
`formidable causes of keratitis,
`often results in the need for cor-
`
`neal transplantation. The infec-
`tion is almost exclusive to contact
`lens wearers. Its diagnosis is often
`delayed because it can mimic bacte-
`rial, fungal or, more commonly,
`herpetic kcratitis. 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
`
`34 REVIEW OF OPTOMETRY JULY 'l5, 20l2
`
`U.S. Often, treatment involves a
`combined approach, including the
`use of a biguanide (either poly—
`hexamcthylene biguanide 0.02%
`or chlorhexidine 0.02%) combined
`with a diamidine (either hexamidine
`0.1% or propamidine 0.1%).‘36
`
`Band Keratopathy
`This ocular degeneration is char—
`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—
`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—
`mic solution of ethylenediaminetet—
`raacetic acid (EDTA), an effective
`treatment due to its chelating effect
`on calcium and other metal ions.7
`Therapy starts with first debriding
`the epithelium and then applying a
`2% EDTA compounded solution
`to the cornea for three to five min-
`
`Th is material was copies:
`at the NLM a riti may be
`Eula] sari: US E: wright 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-
`trol the keratopathy.
`
`Intravitreal Injections
`Although intravitreal injections
`for macular degeneration are com-
`monplace today, compounding
`pharmacists have been supplying
`various preparations of antibiotics
`and steroids for intraocular injec-
`tion for years.
`Today, the off-label use of the
`anti—VEGF Avastin (hevacizumab,
`Genentech), a systemic cancer
`therapy reformulated for intra-
`ocular use, is the most commonly
`compounded intravitreal prepara—
`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-
`tis injection costs approximately
`$2,000 while a shot of Avastin is
`closer to $50.)
`A 2011 outbreak of endophthal-
`mitis cases in Avastin—treated
`patients was traced to a single corn-
`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 36.)
`A new entrant to the anti-VEGF
`market, Eylca (aflibercept, Regen-
`eron Pharmaceuticals), offers com-
`parable efficacy to Lucentis but
`with less frequent dosing, especially
`in the first year of therapy. Depend-
`ing on its cost, Eylea’s reduced
`treatment regimen and manufactur-
`ing safeguards may temper enthusi-
`asm for reformulated Avastin used
`off-label.
`
`APOTEX 1046, pg. 5
`
`APOTEX 1046, pg. 5
`
`

`

`
`
`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-
`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—
`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-
`cerns, take compliance issues out of
`the hands of patients, and are direct
`to the intended target site.
`Currently, the use of anti—VEGF
`treatments is increasing as both
`on-Iabel and off—label indications
`
`expand beyond age-related macular
`degeneration. For chronic disease
`states, such as glaucoma or diabetic
`retinopathy, novel intravitreal injec-
`tions could someday replace and/
`or supplement current standard—
`of—care topical medications or laser
`treatments. For instance, a brimo-
`
`nidine intravitreal implant is now
`in two Phase II studies—one for
`
`glaucomatous optic neuropathy and
`one for the treatment of geographic
`atrophy due to AMD.”
`
`Antifibrosis
`
`Mitomycin—C is an antitumor
`antibiotic used in cancer chemo-
`
`therapy. It is also comnlonly
`employed in various ophthalmo-
`logical surgical procedures—such as
`pterygium removal, trabeculectomy
`and photorefractive keratectorny—
`to prevent vascularization, scar for-
`mation and haze.
`
`Most physicians ask a corn-
`pounding pharmacist to make a
`
`36 REVIEW OF OPTOMETRY .llllY If», POlZ
`
`\w-
`
`-
`
`Thismacerial was carried
`attl‘re NLM and may be
`Su biatt U5 {opy‘righti Laws
`
`solution of 0.02% to 0.05% con
`
`centration and apply it directly to
`the surgical site for 20 seconds to
`five minutes, depending on the sur—
`gical or clinical situation.'0~"
`
`Corneal Collagen Crosslinking
`Riboflavin (vitamin B1) 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-
`toconus, corneal ectasia and even
`some cases of bacterial keratitis.
`The riboflavin acts as a photo—
`sensitizer that strengthens the colla—
`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. '2'”
`
`ln-Office Compounding
`In-offiee dilutions are off-label
`and anecdotal. But that doesn’t
`mean off-label is off limits.
`
`One of the more popular exam—
`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 use
`a ratio of two drops of brimonicline
`per linl 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-
`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—agonisrs. Also,
`
`APOTEX 1046. pg. 6
`
`APOTEX 1046, pg. 6
`
`

`

`don’t use it on post-LASIK patients because it might
`cause slippage 0f the flap.”
`Another in-office dilution: adding '10 to 20 drops of
`a topical anesthetic, such as propaI-acaine, 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.“ 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-
`scribing a compounded ophthalmic preparation a suc~
`cessful venture for both you and your patient. As we
`know, one size does not fit all. El
`Dr. Autry practices in a referral center in Hons-
`ton. She maintains a pharmacist license, and lectures
`extensively on pharmaceutical and ocular disease
`topics. She than/es compounding pharmacists Ken
`Hughes, R.Ph., in Belltrire, Texas, and Tim Clerk,
`R.I’h., in Southern Pines, N. C., for their assistance
`with this article.
`
`
`
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`lial detects: cl nical and in vitro toxicity studies. BrJ Opllll‘almfll. 2001 Oct;85(10):1188<97,
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`5 KIImar R, LloydD RLeent advancesrnthelrcalment ot Acnttamocba kerantrs 01in Intcct
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`l. Toieri SM. Fotouhi A Klieiltosh A Evaluation 01 the prophylactic use 01
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`prospective cinicalsludy,BMCOphthalmol20048op1414:12.
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`mary trabccu ectaniy; five’year lollow—up. Ophthalmology. 2002 dul;lDEi(7):133674 t.
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`tor the treatment 01 kera oconus. AInJ Ophthalmol. 2003 May11351512620-7.
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`nea. Cornea, 2007 May;26(4):385~éi,
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`tious keralitis SSDUlalBL with corneal melts, Cornea. 2008 Jun;27(5):500A4.
`15, Munoz G, Albarran-Diego C. Sakla HF, JavaloyJ increased risk lor llac dislocation with
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`Surg. 2009 Aug:35(8):1338 42.
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`
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`APOTEX 1046. pg. 7
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`APOTEX 1046, pg. 7
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