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`LOTEMAXTM
`
`loteprednol etabonate
`ophthalmic suSpension, 0.5%
`STEREE OPHTHALMC SUSPENSION
`
`DESCRIPTION:
`
`LOTEMAXT" (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-
`inflammatory corticosteroid for ophthalmic use. Loteprednol etabonateis a white to off-white
`powder
`
`Loteprednol etabonate is represented by the following structural formula:
`
`oeuzet
`O
`
`Cal-[3,001
`
`Mol. Wt. 466.96
`
`Chemical name: chloromethyl l7a-[(ethoxycarbonyl)oxy]-l lB-hydroxy-3-oxoandrosta-1,4-
`diene-l7flocarboxylate
`
`Each mL contains: ACTIVE: Loteprednol Embonate 5 mg (0.5%);
`INAC'ITVES: Edetate Disodiurn, Glycerin, Povidone, Purified Water and Tyloxapol.
`Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.36.6. The
`suspension is essentially isotonic with a tonicin of 250 to 310 mOsmol/kg.
`PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
`
`CLINICAL PHARMACOLOGY:
`
`Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably
`delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte
`migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar
`formation associated with inflammation. There is no generally accepted explanation for the
`mechanism of action of ocular corticosteroids. However, corticosteroids are thought to
`act by the induction of phospholipase A, inhibitory proteins, collectively called lipocortins. It is
`postulated that these proteins control the biosynthesis of potent mediators of inflammation such
`as prostaglandins and leukotrienes by inhibiting the release of their common precursor
`arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase
`A1. Corticosteroids are capable of producing a rise in intraocular pressure.
`
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`Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20
`position ketone group is absent
`It is highly lipid soluble which enhances its penetration into
`cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-
`related compatmds so that it will undergo a predictable transformation to an inactive metabolite.
`Based upon in vivo and in virra preclinical metabolimt studies, loteprednol etabonate undergoes
`extensive metabolism to inactive carboxylic acid metabolites.
`
`'
`
`Results from a bioavailability study in normal volunteers established that plasma levels of
`loteprednol etabonate and A‘ cortienic acid etabonate (PI 91), its primary, inactive metabolite,
`were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained
`following the ocular administration of one droptn each eye of 0.5% loteprednol etabonate 8
`times daily for 2 days or 4 times daily for 42 days. This study suggests that limited
`(<1 ng/ml) systemic absorption occurs with LOTEMAX.
`‘
`
`Clinical Studies:
`
`flogtgpgrwe Inflammation: Placebo-controlled clinical studies demonsu’ated that LOTEMAX
`is efi‘ective for the treatment of anterior chamber inflammation as measured by cell and flare.
`
`M Controlled clinical studies of patients with uveitis demonstrated that LOTEMAX was
`less efi'ectivethan prednisolone acetate 1%. Overall, 72% of patients treated with LOTEMAX
`experienced resolution of anterior chamber cell by day 28, compared to 87% of patients treated
`with 1% prednisolone acetate. The incidence ofpatients with clinically significantincreases in
`101’ (210 mmHg) was 1% with LOTEMAX and 6% with 1% prednisolone acetate
`
`Giant Emilia! qu'flcrivitg': Placebo—controlled clinical studies demonstrated that LO'I'EMAX
`was effective in reducing the signs and symptoms of giant papillary conjunctivitis after 1 week of
`treatment and continuing for up to 6 weeks while on nutment.
`
`gamma! Allergic Coniunaivitig; A placebo-controlled clinical study demonstrated that
`LOTEMAX was efi‘ective in reducing the signs and symptoms of allergic conjunctivitis during
`peak periods of pollen exposure.
`
`INDICATIONS AND USAGE:
`
`LOTEMAX is indicated for the treatment of steroid responsive inflammatory conditions of the
`palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic
`conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis,
`selected infective conjunctivitides, when the inherent hand of steroid use is accepted to obtain
`an advisable diminution in edema and inflammation
`
`LOTEMAX is less efi'ective than prednisolone acetate 1% in two 28-day controlled clinical
`studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX experienced
`resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone
`
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`acetate 1%. The incidence of patients with clinically significant increases in IOP (2 10 mail-lg)
`was 1% with LO’I'EMAX and 6% withprednisolone acetate 1%. LOTEMAX should not be used
`in patients who require a more potent corticosteroid for this indication.
`
`LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular
`mrgery.
`
`.
`CONTRAINDICATIONS:
`LOTEMAX, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of
`the cornea and conjtmctiva including epithelial herpes simplex keratitis (dendritic keratitis),
`vaeeinia, and varicella, and also in mycobacterial infection ofthe eye and fungal diseases of
`ocular su'ucunes. LOTEMAX is also contraindicated in individuals with known or suspected
`hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
`
`WARNINGS:
`
`Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects
`in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids
`should be used with caution in the presence of glaucoma.
`
`Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of
`secondary ocular infections. In those diseases causing'thinning of the cornea or sclera,
`perforationshave been known to occur with the use of topical steroids. In acute pmulent
`conditions of the eye, steroids may mask infection or enhance existing infection.
`
`Use of ocular steroids may prolong the course and may exacerbate the severity of many viral
`infections of the eye (including herpes simplex). Employment of a corticosteroid medicationin
`the treatment of patients with a history of herpes simplex requires great caution.
`
`The use of steroids after cataract surgery may delay healing and increase the incidence of hleb
`formation.
`
`PRECAUTIONS:
`
`General: For ophthalmic use only. The initial prescription and renewal of the medication order
`beyond 14 days should be made by a physician only after examination of the patient with the aid
`ofmagnification, such as slit lamp biomicroseopy and, where appropriate, fluoreseein staining
`If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
`
`Ifthis product is med for 10 days or longer, intraocular pressure should be monitored even
`though it may be dificult in children and uncooperative patients (see WARNINGS).
`
`Fungal infections of the cornea are particularly prone to develop coincidentally with long-term
`local steroid application. Fungus invasion must be considered in any persistent corneal
`ulceration where a steroid has been used or is in use. Fungal cultures should be taken when
`appropriate.
`
`mum 14\LOTEM.AX\299pi29I.doc
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`Information for Patients: Patients should be advised not to allow the dropper tip to touch any
`sm‘face, as this may contaminate the suspension. lfpain develops, redness, itching or
`inflammation bwomes aggravated, the patient should be advised to consult a physician As with
`all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to
`wear sofi contact lenses when using LOTEMAX'“.
`
`Carcinogenesis, mutagenesis, impairment of fertility: Long-term animal studies have not been
`conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate
`was not genotoxic in the Ames test, the mouse lymphoma tk assay, or in a chromosome
`aberration test in human lymphocytes, three in vitro tests. In vivo evidence of genotoxicity, an
`increased frequency of micronucleated immature erythrocytes, was not observed in mice that
`received a single 4 gm/kg dose of loteprednol etabonate (50,000 times the maximum daily
`clinical dose). Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of
`loteprednol ctabonate, respectively, (600 and 300 times the maximum clinical dose, respectively)
`prior to and during mating did not impair fertility in either gender.
`
`Pregnancy: Tetatogenic efi‘ects: Pregnancy Category C. Loteprednol etabonate has been shown
`to be embryotoxic (delayed ossification) and tnatogenic (increased incidence of meningocele,
`abnormal lefi common carotid artery, and limb flexures) when administered orally to rabbits
`during organogenesis at a dose of 3 mg/kyday (35 times the maximum daily clinical dose), a
`dose which caused no maternal toxicity; the no-observed-effect-lcvel (NOEL) for these effects
`was 0.5 mgilrg/day (6 times the maximum daily clinical dose). Oral treatment ofrats during
`organogenesis with 50 or_ 100 mg/kyday (600 and 1,200 times the maximum clinical dose)
`resulted in embryotoxicity (increased post-implantation losses with 100 mg/kg/day, and
`decreased fetal body weight and skeletal ossification with 50 and 100 myltg/day); doses of 5 (60
`times the maximum daily clinical dose), 50 and 100 mg/kg/day caused teiatogenicity (absent
`innominate artery at all doses, and cleft palate and umbilical hernia at 50 and 100 mg/kg/day).
`Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during
`munent) when administered to pregnant rats during organogenesis at doses of 5 to 100
`mg/kg/day but not at 0.5 mg/kg/day. The NOELs for the embryotoxic and teratogenic efi'ects in
`rats were 5 mg/kg/day and 0.5 mg/kg/day (60 and 6 times the maximmn daily clinical dose) for
`embryotoxicity and teratogenicity, respectively.
`
`Oral exposure of pregnant rats to 5 and 50 mg/kyday of loteprednol etabonate during the fetal
`period, a maternally toxic treatment regimen (significantly decreased body weight gain), resulted
`in teratcgcnicity (umbilical herniation) and embryotoxicity (decreased fetal birth weight); the
`NOEL for these effects was 0.5 mg/kyday. Oral exposure of female rats to 50 mg/kg/day of
`loteprednol etabonatc from the start of the fetal period through the end of lactation, a maternally
`toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased
`growth and survival, and retarded development in the offspring during lactation; the NOEL for
`these effects was 5 mg/kg/day. Loteprednol etabonate had no efi’ect on the duration of gestation
`or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the
`fetal period.
`
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`Oral treatment of female rats with 25 mg/kg/day (300 times the maximum daily clinical dose)
`from prior to mating through parturition increased the duration of gestation.
`
`Nursing Mothers: It is not known whether topical ophthalmic administration of corticosteroids
`could result in sufficient systemic absorption to produce detectable quantities in human milk.
`Systemic steroids appear in human milk and could suppress growth, interfere with endogenous
`corticosteroid production, or cause other untoward efl'ects. Caution should be exercised when
`LOTEMAX is administered to a nursing woman.
`
`Pediatric Use: Safety and efi'ectiveness in pediatric patients have not been established.
`
`ADVERSE REACTIONS:
`
`-
`
`Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may
`be associated with optic nervedamage, visual acuity and field defects, posterior subcapsular
`cataract formation, secondary ocular infection from pathogens including herpes simjalex, and
`perforation ofthe globe where there is thinning ofthe cornea or sclcra.
`
`Ocular adverse reactiom occurring in 545% of patients treated with loteprednol etabonate
`ophthalmic suspension (0.2%-0.5%) in clinical studies included abnormal vision/blurring,
`burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching,
`injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients
`include conjunctivitis, corneal abnormalities, eyelid erytherna, keratoconjunctivitis, ocular
`irrimion/pain/discomfort, papillae, and uveitis. Some of these events were similar to the
`underlying ocular disease being studied.
`
`Non-ocular adverse reactions occurred in less than 15% of patients. These include headache,
`rhinitis and pharyngitis.
`
`In controlled, randomized studies of individuals treated for 28 days or longer with loteprednol
`etabonate, the incidence of significant elevation of intraocular pressure (2 10 mm Hg) was 2%
`(15/901) among patients receiving loteprednol etabonate, 7% (1 1/164) among patients receiving
`1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.
`
`DOSAGE AND ADMINISTRATION:
`SHAKE VIGOROUSLY BEFORE USING.
`
`W Apply one to two dmps of LOTEMAX into the
`conjunctiva! sac of the affected eye(s) four times daily. During the initial treatment within the
`firstweek, the dosing may be increased, up to 1 drop every hour, ifneoessary. Care should be
`taken not to discontinue therapy prematurely. If signs and symptoms fail to improve afier two
`days, the patient should be re-evaluated (See PRECAUTIONS).
`
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`Page 50f16
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`

`WApply one to two drops ofLOTEMAX into the conjunctiva! sac
`ofthe operated eye(s) four times daily beginning 24 hams afier surgery and continuing
`throughout the first 2 weeks of the postoperative period.
`
`.
`HOW SUPPLIED:
`LOTEMAX'" (loteprednol embonnte ophthalmic suspension) is supplied in a plastic bottle with
`a controlled drop tip in the following sizes:
`2.5 mL (NDC 24208-299-25) E A3299“
`5 mL (NDC 24208-299—05) - ABZ9907
`10 mL (NDC 24208-29940) - A329909
`15 mL (NDC 24208-29945) - ABZ9911
`
`DO NOT USE ll" NECKBAND IMPRINTED WITH “Protective Seal” and yellow (mortar
`and pestle graphic) IS NOT INTACI'.
`
`-
`
`Storage: Store upright between 15° - 25°C (59° - 77°F). DO NOT FREEZE.
`
`KEEP OUT OF REACH OF CHILDREN.
`
`Rx only
`
`Manufactured by:
`Bausch & Lomb Pharmaceuticals, Inc., Tampa. Florida 33637
`under Agreement with Pharmos Corporation.
`'
`US. Patent No. 4,996,335
`US. Patent No. 5,540,930
`O Bausch & Lamb Pharmaceuticals, Inc.
`
`X050317 (Folded)
`XMlOOS9 (Flat)
`Rev. 2/98-8B
`
`l H:\RA\71I4\LOTEMAX\299pi298.do¢
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`I Page 6 of16
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`DIMENSIONS: 3 1/8" x13/16"
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`' Page 11 of16
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`Page 11 of 16
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`Page 14 of 16
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`Page 14 of 16
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`'Page15of16
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`Page 15 of 16
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`~ Page 16' of 1.6,W-
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`Page 16 of 16
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