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HIGHLIGHTS OF PRESCRIBING INFORMATION
The highlights do not include all the information needed to u Bromday (bromfenac ophthalmic
solution) 0.09% safely and effectively.
See full prescribing information for Bromday.
Bromday (bromfenac ophthalmic solution) 0.09% Initial U.S. Approval: 1997 ------------INDICATIONS AND USAGE---------
Bromday is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative
inflammation and reduction of ocular pain in patients
who have undergone cataract extraction
(1). ---------DOSAGE AND ADMINISTRATION---
Instill one drop into the affected eye(s) once daily beginning 1 day prior to surgery, continued on the day of surgery and through the first 14 days post-surgery (2.1). ------DOSAGE FORMS AND STRENGTHS --Topical ophthalmic solution: bromfenac 0.09% (3) -------WARNINGS AND PRECAUTIONS-----
•Sulfite Allergic Reactions (5.1) •Slow or Delayed Healing (5.2) •Potential for cross-nsitivity (5.3) •Increa bleeding of ocular tissues (5.4) •Corneal effects including keratitis (5.5) • Contact Lens Wear (5.6) -------------ADVERSE REACTIONS-------------
The most commonly reported adver reactions in 27% of patients were abnormal nsation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) (6.1). To report SUSPECTED ADVERSE REACTIONS,
contact ISTA Pharmaceuticals, Inc. at 1-877-788-2020, or FDA at 1-800-FDA-1088 or v/medwatch. See 17 for PATIENT COUNSELING INFORMATION Revid: 9/2010
FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 2.2 U with Other Topical Ophthalmic Medications 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTION
S 5.1 Sulfite Allergic Reactions 5.2 Slow or Delayed Healing 5.3 Potential for Cross-Sensitivity 5.4 Incread Bleeding Time 5.5 Keratitis and Corneal Reactions 5.6 Contact Lens Wear 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 6.2 Post-Marketing Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric U 8.5 Geriatric U 11 DESCRIPTION
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis and
Impairment of Fertility 14 CLINICAL STUDIES 14.1 Ocular Inflammation and Pain 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Slowed or Delayed Healing
17.2 Sterility of Dropper Tip 17.3 Concomitant U of Contact Lens
17.4 Concomitant Topical Ocular Therapy
*Sections or subctions omitted from the full prescribing
information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS
AND
USAGE Bromday (bromfenac ophthalmic solution)
0.09% is indicated for the treatment of
postoperative inflammation and reduction of
ocular pain in patients who have undergone
cataract surgery.
2 DOSAGE
AND
ADMINISTRATION 2.1 Recommended
Dosing
For the treatment of postoperative
inflammation in patients who have
undergone cataract extraction, one drop of Bromday ophthalmic solution should be
applied to the affected eye(s) once daily
beginning 1 day prior to cataract surgery,
continued on the day of surgery, and
through the first 14 days of the
postoperative period.
2.2 U with Other Topical Ophthalmic
Medications
Bromday ophthalmic solution may be
administered in conjunction with other
topical ophthalmic medications such as
alpha-agonists, beta-blockers, carbonic
anhydra inhibitors, cycloplegics, and
mydriatics. Drops should be administered
at least 5 minutes apart.
3 DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution: bromfenac 0.09%.
4 CONTRAINDICATIONS
None.
5 WARNINGS
AND
PRECAUTIONS 5.1 Sulfite
Allergic
Reactions
Contains sodium sulfite, a sulfite that may
cau allergic-type reactions including
anaphylactic symptoms and life-threatening or
less vere asthmatic episodes in certain
susceptible people. The overall prevalence of
sulfite nsitivity in the general population is
unknown and probably low. Sulfite nsitivity is
en more frequently in asthmatic than in non-asthmatic people.
5.2 Slow or Delayed Healing
All topical nonsteroidal anti-inflammatory
drugs (NSAIDs) may slow or delay healing.
Topical corticosteroids are also known to
slow or delay healing. Concomitant u of
topical NSAIDs and topical steroids may
increa the potential for healing problems.
5.3 Potential for Cross-Sensitivity求职简历免费模板
There is the potential for cross-nsitivity to
acetylsalicylic acid, phenylacetic acid
derivatives, and other NSAIDs. Therefore,
caution should be ud when treating
individuals who have previously exhibited
nsitivities to the drugs.
5.4 Incread Bleeding Time
With some NSAIDs, there exists the
potential for incread bleeding time due to interference with platelet aggregation.
There have been reports that ocularly
applied NSAIDs may cau incread
bleeding of ocular tissues (including
hyphemas) in conjunction with ocular
surgery.
It is recommended that Bromday ophthalmic
solution be ud with caution in patients with
known bleeding tendencies or who are
receiving other medications which may prolong bleeding time.
5.5 Keratitis and Corneal Reactions
U of topical NSAIDs may result in keratitis.
In some susceptible patients, continued u of
topical NSAIDs may result in epithelial
breakdown, corneal thinning, corneal erosion,
corneal ulceration or corneal perforation. The events may be sight threatening. Patients with
evidence of corneal epithelial breakdown
should immediately discontinue u of topical
NSAIDs and should be cloly monitored for
corneal health.
Post-marketing experience with topical
NSAIDs suggests that patients with一无所有的反义词
complicated ocular surgeries, corneal
denervation, corneal epithelial defects,
diabetes mellitus, ocular surface dias
(e.g., dry eye syndrome), rheumatoid
arthritis, or repeat ocular surgeries within a short period of time may be at incread
risk for corneal adver events which may become sight threatening. Topical NSAIDs should be ud with caution in the
patients.
Post-marketing experience with topical
NSAIDs also suggests that u more than
沙滩上的童话
24 hours prior to surgery or u beyond 14
days post surgery may increa patient risk for the occurrence and verity of corneal
adver events.
5.6 Contact Lens Wear
Bromday should not be administered while
wearing contact lens
6 ADVERSE
REACTIONS
6.1 Clinical Trial Experience
The most commonly reported adver
experiences reported following u of
bromfenac after cataract surgery include:
abnormal nsation in eye, conjunctival
hyperemia, eye irritation (including
burning/stinging), eye pain, eye pruritus, eye
redness, headache, and iritis. The events
were reported in 2-7% of patients.
诗是什么6.2 Post-Marketing
Experience The following events have been identified
during post-marketing u of bromfenac什么泡脚好
ophthalmic solution 0.09% in clinical practice.
Becau they are reported voluntarily from a
population of unknown size, estimates of
frequency cannot be made. The events, which have been chon for inclusion due to either
their riousness, frequency of reporting,
possible causal connection to topical
bromfenac ophthalmic solution 0.09% or a
combination of the factors, include corneal
erosion, corneal perforation, corneal thinning,
and epithelial breakdown. [e Warnings and
Precautions (5)]
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy
Teratogenic Effects: Pregnancy相册英文
Category C. Reproduction studies
performed in rats at oral dos up to 0.9
mg/kg/day (1300 times the recommended
human ophthalmic do [RHOD]) and in
rabbits at oral dos up to 7.5 mg/kg/day
(11,000 times RHOD) revealed no
evidence of teratogenicity due to
bromfenac. However, 0.9 mg/kg/day in rats caud embryo-fetal lethality, incread
neonatal mortality, and reduced postnatal
growth. Pregnant rabbits treated with 7.5
mg/kg/day caud incread post-
山药胡萝卜粥
implantation loss.
There are no adequate and well-controlled studies in pregnant women. Becau
animal reproduction studies are not always predictive of human respon, this drug
should be ud during pregnancy only if
the potential benefit justifies the potential
risk to the fetus.
Nonteratogenic Effects:
Becau of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal
cardiovascular system (closure of ductus
arteriosus), the u of Bromday ophthalmic
solution during late pregnancy should be
avoided.
8.3 Nursing
Mothers
Caution should be exercid when Bromday is administered to a nursing woman.
8.4 Pediatric
U
Safety and efficacy in pediatric patients below the age of 18 have not been established. 8.5 Geriatric U
There is no evidence that the efficacy or safety
profiles for Bromday differ in patients 65 years
of age and older compared to younger adult patients. 11 DESCRIPTION
Bromday (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal
anti-inflammatory drug (NSAID) for ophthalmic u. Each mL of Bromday contains 1.035 mg bromfenac sodium
(equivalent to 0.9 mg bromfenac free acid).
Bromfenac sodium is designated chemically as sodium 2-amino-3-(4
bromobenzoyl) phenylacetate
squihydrate, with an empirical formula of
C 15H 11BrNNaO 3• 1½H 2O. The structural
structure for bromfenac sodium is: Bromfenac sodium is a yellow to orange
crystalline powder.
The molecular weight of bromfenac sodium is 383.17. Bromday
ophthalmic solution is supplied as a sterile
aqueous 0.09% solution, with a pH of 8.3. The osmolality of Bromday ophthalmic solution is approximately 300 mOsmol/kg. Each mL of Bromday ophthalmic solution contains: Active : bromfenac sodium hydrate 0.1035% Prervative : benzalkonium chloride (0.05 mg/mL) Inactives :
boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone (20 mg/mL), sodium borate, sodium sulfite anhydrous (2 mg/mL), sodium hydroxide to adjust pH and water for injection, USP. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygena 1 and 2. Prostaglandins have been shown in many
animal models to be mediators of certain kinds
of intraocular inflammation. In studies
performed in animal eyes, prostaglandins have
been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, incread
vascular permeability, leukocytosis, and incread intraocular pressure. 12.3 Pharmacokinetics
The plasma concentration of bromfenac following ocular administration of 0.09% Bromday (bromfenac ophthalmic solution) in humans is unknown. Bad on the maximum propod do of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic
concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term carcinogenicity studies in rats and
mice given oral dos of bromfenac up to 0.6 mg/kg/day (900 times the recommended human ophthalmic do [RHOD] of 1.67 mcg/kg in 60 kg person on a mg/kg/basis, assuming 100% absorbed) and 5 mg/kg/day (7500 times RHOD), respectively revealed no significant increas in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the rever mutation, chromosomal aberration, and micronucleus tests.
Bromfenac did not impair fertility when
administered orally to male and female rats at
dos up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (1300 and 450 times RHOD,
respectively).
14 CLINICAL
STUDIES
14.1 Ocular inflammation and pain following cataract surgery
Clinical efficacy was evaluated in three
randomized, double-masked, placebo-
controlled trials in which subjects requiring cataract surgery were assigned to Bromday or placebo. Patients were dod with one
drop per eye starting the day before
surgery and continuing for 14 days. The
primary endpoint was clearing of ocular
inflammation by day 15. An additional
efficacy endpoint was the number of
patients who were pain free on day 1 after
cataract surgery.
In 2 of the 3 studies, Bromday ophthalmic
solution had statistically significant higher
incidence of completely clearing
inflammation (46-47% vs. 25-29%) and
also had a statistically significant higher
incidence of subjects that were pain free at day 1 post cataract surgery (83-89% vs.
51-71%).
16 HOW
SUPPLIED/STORAGE
AND HANDLING
Bromday (bromfenac ophthalmic solution)
0.09% is supplied in a white LDPE plastic
squeeze bottle with a 15 mm LDPE white
dropper-tip and 15 mm polypropylene gray cap as follows:
1.7 mL in 7.5 mL container (NDC 67425-999
17) STORAGE
Store at 15º – 25ºC (59º – 77ºF).
17 PATIENT
COUNSELING INFORMATION
17.1 Slowed or Delayed Healing
Patients should be advid of the possibility
that slow or delayed healing may occur while
using NSAIDs.
17.2 Sterility of Dropper Tip
Patients should be advid to not touch
dropper tip to any surface, as this may
contaminate the contents.
17.3 Concomitant U of Contact Lens
Contact lens should not be worn during the
u of this product.
17.4 Concomitant Topical Ocular Therapy
If more than one topical ophthalmic
medication is being ud, the medicines
should be administered at least 5 minutes apart
Rx Only
©ISTA Pharmaceuticals®, Inc. Manufactured for: ISTA Pharmaceuticals, Inc. Irvine, CA 92618
By: Bausch & Lomb Incorporated
Tampa, FL 33637
Under licen from:
奢侈包包Senju Pharmaceuticals Co., Ltd.
Osaka, Japan 541-0046
® and ™ marks owned by ISTA Pharmaceuticals, Inc.
