Bosconar may be available in the countries listed below.
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Sunday, 1 November 2009
Bromday
bromfenac
Dosage Form: ophthalmic solution
FULL PRESCRIBING INFORMATION
Indications and Usage for Bromday
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.
Bromday Dosage and Administration
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.
Use 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 anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.
Dosage Forms and Strengths
Topical ophthalmic solution: bromfenac 0.09%.
Contraindications
None.
Warnings and Precautions
Sulfite Allergic Reactions
Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
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 use of topical NSAIDs and topical steroids may increase the potential for healing problems
Potential for Cross-Sensitivity
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Increased Bleeding Time
With some NSAIDs, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
It is recommended that Bromday ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Keratitis and Corneal Reactions
Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.
Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.
Contact Lens Wear
Bromday should not be administered while wearing contact lenses.
Adverse Reactions
Clinical Trial Experience
The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients.
Post-Marketing Experience
The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. [see Warnings and Precautions (5)]
USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses 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 caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss.
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects:
Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of Bromday ophthalmic solution during late pregnancy should be avoided.
Nursing Mothers
Caution should be exercised when Bromday is administered to a nursing woman.
Pediatric Use
Safety and efficacy in pediatric patients below the age of 18 have not been established.
Geriatric Use
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.
Bromday Description
Bromday™ (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. 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 sesquihydrate, with an empirical formula of C15H11BrNNaO3• 1½H2O. The structural formula 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%
Preservative: 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.
Bromday - Clinical Pharmacology
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 cyclooxygenase 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, increased vascular permeability, leukocytosis, and increased intraocular pressure.
Pharmacokinetics
The plasma concentration of bromfenac following ocular administration of 0.09% Bromday (bromfenac ophthalmic solution) in humans is unknown. Based on the maximum proposed dose 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.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (900 times the recommended human ophthalmic dose [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 increases in tumor incidence.
Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests.
Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (1300 and 450 times RHOD, respectively).
Clinical Studies
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 dosed 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%).
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).
Patient Counseling Information
Slowed or Delayed Healing
Patients should be advised of the possibility that slow or delayed healing may occur while using NSAIDs.
Sterility of Dropper Tip
Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
Concomitant Use of Contact Lenses
Contact lenses should not be worn during the use of this product.
Concomitant Topical Ocular Therapy
If more than one topical ophthalmic medication is being used, 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 license from:
Senju Pharmaceuticals Co., Ltd.
Osaka, Japan 541-0046
® and ™ marks owned by ISTA Pharmaceuticals, Inc.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Bromday™
(bromfenac ophthalmic solution) 0.09%
Sterile Rx only
Each mL of Bromday ophthalmic solution contains:
Active: bromfenac sodium hydrate 0.1035%
Preservative: benzalkonium chloride 0.005%
Inactives: boric acid, disodium edetate, polysorbate 80, povidone, sodium borate, sodium sulfite anhydrous, sodium hydroxide to adjust the pH, and water for injection, USP.
This product is sterile when manufactured and should be dispensed in the original unopened container. Instruct patient on precautions to avoid contamination.
For topical application in the eye.
Usual dosage:
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.
See accompanying prescribing information.
Store at 15-25°C (59-77°F).
| Bromday bromfenac solution/ drops | ||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021664 | 09/20/2010 | |
| Labeler - Ista Pharmaceuticals, Inc (957212350) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Ista Pharmaceuticals, Inc | 957212350 | ANALYSIS | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bausch & Lomb Incorporated | 807927397 | MANUFACTURE | |
More Bromday resources
- Bromday Side Effects (in more detail)
- Bromday Dosage
- Bromday Use in Pregnancy & Breastfeeding
- Bromday Drug Interactions
- Bromday Support Group
- 0 Reviews for Bromday - Add your own review/rating
- Bromday Advanced Consumer (Micromedex) - Includes Dosage Information
- Bromday Consumer Overview
- Bromday MedFacts Consumer Leaflet (Wolters Kluwer)
- Xibrom Monograph (AHFS DI)
- Xibrom Consumer Overview
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Digibar 190 oral and rectal
Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)
Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen
What is barium sulfate?
Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.
Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.
Barium sulfate may also be used for purposes not listed in this medication guide.
What is the most important information I should know about barium sulfate?
You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.
Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.
Tell your doctor if you are pregnant or breast-feeding before your medical test.
Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.
Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation
What should I discuss with my health care provider before using barium sulfate?
You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.
To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:
asthma, eczema, or allergies;
a blockage in your stomach or intestines;
cystic fibrosis;
a colostomy;
rectal cancer;
heart disease or high blood pressure;
Hirschsprung's disease (a disorder of the intestines);
a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);
a recent history of surgery on your esophagus, stomach, or intestines;
a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;
if you have recently had a rectal biopsy;
if you have ever choked on food by accidentally inhaling it into your lungs;
if you are allergic to simethicone (Gas-X, Phazyme, and others); or
if you are allergic to latex rubber.
It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.
How should I use barium sulfate?
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Barium sulfate comes in tablets, paste, cream, or liquid forms.
In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.
You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.
If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.
Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.
Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.
Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.
What happens if I miss a dose?
If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.
What should I avoid before or after using barium sulfate?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Barium sulfate side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
severe stomach pain;
severe cramping, diarrhea, or constipation;
sweating;
ringing in your ears;
confusion, fast heart rate; or
pale skin, weakness.
Less serious side effects may include:
mild stomach cramps;
nausea, vomiting;
loose stools or mild constipation.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect barium sulfate?
There may be other drugs that can interact with barium sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
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Where can I get more information?
- Your doctor or pharmacist can provide more information about barium sulfate.
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