Besivance

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Besivance uses


1 INDICATIONS AND USAGE

Besivance® (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

Aerococcus viridans*

CDC coryneform group G

Corynebacterium pseudodiphtheriticum*

Corynebacterium striatum*

Haemophilus influenzae

Moraxella catarrhalis*

Moraxella lacunata*

Pseudomonas aeruginosa*

Staphylococcus aureus

Staphylococcus epidermidis

Staphylococcus hominis*

Staphylococcus lugdunensis*

Staphylococcus warneri*

Streptococcus mitis group

Streptococcus oralis

Streptococcus pneumoniae

Streptococcus salivarius*

*Efficacy for this organism was studied in fewer than 10 infections.

Besivance® (besifloxacin ophthalmic suspension) 0.6%, is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius*

*Efficacy for this organism was studied in fewer than 10 infections. (1)

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2 DOSAGE AND ADMINISTRATION

Invert closed bottle and shake once before use.

Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days.

Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days. (2)

3 DOSAGE FORMS AND STRENGTHS

7.5 mL size bottle filled with 5 mL of Besivance ophthalmic suspension, 0.6% (3)

4 CONTRAINDICATIONS

None

None (4)

5 WARNINGS AND PRECAUTIONS

Topical Ophthalmic Use Only.

Growth of Resistant Organisms with Prolonged Use. (5.2)

Avoidance of Contact Lenses. Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance. (5.3)

5.1 Topical Ophthalmic Use Only

NOT FOR INJECTION INTO THE EYE.

Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

5.2 Growth of Resistant Organisms with Prolonged Use

As with other anti-infectives, prolonged use of Besivance 0.6% may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.

5.3 Avoidance of Contact Lenses

Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance.

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6 ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Besivance in approximately 1,000 patients between 1 and 98 years old with clinical signs and symptoms of bacterial conjunctivitis.

The most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2% of patients.

Other adverse reactions reported in patients receiving Besivance occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

The most common adverse reaction reported in 2% of patients treated with Besivance was conjunctival redness. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. Oral doses of Besivance up to 1000 mg/kg/day were not associated with visceral or skeletal malformations in rat pups in a study of embryo-fetal development, although this dose was associated with maternal toxicity and maternal mortality. Increased post-implantation loss, decreased fetal body weights, and decreased fetal ossification were also observed. At this dose, the mean Cmax in the rat dams was approximately 20 mcg/mL, >45,000 times the mean plasma concentrations measured in humans. The No Observed Adverse Effect Level (NOAEL) for this embryo-fetal development study was 100 mg/kg/day (Cmax, 5 mcg/mL, >11,000 times the mean plasma concentrations measured in humans).

In a prenatal and postnatal development study in rats, the NOAELs for both fetal and maternal toxicity were also 100 mg/kg/day. At 1000 mg/kg/day, the pups weighed significantly less than controls and had a reduced neonatal survival rate. Attainment of developmental landmarks and sexual maturation were delayed, although surviving pups from this dose group that were reared to maturity did not demonstrate deficits in behavior, including activity, learning and memory, and their reproductive capacity appeared normal.

Since there are no adequate and well-controlled studies in pregnant women, Besivance should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

Besivance has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Besivance is administered to a nursing mother.

8.4 Pediatric Use

The safety and effectiveness of Besivance® in infants below one year of age have not been established. The efficacy of Besivance in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials.

There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals.

8.5 Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

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11 DESCRIPTION

Besivance (besifloxacin ophthalmic suspension) 0.6%, is a sterile ophthalmic suspension of Besivance formulated with DuraSite®† (polycarbophil, edetate disodium dihydrate and sodium chloride). Each mL of Besivance contains 6.63 mg Besivance hydrochloride equivalent to 6 mg Besivance base. It is an 8-chloro fluoroquinolone anti-infective for topical ophthalmic use.

C19H21ClFN3O3-HCl

Mol Wt 430.30

Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1- cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride.

Besivance hydrochloride is a white to pale yellowish-white powder.

Each mL contains:

Active: Besivance 0.6% (6 mg/mL);

Inactives: polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide and water for injection.

Preservative: benzalkonium chloride 0.01%

Besivance is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.

Besivance hydrochloride structural formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Besivance is a fluoroquinolone antibacterial .

12.3 Pharmacokinetics

Plasma concentrations of Besivance were measured in adult patients with suspected bacterial conjunctivitis who received Besivance bilaterally three times a day (16 doses total). Following the first and last dose, the maximum plasma Besivance concentration in each patient was less than 1.3 ng/mL. The mean Besivance Cmax was 0.37 ng/mL on day 1 and 0.43 ng/mL on day 6. The average elimination half-life of Besivance in plasma following multiple dosing was estimated to be 7 hours.

12.4 Microbiology

Besivance is an 8-chloro fluoroquinolone with a N-1 cyclopropyl group. The compound has activity against Gram-positive and Gram-negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division. Besivance is bactericidal with minimum bactericidal concentrations (MBCs) generally within one dilution of the minimum inhibitory concentrations (MICs).

The mechanism of action of fluoroquinolones, including Besivance, is different from that of aminoglycoside, macrolide, and β-lactam antibiotics. Therefore, Besivance may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to Besivance. In vitro studies demonstrated cross-resistance between Besivance and some fluoroquinolones.

In vitro resistance to Besivance develops via multiple-step mutations and occurs at a general frequency of < 3.3 x 10-10 for Staphylococcus aureus and < 7 x 10-10 for Streptococcus pneumoniae.

Besivance has been shown to be active against most isolates of the following bacteria both in vitro and in conjunctival infections treated in clinical trials as described in the INDICATIONS AND USAGE section:

Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, C. striatum*, Haemophilus influenzae, Moraxella catarrhalis*, M. lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, S. epidermidis, S. hominis*, S. lugdunensis*, S. warneri*, Streptococcus mitis group, S. oralis, S. pneumoniae, S. salivarius*

*Efficacy for this organism was studied in fewer than 10 infections.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to determine the carcinogenic potential of Besivance have not been performed.

No in vitro mutagenic activity of Besivance was observed in an Ames test (up to 3.33 mcg/plate) on bacterial tester strains Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA. However, it was mutagenic in S. typhimurium strain TA102 and E. coli strain WP2(pKM101). Positive responses in these strains have been observed with other quinolones and are likely related to topoisomerase inhibition.

Besivance induced chromosomal aberrations in CHO cells in vitro and it was positive in an in vivo mouse micronucleus assay at oral doses ≥ 1500 mg/kg. Besivance did not induce unscheduled DNA synthesis in hepatocytes cultured from rats given the test compound up to 2,000 mg/kg by the oral route. In a fertility and early embryonic development study in rats, Besivance did not impair the fertility of male or female rats at oral doses of up to 500 mg/kg/day. This is over 10,000 times higher than the recommended total daily human ophthalmic dose.

14 CLINICAL STUDIES

In a randomized, double-masked, vehicle controlled, multicenter clinical trial, in which patients 1-98 years of age were dosed 3 times a day for 5 days, Besivance was superior to its vehicle in patients with bacterial conjunctivitis. Clinical resolution was achieved in 45% (90/198) for the Besivance treated group versus 33% (63/191) for the vehicle treated group (difference 12%, 95% CI 3% - 22%). Microbiological outcomes demonstrated a statistically significant eradication rate for causative pathogens of 91% (181/198) for the Besivance treated group versus 60% (114/191) for the vehicle treated group (difference 31%, 95% CI 23% - 40%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

16 HOW SUPPLIED/STORAGE AND HANDLING

Besivance® (besifloxacin ophthalmic suspension) 0.6%, is supplied as a sterile ophthalmic suspension in a white low density polyethylene (LDPE) bottle with a controlled dropper tip and tan polypropylene cap. Tamper evidence is provided with a shrink band around the cap and neck area of the package.

5 mL in 7.5 mL bottle

NDC 24208-446-05

Storage: Store at 15°-25°C (59°- 77°F). Protect from light. Invert closed bottle and shake once before use.

17 PATIENT COUNSELING INFORMATION

Patients should be advised to avoid contaminating the applicator tip with material from the eye, fingers or other source.

Although Besivance is not intended to be administered systemically, quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose. Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.

Patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Besivance or other antibacterial drugs in the future.

Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance.

Patients should be advised to thoroughly wash hands prior to using Besivance.

Patients should be instructed to invert closed bottle (upside down) and shake once before each use. Remove cap with bottle still in the inverted position. Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s).

Bausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807

Besivance® is a registered trademark of Bausch & Lomb Incorporated or its affiliates.

All other product/brand names are trademarks of their respective owners.

©Bausch & Lomb Incorporated

U.S. Patent Nos. 6,685,958; 6,699,492; 5, 8,415,342; 8,481,526; 8,604,020 and 8,937,062

†DuraSite is a trademark of InSite Vision Incorporated.

9142606 (flat)

9142706 (folded)

NDC 24208-446-05

BAUSCH + LOMB

Besivance®

Besivance ophthalmic

suspension, 0.6%

Rx only

Sterile

FOR OPHTHALMIC

USE ONLY.

5 mL

carton.jpg

Besivance pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Besivance available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Besivance destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Besivance Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Besivance pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. "Besifloxacin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "Besifloxacin". http://www.drugbank.ca/drugs/DB0677... (accessed August 28, 2018).
  3. "BFE2NBZ7NX: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Besivance?

Depending on the reaction of the Besivance after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Besivance not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Besivance addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Besivance, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Besivance consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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