Besigen0.6%

Besigen ophthalmic suspension is FDA-approved for the treatment of bacterial conjunctivitis (pink eye) caused by susceptible strains of bacteria in patients 1 year of age and older.

Established/Approved Use

• Bacterial conjunctivitis caused by susceptible isolates of organisms such as Staphylococcus aureus, coagulase-negative staphylococci (including Staphylococcus epidermidis), Streptococcus pneumoniae, Streptococcus mitis group, Haemophilus influenzae, and other susceptible ocular pathogens.

Besigen is intended for topical ophthalmic (eye) use only and is not approved for any systemic infection, viral conjunctivitis, or fungal/other non-bacterial eye infections.

Each mL of Besifloxacin ophthalmic suspension (0.6%) contains besifloxacin (as besifloxacin hydrochloride) equivalent to 6 mg of besifloxacin base, formulated in a sustained-release, mucoadhesive ophthalmic vehicle intended for topical instillation into the eye.

Besigen is a fourth-generation fluoroquinolone antibacterial agent belonging to the chlorofluoroquinolone subclass, distinguished by a chlorine atom at the C-8 position of the quinolone ring, which contributes to enhanced potency against Gram-positive ocular pathogens and reduced potential for resistance selection compared with older fluoroquinolones.

It is formulated exclusively as a topical ophthalmic suspension for the treatment of bacterial conjunctivitis and is not available in oral, injectable, or systemic dosage forms.

Besifloxacin exerts its bactericidal effect by inhibiting two essential bacterial enzymes, DNA gyrase (topoisomerase II) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination. Inhibition of these enzymes leads to breakage of bacterial DNA strands and rapid bacterial cell death.

Besifloxacin demonstrates broad-spectrum in vitro activity against many Gram-positive and Gram-negative bacteria commonly implicated in bacterial conjunctivitis. Following topical ocular administration, systemic absorption is minimal, with plasma concentrations generally below the limit of quantification.

Besigen is for topical ophthalmic (eye) use only. It must never be injected (including subconjunctival injection) or introduced into the anterior chamber of the eye.

• Shake well before use.
• Wash hands prior to administration and avoid touching the dropper tip to any surface, including the eye, to prevent contamination of the suspension.
• Instill the prescribed number of drops into the lower conjunctival sac of the affected eye(s) as directed.
• Remove soft contact lenses before use; do not wear contact lenses while signs and symptoms of bacterial conjunctivitis are present.

Because Besigen is applied topically to the eye and systemic absorption is minimal, clinically significant systemic drug-drug interactions have not been well established in clinical studies.

• Other topical ophthalmic products: If using other eye drops or ointments concurrently, separate administration by at least 5-10 minutes to prevent dilution or washout of Besigen.
• Inform your physician or pharmacist of all other eye medications you are using before starting Besigen.

The most commonly reported adverse reaction with Besigen in clinical trials was:

• Conjunctival redness (eye redness)

Other reported adverse reactions, generally mild and localized to the eye, include:

• Blurred vision
• Eye pain, irritation, or itching (ocular discomfort)
• Headache
• Mucopurulent discharge
• Eyelid crusting or redness
• Reduced visual acuity

Hypersensitivity reactions (see Contraindications) can occur rarely; discontinue Besigen and seek medical attention if signs of an allergic reaction occur.

Pregnancy: There are no adequate and well-controlled studies of Besigen in pregnant women. Systemic absorption after topical ocular administration is minimal. Besigen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; consult a physician before use.

Lactation: It is not known whether Besigen is excreted in human breast milk after topical ophthalmic use. Because many drugs are excreted in human milk, caution should be exercised and a physician consulted before using Besigen while breastfeeding.

• Topical ophthalmic use only: Besigen is not for injection (including subconjunctival injection) or for introduction into the anterior chamber of the eye.
• Hypersensitivity reactions: Discontinue use at the first sign of a rash, allergic reaction, or other hypersensitivity symptom.
• Growth of resistant organisms: Prolonged use of Besigen may result in overgrowth of non-susceptible organisms, including fungi. If the infection is not improved after the prescribed course, or worsens, discontinue use and re-evaluate with a physician.
• Contact lenses: Patients should not wear contact lenses while exhibiting signs and symptoms of bacterial conjunctivitis or during treatment with Besigen.
• Antibiotic stewardship: Take Besigen exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice, to reduce the risk of antibiotic resistance.

Overdose is unlikely with topical ophthalmic use of Besigen. If excessive medication is instilled into the eye, it may be flushed out with lukewarm water.

If Besigen is accidentally ingested or a significant overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services rather than attempting home treatment.

Store Besigen ophthalmic suspension at 15°C to 25°C (59°F to 77°F). Do not freeze. Keep the bottle tightly closed when not in use and out of reach of children.

• Renal impairment: No dose adjustment is required, as systemic absorption of Besigen after topical ocular use is minimal.
• Hepatic impairment: No dose adjustment is required for the same reason; no specific studies have been conducted.
• Elderly patients: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients; no dose adjustment is needed.
• Pediatric patients: Approved for use in children 1 year of age and older at the same dose as adults. Safety and efficacy in infants below 1 year of age have not been established.

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Besigen ophthalmic suspension is approved for the treatment of bacterial conjunctivitis in children 1 year of age and older, using the same dose as adults: 1 drop in the affected eye(s) 3 times daily, 4 to 12 hours apart, for 7 days.

Safety and efficacy of Besigen in infants below 1 year of age have not been established, and use in this age group is not recommended unless specifically directed by a physician.