Besiven 0.6%

Indications

Besiven Ophthalmic Suspension is specifically formulated to treat bacterial conjunctivitis caused by sensitive strains of the following bacteria:

• Corynebacterium pseudodiphtheriticum
• Corynebacterium striatum
• Haemophilus influenzae
• Moraxella lacunata
• Staphylococcus aureus
• Staphylococcus epidermidis
• Staphylococcus hominis
• Staphylococcus lugdunensis
• Streptococcus mitis group
• Streptococcus oralis
• Streptococcus pneumoniae
• Streptococcus salivarius

Efficacy against these organisms has been validated in studies involving fewer than 10 infections.

Pharmacology

Besifloxacin is an 8-chloro fluoroquinolone featuring an N-1 cyclopropyl group. This compound exhibits potent activity against both Gram-positive and Gram-negative bacteria by inhibiting bacterial DNA gyrase and topoisomerase IV. DNA gyrase is crucial for DNA replication, transcription, and repair, while topoisomerase IV is essential for the separation of chromosomal DNA during bacterial cell division.

In clinical studies involving adult patients with suspected bacterial conjunctivitis, plasma concentrations of Besifloxacin were assessed after receiving three doses daily (a total of 16 doses). The maximum plasma concentration for each patient remained under 1.3 ng/ml. The average maximum concentration (C max) was recorded at 0.37 ng/ml on day 1 and 0.43 ng/ml on day 6, with an estimated elimination half-life of approximately 7 hours following multiple doses.

Dosage & Administration

• Adults and Children (1 year and older): Administer one drop in the affected eye(s) three times daily for a duration of 7 days.

Pediatric Use: The safety and efficacy of Besifloxacin in infants under one year of age have not been established. Its effectiveness in treating bacterial conjunctivitis in children aged one year and older has been demonstrated in controlled clinical trials.

Geriatric Use: No significant differences in safety or effectiveness have been observed between older and younger patients.

Consult a healthcare professional before using this medication.

Interactions

No interactions have been identified. For topical ophthalmic use only.

Contraindications

Hypersensitivity to the active ingredient or any component in this formulation.

Side Effects

The most commonly reported ocular side effect is conjunctival redness, occurring in about 2% of patients. Other side effects noted in approximately 1-2% of patients include blurred vision, eye pain, irritation, itching, and headaches.

Pregnancy & Lactation

Pregnancy Category C: Adequate and well-controlled studies in pregnant women have not been conducted. While Besifloxacin has not been measured in human breast milk, it is assumed to be excreted. Caution is advised when administering to nursing mothers.

Precautions & Warnings

Besiven is intended for topical ophthalmic use only. It should not be injected subconjunctivally or directly into the anterior chamber of the eye. As with other anti-infective agents, prolonged use may lead to the growth of non-susceptible organisms, including fungi. If a superinfection occurs, discontinue use and consider alternative therapies. To avoid contamination, do not let the dropper tip touch the eye, eyelid, or any surface of the affected area. Contact lenses should not be worn during the treatment period with Besiven. Shake well before each use.

Therapeutic Class

Ophthalmic Antibacterial Agents

Storage Conditions

Store at room temperature, away from light and moisture. It is recommended to use the contents within one month after opening the bottle. Shake well before use.