Lotepro G (Loteprednol Etabonate 0.5% & Gatifloxacin 0.3%)
Therapeutic Group: Ophthalmic
Presentation
Lotepro G Sterile Ophthalmic Suspension: Each ml contains Loteprednol Etabonate INN 5 mg & Gatifloxacin Sesquihydrate INN equivalent to Gatifloxacin 3 mg.
Description
Lotepro G is a combination of a topical anti-inflammatory corticosteroid, Loteprednol Etabonate & an 8-methoxyfluoroquinolone antibiotic, Gatifloxacin.
Loteprednol etabonate is structurally similar to other corticosteroids. It is highly lipid soluble which enhances its penetration into cells.
The antibacterial action of Gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. It appears that the C-8-methoxy moiety contributes to enhanced activity and lower selection of resistant mutants of gram-positive bacteria compared to the nonmethoxy C-8 moiety.
Indications
Loteprednol & gatifloxacin combination is indicated for the treatment of post operative inflammatory conditions of the eye.
Dosage & Administration
Shake the bottle well before use.
Apply one or two drops of this suspension into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Precautions
General: Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Fungal infections of the cornea are particularly prone to develop coincidentally with long term local steroid application.
Patients with bleeding tendencies: This fixed dose combination should be used with care in patients with known bleeding tendencies, or in patients who are receiving other medications which may prolong bleeding time.
Ability to drive: As this fixed dose combination may cause transient blurring on instillation, the use of hazardous machinery or driving is not recommended unless vision is clear.
Use in Pregnancy & Lactation
Pregnancy: Since there are no adequate and well controlled studies in pregnant women, Gatifloxacin & Loteprednol combination ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Since many drugs are excreted in human milk, caution should be exercised when Loteprednol & Gatifloxacin combination ophthalmic solution is administered to a nursing woman.
Drug Interaction
No information provided.
Over Dose
No information provided.
Storage
Protect from light. Store in a cool and dry place. Keep out of the reach of children. Do not use more than 4 weeks after opening.
Commercial Pack
Lotepro G Sterile Ophthalmic Suspension: Plastic dropper bottle containing 5 ml Sterile Ophthalmic Suspension.
Others
Pediatric use
Safety and efficacy in pediatric patients have not been established.
Geriatric use
Safety and efficacy in geriatric patients have not been established.
Adverse effects
The adverse events reported with the fixed dose combination were irritation, pain, redness, photophobia, stinging, itching, discharge & blurred vision. Redness was the most commonly observed adverse event occurring in 6% of patients. Itching, discharge, photophobia & blurred vision were seen in less than 2% cases.
