Combinations
Loteprednol Etabonate
Moxifloxacin Hydrochloride
Equivalent to Moxifloxacin
Benzalkonium Chloride Solution I.P. (As Preservative)
Sterile Aqueous Buffered Vehicle
Category:
Antibiotic + Steroid
Dosage form
0.5% w/v
Ophthalmic Solution (Eye drops)
0.5%
0.02% v/v
q.s.
Ophthalmic Suspension
Description:
Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl ring at the C7 position. The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (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.
Indications:
RVDROPS-LP is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. (to treat ocular infection & inflammation)
Dosage and Administration:
Shake vigorously before using.
Apply one drop of RVDROPS-LP into the conjunctival sac of the affected eye(s) every six to eight hours. During the initial 24 to 48 hours, the dosing may be increased but the frequency should be decreased gradually as warranted by improvement in clinical signs.
Contraindiacations:
Loteprednol �Moxifloxacin combination as with other steroid anti-infective ophthalmic combination drugs is contraindicated in most viral diseases of the cornea and conjunctiva Loteprednol �Moxifloxacin combination is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Precaution: Pregnancy Teratogenic effects
Pregnancy Category C
There are no adequate and well controlled studies in pregnant women. RVDROPS-LP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation:
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Rvdrops-LP is administered to a nursing woman.
Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Storage:
Store in a cool & dark place
Presentation:
RVDROPS-LP Eye Drops is available in a pack of 5 ml.
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