VIGOQUIN-LP | Loteprednol Etabonate & Moxifloxcin Ophthalmic Suspension
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory
COMPOSITION
Loteprednol Etabonate………………………………………………………….0.5% w/v
Moxifloxacin Hydrochloride IP equivalent to Moxifloxacin…….0.5% w/v
Water for Injections IP………………………………………………………q.s.
CONTRAINDICATIONS
Vigoquin-LP is contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Vigoquin-LP is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
MODE OF ACTION
MOXIFLOXACIN
The antibacterial action of moxifloxacin results from inhibition of topoisomerase |I (DNA gyrase) and topoisomerase IV. DNA gyrase is as essential enzymes 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.
LOTEPREDNOL
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte. migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.
INDICATIONS AND USAGE
For the treatment of post-operative steroid responsive inflammatory ocular infections or risk of bacterial ocular infections exists. For the treatment of patients with bacterial conjunctivitis.
ADVERSE EFFECTS
MOXIFLOXACIN
Ocular hyperemia, keratoconjunctivitis, sicca, abnormal sensation in eye, ocular discomfort, corneal epithelium defect, conjunctivitis haemorrhage, visual acuity reduced, eyelid edema, eye pain.
LOTEPREDNOL
Non Ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis.
DOSAGE
SHAKE WELL BEFORE USE
The recommended dosage regimen for patients one year of age and older is one drop in the affected eye(s) 3 times a day.
PHARMACEUTICAL PRECAUTIONS
It is desirable that the contents should not be used for more than a month after opening container. Do not touch the dropper tip or let it touch any surface since this may contaminate the solution. If irritation persists or increases, discontinue the use and consult the doctor.
PACKING:
Vigoquin-LP eye drops are available in 5ml in lyondellbasel Purell low density polyethylene dispensing system consisting of plastic bottle with good flexibility. Tamper evidence ring around the closure and neck area of the bottle.
STORAGE INSTRUCTIONS:
Store in cool & dry place. Protect from light. Do not freeze. Keep out of reach of children.
Use the solution within one month after opening the container.
For external use only.
Effects on Ability to Drive and Use Machines:
HYLOSOFT HPF ophthalmic solution may cause blurred vision for a short time after application even at normal dosages and with proper use. This can subsequently impair reaction time while driving or operating machinery.
Undesirable Effects:
Because it is preservative-free, HYLOSOFT HPF is well tolerated even when used over a long period of time. Safety data does not provide any evidence that would represent an unacceptable hazard to its use in humans. In rare cases hypersensitive reactions like burning, itching, tearing has been reported which recedes immediately on discontinuation of HYLOSOFT HPF.
Packing:
10ml volume available in aeropump bottle specially to avoid contamination of the contents.
Storage Instruction: Store at a temperature not exceeding 30°C. Do not freeze. Protect from light and moisture.
Use the solution within 30 days after opening the container.
For external use only.
