Moxifloxacin & Prednisolone Acetate Ophthalmic Solution. It is indicated for the reduction of post-operative inflammatory conditions of the eye.

Trade Name :
Moxil P

Composition :
Each ml contains
Moxifloxacin Hydrochloride IP equivalent to Moxifloxacin 0.5% w/v + Prednisolone Acetate IP 1% w/v w/v + Benzalkonium Chloride IP 0.02% v/v, Sterile Aqueous Base q.s.

Dosage Form :
Eye Drops

Indications :
Moxil P Ophthalmic Solution is indicated for the reduction of post-operative inflammatory conditions of the eye.

Dosage and Method of Administration: :
Instil one drop three times a day in the affected eye(s). The frequency of instillation of drops and the duration of treatment will vary depending on the severity of the underlying condition and the response to the treatment.
The dropper tip should not be allowed to touch any surface since this may contaminate the solution. If irritation persists or increases, the use should be discontinued.

Mechanism of Action :
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.
Prednisolone acetate is a corticosteroid (anti-inflammatory agent) inhibits the edema, fibrin deposition, capillary dilation and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen and scar formation.

Warnings and Precautions :
Prolonged use of steroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

Contraindications :
Moxil P is contraindicated in epithelial herpes simplex keratitis (Dendritic keratitis), vaccinia, varicella, and in many other viral diseases of the conjunctiva and cornea, Mycobacterial infection of the eye and fungal diseases of ocular structures and in individuals hypersensitive to any of the components of the medication.

Adverse Effects :
The most frequently reported drug-related undesirable effects seen with moxifloxacin are conjunctival irritation, increased lacrimation, keratitis and papillary conjunctivitis.

USE IN SPECIFIC POPULATIONS :
Pregnant women :
There are no adequate and well controlled studies in pregnant women with moxifloxacin or prednisolone. Moxil P should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactating women :
Caution should be exercised when Moxil P is administered to a nursing mother.
Geriatric Population :
No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Shelf-Life :
15 Months

Packaging Information :
Product is packed in a 5 ml plastic bottle with a plastic nozzle pre sterilized and plastic cap.

Storage and Handling Instructions :
Store in a cool, dark place. Protect from light. Keep away from reach of children. Use this solution within one month of opening the vial.