Composition :
1 ml of the solution contains
LoteprednolEtabolate 0.5% w/v + Moxifloxacin Hydrochloride IP eq to Moxifloxacin 0.5% w/v + Benzalkonium Chloride IP 0.01% w/v, Aqueous Suspension Base q.s.

Indications :
LOTECARE MX 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 :
Invert closed bottle and shake once to fill tip before instilling drops. Apply one to two drops of LOTECARE MX into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.

Contraindications :
LOTECARE MX, as with other ophthalmic corticosteroids, 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. 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.

Warning and Precautions :
Intraocular pressure (IOP) increase - Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored
Cataracts- Use of corticosteroids may result in posterior sub-capsular cataract formation.
>> Bacterial infections–Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infection. In acute purulent conditions, steroids may mask infection or enhance existing infection.

Adverse Effects :
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior sub-capsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
The most common adverse drug reactions reported were anterior chamber inflammation (5%), eye pain (2%), and foreign body sensation (2%).

CLINICAL PHARMACOLOGY :
Mechanism of Action:
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the oedema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established. However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.
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.

USE IN SPECIFIC POPULATIONS :
Pregnancy Teratogenic Effects :
There are no adequate and well controlled studies in pregnant women. LOTECARE MX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers :
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 LOTECARE MX is administered to a nursing woman.
Paediatric Use :
Safety and efficacy in paediatric patients have not been established.
Geriatric Use :
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Packaging :
5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml solution.

Storage Conditions :
In dry place protected from light at a temperature below 25°С. Do not freeze. After instillation the vial should be tightly closed. Keep out of reach of children.

Shelf-Life :
15 months after opening the vial it is suitable for use within 1 month.
Do not use after the expiration date stated on the package