Composition :
1 ml of the solution contains
Moxifloxacin Hydrochloride eq. to Moxifloxacin 0.5% w/v + Dexamethasone Sodium Phosphate IP 0.1 w/v + Hydroxymethyl Cellulose IP 0.25% w/v + Benzalkonium Chloride Solution IP 0.02% v/v
Pharmacotherapeutic Group :
Glucocorticosteroid for topical use + antibacterial
Indications :
Bacterial inflammatory diseases of an eye and its appendages:
Acute and subacute conjunctivitis.
Keratitis.
Anterior uveitis;
Blepharitis and other inflammatory disease of eyelids;
Prophylaxis and treatment of infectious complications after wounds of an eye and its appendages and at operations on an eyeball
Bacterial inflammatory diseases of an ear.
Acute otitis externa.
Acute otitis media at shunt of an eardrum.
Acute otitis media with granulations and otorrhea at presence of the shunt of an eardrum.
Dosage and Administration :
Bacterial inflammatory diseases of an eye and its appendages: 1-2 drops instil in conjunctival sac every 4 – 6 h. First 24 – 48 h instillations can be made each two hours.
Contraindications :
Hypersensitivity to active substance of a preparation or to any auxiliary components which are a part of the given medicinal form of a preparation;
simplex herpetic keratitis and other virus defeats of a cornea and conjunctiva;
eye tuberculosis;
mycotic lesion of eye;
virus infections of acoustical meatus;
punching an eardrum;
children’s age till 18 years;
pregnancy;
Lactation period.
Adverse Effects :
Corneal infiltrations, burning, reddening, an itch of eyes, conjunctivitis, keratitis, periocular hypostasis, face hypostasis, feeling of an alien body in an eye, photophobia, blur of vision, dryness of an eye, eyelid hypostasis, hyperaemia of conjunctiva, a glaucoma and damage of an optic nerve, decrement in visual acuity and coning of vision, formation of a cataract, a secondary infection (fungoid and bacterial), corneas thinning and/or punching of an eyeball, delay of wounds healing, discomfort and ear pain, ear itch, stuffiness in ear, gustatory perversion, skin rash.
Over-Dosage :
Overdose of a preparation can be shown by following local symptoms: occurrence of punctate keratitis, erythema, hyper lacrimation, hypostasis and itch of eyelids. The specific antidote is not present. It is necessary to wash out eyes water, to cancel a preparation and to appoint symptomatic therapy. Data about system displays of overdose are not present.
Packaging :
10 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 10 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
OPHTHAL