Class: Corticosteroid, antibiotic

Manufacturer: Ciron Drugs and Pharmaceutical Pvt. N-118 & 119, MIDC, Tarapur, Boisar, Dist-Thane 401 506, Maharashtra State, India.

Dosage Form: Eye drops

Similar Brands:

Uses:

Apdrops DX is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection of a risk bacterial infection coexists.

Dosage:

Instill one drop in the affected eye 3 times a day for 7 days.

Side Effects:

Adverse effects have occurred with steroid/anti-infective combination drugs, which can be attributed to the steroid component, the anti-infective component, or the combination. The most frequently reported ocular adverse events with moxifloxacin when used alone were conjuctivities, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, sub-conjuctivalhaemorrhage and tearing. These events occurred in approximately 1 to 6% of patients. Non-ocular adverse events reported at rate of 1 to 4% were fever, increased cough, infection, otitis media, pharyngitis, rash and rhinitis.

The adverse reactions reported due to the steroid component when used alone are elevation of intraocular pressure (OP) with possible development of glaucoma and infrequent optic nerve damage; posterior subcapsular cataract formation and delayed healing.

Warnings & Precautions:

Not for injection into eye. Prolonged use of steroids may result in glaucoma. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children an uncooperative patients. In those diseases, causing thining of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The possibility of fungal infections of the cornea should be considered after longterm steroids dosing. If super infection occurs, appropriate therapy should be initiated.

Pregnancy & Lactation:

Pregnancy

Apdrops dx should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Lactation

It is not known whether topical administration of the combination would result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when the combination is administered to nursing women.

Drug Interactions:

Drug-drug interactions studies have not been conducted with moxifloxacin hydrochloride ophthalmic solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYO2C19, or CYP1A2 indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

Contraindications:

Epithelial herpes simplex keratitis (dentritic keratitis), vaccinia, varicella and in many other viral diseases of the conjuctivia and cornea.Mycobacteria infections of the eye.Fungal disease of ocular structures.Hypersensitivity to any of the components of the medication.

Price: Ksh 925

Notes:

Composition

Each ml contains:

Moxifloxacin hydrochloride BP 5.45mg (equivalent to moxifloxacin 5.0mg), Dexamethasone Sodium Phosphate BP (equivalent to dexamethasone phosphate 1.0mg), benzalkonium Chloride NF 001%w/v (as preservative), Sterile aqueous vehicle q.s.

List of excipients

Boric Acid BP, Borax (Sodium borate) BP, Sodium Chloride BP, Hydroxyproplybetadex BP, Bezalkonium Chloride USPNF, water for injections BP.

Notorious effects of excipients

Any local irritability or cytotoxic effects are generally of limited clinical significance when benzalkonium chloride containing solutions are used for limited periods of time. Acid taking.

Effects on ability to drive and use machine

As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

Ajanta Pharma Limited