Celsus Ciprofloxacin + Dexamethasone Eye Drops

Celsus Ciprofloxacin + Dexamethasone Eye Drops

Manufacturer:

EL Lab

Distributor:

Celsus
Full Prescribing Info
Contents
Ciprofloxacin, dexamethasone.
Description
Each mL contains: Ciprofloxacin hydrochloride equivalent to Ciprofloxacin 0.3% w/v; Dexamethasone 0.1 % w/v; Benzalkonium chloride NF (preservative) 0.01% w/v; Sterile aqueous vehicle (q.s.).
Ciprofloxacin with Dexamethasone is a combination of ciprofloxacin, fluoroquinolone antimicrobial and dexamethasone, a potent corticosteroid.
Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant.
The antibiotic in the combination (ciprofloxacin) is included to provide action against susceptible organisms.
Ciprofloxacin is highly effective against most of the pathogenic bacteria causing ocular infections such as: Staphylococci including penicillin and methicillin-resistant strains, coagulase negative Staph. spp., Strep. pneumoniae, Streptococci spp., Micrococcus, Corynebacterium, M. catarrhalis, N. gonorrhoeae, E. coli, Moraxella spp., Klebsiella spp., Proteus vulgaris, H. influenzae, H. aegypticus, Propionobacterium, Pseudomonas spp. and Chlamydia trachomatis. The primary antibacterial activity of Ciprofloxacin is believed to involve inhibition of bacterial DNA gyrase, the enzyme responsible for introducing negative supercoils into the bacterial DNA and death of bacteria.
Thus, a combination of dexamethasone a potent corticosteroid and ciprofloxacin a broad-spectrum antibacterial in a topical formulation will together effectively resolve inflammation and infection in severe eye conditions.
Indications/Uses
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection depending upon the evaluation of the attending physician. They are also indicated in allergic keratoconjunctivitis with secondary bacterial infections.
Dosage/Direction for Use
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops three to four times a day depending upon the evaluation of the attending physician.
Overdosage
Clinically apparent signs and symptoms of an overdose of Ciprofloxacin with Dexamethasone ophthalmic solution (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.
A topical overdose may be flushed from the eye(s) with warm tap water.
Contraindications
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and in many other viral diseases of the conjunctiva and cornea. Mycobacterial infections of the eye. Fungal diseases of ocular structures. Hypersensitivity to any of the components of the medication.
Warnings
Pregnancy: Ciprofloxacin with Dexamethasone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. It is also not known whether ciprofloxacin is excreted in human milk following topical ophthalmic administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.
Moreover, because of the potential of serious adverse reactions from ciprofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Special Precautions
If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Not for injection into the eye. 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. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infections. The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. If super infection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and appropriate fluorescein staining.
Use In Pregnancy & Lactation
Pregnancy: Ciprofloxacin with Dexamethasone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. It is also not known whether ciprofloxacin is excreted in human milk following topical ophthalmic administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.
Moreover, because of the potential of serious adverse reactions from ciprofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
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 drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, conjunctivitis/keratitis, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness have been received.
The reactions due to the steroid component are: Elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
Secondary Infection: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.
Storage
Keep cap tightly closed after use. Store at temperatures not exceeding 30°C.
ATC Classification
D07CB04 - dexamethasone and antibiotics ; Belongs to the class of moderately potent (group II) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.
Presentation/Packing
Eye drops (sterile) 0.3%/0.1% x 5 mL x 1's.
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