CIPROCOT-D EYE/EAR DROP

CIPROCOT-D Eye/Ear Drops 

I can read the composition panel in the uploaded image clearly. CIPROCOT-D is a combination of an antibiotic, a corticosteroid, and a preservative.

Composition

Each 1 mL contains:

IngredientStrengthClassMain roleCiprofloxacin Hydrochloride I.P.Equivalent to Ciprofloxacin 0.3% w/vFluoroquinolone antibioticTreats susceptible bacterial infectionDexamethasone I.P.0.1% w/vCorticosteroidReduces inflammation, redness and swellingBenzalkonium Chloride Solution I.P.0.01% w/vPreservativePrevents microbial contaminationSterile Aqueous Vehicle I.P.q.s.VehicleMakes up the final ophthalmic/otic preparation

The standard ciprofloxacin/dexamethasone combination contains 0.3% ciprofloxacin and 0.1% dexamethasone; the formulation shown in your image additionally specifies benzalkonium chloride as preservative. (EFDA)

1. Ciprofloxacin Hydrochloride — 0.3%

Drug class

Fluoroquinolone antibacterial

The label specifies ciprofloxacin hydrochloride in an amount equivalent to ciprofloxacin 0.3% w/v.

That corresponds to approximately:

3 mg ciprofloxacin equivalent per 1 mL.

Mechanism of action

Ciprofloxacin inhibits bacterial enzymes involved in DNA replication:

• DNA gyrase

• Topoisomerase IV

This interferes with bacterial DNA replication and repair, ultimately producing a bactericidal effect against susceptible bacteria.

Purpose in the drops

It is the antibacterial component and is used when a susceptible bacterial infection is present or there is a clinically appropriate risk of bacterial infection.

2. Dexamethasone — 0.1%

Drug class

Corticosteroid / glucocorticoid

The formulation contains:

Dexamethasone 0.1% w/v

which corresponds to approximately:

1 mg dexamethasone per 1 mL.

Mechanism

Dexamethasone suppresses inflammatory processes by affecting inflammatory mediators and immune-cell activity.

It therefore reduces:

• Inflammation

• Redness

• Swelling

• Irritation

• Local inflammatory discomfort

Why is dexamethasone combined with ciprofloxacin?

Some ocular/otic conditions have both bacterial infection and significant inflammation.

Therefore:

Ciprofloxacin → controls susceptible bacteria

Dexamethasone → controls associated inflammation

This provides simultaneous antibacterial and anti-inflammatory action.

3. Benzalkonium Chloride — 0.01%

Class

Preservative

The label specifies benzalkonium chloride solution 0.01% w/v.

Its principal purpose in a multidose eye/ear-drop preparation is to limit microbial contamination after the container is opened.

It is not the principal therapeutic ingredient.

Some people may experience irritation or sensitivity to preservatives such as benzalkonium chloride, particularly with frequent or prolonged ophthalmic use.

4. Sterile Aqueous Vehicle — q.s.

q.s. = quantity sufficient

The sterile aqueous vehicle forms the liquid base of the preparation and provides the required volume for the active ingredients and preservative.

Because it is an ophthalmic/otic preparation, the vehicle is prepared under conditions appropriate for a sterile product.

Overall pharmacological action

The formulation can be summarized as:

Ciprofloxacin 0.3%

↓
Antibacterial action
↓
Inhibits bacterial DNA gyrase/topoisomerase IV
↓
Kills susceptible bacteria

Dexamethasone 0.1%

↓
Anti-inflammatory action
↓
Suppresses inflammatory response
↓
Reduces redness, swelling and inflammation

Benzalkonium chloride 0.01%

↓
Preservative
↓
Helps maintain product integrity after opening

What the formulation is used for

Ciprofloxacin/dexamethasone combinations are used for selected bacterial infections accompanied by inflammation, depending on whether the product is being used in the eye or ear and on the specific diagnosis.

Importantly, a ciprofloxacin/dexamethasone product should not automatically be used for every red eye or earache. The steroid component can worsen or mask certain infections, including some fungal or viral infections. Official labeling for ciprofloxacin/dexamethasone products specifically warns against inappropriate use in certain viral/fungal infections. (DailyMed)

Composition in prescription format

Each mL contains:
Ciprofloxacin Hydrochloride I.P. — equivalent to Ciprofloxacin 0.3% w/v
Dexamethasone I.P. — 0.1% w/v
Benzalkonium Chloride Solution I.P. — 0.01% w/v
Sterile Aqueous Vehicle I.P. — q.s.

Approximate active amount per 1 mL

• Ciprofloxacin equivalent: 3 mg

• Dexamethasone: 1 mg

• Benzalkonium chloride: 0.1 mg

Pack size shown: 10 mL

Brand: CIPROCOT-D
Dosage form: Eye/Ear Drops
Manufacturer shown: Vellition Healthcare

Important warning

Because this product contains a corticosteroid, prolonged or inappropriate use should be avoided unless directed by an eye/ear specialist. Steroid-containing ophthalmic preparations can delay healing and, with prolonged use, may contribute to complications such as increased intraocular pressure. For an unexplained red or painful eye, particularly with reduced vision or marked light sensitivity, medical examination is important.