Eyephen Plus0.1%+0.5%

Eyephen Plus is an ophthalmic (eye) combination of a corticosteroid and a broad-spectrum antibiotic. It is indicated for steroid-responsive inflammatory ocular conditions in which there is a bacterial infection or a risk of bacterial infection.

Established/Guideline-Supported Uses

• Steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye (e.g. allergic conjunctivitis, episcleritis, superficial punctate keratitis) where a bacterial infection or risk of one is also present
• Acute purulent (bacterial) conjunctivitis
• Corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies, when accompanied or risked by bacterial infection
• Iritis and uveitis of the anterior segment with concurrent or risk of bacterial infection
• Postoperative inflammation following ocular surgery, when infection risk is also a concern

Important Note on Use

Eyephen Plus is intended for short-term use under medical supervision. It is not intended for infections of the eye caused by viruses, fungi, or mycobacteria (see Contraindications), and it should not be used simply as a general-purpose eye drop for undiagnosed red or irritated eyes.

Each mL of ophthalmic solution (eye drop) typically contains Dexamethasone (as sodium phosphate) 1 mg (0.1% w/v) and Chloramphenicol 5 mg (0.5% w/v). An ophthalmic ointment form with corresponding strengths may also be available. Exact strength and formulation should be confirmed on the product label.

Eyephen Plus is a fixed-dose combination ophthalmic preparation that pairs a potent synthetic glucocorticoid (dexamethasone) with a broad-spectrum bacteriostatic antibiotic (chloramphenicol). It is formulated as eye drops (and sometimes eye ointment) for topical application to the eye.

The corticosteroid component suppresses inflammation, redness, swelling, and allergic-type reactions of the ocular surface, while the antibiotic component treats or prevents bacterial infection that may accompany the inflammatory condition or be introduced during a course of steroid therapy. The combination is intended for short courses under ophthalmologic or physician supervision rather than long-term or unsupervised use.

Eyephen Plus belongs to the therapeutic class of Ophthalmic Corticosteroid + Antibiotic combinations, combining an anti-inflammatory corticosteroid (glucocorticoid) with a broad-spectrum antibacterial agent for topical ocular use.

Dexamethasone

Dexamethasone is a synthetic glucocorticoid that suppresses the inflammatory response by inhibiting the release of inflammatory mediators (prostaglandins, leukotrienes), reducing capillary permeability, and suppressing migration of inflammatory cells (leukocytes, macrophages) to the site of injury. This reduces the classic signs of ocular inflammation: edema, redness, and cellular infiltration.

Chloramphenicol

Chloramphenicol is a broad-spectrum antibiotic that is bacteriostatic (and bactericidal at higher concentrations against some organisms). It inhibits bacterial protein synthesis by binding reversibly to the 50S ribosomal subunit, blocking peptidyl transferase activity. It is active against a wide range of Gram-positive and Gram-negative organisms commonly implicated in bacterial conjunctivitis, including Staphylococcus species, Streptococcus pneumoniae, Haemophilus influenzae, and Escherichia coli.

When Dexamethasone + Chloramphenicol is applied topically to the eye, systemic absorption is generally low, but some systemic absorption can occur, particularly with prolonged use, broken corneal epithelium, or use in infants.

How to Apply Eye Drops

• Wash hands thoroughly before use.
• Tilt the head back, gently pull down the lower eyelid to form a small pocket, and instil the prescribed number of drops without letting the dropper tip touch the eye, eyelid, or any surface.
• Close the eye gently for 1-2 minutes and apply light pressure at the inner corner of the eye (near the nose) to reduce systemic absorption.
• If using both drops and ointment, or two different eye medicines, wait at least 5-10 minutes between applications, and apply drops before ointment.
• Do not touch the dropper or tube tip to any surface, including the eye, to avoid contamination.
• Replace the cap tightly after each use.
• If a contact lens wearer, remove lenses before application and do not reinsert until advised by a physician, as the product may contain preservatives that can be absorbed by soft lenses.

Eyephen Plus has limited clinically significant drug interactions when used topically in the eye, but the following should be noted:

• Other topical ophthalmic corticosteroids or antibiotics: Concurrent use of additional topical steroid or antibiotic products should only be done under medical supervision to avoid additive effects or antagonism.
• Live vaccines: Although systemic absorption from topical ocular use is low, corticosteroids can theoretically impair immune response; inform the physician of any planned vaccinations if using for a prolonged period.
• Enzyme-inducing/inhibiting drugs (systemic use context): Chloramphenicol is a known inhibitor of hepatic cytochrome P450 enzymes when given systemically, which can raise levels of drugs such as phenytoin and warfarin; this is a much lower concern with topical ophthalmic use but should still be disclosed to the physician if the patient is on such systemic medicines, especially with prolonged or high-frequency ocular use.

Always inform your physician or pharmacist about all other medicines, including other eye drops, being used.

Most side effects of Eyephen Plus are local and mild-to-moderate, related to the site of application.

Common

• Transient burning, stinging, or discomfort on instillation
• Eye redness, itching, or irritation
• Blurred vision (transient)
• Foreign body sensation
• Photophobia (light sensitivity)

Less Common but Important

• Elevated intraocular pressure/glaucoma with prolonged use
• Posterior subcapsular cataract formation with prolonged use
• Delayed wound/corneal healing
• Secondary ocular infection (bacterial, viral, or fungal) due to suppression of the host immune response, especially with prolonged use
• Allergic-type hypersensitivity reactions (eyelid swelling, rash)

Rare but Serious

• Rare case reports of serious blood disorders (aplastic anemia, bone marrow suppression) have been associated with chloramphenicol, including with topical ophthalmic use, although this is very rare with eye drops (see Precautions and Warnings).
• Optic nerve damage and visual field defects with long-term corticosteroid use
• Globe/corneal perforation, particularly where thinning of the cornea or sclera has occurred

Report any unusual bruising, bleeding, sore throat, fever, or signs of infection promptly to a physician.

Eyephen Plus should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Systemic absorption from topical ophthalmic use is generally low, but corticosteroids have been associated with fetal effects in animal studies when given systemically at high doses, and chloramphenicol carries theoretical concerns (including “gray baby syndrome”) that are primarily linked to systemic, not topical ophthalmic, exposure. Use only under medical supervision and for the shortest effective duration.

It is not known whether topically applied dexamethasone or chloramphenicol are excreted in clinically significant amounts in human breast milk. Caution is advised when prescribing to breastfeeding mothers; consult a physician before use during lactation.

Ocular Steroid Risks with Prolonged Use

Prolonged use of Eyephen Plus can result in elevated intraocular pressure and glaucoma with optic nerve damage, and posterior subcapsular cataract formation. Intraocular pressure should be monitored if used for more than 10 days.

Masking or Worsening of Infection

Use of corticosteroids in the presence of undiagnosed infection may mask signs of infection or enhance existing infection. In diseases causing corneal or scleral thinning, perforation has occurred with topical steroid use. If a corneal lesion fails to improve after use, fungal infection should be suspected and appropriate testing performed; prolonged corticosteroid use may enhance fungal or viral ocular infection.

Chloramphenicol-Associated Blood Dyscrasias (Stewardship Note)

Serious, rare, and sometimes fatal blood disorders (aplastic anemia, bone marrow suppression) have been reported very rarely in association with chloramphenicol, including in isolated case reports following topical ophthalmic use, although current evidence indicates the absolute risk with eye drops is extremely low. As a precaution, Eyephen Plus should be used only as prescribed, for the shortest necessary duration, and any unusual bruising, bleeding, persistent sore throat, mouth ulcers, or fever during or after treatment should be reported to a physician promptly. Take exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice.

Not for Injection or Other Routes

This product is for ophthalmic (topical eye) use only. It must not be injected or used in any route other than as directed on the label.

Prolonged Antibiotic Use

As with other antibiotic preparations, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute appropriate alternative therapy.

Contact Lenses

Avoid wearing contact lenses during treatment unless otherwise directed by a physician.

Topical ocular overdose (e.g. excessive drops) is unlikely to cause serious systemic toxicity but may cause increased local irritation. If excessive drops are accidentally instilled, the eye may be flushed with lukewarm water.

If the product is accidentally ingested or a child swallows a significant amount, seek immediate medical attention or contact a poison control center/emergency services right away. Do not attempt home treatment for accidental ingestion; take the product container with you to the healthcare facility if possible.

Store at room temperature (below 30°C), away from light and moisture. Do not freeze. Keep the container tightly closed when not in use. Discard any remaining product 4 weeks (28-30 days) after opening, as recommended for most multi-dose ophthalmic preparations, or per the manufacturer's specific instructions. Keep out of reach of children.

Pediatric Use

Safety and efficacy of Eyephen Plus in neonates and young infants have not been well established, and caution is advised due to a theoretical risk of increased systemic absorption in this age group. Use in children should be under close medical supervision, for the shortest effective duration.

Elderly

No specific dose adjustment is generally required in elderly patients; use as directed by the physician with routine monitoring for intraocular pressure and cataract if long-term use is needed.

Renal/Hepatic Impairment

Because systemic absorption from topical ocular use is low, no specific dosage adjustment is generally required for renal or hepatic impairment; however, caution and physician guidance are advised, particularly with prolonged or frequent use.

Treatment with Eyephen Plus is generally intended for short-term use, typically not exceeding 7-10 days, and should be reassessed by a physician if longer therapy is being considered, due to the cumulative risks of corticosteroid-related ocular side effects with prolonged use. Do not use for longer than the duration prescribed.

Ophthalmic Corticosteroid; Ophthalmic Antibiotic (Amphenicol class)

Dexamethasone acts as a glucocorticoid receptor agonist, suppressing inflammatory mediator release and immune cell migration to reduce ocular inflammation. Chloramphenicol acts by binding to the bacterial 50S ribosomal subunit, inhibiting peptidyl transferase and blocking bacterial protein synthesis, resulting in a bacteriostatic (and at higher local concentrations, bactericidal) effect against susceptible organisms.

C

Use of Eyephen Plus in children should be under close physician supervision. Safety and efficacy in neonates and infants have not been formally established, and this age group may have relatively greater systemic absorption from ocular tissue. When prescribed for a child, use the lowest effective dose for the shortest necessary duration and follow the physician's instructions precisely.