Stenicol

Approved Indications

• Ophthalmic Use:
• Treatment of bacterial conjunctivitis and other superficial ocular infections sensitive to chloramphenicol combined with inflammation (e.g., conjunctivitis with significant inflammation).
• Management of ocular inflammatory conditions where steroid anti-inflammatory action is needed alongside antibacterial therapy.
• Postoperative ocular inflammation with or without infection.
• Otic Use:
• Treatment of bacterial external ear infections (otitis externa) with inflammation susceptible to chloramphenicol.
• Useful in managing ear infections with concurrent inflammation.

Clinically Accepted Off-Label Uses

• Certain mixed infections of the eye or ear where bacterial infection and inflammation coexist.
• Steroid-responsive inflammatory conditions complicated by secondary bacterial infections.

Ophthalmic (Eye Drops)

• Adults and Children (>2 years):
• Instill 1-2 drops into the affected eye every 4 hours initially.
• Dose may be adjusted based on clinical response; typically tapered as inflammation subsides.
• Maximum duration: usually not beyond 10 days to avoid steroid-related complications.
• Children <2 years: Use with caution; consult specialist.

Otic (Ear Drops)

• Adults and Children >2 years:
• Instill 3-4 drops into affected ear every 6 hours.
• Treatment duration typically 7 days or as directed by physician.
• Special Populations:
• Use caution in patients with perforated tympanic membrane.
• Dose adjustment not generally required for renal or hepatic impairment due to topical administration.

• Dexamethasone: A potent synthetic glucocorticoid that binds to intracellular glucocorticoid receptors, regulating gene expression to suppress pro-inflammatory cytokines, reduce leukocyte migration, and inhibit edema and capillary permeability. This anti-inflammatory effect reduces ocular or auricular inflammation and associated symptoms.
• Chloramphenicol: A broad-spectrum bacteriostatic antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide bond formation. This effectively halts bacterial growth, targeting susceptible aerobic and anaerobic Gram-positive and Gram-negative bacteria.

The combination provides both anti-inflammatory action (reducing tissue damage and symptoms) and antibacterial effects (eliminating or inhibiting pathogenic bacteria), suitable for infected inflammatory eye or ear conditions.

• Absorption:
• Minimal systemic absorption when applied topically to eye or ear.
• Small amounts of chloramphenicol and dexamethasone can be absorbed systemically but usually not clinically significant.
• Distribution:
• Primarily localized to surface tissues of the eye or ear canal.
• Metabolism:
• Systemic chloramphenicol is metabolized by hepatic glucuronidation; minimal systemic levels here.
• Dexamethasone metabolized hepatically if absorbed systemically.
• Excretion:
• Systemic metabolites excreted renally.

• Pregnancy:
• Topical ophthalmic and otic dexamethasone + chloramphenicol are generally considered category C for systemic corticosteroids and category B or C for chloramphenicol depending on systemic exposure.
• Use only if clearly needed; avoid systemic exposure.
• Lactation:
• Minimal systemic absorption suggests low risk; however, caution advised.
• Avoid contact with breast tissue during administration.

• Dexamethasone: Corticosteroid, Glucocorticoid
• Chloramphenicol: Antibiotic, Broad-spectrum bacteriostatic agent
• Combination Class: Topical corticosteroid-antibiotic preparation

• Known hypersensitivity to dexamethasone, chloramphenicol, or formulation excipients
• Viral infections of the eye or ear (e.g., herpes simplex keratitis, vaccinia)
• Fungal eye or ear infections
• Tuberculosis of the eye or ear
• Bacterial infections resistant to chloramphenicol
• Use in neonates (chloramphenicol risk of "gray baby syndrome")

• Prolonged use may cause increased intraocular pressure (glaucoma) and cataracts. Monitor intraocular pressure in chronic users.
• Risk of secondary infections with corticosteroids; discontinue if infection worsens.
• Chloramphenicol carries risk of aplastic anemia (rare but serious) with systemic use; topical use rarely causes systemic toxicity.
• Avoid use if suspected perforated tympanic membrane in ear infections unless directed by specialist.
• Use with caution in children and pregnant women.

Common:

• Local burning or stinging on application
• Eye irritation or redness
• Transient blurred vision (ophthalmic use)
• Ear discomfort or itching (otic use)

Less Common:

• Increased intraocular pressure
• Allergic contact dermatitis or hypersensitivity reactions
• Secondary fungal or bacterial superinfection
• Rare systemic effects from chloramphenicol such as blood dyscrasias (very rare with topical use)

• No significant systemic drug interactions due to minimal systemic absorption.
• Concomitant use with other topical eye or ear medications should be monitored to avoid additive toxicity or antagonism.
• Use caution with other corticosteroids to prevent cumulative steroid effects.

• Continued recommendation for combined corticosteroid-antibiotic topical agents for inflammatory bacterial conjunctivitis and otitis externa with inflammation.
• Emphasis on limiting duration of steroid-containing preparations to avoid steroid-related complications.
• Regulatory alerts reinforcing caution for chloramphenicol use in neonates due to rare toxicity risk.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from excessive moisture and light
• Keep container tightly closed
• Do not freeze
• Keep out of reach of children
• Discard eye or ear drops after recommended duration post-opening (usually 28 days)