Ophthalmic Ocular inflammation with existing bacterial infection, Ocular inflammation with risk of bacterial infection
Adult: Available preparations:
Each mL of eye drop susp contains dexamethasone 1 mg, neomycin 3.5 mg, and polymyxin B 10,000 units
Each mL of eye drop susp contains dexamethasone 1 mg, neomycin 3,500 IU, and polymyxin B 6,000 IU
Each g of eye ointment contains dexamethasone 1 mg, neomycin 3.5 mg, and polymyxin B 10,000 units
Each g of eye ointment contains dexamethasone 1 mg, neomycin 3,500 IU, and polymyxin B 6,000 IU
As eye drop susp: Instil 1-2 drops into the conjunctival sac(s) of the affected eye(s) up to 4-6 times daily. In severe disease: Instil 1-2 drops hourly; dose frequency may be decreased as signs and symptoms improve. As eye ointment: Apply a small amount or approx half an inch ribbon into the conjunctival sac(s) of the affected eye(s) up to 3-4 times daily. Re-assess patient if symptoms persist after 2 days. Available preparations may vary among countries (refer to specific product guideline). Child: ≥2 years As eye drop susp: Same as adult dose.
Contraindications
Hypersensitivity to dexamethasone, neomycin, and polymyxin B. Viral infection of the cornea and conjunctiva (e.g. epithelial herpes simplex keratitis [dendritic keratitis], vaccinia and varicella infections), mycobacterial ocular infection, fungal diseases of ocular structures, untreated parasitic ophthalmic infections.
Special Precautions
Patient with glaucoma, history of ocular herpes simplex infection, personal or family history of diabetes mellitus; disease that causes thinning of the sclera or cornea. Use after cataract surgery. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions including cutaneous sensitisation; secondary ocular infections (including fungal infections), ocular hypertension and/or glaucoma, optic nerve damage, defects in visual acuity and fields of vision, corneal and scleral thinning leading to perforation, posterior subcapsular cataract formation (prolonged use); delayed wound healing; Cushing’s syndrome and/or adrenal suppression (intensive or prolonged use in predisposed patients). Eye disorders: Keratitis, eye pruritus, ocular discomfort, eye irritation, photophobia, mydriasis, eyelid ptosis, eye pain, foreign body sensation in the eyes, ocular hyperaemia, increased lacrimation, eye swelling. Nervous system disorders: Headache. Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome.
Patient Counseling Information
This drug may cause blurring of vision, if affected, do not drive or operate machinery. Do not wear contact lenses during treatment of bacterial infection of the eye. If use of contact lenses is allowed by the physician during treatment with the eye drops, remove contact lenses prior to application and wait for at least 15 minutes before reinsertion.
Monitoring Parameters
Monitor intraocular pressure in patients with glaucoma and when used for >10 days. Perform frequent slit lamp microscopy in patients with history of ocular herpes simplex.
Drug Interactions
CYP3A4 inhibitors (e.g. ritonavir, cobicistat) may increase the serum plasma concentrations and effects of dexamethasone. May increase risk of healing problems with topical NSAIDs.
Action
Description: Mechanism of Action: Dexamethasone is a corticosteroid that suppresses the response to various inflammatory agents.
Neomycin, an aminoglycoside antibiotic, binds with the ribosomal RNA of the susceptible bacteria thus inhibiting the protein synthesis and resulting to misreading of the bacterial genetic code.
Polymyxin B, a polymyxin antibiotic, binds to membrane phospholipids of the susceptible bacteria which disrupts the cytoplasmic membrane, thereby causing a leakage of essential metabolites. Pharmacokinetics: Absorption: Sufficiently absorbed after ophthalmic application.
Chemical Structure
Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5743, Dexamethasone. https://pubchem.ncbi.nlm.nih.gov/compound/Dexamethasone. Accessed Aug. 25, 2023.
Neomycin Source: National Center for Biotechnology Information. PubChem Database. Neomycin, CID=8378, https://pubchem.ncbi.nlm.nih.gov/compound/Neomycin (accessed on Jan. 21, 2020)
Polymyxin B Source: National Center for Biotechnology Information. PubChem Database. Polymyxin b, CID=49800004, https://pubchem.ncbi.nlm.nih.gov/compound/Polymyxin-b (accessed on Jan. 21, 2020)
Storage
Ophthalmic ointment: Store between 2-25°C. Ophthalmic suspension: Store between 8-27°C.
S01CA01 - dexamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
References
Anon. Dexamethasone (EENT). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/07/2020.Anon. Neomycin (EENT). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/07/2020.Anon. Neomycin, Polymyxin B, and Dexamethasone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/07/2020.Anon. Polymyxin B (EENT). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/07/2020.Buckingham R (ed). Dexamethasone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/07/2020.Buckingham R (ed). Neomycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/07/2020.Buckingham R (ed). Polymyxin B Sulfate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/07/2020.Dexatrol Eye Drops (Averroes Pharmaceutical Sdn. Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 21/10/2020.Maxitrol Eye Drops (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk/. Accessed 10/07/2020.Maxitrol Ointment (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk/. Accessed 10/07/2020.Maxitrol Suspension, Sterile Ophthalmic Ointment (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 21/10/2020.Neomycin and Polymyxin B Sulfate and Dexamethasone Ointment (Putney, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/07/2020.Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone Suspension (Sandoz Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/07/2020.
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