Neladex (Polymyxin B, Neomycin, Dexamethasone) Eye/Ear drops, 5 ml

What is Neladex (Polymyxin B, Neomycin, Dexamethasone) Eye/Ear Drops?

Neladex is a combination medication that contains polymyxin B, neomycin, and dexamethasone. It is used to treat inflammatory conditions of the eye or ear that are associated with or at risk of bacterial infections.

This medication is suitable for both adults and children over the age of 8.

The drops work by reducing inflammation and preventing or treating bacterial infections, making them effective for various eye or ear conditions.

What Are the Indications for Using Neladex?

Neladex is indicated for the treatment of inflammatory conditions of the eye that are associated with a surface bacterial infection or are at risk of developing such an infection. The medication is particularly useful in cases where corticosteroid treatment is appropriate, including:

• Inflammation of the conjunctiva of the eyelid or eyeball
• Inflammation of the cornea and the front part of the eye
• Chronic anterior uveitis
• Corneal damage caused by chemicals, radiation, thermal burns, or foreign bodies

What Precautions Should Be Taken Before Using Neladex?

Before using Neladex, it is important to be aware of certain precautions:

• Hypersensitivity: Do not use if you have a known hypersensitivity to any of the active ingredients (polymyxin B, neomycin, dexamethasone) or other components of the formulation.
• Herpetic Infections: It should not be used in cases of simple epithelial herpes keratitis (dendritic keratitis).
• Viral Infections: Avoid use if you have smallpox, chickenpox, or any other viral infection of the cornea or conjunctiva (except keratitis caused by the herpes zoster virus).
• Fungal and Mycobacterial Infections: Neladex is contraindicated in fungal diseases of the eye structures and mycobacterial eye infections.
• Post-Removal of Foreign Bodies: Do not use after uncomplicated removal of foreign bodies from the cornea or in any other infection or injury affecting the surface epithelium of the cornea.

What Are the Potential Drug Interactions with Neladex?

While no specific drug interaction studies have been conducted for Neladex, caution is advised when using the medication with certain other drugs:

• CYP3A4 Inhibitors: Medications like ritonavir and cobicistat may increase the systemic effects of dexamethasone, potentially leading to Cushing's syndrome or adrenal suppression.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Concurrent use of NSAIDs and corticosteroids may increase the risk of corneal healing problems.
• Mydriatic Eye Drops: Combining Neladex with eye drops that dilate the pupil (like atropine) can further increase intraocular pressure.

How Should Neladex Be Used?

For proper application of Neladex, follow these guidelines:

• Dosage: Instill 1–2 drops into the conjunctival sac.
• Frequency: For severe infections, the drops can be used every hour, reducing the frequency as inflammation subsides. For milder conditions, 4-6 applications per day are usually sufficient.
• Special Populations:
  • Children: The safety and efficacy of Neladex in children have not been established, and its use is not recommended in those under 8 years old.
  • Elderly: The dosage is the same as for adults.
  • Liver and Kidney Issues: There is no need for dosage adjustment in patients with liver or kidney issues due to the low systemic absorption of the active ingredients.

What Are the Possible Side Effects of Neladex?

The use of Neladex can lead to several side effects, though they are generally uncommon:

• Uncommon Side Effects: Hypersensitivity, keratitis, increased intraocular pressure, eye discomfort, and irritation.
• Unknown Frequency: Ulcerative keratitis, blurred vision, photophobia, eyelid ptosis, eye pain, eye swelling, and increased tear production.
• Systemic Effects: Although rare with local application, systemic absorption of corticosteroids can lead to conditions like Cushing's syndrome or adrenal suppression.

How Should Neladex Be Stored?

• Shelf Life: Neladex has a shelf life of 3 years. Once the bottle is opened, it should be used within 28 days.
• Storage Conditions: Store the medication at a temperature not exceeding 25°C (77°F) and keep it out of reach of children.