Product image of Panotile (Fludrocortisone Acetate, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride) supplied by GNH India

Panotile

Active Ingredient:
Fludrocortisone Acetate, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride
Origin:
EU

Panotile (Fludrocortisone Acetate, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride)

Fludrocortisone acetate, the active ingredient in Panotile, is a corticosteroid presented as a topical ear preparation for otic use. It treats inflammatory conditions of the outer ear, particularly in patients requiring anti‑inflammatory and mineralocorticoid effects. GNH India supplies Panotile as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

GNH India supplies Panotile as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Zambon Nederland B.V.

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Indications & Clinical Uses

Panotile combines corticosteroid and antibiotic actions to address ear‑related inflammatory and infectious conditions.

  • Otitis externa: reduces inflammation and pain while controlling bacterial growth.
  • Ear canal dermatitis: alleviates itching and redness caused by inflammatory skin changes.
  • Post‑procedural ear care: helps prevent infection and swelling after minor ear surgeries or instrumentation.

How It Works

  • Fludrocortisone acetate binds to intracellular glucocorticoid receptors, modulating gene transcription to suppress pro‑inflammatory cytokines and reduce vascular permeability. Neomycin and polymyxin B disrupt bacterial cell‑wall synthesis, providing broad‑spectrum antimicrobial activity, while lidocaine blocks sodium channels to produce local anaesthesia.

Side Effects

Panotile may cause local and systemic reactions, although many patients tolerate it well.

Common Side Effects

  • Ear itching: mild irritation at the application site.
  • Burning sensation: transient warmth after dosing.
  • Mild otalgia: slight ear pain unrelated to infection.
  • Redness: localized erythema around the treated area.
  • Tinnitus: temporary ringing in the ear.
  • Dryness: reduced moisture in the ear canal.

Serious or Rare Side Effects

  • Allergic contact dermatitis: rash, swelling, or hives.
  • Otitis media with effusion: fluid accumulation behind the tympanic membrane.
  • Systemic corticosteroid effects: adrenal suppression with prolonged use.
  • Ototoxicity: hearing loss or balance disturbances.
  • Severe local infection: worsening redness, pus, or fever.
  • Anaphylaxis: rapid onset of breathing difficulty and hypotension.

Precautions & Warnings

Before using Panotile, consider patient history and proper administration techniques.

  • Contraindication: known hypersensitivity to any component.
  • Caution: avoid prolonged use to reduce risk of systemic corticosteroid absorption.
  • Monitor: patients with diabetes or hypertension for potential fluid retention.
  • Pediatric use: limit duration and frequency in children.
  • Pregnancy and lactation: use only if clearly needed and prescribed.
  • Store at ambient temperature: keep in original container, protect from moisture and direct sunlight.

Avoid Interactions

Panotile can interact with other otic medications and systemic drugs that affect corticosteroid metabolism.

Major Interactions (Avoid)

  • Systemic steroids: may increase total corticosteroid load, raising risk of systemic effects.
  • Ototoxic antibiotics (e.g., aminoglycosides): additive risk of hearing loss.

Moderate Interactions (Monitor Closely)

  • Antifungal ear drops: may reduce antibacterial efficacy.
  • Vasoconstrictive nasal sprays: could enhance local vasoconstriction when used concurrently.
  • Anticoagulants: monitor for increased bleeding if ear trauma occurs.
  • Immunosuppressants: heightened infection risk.
  • Topical NSAIDs: may increase local irritation.

Frequently Asked Questions

Panotile is an otic formulation that combines a corticosteroid with antibiotics and a local anaesthetic. It is used to treat inflammatory ear conditions such as otitis externa, ear canal dermatitis, and to prevent infection after minor ear procedures.

Fludrocortisone acetate binds to glucocorticoid receptors inside cells, altering gene expression to suppress inflammatory mediators and reduce swelling. This anti‑inflammatory action complements the antibacterial effects of neomycin and polymyxin B and the analgesic effect of lidocaine.

The prescribed dose of Panotile is determined by the treating clinician based on the severity of the ear condition, patient age, and response to therapy. Patients should follow the specific instructions provided by their healthcare professional.

Panotile should be used in pregnancy or while breastfeeding only if the potential benefit outweighs any risk. Clinicians typically assess the need carefully, as systemic absorption of corticosteroids can affect fetal development or infant health.

To order Panotile, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with single‑agent steroid ear drops, Panotile offers combined anti‑inflammatory, antibacterial and analgesic actions in one formulation, potentially reducing the need for multiple products. Alternatives may include separate steroid and antibiotic drops, which require more complex dosing schedules.

Panotile should be stored at ambient temperature, ideally below 25 °C, in its original packaging. Keep the container tightly closed, protect it from moisture and direct sunlight to maintain product stability.

Panotile is applied topically to the external ear canal. The recommended technique involves gently pulling the ear upward and backward (or downward for children), instilling the prescribed number of drops, and allowing the medication to remain in place for a few minutes before the patient resumes normal activities.

Serious risks include allergic reactions such as contact dermatitis, systemic corticosteroid effects like adrenal suppression with prolonged use, and rare ototoxicity leading to hearing loss. Patients should report any severe ear pain, swelling, or systemic symptoms promptly.

Panotile is contraindicated in individuals with known hypersensitivity to fludrocortisone acetate, neomycin, polymyxin B, lidocaine or any excipients in the formulation. Caution is also advised for patients with active middle‑ear infections, perforated tympanic membranes, or uncontrolled systemic diseases.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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