Otal®: Comprehensive Guide to Ear Drops for Infections and Pain Relief

Otal® is a specialized pharmaceutical formulation designed to address a range of conditions affecting the external ear. This article provides an in-depth guide to Otal®, covering its composition, pharmacological properties, indications, adverse effects, precautions, contraindications, dosage recommendations, and essential patient information.

Composition

Each 100 ml of Otal® contains a combination of active ingredients:

  • Framycetin Sulphate: 390mg (Equivalent to 300 mg Framycetin base)
  • Gramicidin: 2.5mg
  • Dexamethasone: 100mg
  • Cinchocaine HCL: 1gm

Pharmacological Properties

Framycetin Sulphate

Framycetin, derived from streptomyces fradii, is a potent bactericidal agent effective against both gram-positive and gram-negative organisms. It acts as an aminoglycoside antibiotic, inhibiting protein synthesis by causing misreading of the bacterial genetic code.

Gramicidin

Gramicidin exhibits bactericidal activity against various gram-positive organisms. It enhances bacterial cell membrane permeability, forming channels through the lipid bi-layer and facilitating the entry of inorganic cations.

Dexamethasone

Dexamethasone, a synthetic fluorinated corticosteroid, plays a crucial role in suppressing inflammatory responses. It also possesses anti-edematous and anti-pruritic effects.

Cinchocaine

Cinchocaine, classified as a topical anesthetic of the amide type, contributes to surface anesthesia.

Indications

Otal® is recommended for the following conditions:

  1. Superficial Bacterial Infections of the External Auditory Canal: Especially effective against organisms sensitive to Otal® ear drops.
  2. Severe Inflammatory Conditions of the External Ear: This includes edema, pruritus, and dermal reactions of the external auditory meatus.
  3. Pain Relief in Otalgia: Otal® provides relief in cases of ear pain.

Otal® ear drops are specifically suggested for use in:

  • Acute diffuse otitis externa.
  • Furunculosis of the external auditory canal.
  • Acute congestive or serous otitis media with an intact drum.

Adverse Effects

While Otal® is generally well-tolerated, some individuals may experience hypersensitivity reactions. These reactions could include contact dermatitis, burning sensations, erythema, rash, and urticaria. In such cases, discontinuation of therapy and consultation with a physician are recommended.

Precautions

  • Topical Corticosteroid Concerns: When used with framycetin, topical corticosteroids may mask clinical signs of fungal and viral infections.
  • Contraindications: Otal® is contraindicated in individuals with hypersensitivity to any of its components and in cases of viral or fungal infections.

Dosage Recommendations

For optimal results, follow these dosage recommendations:

  • Adults: Instill 3-5 drops of Otal® into the affected ear(s) 3-4 times daily.
  • Infants & Children (Below 3 Years): Administer 2-3 drops of Otal® due to the smaller capacity of the ear canal.

Alternatively, a cotton wick or gauze saturated with the solution can be inserted into the external auditory canal, kept moist by adding further solution every 4 hours. The wick should be replaced every 24 hours.

Patient Information

  • Applicator Tip: Avoid touching the applicator tip.
  • Cap Usage: Replace the cap after each use.
  • Single-Patient Use: Otal® should not be used by more than one patient.

How Otal® is Supplied

Otal® comes in plastic dropper bottles containing 5ml of sterile solution.

Remember, it’s crucial to keep all medicaments out of the reach of children.

For any inquiries, consult your healthcare provider or contact AMOUN PHARMACEUTICAL CO. SAE, El-Obour City, Cairo, Egypt.

In conclusion, Otal® stands as a reliable and effective solution for various ear conditions, providing relief and promoting ear health. Always use Otal® as directed by your healthcare professional.