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Kenacomb Otic

Active Ingredients:(triamcinolone acetonide/neomycin sulphate/nystatin/gramicidin)

DESCRIPTION

Kenacomb Otic contains the synthetic corticosteroid triamcinolone acetonide; the antifungal agent nystatin; and the antibiotic agents neomycin sulphate and gramicidin.

Note:Each gram of Kenacomb Otic provides 1mg triamcinolone acetonide, 2.5mg neomycin as the sulphate, 0.25mg gramicidin and 100,000 units nystatin in an ointment base (plastibase), or viscous liquid (plastibase). Plastibase is a proprietary mixture of polyethylene and liquid paraffin.

CLINICAL PHARMACOLOGY

Kenacomb Otic is intended for application to the external auditory canal.

Triamcinolone acetonide, a topical corticosteroid has anti-inflammatory, antipruritic, and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognisable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Neomycin and gramicidin provide antibacterial activity against microorganisms likely to be responsible for bacterial infections of the external auditory canal.

Nystatin, an antifungal antibiotic, is included for the prevention or treatment of Candida albicans infections.

These ingredients give symptomatic relief of the pain, burning and itching of infected otitis externa, while combatting the relevant bacterial and/or monilial infection.

PHARMACOKINETICS

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressing.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption (see DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through the same pharmacokinetic pathways as systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Nystatin and gramicidin are not absorbed from intact skin or mucous membranes. Neomycin can be absorbed through inflamed skin. Once absorbed, it is rapidly excreted unchanged through the kidneys. The half-life is approximately 2 to 3 hours.

MICROBIOLOGY

Nystatin acts by binding to steroids in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.

On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy.

Nystatin exhibits no activity against bacteria, protozoa, or viruses.

Neomycin exerts its anti-bacterial activity against a number of gram-negative organisms by inhibiting protein synthesis. It is not active against Pseudomonas aeruginosa, and resistant strains of gram-negative bacteria may develop.

Gramicidin exerts it s antibacterial activity against many gram-positive organisms by altering cell membrane permeability.

PRESENTATION

Ear Drops: 7.5mL (dropper bottle).

Ointment: Tube : 5g (with cannula tip).

POISON SCHEDULES

Prescription Only Medicine

REGISTRATION NUMBERS

Kenacomb Otic Ear Drops AUST R 19200

Kenacomb Otic Ointment AUST R 19201

SPONSOR

Sigma Pharmaceuticals (Australia) Pty Ltd

96 Merrindale Drive

Croydon

Victoria 3136

Australia

Telephone: (03) 9839-2800

DATE OF APPROVAL: January 15, 1997

Safety Up-date: September 1997

Date of Safety Related Notification: 05 June 2009

Date of Last Amendment: 23 January 2010

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