Triamcinolone + Nystatin + Neomycin + Gramicidin: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

Otic/Aural
Otitis externa

Adult: As otic ointment containing triamcinolone acetonide 0.1%, neomycin (as sulphate) 0.25%, gramicidin 0.025%, nystatin 100,000 units/g: Apply a small amount directly into the aural canal 2-3 times daily.
Child: As otic ointment containing triamcinolone acetonide 0.1%, neomycin (as sulphate) 0.25%, gramicidin 0.025%, nystatin 100,000 units/g: Apply a small amount directly into the aural canal 2-3 times daily.
Elderly: Use sparingly for short periods of time.

Topical/Cutaneous
Corticosteroid-responsive dermatoses with secondary infection

Adult: As cream/ointment containing triamcinolone acetonide 0.1%, neomycin (as sulphate) 0.25%, gramicidin 0.025%, nystatin 100,000 units/g: Apply sparingly to the affected area 2-3 times daily.
Child: As cream/ointment containing triamcinolone acetonide 0.1%, neomycin (as sulphate) 0.25%, gramicidin 0.025%, nystatin 100,000 units/g: Apply sparingly to the affected area 2-3 times daily.
Elderly: Use sparingly for short periods of time.

Contraindications

Tuberculous, viral lesions of the skin (e.g. herpes simplex and varicella); fungal lesions not susceptible to nystatin, facial rosacea, acne vulgaris or perioral dermatitis. Not to be applied to the external auditory canal in patients with perforated tympanic membranes. Do not use on extensive areas to reduce risk of systemic absorption and neomycin-induced ototoxicity. Not recommended for <1 yr.

Special Precautions

Patients with established hearing loss. Avoid occlusive dressing and prolonged or recurrent use. Avoid contact with eyes or mucous membranes. If there is no clinical improvement after 7 days, discontinue use as the infection may be masked by the steroid. Limit use to 5 days if used on the face or on children ≥1 yr. Use with caution and sparingly on inflamed or damaged skin (e.g extensive burns, trophic ulceration). Pregnancy.

Adverse Reactions

Prolonged use may cause sensitivity reactions, impaired wound healing, thinning of skin, striae, telangiectasia, hirsutism, hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome. Ototoxicity and nephrotoxicity.

Action

Description: Triamcinolone is a fluorinated corticosteroid with anti-inflammatory, antipruritic and anti-allergic actions. Nystatin, a polyene antifungal antibiotic, binds to ergosterol and interferes with the permeability of cell membrane of susceptible fungi e.g Candida spp. Neomycin is an aminoglycoside, often used topically in the infections against susceptible staphylococci and other organisms. Gramicidin, an antibacterial substance extracted from tyrothricin, is active against many Gram-positive bacteria. Used together, this combination provides a wide coverage against gram-positive, gram-negative bacteria and yeast which are responsible for most of the skin infections.
Pharmacokinetics:
Absorption: Nystatin: Poorly absorbed from GI tract; not absorbed from skin and mucous membranes when applied topically. Neomycin: Poorly absorbed from GI tract, absorption increased in damaged or inflamed mucosa or skin.
Distribution: Triamcinolone: Crosses placenta
Excretion: Triamcinolone: Plasma half life: 2- >5 hr. Neomycin: Rapidly excreted by kidneys; half life: 2-3 hr.

Storage

Otic/Aural:
Do not store above 25°C.
Topical/Cutaneous:
Ointment: Do not store above 25°C. Cream: Do not store above 25°C. Do not freeze.

MIMS Class

Ear Antiseptics with Corticosteroids / Topical Anti-Infectives with Corticosteroids

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