Triclir

Colorless solution.
Each mL of this product contains: Neomycin sulfate, USP 3.5 mg (in aqueous propylene glycol solution), Polymyxin B sulfate, USP 10,000 units, Fluocinolone acetonide, USP 0.025% (equivalent to 250 mcg/mL).

Pharmacology: Pharmacodynamics: This product is a potent agent in the treatment of inflammatory and pruritic dermatoses. In relation to other corticosteroids used topically as adjunctive therapy, this has been shown as effective and, in many instances, was effective when other agents gave inadequate therapeutic response.
The mechanism of action of this product is as a corticosteroid hormone receptor agonist. It is the acetonide salt form of Fluocinolone, a synthetic fluorinated corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties.
Neomycin is an aminoglycoside. It inhibits bacterial protein synthesis through irreversible binding to the 30S ribosomal subunit of susceptible bacteria. Neomycin sulfate provides effective local antibacterial action against many Gram-positive and Gram-negative pathogens, such as Staphylococcus aureus, Streptococci and Proteus vulgaris, encountered in local infections of the ear and adjacent structures.
Polymyxins bind to the cell membrane and alter its structure, making it more permeable. Polymyxin B sulfate is antibacterial for many Gram-negative organisms, including Pseudomonas aeruginosa, a common cause of otitis externa; Escherichia coli and Aerobacter aerogenes. Neomycin sulfate and Polymyxin B sulfate have complementary action against such pathogens as Haemophilus, Corynebacterium, Neisseria, Klebsiella and Pneumococcus.
Propylene glycol is a water-miscible vehicle with low surface tension which facilitates spreadability and penetration of the medication. Fluocinolone acetonide, Neomycin sulfate and Polymyxin B sulfate are highly soluble and stable in this vehicle. The relatively slow rate of evaporation maintains the solution state for an adequate time to allow distribution and contact with all parts of the lesion.
Pharmacokinetics: Fluocinolone acetonide: Rapidly absorbed. Corticosteroids are metabolized 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. Has a half-life of 1.3 to 1.7 hours.
Polymyxin B sulfate: Not absorbed from the normal alimentary tract. The drug is excreted slowly by the kidneys.
Neomycin sulfate: Poorly absorbed from the normal gastrointestinal tract. Although only approximately 3% of neomycin is absorbed through intact intestinal mucosa, significant amounts may be absorbed through ulcerated or denuded mucosa or if inflammation is present. Neomycin undergoes negligible biotransformation after parenteral administration. The small absorbed fraction is rapidly distributed in the tissues and is excreted by the kidney in keeping with the degree of kidney function. Has a half-life of 2 to 3 hours.

This product is indicated for the treatment of inflammatory and pruritic dermatoses. It is intended for use in acute or chronic otitis externa due to or complicated by organisms susceptible to Neomycin sulfate or Polymyxin B sulfate.
This medication also has therapeutic value in the adjunctive management of acute or chronic dermatoses of external ear whether allergic, seborrheic or neurogenic in origin such as atopic dermatitis, neurodermatitis, contact dermatitis, seborrheic dermatitis, chronic eczematous dermatitis and psoriasis vulgaris.

This product is intended for topical use only. The ear should be carefully cleansed and dried, this product may then be applied to the affected ear with the dropper or be used to saturate a wick placed in the external auditory canal. The suggested dosage is 3 to 4 drops, 2 to 4 times daily, or more frequently as required. It is advisable to warm the drops to body temperature before they are placed in the ear in order to avoid caloric stimulation of the vestibular apparatus.

If too much Triclir is applied to the ear, the excess drug should be drained by letting it flow out of the ear. This is not expected to cause adverse effects since little if any absorption is expected to take place. If Triclir is accidentally swallowed, seek medical attention immediately.

Topical corticosteroids are contraindicated in tuberculous, fungal and viral lesions of the skin. This product is contraindicated in individuals with a history of hypersensitivity to any of its components. It should not be used where there is perforation of the tympanic membrane. The preparation is not intended for ophthalmic use.

For topical use only.
Not to be used one month after opening.

This product preparation is virtually non-sensitizing and non-irritating. Should sensitivity or idiosyncratic reactions occur, the agent should be discontinued and appropriate steps should be taken.
If local infections should continue or become severe, appropriate systemic antibacterial therapy, based on susceptibility testing should be considered.

Fluocinolone acetonide: US FDA Pregnancy Category C. Topical corticosteroids should not be used extensively on pregnant patients, in large amounts or for extended periods of time. It is excreted into human milk and the effects on the nursing infant are unknown.
Polymyxin B sulfate: Pregnancy Category C. Because it is poorly absorbed after topical application, Polymyxin B sulfate is considered a low risk to the nursing infant.
Neomycin sulfate: Pregnancy Category D. Although serious side effects to the fetus or newborn have not been reported, the potential for harm exists. There are no data on the excretion of Neomycin sulfate into human milk although a potential for harm to the nursing infant exists. Use of Neomycin sulfate for pregnant or lactating women is not recommended.

Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, allergic contact dermatitis, secondary infections, skin atrophy, nephrotoxicity, ototoxicity.

Kanamycin, paromomycin, streptomycin.

Store at temperatures not exceeding 30°C.

Ear Antiseptics with Corticosteroids

S02CA05 - fluocinolone acetonide and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in the treatment of ear diseases.

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