Fort Dodge

NYSTATIN-NEOMYCIN SULFATE-THIOSTREPTON-TRIAMCINOLONE ACETONIDE CREAM USP

NADA 96-676, Approved by FDA

FOR TOPICAL USE ON DOGS AND CATS ONLY

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

Panolog Cream (Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone Acetonide Cream USP) combines nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide.

Each gram contains:

in an aqueous, nonirritating vanishing cream base with cetearyl alcohol (and) ceteareth-20, ethylenediamine hydrochloride, methylparaben, propylparaben, propylene glycol, sorbitol solution, titanium dioxide, sodium citrate, citric acid, white petrolatum, simethicone emulsion and purified water.

ACTIONS

By virtue of its four active ingredients, Panolog Cream provides four basic therapeutic effects: anti-inflammatory, antipruritic, antifungal and antibacterial. Triamcinolone acetonide is a potent synthetic corticosteroid providing rapid and prolonged symptomatic relief on topical administration. Inflammation, edema and pruritus promptly subside, and lesions are permitted to heal. Nystatin is the first well-tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous infections caused by Candida albicans (Monilia). Nystatin is fungistatic in vitro against a variety of yeast and yeastlike fungi including many fungi pathogenic to animals. No appreciable activity is exhibited against bacteria. Thiostrepton has a high order of activity against gram-positive organisms, including many which are resistant to other antibiotics; neomycin exerts antimicrobial action against a wide range of gram-positive and gram-negative bacteria. Together they provide comprehensive therapy against those organisms responsible for most superficial bacterial infections.

INDICATIONS

Panolog Cream is indicated in the management of dermatologic disorders in dogs and cats, characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated or threatened by bacterial or candidal (Candida albicans) infections. It is also of value in eczematous dermatitis, contact dermatitis and seborrheic dermatitis; and as an adjunct in the treatment of dermatitis due to parasitic infestation.

CONTRAINDICATIONS

Panolog Cream (Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone Acetonide Cream USP) should not be used ophthalmically.

WARNINGS

Panolog Cream is indicated for topical use in dogs and cats only. Not for use in animals which are raised for food.

Absorption of triamcinolone acetonide through topical application and by licking may occur. Therefore animals should be observed closely for signs of polydipsia, polyuria and increased weight gain particularly when the preparation is used over large areas or for extended periods of time.

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta and metritis.

Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies including deformed forelegs, phocomelia and anasarca.

PRECAUTIONS

Panolog Cream is not intended for the treatment of deep abscesses or deep-seated infections such as inflammation of the lymphatic vessels. Parenteral antibiotic therapy is indicated in these infections.

Panolog Cream has been extremely well tolerated. The occurrence of systemic reactions is rarely a problem with topical administration.

Sensitivity to neomycin may occur. If redness, irritation or swelling persists or increases, discontinue use. Do not use if pus is present since the drug may allow the infection to spread.

Avoid ingestion. Oral or parenteral use of corticosteroids, depending on dose, duration and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal.

SIDE EFFECTS

SAP and SGPT (ALT) enzyme elevations, polydipsia and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs.

Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

DOSAGE AND ADMINISTRATION

Frequency of administration is dependent on the severity of the condition. For mild inflammations, application may range from once daily to once a week; for severe conditions Panolog Cream may be applied as often as 2 to 3 times daily, if necessary. Frequency of treatment may be decreased as improvement occurs.

Clean affected areas, removing any encrusted discharge or exudate. Apply Panolog Cream sparingly in a thin film.

HOW SUPPLIED

Panolog Cream is supplied in 7.5 gram and 15 gram tubes.

STORAGE

Do not store above 86°F (30°C).

© 2005 Fort Dodge Animal Health. All Rights Reserved.

Fort Dodge Animal Health, Fort Dodge, Iowa 50501 USA

01615

Revised June 2005

12830C

NAC No.: 10031422