Nystatin + thiostrepton + neomycin + triamcinolone ointment (Rx)

Trade Names:

Animax® Ointment

Derma-Vet™ Ointment

Dermalog® Ointment

Dermalone™ Ointment

EnteDerm™ Ointment

Panolog® Ointment

Quadritop™ Ointment

Resortin™

General Description:

This drug is a combination of medications that are commonly used in dogs and cats to treat ear disorders and certain skin conditions.

What is this drug?

• A combination of an antibiotic, antifungal, and corticosteroid
• Applied directly in the ear or applied directly on the skin

Reasons for prescribing:

• To treat ear infections
• To treat certain skin infections

What dogs/cats should not use this medication?

• Animals with a ruptured ear drum
• Animals with a deep skin infection or an abscess
• Animals that may be pregnant or nursing
• Animals that will require allergic skin testing in the near future
• Animals with a known hypersensitivity or allergy to this drug should not use this medication

Directions:

Read and follow the prescription label carefully.

Give the exact amount prescribed and only as often as directed.

Give this medication for as long as your veterinarian directs.

Do not skip doses or stop giving the medication without consulting your veterinarian.

Dose adjustments may be made based upon an assessment of how your dog or cats is responding clinically.

It may be necessary to clip the hair around the affected area to assist with the treatment of the skin infection.

It may be necessary to clip excess hair from around the ear to assist with cleaning and applying ear medications.

If your pet requires more than one ear medication, discuss with your veterinarian if it is preferable to administer the medications at different times of the day.

Wait until after the ear or skin is clean and dry before administering any medications into the ear or onto the skin.

Avoid getting this medication in your pet's eyes, nose, or mouth.

Always wash your hands before and after applying any topical medication.

If treating a potentially contagious skin condition, consider using gloves to apply the medication and consult with your veterinarian about further measures to avoid spreading the infection.

If you are having difficulty applying the medication or your pet is in discomfort, contact your veterinarian.

Call ahead for refills.

Ideally, give this medication at the same time(s) daily.

Administration of ear medications

• Wash your hands before applying any ear medication
• The ear should be clean and dry prior to administering medications
• Check label directions and shake bottle if necessary
• Lift the ear flap so that it is pointing straight up
• Hold the medication bottle insertion tip into the canal
• Gently squeeze the desired amount of medication into the canal
• Massage near the base of the ear to encourage the medication to work into the deeper aspects of the canal
• Wash your hands after applying any ear medication
• Always praise and reward your pet to encourage cooperation

What if a dose is missed?

If a dose is missed, give it as soon as you can. If it is time already for the next dose, skip the missed dose and go back to the normal schedule. Do not give two doses at the same time.

What to tell/ask a veterinarian before giving medication?

Talk to your veterinarian about:

• When your pet will need to be rechecked
• How often does your pet's ears need to be cleaned
• What tests may need to be performed prior to and during treatment with this drug
• What are the risks and benefits of using this drug

Tell your veterinarian about:

• If your pet has experienced previous ear problems
• If your pet has experienced side-effects on other drugs/products
• If your pet has experienced digestive upset now or ever
• If your pet has experienced liver or kidney disease now or ever
• If your pet has experienced any other medical problems or allergies now or ever
• All medicines and supplements that you are giving your pet or plan to give your pet, including those you can get without a prescription. Your veterinarian may want to check that all of your pet's medications can be given together.
• If your pet is pregnant, nursing or if you plan to breed your pet

Storage and Warnings:

Nystatin-neomycin-thiostrepton-triamcinolone ointment should be stored in a childproof container in a cool, dry place at room temperature away from heat and direct sunlight.

Pregnant women or women trying to become pregnant should wear gloves when applying this medication or wash hands immediately after application.

Keep this and all medication out of reach of children and pets.

Call your physician immediately if you accidentally take this product.

Potential side effects:

• This medication may cause local irritation or redness
• This medication can cause an increase in thirst, urination, and appetite
• This medication can affect the gastrointestinal system causing vomiting and diarrhea
• This medication can cause weight gain, panting, dull hair coat, muscle wasting, and behavior changes
• This medication can affect the immune system at high doses causing an increased susceptibility to infections and delayed wound healing
• This medication can affect the regulation of animals with Cushing's disease and diabetes mellitus
• Prolonged use of any antibiotic may lead to the development of bacterial resistance and overgrowth of other organisms
• If these symptoms persist or you notice anything else unusual, contact your veterinarian

Can this drug be given with other drugs?

• Do not give new food or medications without first talking to your veterinarian
• If your pet experiences any unusual reactions when taking multiple medications, contact your veterinarian

Overdosing?

Contact your veterinarian immediately if you pet has accidentally ingested this medication or has received more than the prescribed amount.

What else should I know?

Notify your veterinarian if your animal's condition does not improve or worsens despite this treatment.

As with all prescribed medicines, nystatin-neomycin-thiostrepton-triamcinolone ointment should only be given to the pet for which it was prescribed.

It should be given only for the condition for which it was prescribed. Never use ear or skin medications in the eye.

It is important to have any ear problems assessed by a veterinarian prior to applying any medications as incorrect treatment can result in damage to the ear.

Discuss with your veterinarian what is recommended to treat underlying conditions that may predispose your pet to reoccurring ear problems.

This is just a summary of information about nystatin-neomycin-thiostrepton-triamcinolone ointment. If you have any questions or concerns about nystatin-neomycin-thiostrepton-triamcinolone ointment or the condition it was prescribed for, please contact your veterinarian.

ANIMAX^® OINTMENT

Dechra

VETERINARY

nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment

NADA # 140-847. Approved by FDA.

For use in dogs and cats only.

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

DESCRIPTION: Animax Ointment combines nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide in a non-irritating polyethylene and mineral oil base.

Each mL contains:

The preparation is intended for local therapy in a variety of cutaneous disorders of dogs and cats; it is especially useful in disorders caused, complicated, or threatened by bacterial and/or candidal (monilial) infection.

ACTIONS: By virtue of its four active ingredients, Animax Ointment 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 pruritis 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 yeast-like 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.

WARNINGS: 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 the offspring. In dogs, other congenital anomalies have resulted: deformed forelegs, phocomelia, and anasarca.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS: Animax Ointment is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs and in anal gland infections in dogs.

The preparation is also indicated in the management of dermatologic disorders 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.

PRECAUTIONS: Animax Ointment 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.

Animax Ointment (Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone Acetonide Ointment) has been extremely well tolerated. Cutaneous reactions attributable to its use have been extremely rare. The occurrence of systemic reactions is rarely a problem with topical administration. There is some evidence that corticosteroids can be absorbed after topical application and cause systemic effects. Therefore, an animal receiving Animax Ointment therapy should be observed closely for signs such as polydipsia, polyuria, and increased weight gain.

Animax Ointment is not generally recommended for the treatment of deep or puncture wounds or serious burns.

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 of use, 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, vomiting, and diarrhea (occasionally bloody) have been observed following parenteral or systemic use of synthetic corticosteroids in dogs.

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

Temporary hearing loss has been reported in conjunction with treatment of otitis with products containing corticosteroids. However, regression usually occurred following withdrawal of the drug. If hearing dysfunction is noted during the course of treatment with Animax Ointment, discontinue its use.

CAUTION: Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue the use of Animax Ointment.

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 Animax Ointment may be applied as often as two to three times daily, if necessary. Frequency of treatment may be decreased as improvement occurs.

Wear gloves during the administration of the ointment or wash hands immediately after application.

Otitis

Clean ear canal of impacted cerumen. Inspect canal and remove any foreign bodies such as grass awns, ticks, etc. Instill three to five drops of Animax Ointment.

Preliminary use of a local anesthetic may be advisable.

Infected Anal Glands, Cystic Areas, etc.

Drain gland or cyst and then fill with Animax Ointment.

Other Dermatologic Disorders

Clean affected areas, removing any encrusted discharge or exudate. Apply Animax Ointment (Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone Acetonide Ointment) sparingly in a thin film.

HOW SUPPLIED: Animax Ointment is supplied in tubes as follows:

STORAGE: Store at room temperature; avoid excessive heat (104°F).

240 mL bottle: Do not store above 86°F

TO OPEN: Use cap to puncture seal.

1. Remove entire Applicator Assembly, puncture tube with white portion of the cap.

2. Replace entire Applicator Assembly.

3. To dispense, remove the white portion of the cap.

4. After use replace white cap to close.

IMPORTANT: The opening of this product is covered by a metal tamper-resistant seal.

If this seal has been punctured or is not visible, do not use and return product to place of purchase.

MANUFACTURED FOR: Dechra Veterinary Products, Overland Park, KS 66211

I122/IF122 DECHRA R07/08

#566