Dexium® (dexamethasone) Corticosteroid Tablets for Pets (Rx)

Trade Names:

Dexium® Tablets

General Description:

This drug is a hormone related to cortisone and is used in dogs and cats to treat a variety of conditions. Dexamethasone is available in tablets and as an injectable.

What is this drug?

• A potent corticosteroid
• Given by mouth or injection

Reasons for prescribing:

• To treat certain inflammatory diseases
• To treat certain immune-mediated diseases
• To aid in the treatment of certain cancers
• To aid in the treatment of Addison's disease

What dogs/cats should not take this medication?

• Animals with stomach ulcers
• Animals with liver or kidney disease
• Animals with diabetes or Cushing's disease
• Animals with certain heart disease or high blood pressure
• Animals with infectious diseases
• Animals that will require surgery in the near future
• Animals that will require allergic skin testing in the near future
• Animals that may be pregnant or nursing
• Animals that are pediatric
• Animals with a known hypersensitivity or allergy to this drug should not take this medication

Directions:

Read and follow the prescription label carefully.

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

This medication is often given with food to reduce the potential for stomach upset. Due to the side effects of this medication, always ensure that your pet has access to fresh water and is allowed to urinate more frequently.

Give this medication for as long as your veterinarian directs. Do not skip doses or stop giving the medication without consulting your veterinarian.

Baseline blood work is recommended to assess your pet's general health before starting this drug.

Periodic blood work to monitor its effects on the body is also advised if long-term therapy is necessary.

Dose adjustments may be made based upon these results and an assessment of how your dog or cat is responding clinically.

Call ahead for refills.

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

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
• 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 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:

Dexamethasone should be stored in a childproof container in a cool, dry place at room temperature away from heat and direct sunlight.

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:

• Side effects are usually dose dependent
• This medication can affect the gastrointestinal system causing vomiting and diarrhea. These side effects may be reduced by giving this medication with food
• This medication can cause an increase in appetite, thirst and urination
• 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 cause the development of diabetes or Cushing's disease when given long term
• If these symptoms persist or you notice anything else unusual, contact your veterinarian

Can this drug be given with other drugs?

• Yes, but possible interactions may occur when giving dexamethasone in conjunction with: amphotericin B, cyclophosphamide, cyclosporine, digoxin, estrogens, erythromycin, furosemide, insulin, mitotane, neostigmine, nonsteroidal anti-inflammatories (ex. acetaminophen, deracoxib, carprofen, ibuprofen, meloxicam), phenobarbital, phenytoin, pyridostigmine, rifampin, and certain vaccines
• Drugs other than those listed may also interact with dexamethasone
• 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 your pet receives 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, dexamethasone 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.

This is just a summary of information about dexamethasone. If you have any questions or concerns about dexamethasone or the condition it was prescribed for, please contact your veterinarian.

Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the USA product label or package insert.

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DEXIUM^® TABLETS

Bimeda

(Dexamethasone Tablets, U.S.P.)

FOR DOGS AND CATS ONLY

NADA 095-218, Approved by FDA

DESCRIPTION:

Dexamethasone is a synthetic analogue of prednisolone. It acts similarly to prednisolone but has more potent anti-inflammatory, hormonal and metabolic effects. It is described chemically as 9-alpha-fluoro, 16-alpha-methyl prednisolone.

ACTION:

Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity. Dexamethasone, as with other corticosteroids, is not specific. It differs from other corticosteroids only in its anti-inflammatory potency and ability to manifest mineralocorticoid properties.

INDICATIONS:

Dexamethasone is indicated for use as an anti-inflammatory agent.

DOSAGE AND ADMINISTRATION:

Dosage and administration for Dexium Tablets are as follows:

Dogs: Administer orally at 0.25 to 1.25 mg. per day up to 7 days

Cats: Administer orally at 0.125 to 0.5 mg. per day up to 7 days

CONTRAINDICATIONS:

Do not use in viral infections. Except for emergency therapy, do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome and peptic ulcers. Existence of congestive heart failure, diabetes and osteoporosis are relative contraindications.

PRECAUTIONS:

Because of the anti-inflammatory action of corticosteroids, signs of infection may be hidden and it may be necessary to stop treatment until diagnosis is made. Overdosage of some glucocorticoids may result in sodium retention, fluid retention, potassium loss and weight gain. When therapy with Dexamethasone is to be discontinued after long use, the dosage should be reduced gradually. The administration of ACTH during the period of gradual dosage reduction may help to accelerate the normal adrenocortical function.

Use of corticosteroids, depending on dose, duration, and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapid acting corticosteroid should be considered in unusually stressful situations.

SIDE EFFECTS: Side reactions such as weight loss, anorexia, diarrhea, polydypsia, and polyuria have been frequently observed during corticosteroid therapy.

SAP AND SGPT (ALT) enzyme elevations, polydypsia 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.

WARNING: 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.

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

HOW SUPPLIED: Available in bottles of 100 and 1000 tablets, each tablet containing 0.25 mg. Dexamethasone.

STORAGE: Store at controlled room temperature 20°-25°C (68°-77°F), with excursions permitted to 15°-30°C (59°-86°F).

FOR ANIMAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

Dexium is a Registered Trademark of Bimeda, Inc.

Manufactured by: Bimeda, Inc., Le Sueur, MN 56058

Bimeda, Inc. is a Division of Cross Vetpharm Group Ltd.

8DEX002 Rev: 8/10

Net Contents:	Product No.
100 Tablets - 0.25 mg	1DEX009	8DEX004-1108
1000 Tablets - 0.25 mg	1DEX007	8DEX001-1108