BETAGEN™ TOPICAL SPRAY

GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE TOPICAL SPRAY

ANADA #200-188, Approved by FDA.

Veterinary

For Topical Use in Dogs Only

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

INDICATIONS: For the treatment of infected superficial lesions in dogs caused by bacteria sensitive to gentamicin.

Gentamicin sulfate + Betamethasone valerate Spray

Trade Names:

Betagen™ Topical Spray

GenOne™ Spray

Gentamicin Sulfate Topical Spray

Gentamicin Topical Spray

GentaSpray

GentaVed® Topical Spray

Gentocin® Topical Spray

Relifor™

Topagen® Spray

General Description:

This topical spray contains an antibacterial and an anti-inflammatory drug. It is useful for treating superficial lesions in dogs caused by bacteria susceptible to gentamicin. It also helps reduce the accompanying inflammation and itching.

What is this drug?

• A combination of an aminoglycoside antibiotic (gentamicin sulfate) and a glucocorticoid (betamethasone)
• Used topically

Reasons for prescribing:

• For use in dogs for the treatment of infected superficial lesions accompanied by inflammation and/or itching. Gentamicin treats the bacterial infection while betamethasone helps with the swelling and itching.

What pets should not use this medication?

• This product is approved for use in dogs
• Pets with a viral or fungal infection
• Do not use this product if your pet is pregnant
• If your pet has had an allergic reaction to either of the ingredients or similar products

Directions:

Read and follow the label carefully.

Your veterinarian may want to perform a culture evaluation of the lesion prior to starting this medication.

Prior to use, remove excessive hair from the treatment area. Clean and dry the lesion and adjacent area.

To use, hold the spray bottle 3 to 6 inches from the lesion.

Follow your veterinarians directions for the number of sprays per day and duration of treatment.

Therapy is usually for 7 consecutive days only.

Do not increase the dosage or use longer than instructed. Adverse reactions and toxicities can occur.

What if a dose is missed?

If a treatment is missed, perform it as soon as you can. If it is time already for the next treatment, skip the missed treatment and go back to the normal schedule.

What to tell/ask a veterinarian before giving medication?

Talk to your veterinarian about:

• When will your pet 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 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 medicines can be given together.
• If your pet is pregnant, nursing or if you plan to breed your pet

Storage and Warnings:

Store between 2° and 30°C (36° and 86°F) away from moisture and heat. Shake bottle well before use.

Wash your hands before and after use. Use in a well-ventilated area when applying medication.

Do not allow your pet to ingest this product. Avoid getting it in your pet's eyes.

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:

• Serious side effects are unlikely if used as directed for no longer than 7 days of therapy
• Cushing's syndrome, delayed wound healing and immunosuppression have been reported in patients with prolonged or repeated steroid therapy.
• Some pets show side effects to the corticosteroids. These could include: increased thirst and urination, panting, diarrhea, vomiting and behavior changes.
• Gentamicin can cause premature birth in pregnant animals. Corticosteroids can cause birth defects during the first phase of pregnancy.
• If you notice any unusual symptoms, discontinue use and contact your veterinarian

Can this drug be given with other drugs?

• Yes, but do not give or use other corticosteroids or aminogylcoside antibiotics during treatment with this medication unless prescribed by your veterinarian.
• If ingested, there is an increased risk of stomach ulcers in pets also taking non-steroidal anti-inflammatories like aspirin, carprofen, etodolac, etc.
• If your pet experiences any unusual reactions when taking multiple medications, contact your veterinarian.

Overdosing?

Early signs of overdose or toxicity include loss of hearing or balance or vomiting. If you see these signs, know or suspect an overdose, contact your veterinarian immediately.

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, Gentamicin sulfate + Betamethasone valerate Spray should only be used on the pet for which it was prescribed.

It should also only be used for the condition for which it was prescribed.

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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BETAGEN™ TOPICAL SPRAY

Med-Pharmex

GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE TOPICAL SPRAY

ANADA #200-188, Approved by FDA.

Veterinary

For Topical Use in Dogs Only

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

DESCRIPTION: Each mL contains: gentamicin sulfate equivalent to 0.57 mg gentamicin base, betamethasone valerate equivalent to 0.284 mg betamethasone, 163 mg isopropyl alcohol, propylene glycol, methylparaben and propylparaben as preservatives, purified water q.s. Hydrochloric acid may be added to adjust pH.

CHEMISTRY: Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture of sulfate salts of the antibiotics produced in this fermentation. The salts are weakly acidic and freely soluble in water.

Gentamicin sulfate contains not less than 500 micrograms of gentamicin base per milligram.

Betamethasone valerate is a synthetic glucocorticoid.

PHARMACOLOGY: Gentamicin, a broad-spectrum antibiotic, is a highly effective topical treatment for bacterial infections of the skin. In vitro, gentamicin is bactericidal against a wide variety of gram-positive and gram-negative bacteria isolated from domestic animals. ^1,2 Specifically, gentamicin is active against the following organisms isolated from canine skin: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positive and negative Proteus sp., Escherichia coli, Enterobacter sp., Staphylococcus sp., and Streptococcus sp.

Betamethasone valerate emerged from intensive research as the most promising of some 50 newly synthesized corticosteroids in the experimental model described by McKenzie³, et al. This human bioassay technique has been found reliable for evaluating the vasoconstrictor properties of new topical corticosteroids and is useful in predicting clinical efficacy.

Betamethasone valerate in veterinary medicine has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive infected superficial lesions in dogs.

WARNING: Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered 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 produced cleft palate. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

INDICATIONS: For the treatment of infected superficial lesions in dogs caused by bacteria sensitive to gentamicin.

CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment with this product should be discontinued and appropriate therapy instituted.

DOSAGE AND ADMINISTRATION: Prior to treatment, remove excessive hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days.

Each depression of the sprayer head delivers 0.7 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.

TOXICITY: Gentamicin sulfate with betamethasone valerate topical spray was well tolerated in an abraded skin study in dogs. No treatment-related toxicological changes in the skin were observed.

Systemic effects directly related to treatment were confined to histological changes in the adrenals, liver, and kidney and to organ-to-body weight ratios of adrenals. All were dose related, were typical for or not unexpected with corticosteroid therapy, and were considered reversible with cessation of treatment.

SIDE EFFECTS: Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, 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.

Cushings syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

PRECAUTIONS: Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to the use of this preparation. Use of topical antibiotics may permit overgrowth of non-susceptible bacteria, fungi, or yeasts. If this occurs, treatment should be instituted with other appropriate agents as indicated.

Administration of recommended dose beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely.

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.

In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

If ingestion should occur, patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gains, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

HOW SUPPLIED: Plastic spray bottle containing 60 mL, 120 mL or 240 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.

Store upright between 2° and 30°C (36° and 86°F).

REFERENCES:

1. Hennessey PW, et al. In vitro activity of gentamicin against bacteria isolated from domestic animals. Veterinary Medicine/Small Animal Clinician.November 1971; 1118-1122.

2. Bachmann HJ, et al. Comparative in vitro activity of gentamicin and other antibiotics against bacteria isolated from clinical samples from dogs, cats, horses and cattle. Veterinary Medicine/Small Animal Clinician. October 1975; 1218-1222.

3. McKenzie, HW., Atkinson, RM: Topical activities of betamethasone esters in man. Arch Derm. 1964; 19:741-746.

April 1999

Manufactured by Med-Pharmex, Inc., Pomona, CA 91767

NET CONTENTS:	NDC
60 mL	54925-028-60
120 mL	51259-0028-12
240 mL	51259-0028-24