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GenOne Topical Spray

GenOne Topical Spray by VetOne

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GENONE™ SPRAY

(Gentamicin Sulfate with Betamethasone Valerate)

For Topical Use in Dogs Only

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 GenOne™ Spray.

TOXICITY:
GenOne™ 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.
Cushing’s 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.

GENONE™ SPRAY
(Gentamicin Sulfate with Betamethasone Valerate)

Storage
Keep out of reach of children and animals.

Store GenOne Spray bottle in an upright position between 36 and 86 degrees F.

It is a violation of Federal Law to use this product in a manner inconsistent with its labeling.

Gentamicin, one of the active ingredients in GenOne Spray, is a broad-spectrum antibiotic. It is effective against a number of gram-positive and gram-negative bacteria. Betamethasone, the product's other active ingredient, is a synthetic corticosteroid that reduces inflammation and itchiness associated with an infection when applied topically.

Uses
For topical application in dogs only

GenOne is only for use on dogs. Do not use on cats or other animals. Not for human use.

Read all package instructions and precautionary statements before use.

Follow the instructions given in your veterinarian's prescription.

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.

Dose 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 GenOne™ Spray.

Toxicity
GenOne™ 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.

Possible 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.
Cushing’s 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. 

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