GentaVed

Vedco, Inc.

GentaVed Topical Spray Gentamicin Sulfate With Betamethasone Valerate TOPICAL SPRAY

FULL PRESCRIBING INFORMATION: CONTENTS*

• CAUTION
• GENTAVED DESCRIPTION
• CHEMISTRY
• PHARMACOLOGY
• WARNING
• INDICATIONS
• GENTAVED CONTRAINDICATIONS
• GENTAVED DOSAGE AND ADMINISTRATION
• TOXICITY
• SIDE EFFECTS
• PRECAUTIONS
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

Manufactured For:
VEDCO, INC.
St. Joseph, MO 64507

Manufactured by
Sparhawk Laboratories, Inc.
Lenexa, KS 66215 USA

ANADA 200-416, Approved by FDA

Veterinary

For Topical Use in Dogs Only

For Animal Use Only

Keep Out of Reach of Children

CAUTION

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

GENTAVED DESCRIPTION

Each mL contains: gentamicin sulfate, USP 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 the 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.

Each mL contains: gentamicin sulfate, USP equivalent to 0.57 mg gentamicin base, betamethasone valerate, USP 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.

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 costicosteriods administrated 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 abnormalities 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 susceptible to gentamicin.

GENTAVED CONTRAINDICATIONS

If hypersensitivity to any of the components occurs, discontinue treatment and institute appropriate therapy.

GENTAVED 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.

TOXICITY

Gentamicin Sulfate with betamethasone valerate topical spray was well tolerated in a 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 corticosteroids 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 yeast. If this occurs, treatment should be instituted with other appropriate agents as indicated.

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

Avoid ingestion. Oral or parental 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 over dose which include sodium retention, potassium loss, fluid retention, weight gains, polydipsia, and/or polyuria. Prolonged use or overdose may produce adverse immuno-suppressive effects.

HOW SUPPLIED

Plastic spray bottle containing 60 mL, 120 mL, or 240 mL of GentaVed Topical Spray.

Store upright between 20^o-25^oC (68^o-77^oF), excursions permitted between 15^o and 30^o (between 59^o and 86^oF).

TAKE TIME OBSERVE LABEL DIRECTIONS.

G-4357-02                  Rev. 11-12

VINV-GENT-SPR1