GentaSoothe Topical Spray
Product Type: PRESCRIPTION ANIMAL DRUG LABEL
Autor Name: Teva Animal Health, Inc.
Code Source: 59130-635
Route of Administration: TOPICAL
Topical Spray
(Gentamicin Sulfate With Betamethasone Valerate)
Veterinary
CAUTION: Federal Law restricts this drug
to use by or on the order of a
licensed veterinarian
ANADA 200-388, Approved by FDA
Net Contents: 120 mL
TEVA
Teva Animal Health, Inc.
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.
For topical use in dogs only.
For animal use only.
Keep out of Reach of Children. Usual dose: Two depressions of the
sprayer head 2 to 4 times daily for 7 days.
Read accompanying directions carefully. Store upright between 2 C and 30 C
(36 F and 86 F)
Manufactured For Iss1110
Teva Animal Health, Inc. 500103-07-TAH
St. Joseph, MO 64503
ANADA 200-388, Approved by FDA
GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE TOPICAL SPRAY
Gentamicin Sulfate, USP With Betamethasone
Valerate, USP Topical Spray)
Veterinary For Topical Use in Dogs Only For Animal Use 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 purpures . 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.
Betsmethssone 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, indolepositive
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 McKenzie, 3 et al. This human
bioassay technique has been found reliable for
evaluating 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.
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.
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.
caused by bacteria susceptible to gentamicin.
CONTRAINDICATIONS: If hypersensitivity of any of the components
occurs, discontinue treatment and institute appropriate therapy.
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.
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 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
corticosteroids 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 includes sodium
retention, potassium loss, fluid retention, weight gains, polydipsia and/or
polyuria. Prolonged use or overdosage may produce adverse
immunosuppressive effects.
and 120 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.
Store upright between 2 C and 30 C (36 F and 86 F).
REFERENCES:
1. Hennessy, 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 clincial samples from
dogs, cats, horses and cattle. Veterinary Medicine/Small Animal Clinician . October 1975; 1218-1222.
3. McKenzie, HW and Atkinson, RM. Topical activities of betamethasone
esters in Man. Arch Derm. May 1964;741-746.
Manufactured for Iss1110
Teva Animal Health, Inc.
St. Joseph, MO 64503
Bottle Label Image
Front Onsert Image
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GS Dozen Box Image
Autor Name: Teva Animal Health, Inc.
Code Source: 59130-635
Route of Administration: TOPICAL
GentaSoothe
Generic: Gentamicin sulfate and betamethasone valerateIngredients:
- ISOPROPYL ALCOHOL : Inactive ingredient
- GENTAMICIN SULFATE GENTAMICIN : Active ingredient - moiety is basis of strength - 0.57 mg in 1 mL
- BETAMETHASONE VALERATE BETAMETHASONE : Active ingredient - moiety is basis of strength - 0.284 mg in 1 mL
- PROPYLENE GLYCOL : Inactive ingredient
- METHYLPARABEN : Inactive ingredient
- PROPYLPARABEN : Inactive ingredient
- WATER : Inactive ingredient
Package Description:
- 60 mL in 1 BOTTLE, SPRAY
- 120 mL in 1 BOTTLE, SPRAY
Front Panel Label
GentaSootheTopical Spray
(Gentamicin Sulfate With Betamethasone Valerate)
Veterinary
CAUTION: Federal Law restricts this drug
to use by or on the order of a
licensed veterinarian
ANADA 200-388, Approved by FDA
Net Contents: 120 mL
TEVA
Teva Animal Health, Inc.
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.
For topical use in dogs only.
For animal use only.
Keep out of Reach of Children. Usual dose: Two depressions of the
sprayer head 2 to 4 times daily for 7 days.
Read accompanying directions carefully. Store upright between 2 C and 30 C
(36 F and 86 F)
Manufactured For Iss1110
Teva Animal Health, Inc. 500103-07-TAH
St. Joseph, MO 64503
Chemistry, Pharmacology and Toxicity
PRODUCT INFORMATIONANADA 200-388, Approved by FDA
GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE TOPICAL SPRAY
Gentamicin Sulfate, USP With Betamethasone
Valerate, USP Topical Spray)
Veterinary For Topical Use in Dogs Only For Animal Use 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 purpures . 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.
Betsmethssone 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, indolepositive
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 McKenzie, 3 et al. This human
bioassay technique has been found reliable for
evaluating 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.
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.
WARNING
WARNING: Clinical and experimental data have demonstrated thatcorticosteroids 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 AND CONTRAINDICATIONS
INDICATIONS: For the treatment of infected superficial lesions in dogscaused by bacteria susceptible to gentamicin.
CONTRAINDICATIONS: If hypersensitivity of any of the components
occurs, discontinue treatment and institute appropriate therapy.
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION: Prior to treatment, remove excessivehair 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.
SIDE EFFECTS AND PRECAUTIONS
SIDE EFFECTS: Side effects such as SAP and SGPT enzymeelevations, 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 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
corticosteroids 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 includes sodium
retention, potassium loss, fluid retention, weight gains, polydipsia and/or
polyuria. Prolonged use or overdosage may produce adverse
immunosuppressive effects.
HOW SUPPLIED AND STORAGE
HOW SUPPLIED: Plastic spray bottles containing 60 mL,and 120 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.
Store upright between 2 C and 30 C (36 F and 86 F).
REFERENCES
REFERENCES:
1. Hennessy, 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 clincial samples from
dogs, cats, horses and cattle. Veterinary Medicine/Small Animal Clinician . October 1975; 1218-1222.
3. McKenzie, HW and Atkinson, RM. Topical activities of betamethasone
esters in Man. Arch Derm. May 1964;741-746.
Manufactured for Iss1110
Teva Animal Health, Inc.
St. Joseph, MO 64503
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