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Side Effects & Adverse Reactions

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 can induce cleft palates in offspring when given to pregnant animals during the period of palate closure of the embryos. Other congenital anomalies, including deformed forelegs, phocomelia and anasarca, have been reported in offspring of dogs which received corticosteroids during pregnancy.

Avoid ingestion.

SIDE EFFECTS: Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia and polyuria have occurred following the use of parenteral or systemic synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs and cats. Cushing’s syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

INDICATIONS: Gentamicin Sulfate with Betamethasone Valerate Otic Solution is indicated for the treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.

History

There is currently no drug history available for this drug.

Other Information

GENTAMICIN SULFATE with BETAMETHASONE VALERATE OTIC SOLUTION

ANADA #200-183, Approved by FDA
For Use in Dogs and Cat Only.

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

DESCRIPTION:  Gentamicin Sulfate with Betamethasone Valerate Otic Solution is packaged in a convenient plastic squeeze bottle for easy application.  Each mL of Gentamicin Sulfate with Betamethasone Valerate Otic Solution contains gentamicin sulfate equivalent to 3 mg gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, 1.0 mg hydroxyethylcellulose, 2.5 mg glacial acetic acid, 200 mg purified water, 19% ethanol, 9.4 mg benzyl alcohol as preservative, 300 mg glycerin and propylene glycol q.s.

CHEMISTRY: Gentamicin is a bactericidal antibiotic of the aminoglycoside group derived from Micromonospora  purpurea of the Actinomyces  group. It is a powder, white to buff in color, basic in nature, readily soluble in water and highly stable in solution.

Betamethasone valerate is a synthetic corticosteroid derivative of prednisolone.

ACTION: Gentamicin Sulfate with Betamethasone Valerate Otic Solution combines the broad-spectrum activity of gentamicin sulfate with the anti-inflammatory and antipruritic activity of betamethasone valerate. In vitro antibacterial activity1 has shown that gentamicin is active against most gram-negative bacteria including Pseudomonas aeruginosa, indole-positive and negative proteus sp., Escherichia coli, Klebsiella pneumoniae, Aerobacter aerogenes, and Neisseria. Gentamicin is also active against strains of gram-positive bacteria including Staphylococcus species and some Streptococcus species.

Betamethasone valerate has emerged from intensive research as the most promising of some 50 newly synthesized corticosteroids in the experimental model described by McKenzie2 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 human medicine has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive dermatoses. In the responsive cases, the local anti-inflammatory activity is sustained by the vasoconstrictor properties of the steroid. 

TOXICITY STUDIES: Parenterally, no toxic effects were observed in rats given gentamicin sulfate 20 mg/kg/day for twenty-four days; in cats given 10 mg/kg/day for forty days. Gentamicin sulfate given to dogs at 6 mg/lb/day, 6 days weekly for three weeks, caused no detectable kidney damage. At higher doses, impairment of equilibrium and of renal function were observed in these species.

Subacute otic toxicity study in dogs showed gentamicin sulfate with betamethasone valerate solution to be well tolerated locally with no adverse systemic effects when administered 5 drops twice a day for 21 consecutive days.

Gentamicin sulfate solution in a 21-day subacute dermal toxicity study in dogs was shown to be well tolerated when applied topically to abraded skin. There were no meaningful findings except a reduction in eosinophil count attributable to absorption of the corticosteroid component.

Genone Manufacturers


  • Mwi
    Genone (Gentamicin Sulfate With Betamethasone Valerate ) Solution [Mwi]
  • Mwi
    Genone (Gentamicin Sulfate) Spray [Mwi]
  • Mwi
    Genone (Gentamicin Sulfate With Betamethasone Valerate) Spray [Mwi]

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