Gentocin Durafilm Recall
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS Not for human use. Keep this and all drugs out of the reach of children. 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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
INDICATIONS GENTOCIN DURAFILM Ophthalmic Solution is indicated for the treatment of external eye infections and inflammation in dogs.
Clinical reports indicate it is useful for the management of some cases of pigmentary keratitis and pannus. Temporary remission of some of the pathological lesions of the aforementioned conditions have been noted following therapy with GENTOCIN DURAFILM Ophthalmic Solution.
There is currently no drug history available for this drug.
DESCRIPTION GENTOCIN DURAFILM Ophthalmic Solution is a sterile preparation for topical application. Each mL of buffered solution (pH approximately 6.5) contains gentamicin sulfate equivalent to 3 mg gentamicin base, 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone alcohol, polyoxyl 40 stearate, polyethoxy 35 castor oil, edetate disodium, 0.1 mg benzalkonium chloride as preservative and water for injection q.s.
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, a synthetic derivative of prednisolone, is 9-alpha-fluoro-16-beta-methyl-prednisolone.