Betagen Recall
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Questions & Answers
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 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.
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: For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
History
There is currently no drug history available for this drug.
Other Information
ANADA #200-188, Approved by FDA
Veterinary
For Topical Use in Dogs 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.
Betamethasone valerate is a synthetic glucocorticoid.
Sources