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Deflux Generic Name & Formulations
Legal Class
Rx
General Description
Dextranomer microspheres 50mg/mL viscous gel in stabilized hyaluronic acid 15mg/mL carrier gel; implant for submucosal inj.
How Supplied
Single-use syringe (1mL)—1
Manufacturer
Deflux Indications
Indications
Vesicoureteral reflux (VUR) grades II–IV in children.
Deflux Dosage and Administration
Adult
Not applicable.
Children
<1yr: not recommended. ≥1yr: see literature. Must use Deflux metal needle for administration. Inject submucosally in urinary bladder near the ureteral orifice.
Deflux Contraindications
Contraindications
Non-functional kidney. Hutch diverticulum. Ureterocele. Active voiding dysfunction. Ongoing UTI.
Deflux Boxed Warnings
Not Applicable
Deflux Warnings/Precautions
Warnings/Precautions
Do not inject intravascularly. Must be administered by qualified surgeon experienced in the use of cystoscope and trained in subureteric injection procedures. Use of >6mL (3mL at each ureteral orifice) at same treatment session: not recommended. Treatment of duplex systems has not been studied. Ureters with grossly dilated orifices. Infection and bleeding risks associated with cystoscopic procedure.
Deflux Pharmacokinetics
See Literature
Deflux Interactions
Not Applicable
Deflux Adverse Reactions
Adverse Reactions
UTI, ureteral dilatation, nausea, vomiting, abdominal pain.
Deflux Clinical Trials
See Literature
Deflux Note
Not Applicable
Deflux Patient Counseling
See Literature
