Generic Name and Formulations:
Dextranomer microspheres 50mg/mL, sodium hyaluronate 15mg/mL; gel for submucosal injection.
Valeant Pharmaceuticals, Inc
Indications for SOLESTA:
Treatment of fecal incontinence in patients who have failed conservative therapy (eg, diet, fiber therapy, antimotility drugs).
See literature. Bowel preparation of rectum using enema required prior to injection. Prophylactic antibiotics are recommended. Inject slowly in deep submucosal layer in the proximal part of the high pressure zone of the anal canal about 5mm above the dentate line. Four 1mL injections are to be given in the following order: posterior, left lateral, anterior, right lateral. Keep needle in place for 15–30 seconds to minimize leakage. A new needle should be used for each syringe and injection site. Post-treatment: Avoid hot baths and physical activity during first 24 hours, antidiarrheal drugs, sexual intercourse, strenuous physical activity for 1 week, anal manipulation for 1 month. Retreatment: If needed, may repeat with max 4mL no sooner than 4 weeks after first injection. Point of injection should be made in between initial injections, shifted 1/8 of a turn.
<18yrs: not recommended.
Active inflammatory bowel disease. Immunodeficiency disorders or ongoing immunosuppressive therapy. Previous radiation treatment to the pelvic area. Significant mucosal or full thickness rectal prolapse. Active anorectal conditions (eg, abscess, fissures, sepsis, bleeding, proctitis, other infections). Anorectal atresia, tumors, stenosis or malformation. Rectocele. Rectal varices. Presence of existing implant in anorectal region.
Should only be used by physicians experienced in anorectal procedures who have successfully completed training and a certification program in Solesta injection procedure. Do not inject intravascularly; may cause vascular occlusion. Avoid injecting in midline of anterior wall of rectum in men with enlarged prostate. Complete external sphincter disruption. Significant chronic anorectal pain. Previous anorectal procedures. Bleeding diathesis. Pregnancy. Nursing mothers.
Tissue bulking agent.
Concomitant anticoagulants, antiplatelets: increased risk of bleeding at injection site.
Anal hemorrhage, anorectal discomfort, chills, diarrhea, injection site hemorrhage, pain.
Syringe (1mL)—4 (w. needles)
Sign Up for Free e-newsletters
Infectious Disease Advisor Articles
- Improving the Care of Aging Adults Living With HIV
- Infection Prevention Differs Between Small, Large Hospitals
- International Antiviral Society-USA Updates Recommendations for HIV Treatment and Prevention
- Previous Missed Appointments Predict Likelihood of Trend in Patients With HIV
- FDA Warns Against Long-Term Azithromycin Use for Some
- Identifying the Source of C difficile in Hospitalized Patients
- Antibiotics Often Unnecessary for Sacral Pressure Ulcers Complicated by Osteomyelitis
- Sensitivity and Specificity of 7 Treponemal Tests for Syphilis Diagnosis
- Automated EHR Algorithm More Effective Than Nurse-Driven Protocol for HCV, HIV Screening
- A Pan-Tuberculosis Regimen: The Debate Continues
- HCV Eradication in HIV/HCV-Coinfection Decreases Immune Activation
- Tolerability of Switching to Long-acting Cabotegravir Plus Rilpivirine From Current HIV-1 Regimen
- Time to Blood Culture Positivity Predictive of Mortality in S Aureus Infective Endocarditis
- C difficile Tied to Increased Graft Loss in Solid Organ Recipients
- Neurodevelopmental Anomalies, Birth Defects Linked to Zika ID'd