Generic Name and Formulations:
Dextranomer microspheres 50mg/mL, sodium hyaluronate 15mg/mL; gel for submucosal injection.
Bausch Health Companies 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
Psychiatry Advisor Articles
- Nomophobia: The Modern-Day Pathology
- Transdermal Nicotine Boosts Mood and Cognitive Function in Late-Life Depression
- Emerging Theories in the Pathophysiology of MDD: Could the Opioid System Be Involved?
- Combination Cognitive Behavioral Therapy With Fluoxetine Effective for Adolescent Depression
- Ketamine Infusions Reduce Suicidal Ideation in Depression: Characterizing Different Responses
- Text Message Reminders Improve Medication Adherence in Bipolar I Disorder
- Improving Medication Adherence in ADHD Lowers Risk for Oppositional Defiant Disorder, Conduct Disorder in Adulthood
- High Suicidality Among Children With ADHD Mediated by Family Functioning, Psychiatry Comorbidities
- Pilot Study Investigates Lithium vs Quetiapine for Bipolar Spectrum Disorder
- How Personalized Hospital Ratings May Drive Patient-Specific Care in the Digital Age