Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reaction (≥2%) is diarrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Demographic characteristics were comparable between the TRULANCE and placebo groups in all studies [see Clinical Studies (14) ] .
Chronic Idiopathic Constipation (CIC) The safety data described below reflect data from 1,733 adult patients with CIC randomized in two double-blind, placebo-controlled clinical trials (Study 1 and Study 2) to receive placebo or 3 mg of TRULANCE once daily for 12 weeks.
Most Common Adverse Reactions Table 1 provides the incidence of adverse reactions reported in at least 2% of CIC patients in the TRULANCE-treated group and at an incidence that was greater than in the placebo group.
Table 1: Most Common Adverse Reactions a in Two Placebo-Controlled Trials of TRULANCE [Study 1 and Study 2] in Patients with CIC Adverse Reaction TRULANCE, 3 mg (N = 863) % Placebo (N = 870) % a: Reported in at least 2% of TRULANCE-treated patients with CIC and at an incidence greater than placebo.
b: Verbatim reports of diarrhea were recorded as adverse reactions;
reports of loose stools and increase in stool frequency were recorded as adverse reactions if they were also reported to be bothersome to the patient.
Diarrheaᵇ 5 1 Diarrhea The majority of reported cases of diarrhea occurred within 4 weeks of treatment initiation.
5 WARNINGS AND PRECAUTIONS Diarrhea: Patients may experience severe diarrhea.
If severe diarrhea occurs, suspend dosing and rehydrate the patient.
( 5.2 ) 5.1 Risk of Serious Dehydration in Pediatric Patients TRULANCE is contraindicated in patients less than 6 years of age.
The safety and effectiveness of TRULANCE in patients less than 18 years of age have not been established.
In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid-secretion into the intestines as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration.
Like all medications, Trulance Immediate Release can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: