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 The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders [see Warnings and Precautions (5.1) ] Cardiac Arrhythmias [see Warnings and Precautions (5.2) ] Seizures [see Warnings and Precautions (5.3) ] Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.4) ] Colonic Mucosal Ulceration and Inflammatory Bowel Disease [see Warnings and Precautions (5.5) ] Aspiration [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥3%) are: bloating, nausea, abdominal pain, and vomiting.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals Inc.
at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets was evaluated in two randomized, investigator-blinded, active controlled trials in 931 adult patients undergoing elective colonoscopy.
The mean age of the study population was 60 years (range 20 to 89 years), 88% of patients were Caucasian and 55% were female [see Clinical Studies (14) ] .
Table 1 shows the most common adverse reactions reported in greater than 3% of patients by treatment group in Study 1 [see Clinical Studies (14) ].
Since diarrhea was considered as a part of the efficacy of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, diarrhea was not defined as an adverse event in this clinical trial.
1 Reported in more than 3% of patients in at least one treatment group 2 Another oral formulation of monobasic sodium phosphate and dibasic sodium phosphate Table 1: Common Adverse Reactions 1 in Patients Undergoing Colonoscopy in Study 1 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 32 tabs (48 g) N=272 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 40 tabs (60 g) N=265 Sodium Phosphate2 40 tabs (60 g) N=268 Bloating 31% 39% 41% Nausea 26% 37% 30% Abdominal Pain 23% 24% 25% Vomiting 4% 10% 9% Electrolyte Abnormalities in Study 1 Hyperphosphatemia A total of, 96%, 96%, and 93% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy.
In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy.
5 WARNINGS AND PRECAUTIONS Renal disease and electrolyte disorders : Use caution in severe renal impairment and those taking concurrent medications that increase risk, ensure adequate hydration, and consider laboratory assessments prior to and after use.
( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk.
( 5.2 ) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold.
( 5.3 , 7.1 ) Suspected GI obstruction or perforation : Rule out diagnosis before administration.
( 4 , 5.4 ) Colonic mucosal ulceration : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease.
Like all medications, Monobasic Sodium Phosphate And Dibasic Sodium Phosphate 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: