Suclear
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Suclear
Suclear Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Suclear FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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 clinical trials of another drug and may not reflect the rates observed in clinical practice.
In randomized, multicenter, controlled clinical trials, the effectiveness of Suclear for colon cleansing was compared with two separate preparations containing two liters of polyethylene glycol plus electrolytes (Studies 1 and 2) [see Clinical Studies]. Suclear and the comparator preparation were administered entirely the day before the colonoscopy in Study 1, whereas they were administered as split doses in Study 2. In addition to collection of spontaneously reported adverse reactions, patients were instructed to complete a symptom scale questionnaire that targeted expected adverse reactions (overall discomfort, stomach cramping, stomach bloating, and nausea). Patients also were asked separately to report vomiting episodes.
Table 1 presents the most common adverse reactions in Study 1 and Study 2.
Table 1: Adverse Reactions Observed in At Least 2% of
Patients Who Received the Day-Before Regimen or Split-Dose Regimen
| Adverse Reaction | Study 1 (Day-Before Regimen) | Study 2 (Split-Dose Regimen) | ||
| Suclear (N=176) n (%) |
Comparator 1† (N=190) n (%) |
Suclear (N=186) n (%) |
Comparator 2‡ (N=185) n (%) |
|
| Overall discomfort# | 122 (69) | 108 (57) | 116 (62) | 121 (65) |
| Abdominal distension# | 92 (52) | 85 (45) | 96 (52) | 112 (61) |
| Abdominal pain#* | 71 (40) | 78 (41) | 70 (38) | 79 (43) |
| Nausea# | 74 (42) | 75 (40) | 86 (46) | 72 (39) |
| Vomiting# | 19 (11) | 15 (8) | 26 (14) | 13 (7) |
| Headache | 1 (1) | 3 (2) | 3 (2) | 2 (1) |
| #Include spontaneously reported adverse reactions as well
as those reported in a symptom scale questionnaire. *Abdominal pain also included reports of upper abdominal pain and abdominal tenderness. †Comparator 1: PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution; and two bisacodyl 5-mg delayed-release tablets. ‡Comparator 2: PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution. |
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Electrolyte Abnormalities
Table 2 presents the incidence of new laboratory abnormalities in Study 1 and Study 2.
Table 2: Shifts from Normal
at Baseline to Outside the Normal Range on the Day of Colonoscopy (for n/N, n= number with the event and N= number with
normal baseline value)
| Laboratory Parameter (direction of change) | Study 1: Day-Before Regimen | Study 2: Split-Dose Regimen | ||
| Suclear % (n/N) |
Comparator 1† % (n/N) |
Suclear % (n/N) |
Comparator 2‡ % (n/N) |
|
| Anion gap (high)* | 3% (5/155) | 5% (8/170) | 10% (17/166) | 8% (12/155) |
| Bicarbonate (low) | 3% (4/156) | 3% (5/167) | 4% (6/170) | 12% (20/161) |
| Bilirubin, total (high) | 8% (12/157) | 10% (17/170) | 11% (19/170) | 4% (6/162) |
| Calcium (high) | 9% (12/139) | 4% (5/139) | 4% (6/141) | 5% (7/144) |
| Chloride (low) | 1% (1/157) | 0% (0/171) | 1% (1/173) | 0% (0/163) |
| Creatinine (high) | 2% (3/145) | 3% (4/155) | 1% (2/167) | 1% (1/153) |
| Creatine kinase (high) | 7% (10/138) | 4% (6/151) | 7% (10/147) | 5% (7/143) |
| eGFR (low)** | 25% (21/84) | 14% (12/88) | 9% (9/101) | 11% (9/85) |
| Glucose (high) | 7% (10/146) | 3% (4/156) | 2% (3/160) | 3% (5/150) |
| Magnesium (low) | 1% (1/158) | 1% (1/169) | 0% (0/169) | 1% (1/163) |
| Osmolality (high) | 2% (3/139) | 5% (8/153) | 4% (6/151) | 8% (12/145) |
| Phosphate (low) | 0% (0/155) | 0% (0/168) | 3% (5/171) | 1% (2/160) |
| Potassium (low) | 4% (5/144) | 3% (4/160) | 4% (6/162) | 4% (7/159) |
| Sodium (low) | 0% (0/157) | 0% (0/169) | 1% (1/169) | 1% (1/163) |
| Uric acid (high) | 6% (8/143) | 7% (11/160) | 4% (7/163) | 3% (4/154) |
| †Comparator 1: PEG-3350, sodium chloride, sodium bicarbonate and
potassium chloride for oral solution; and two bisacodyl 5-mg delayed-release
tablets. ‡Comparator 2: PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution. * Anion gap was calculated using the following formula: [Sodium (mEq/L)] - [Chloride (mEq/L)] + [Bicarbonate (mEq/L)]. Normal range was defined as 12±4, and high was defined as a calculated value > 16. **eGFR was calculated using the Cockcroft-Gault formula. |
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Read the entire FDA prescribing information for Suclear (Sodium, Potassium, Magnesium and PEG-3350) »
Additional Suclear Information
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