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Suclear

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Suclear

Side Effects
Interactions

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.

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.

Read the Suclear (sodium, potassium, magnesium and peg-3350) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities

Certain medical conditions and concomitant medications may increase the risk for developing fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities when taking Suclear. This includes patients receiving drugs which may be associated with hypokalemia (such as diuretics or corticosteroids, or drugs where hypokalemia is a particular risk, such as cardiac glycosides) or hyponatremia. Use caution when Suclear is used in patients on nonsteroidal anti-inflammatory drugs (NSAIDS) or drugs known to induce Antidiuretic Hormone Secretion (SIADH), such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine, as these drugs may increase the risk of water retention and/or electrolyte imbalance. Consider additional patient evaluations as appropriate [see WARNINGS AND PRECAUTIONS].

Potential for Altered Drug Absorption

Oral medication administered within one hour of the start of each Suclear dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.

Stimulant Laxatives

Concurrent use of stimulant laxatives and Suclear may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Suclear.

Last reviewed on RxList: 2/1/2013
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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