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Suclear

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Suclear

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Serious Fluid and Serum Chemistry Abnormalities

Advise all patients to hydrate adequately before, during, and after the use of Suclear. If a patient develops significant vomiting or signs of dehydration after taking Suclear, perform post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse reactions including cardiac arrhythmias, seizures and renal impairment.

Patients with electrolyte abnormalities should have them corrected before treatment with Suclear. Consider the risks of prescribing Suclear in patients with certain medical conditions that predispose them (or who are using medications that increase the risk of) fluid and electrolyte disturbances or that may increase the risk of seizure, arrhythmias, and renal impairment. Use of alcohol may increase the risk of dehydration.

Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of osmotic laxative products for bowel preparation. Carefully consider the risks of prescribing Suclear for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

Seizures

There have been reports of generalized tonic-clonic seizures associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality.

Consider the risks of prescribing Suclear in patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia.

Use in Patients with Renal Impairment

Consider the risks of prescribing Suclear in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti- inflammatory drugs). Advise these patients of the importance of adequate hydration before and after the use of Suclear. Consider performing baseline and post-colonoscopy laboratory tests in these patients (e.g., electrolytes, creatinine, and BUN).

Colonic Mucosal Ulcerations and Ischemic Colitis

Osmotic laxatives may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and Suclear may increase these risks. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease.

Use in Patients with Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering Suclear.

Patients with severe active ulcerative colitis may be at increased risk of exacerbation of their disease with Suclear.

Use in Patients at Risk of Aspiration and Regurgitation

Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during administration of Suclear solution.

Not for Direct Ingestion

Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration or other serious adverse reactions. Each bottle must be diluted with water to the recommended final volume.

Patient Counseling Information

See FDA-Approved Patient Labeling (Medication Guide).

  • Ask patients if they have trouble swallowing or are prone to regurgitation or aspiration. Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during administration of Suclear solution.
  • Instruct patients that each bottle needs to be diluted in water before ingestion and that they need to drink additional water according to the instructions. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, and dehydration.
  • Inform patients that oral medications may not be absorbed properly if they are taken within one hour of starting each dose of Suclear.
  • Tell patients not to take other laxatives while they are taking Suclear.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Suclear. Studies to evaluate the possible impairment of fertility or mutagenic potential of Suclear have not been performed.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Suclear. It is not known whether Suclear can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Suclear should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Suclear is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Suclear in pediatric patients have not been established.

Geriatric Use

Of the 362 patients who received Suclear in clinical trials, 90 (25%) were 65 years of age or older, and 29 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment

The safety of Suclear in patients with renal impairment has not been adequately evaluated. Due to increased risk for electrolyte abnormalities in this population and a potential for reduced clearance of drugs in this setting, consider the risks of using Suclear in patients with renal impairment [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

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

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