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Monday, December 7, 2020

Fleet Enema and The Use in Electrolyte Imbalance Patient

Can fleet enema be given if patient has electrolyte imbalance?

 

Conclusion:

·         Since it contains sodium phosphate, there is a risk of electrolyte imbalance.

·         Use with caution in patient with pre-existing electrolyte disturbances or who are taking diuretics or other medication which may affect electrolyte levels

·         Transient mild hyperphosphatemia following the use of sodium phosphates enemas correlates with retention time, but not with dose. Shorter retention times were associated with smaller increases in serum phosphate concentrations, whereas longer retention times were associated with more variable and generally higher serum phosphate concentrations

·         The majority of 83 serious adverse events reported in the scientific literature associating sodium phosphates enema and hyperphosphatemia were linked with enema overdose, concomitant use of oral and rectal sodium phosphate products, or use by a contraindicated patient. The pharmacokinetics and the serious adverse events pattern show that the correct use of sodium phosphates enema results in a mild transient increase in serum phosphate concentration with no clinically significant consequences.

·         If hypocalcemia and hyperphosphatemia are found together with hypernatremia and hypokalemia, sodium phosphate intoxication should be suspected.

 

Answer

Reference

Special Precaution in patient with pre-existing electrolyte disturbances:

Impaired renal function, heart disease or preexisting electrolyte disturbances or in patients on calcium-channel blockers, diuretics or other medications which may affect electrolyte levels or where colostomy exist.

https://www.mims.com/singapore/drug/info/fleet%20enema/special-precautions  [Accessed on 25/11/20]

Use with caution in patient with pre-existing electrolyte disturbances. Since it contains sodium phosphate, there is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium, and consequently hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia may occur which could result in metabolic acidosis, tetany, renal failure, QT prolongation and/or, in more severe cases, multi-organ failure, cardiac arrhythmia/arrest and death

https://www.activeforever.com/pdf/product-information-fleet-enema-saline-laxative.pdf [Accessed on 25/11/20]

With the use of fleet enema, reports of severe adverse events resulting in severe electrolyte imbalance (hypernatremia, hyperphosphatemia, hypocalcemia, hypokalemia), dehydration and hypovolemia, tetany, QT prolongation, seizures, coma, and death are rare, but have been reported in the literature. Use with caution in patient With pre-existing electrolyte disturbances or who are taking diuretics or other medication which may affect electrolyte levels

https://www.pbm.va.gov/PBM/clinicalguidance/clinicalrecommendations/Sodium_Phosphate_Sodium_Biphosphate_Enema_Safety_Considerations.pdf , July, 2013 [Accessed on 25/11/20]

Study: Not included patient with known or suspected electrolyte abnormalities

 

Conclusion:

1.       Transient mild hyperphosphatemia following the use of sodium phosphates enemas correlates with retention time, but not with dose. Shorter retention times were associated with smaller increases in serum phosphate concentrations, whereas longer retention times were associated with more variable and generally higher serum phosphate concentrations

2.       There were no other significant changes in electrolyte or metabolic parameters, postural hypotension, or adverse experiences.

3.        The majority of 83 serious adverse events reported in the scientific literature associating sodium phosphates enema and hyperphosphatemia were linked with enema overdose, concomitant use of oral and rectal sodium phosphate products, or use by a contraindicated patient. The pharmacokinetics and the serious adverse events pattern show that the correct use of sodium phosphates enema results in a mild transient increase in serum phosphate concentration with no clinically significant consequences

Serum Electrolyte Shifts Following Administration of Sodium Phosphates Enema, 2010 [Accessed on 25/11/20]

 

https://journals.lww.com/gastroenterologynursing/Abstract/2010/05000/Serum_Electrolyte_Shifts_Following_Administration.2.aspx

Case report of fatal electrolyte abnormalities following 2 enema (120 ml each) administration. Patient with severe congestive heart failure, kidney failure, with medication of digoxin, enalapril, aspirin, transdermal nitrate, and furosemide. Patient initially hyperkalemia (7.7), Na 132, Chloride 93 mmol/L, Ca 9.6 (2.4 mmol/L, corrected level 2.54 mmol/L), albumin 33. The day after 2 enema is given, Na 153 mmol/L, K 2.7 mmol/L, Ca 3.7 mg/dL ( 0.92315 mmol/L, corrected: 1.06 mmol/L)

 

Conclusion: If hypocalcemia and hyperphosphatemia are found together with hypernatremia and hypokalemia, NaP intoxication should be suspected. Concomitant hypocalcemia and hyperphosphatemia are common in renal insufficiency. These alterations are generally moderate, however, and serum potassium concentrations tend to be high. 

Szoke et al. Fatal Electrolyte Abnormalities Following Enema Administration. Clinical Chemistry, Volume 58, Issue 11, 1 November 2012, Pages 1515–1518, 

https://doi.org/10.1373/clinchem.2011.170183

 https://academic.oup.com/clinchem/article/58/11/1515/5620880 [Accessed on 25/11/20]

Case report of 85 year old elderly with pre-existing chronic kidney disease:

Baseline:

1.       serum calcium of 9.6 mg/dl( 2.4 mmol/L)

2.       creatinine 1.2 mg/dl (106.1 mmol/L)

3.        sodium 135 mmol/L

4.       BUN 25 mg/dl ( 8.9 mmol/L)

5.        potassium 4.8 mmol/L.

 

On the day after fleet enema is given, the patient’s laboratory tests revealed

1.       serum calcium: 6.7 mg/dl (1.67 mmol/L)

2.       serum creatinine of 1.9 mg/dl (167.96 mmol/L)

3.       serum sodium of 161 mmol/L.

 

 The patient was continued on intravenous fluid and treated with calcium supplementation. The serum phosphorous was found to be elevated at14.6 mg/dl  ( 4.7 mmol/L)

 

On the third hospital day, laboratory tests showed worsening of hypocalcemia, with a total calcium of 4.8 mg/dl ( 1.2 mmol/L) and an ionized calcium of 0.58 mg/dl, despite receiving intravenous calcium, and worsening of acute kidney injury, with creatinine rising to 2.2 mg/dl ( 194.52 mmol/L). Repeat serum phosphorous rose to 22 mg /dl. (7.1 mmol/L) With continued treatment of the patient’s hypocalcemia and renal failure with intravenous calcium and intravenous fluids, he eventually had improvement in his renal function and electrolytes, with repeat laboratory tests showing a serum creatinine of 1.4 mg/dl; total serum calcium of 7.7 mg/dl ( 1.92 mmol/L); ionized calcium of 1.19mg/dl ( 0.3 mmol/L) ; and serum phosphorous of 6.7 mg/dl on the fifth hospital day.

 

Conclusion:

It would be advisable to avoid using sodium phosphate as a preparation for colonoscopy or as a cathartric particulary in elderly patients.

Hajmomenian HR. Severe Hypocalcemia and Hyperphosphatemia after Fleet Enema Administration. Proceedings of UCLA Healthcare -VOLUME 17 (2013)-

 

https://proceedings.med.ucla.edu/wp-content/uploads/2016/11/Severe-Hypocalcemia-and-Hyperphosphatemia-after-Fleet-Enema_CB_edited.pdf , [Accessed on 25/11/20]

Warnings/Precautions

 

Concerns related to adverse effects:

1.   Hypersensitivity

2.   Nephropathy: [US Boxed Warning]: Acute phosphate nephropathy (APN) has been reported (rarely) with use of oral products as a colon cleanser prior to colonoscopy. Some cases have resulted in permanent renal impairment (some requiring dialysis). Risk factors for acute phosphate nephropathy may include increased age (>55 years of age), preexisting renal dysfunction, bowel obstruction, active colitis, or dehydration, and the use of medicines that affect renal perfusion or function (eg, ACE inhibitors, angiotensin receptor blockers, diuretics, and possibly NSAIDs), although some cases have been reported in patients without apparent risk factors. Advise patients of the importance of following the recommended split dosage regimen and the importance of adequate hydration before, during and after use of oral sodium phosphate products. Avoid additional sodium phosphate-based purgative or enema products. Obtain baseline and postprocedure labs in patients at risk of nephropathy; consider hospitalization and intravenous hydration during bowel cleansing for patients unable to hydrate themselves (eg, frail patients). Use is contraindicated in patients with acute phosphate nephropathy. APN has also been reported (rarely) following the use of sodium phosphate enemas. This has been primarily observed in elderly patients with and without preexisting renal impairment and with those receiving standard or doses exceeding usual doses (Ori 2012).

3.   QT prolongation: Prolongation of the QT interval has been reported (associated with hypokalemia, hypocalcemia).

 

Disease-related concerns:

• Cardiovascular: Use caution in patients with heart failure (contraindicated with enema products), unstable angina, history of myocardial infarction arrhythmia, cardiomyopathy; use caution in patients with or at risk for arrhythmias (eg, cardiomyopathy, prolonged QT interval, history of uncontrolled arrhythmias, recent MI) or with concurrent use of other QT-prolonging medications; pre-/postdose ECGs and lab tests should be considered in high-risk patients.

• Electrolyte disturbances: Fluid and electrolyte disturbances may occur. Use with caution in patients with preexisting electrolyte imbalances, dehydration, or risk of electrolyte disturbance (hypocalcemia, hyperphosphatemia, hypernatremia); obtain baseline and postprocedure labs in high-risk patients. Correct dehydration prior to using for bowel preparations.

• GI disorders: Use caution in patients with any of the following: Gastric retention or hypomotility, ileus, severe, chronic constipation, or severe active ulcerative colitis. Use is contraindicated in patients with bowel obstruction (including pseudo) or perforation, congenital megacolon, gastric bypass or bariatric surgery, toxic colitis, or toxic megacolon.

• Inflammatory bowel disease: Use with caution in patients with an acute exacerbation of chronic inflammatory bowel disease; phosphate absorption may be increased. Oral sodium phosphate products may induce colonic aphthous ulceration, which should be considered when interpreting colonoscopic findings in patients with inflammatory bowel disease.

• Renal impairment: Use with caution in patients with renal impairment; patients may be at risk for sodium retention and edema. Close monitoring required to avoid hyperphosphatemia. Obtain baseline and postprocedure labs in patients with renal impairment.

• Seizure disorder: Use with caution in patients with a history of seizures, those at higher risk of seizures or on medication that lowers seizure threshold; obtain baseline and postprocedure labs in high-risk patients.

 

Special populations:

• Bulimia nervosa patients: Laxatives and purgatives have the potential for abuse by bulimia nervosa patients.

• Debilitated patients: Use with caution in debilitated patients; consider each patient's ability to hydrate properly.

• Elderly: Use with caution in elderly patients; ensure they are able to hydrate themselves if using for bowel preparation.

UptoDate: Sodium phosphate: Drug information [Accessed 7 Dec 2020]

 

*General points so some points may not be 100% applicable to rectal route.

 

Prepared by Mei Kuan ; Edited by J. Ho on 7 Dec 2020

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