Alophen oral and rectal

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Applies to bisacodyl: oral tablets delayed-release, rectal suppositories, rectal suspension

Side effects include:

Some degree of abdominal discomfort, nausea, cramps, griping, and/or faintness with therapeutic doses.

Diarrhea, GI irritation, and fluid and electrolyte depletion.

Gastric irritation and the possibility of vomiting if enteric coating of tablets is disrupted. (See Advice to Patients.)

Rectal administration of bisacodyl (the active ingredient contained in Alophen) suspensions or suppositories may cause irritation and a sensation of burning of the rectal mucosa and mild proctitis.

Hepatotoxicity if sufficient tannic acid is absorbed from bisacodyl tannex.

Applies to bisacodyl: compounding powder, oral delayed release tablet, rectal enema, rectal suppository

Gastrointestinal

Bisacodyl causes acute nonspecific inflammatory injury to the rectal mucosa, which can confound the assessment of patients with suspected inflammatory bowel disease.

The surreptitious abuse of laxatives is a common cause of severe chronic diarrhea. In some cases, the stool contains fecal leukocytes, which, in this case, is indicative of the irritant effect of bisacodyl (the active ingredient contained in Alophen) (nonspecific colonic mucosal inflammation), and not necessarily of infection. Surreptitious abuse of laxatives due to bisacodyl can be determined by urinalysis for a metabolite, bisacodyl diphenol. In some cases, stool analysis for bisacodyl could be considered in the diagnostic assessment.

Abdominal cramping has been described as a mild, colicky discomfort. This can be a problem since cramping my indicate not only a side effect of bisacodyl, but underlying gastrointestinal pathology.

Abdominal distension and vomiting are less common gastrointestinal side effects.[Ref]

Gastrointestinal side effects have been reported the most frequently. These have included abdominal cramping, diarrhea, abdominal distention, and vomiting. Severe diarrhea has been reported as a possible result of surreptitious laxative abuse. The sensation of rectal "burning" with administration of bisacodyl enema has been reported.[Ref]

Metabolic

The metabolic consequences of some Fleet bisacodyl (the active ingredient contained in Alophen) enema preparation kits that contain monobasic or dibasic sodium phosphate in patients with renal insufficiency can be profound. Due to the sodium and phosphate absorption, severe hypernatremia, hypophosphatemia, and hypocalcemia may occur.[Ref]

Metabolic side effects have included severe hypernatremia, hypophosphatemia, and hypocalcemia. These effects have been reported primarily with Fleet bisacodyl enema preparation kits that contain monobasic or dibasic sodium phosphate and administered to patients with renal insufficiency. Fleet bisacodyl enemas without these ingredients may be used safely in such patients.[Ref]

Some side effects of Alophen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

No adjustment recommended

Alleviation of constipation can be expected within 8 to 12 hours if taken at bedtime or within 6 hours if taken during waking hours.

LactMed Record Number

448

Last Revision Date

20130907

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