Relief of occasional constipation; restore bowel movement regularity.
Initial treatment of choice for simple constipation caused by a low-fiber and/or low-fluid diet.
Bulk-forming laxatives, stool softeners, or mineral oil preferred in conditions in which straining at defecation should be avoided (e.g., MI, vascular diseases, diseases of the anus or rectum, hernias, recent rectal surgery).
Treatment of constipation that occurs following prolonged bed rest or hospitalization.
Treatment of choice for constipation resulting from diminished colonic motor response in geriatric patients; condition is usually due to psychological or physical laxative dependence.
Bulk-forming laxatives or stool softeners are the preferred treatment for constipation occurring during pregnancy or the puerperium.
Not for use when prompt or thorough bowel evacuation is necessary (e.g., poisonings, radiologic examination, bowel surgery).
Diarrhea
Increase the bulk of stools in patients with chronic, watery diarrhea; subjective improvement noted but the total water content of the stool was unchanged.
GI Pain
Reduce intraluminal rectosigmoid pressure and pain in diverticular disease.
Hypercholesterolemia
Psyllium preparations have been used as an adjunct to dietary therapy to reduce elevated serum total cholesterol, LDL cholesterol, apolipoprotein B (apo B) concentrations and the ratio of LDL-cholesterol to HDL-cholesterol in adults with mild to moderate hypercholesterolemia†.†
Dosage and Administration
Administration
Oral Administration
Administer orally, in conjunction with adequate fluid intake.
For treatment of constipation, administer ≥1 full glass (250 mL) of liquid with each dose. Some manufacturers recommend another full glass of liquid after dose.
When used to increase the bulk of stools in chronic, watery diarrhea, one manufacturer suggests administering 1/3 of a glass (80 mL) of liquid with each dose.
Administer as infrequently as possible at the lowest effective dosage level. Do not use for >1 week unless directed by a clinician.
In patients receiving large dosages, administer in divided doses instead of a single daily dose to reduce the risk of esophageal obstruction.
To minimize side effects, initially administer 0.5–1 dose daily; increase as needed up to 3 doses daily.
Methylcellulose Powder
Fill glass with ≥240 mL (8 ounces) of cold water; level powder and add to water; stir briskly and drink promptly. Chocolate powder may be mixed with milk.
Psyllium Powder
Place dose in empty glass; fill with ≥240 mL of water or other beverage; stir briskly and drink promptly. If mixture thickens, add additional liquid and stir.
Acute abdominal pain, nausea, vomiting, or other symptoms of appendicitis or undiagnosed abdominal pain.
Partial obstruction of the bowel.
Esophageal obstruction, dysphagia, or problems of the throat. (See Obstruction under Cautions.)
Sudden change in bowel habits that lasts >2 weeks.
Warnings/Precautions
Warnings
Obstruction
Bowel and/or esophageal obstruction, swelling or blockage of the throat, choking, or asphyxiation reported when insufficient liquid (e.g., <250 mL) administered with some bulk-forming laxatives. Administer each dose with ≥1 full glass (250 mL) of liquid. (See Administration under Dosage and Administration and also see Contraindications under Cautions.)
Sensitivity Reactions
Psyllium Hypersensitivity
Serious hypersensitivity reactions possible to inhaled or ingested psyllium.
Do not inhale psyllium hydrophilic mucilloid particles. Severe hypersensitivity reactions (e.g., rhinoconjunctivitis, acute bronchospasm, anaphylaxis) may occur in susceptible individuals (e.g., those with psyllium sensitivity or suffering from respiratory disorders) following inhalation of psyllium dust particles.
One manufacturer suggests that health-care personnel dispense powdered psyllium preparations with a spoon instead of pouring them directly from the container to minimize exposure and sensitization to airborne particles of psyllium.
Milk Hypersensitivity
Citrucel® Fiber Shake, Chocolate Flavor, contains dry milk powder; hypersensitivity reactions possible in patients sensitive to milk.
Phenylketonuria
Metamucil® Smooth Texture Sugar Free Orange Flavor contains aspartame (NutraSweet®), which is metabolized in the GI tract to provide 25 mg phenylalanine per 3.4 g dose.
Metamucil® Sugar Free Berry Burst Flavor contains aspartame (NutraSweet®), which is metabolized in the GI tract to provide16 mg phenylalanine per 3.4 g dose.
Citrucel® Sugar Free Orange Flavor contains aspartame (NutraSweet®), which is metabolized in the GI tract to provide 52 mg per 10.2 g dose.
Citrucel® Fiber Shake, Chocolate Flavor contains aspartame (NutraSweet®), which is metabolized in the GI tract to provide 49 mg per 10.7 g dose.
Specific Populations
Pregnancy
Psyllium: Category B.
Pediatric Use
Safety and efficacy of methylcellulose not established in children <6 years of age.
Safety and efficacy of malt soup extract not established in children <2 years of age.
Safety and efficacy of psyllium powders and wafers not established in children <6 years of age.
Safety and efficacy of calcium polycarbophil and psyllium capsules not established in children <12 years of age.
Avoid use of laxatives in infants and children.
Renal Impairment
Use with caution and monitor electrolytes (e.g., magnesium, potassium) in patients with impaired renal function.
Common Adverse Effects
Psyllium: Changes in bowel habits, minor bloating.
Interactions
GI Absorption of Other Drugs
By increasing intestinal motility, can potentially decrease transit time of concomitantly administered oral drugs and thereby decrease their absorption.
Administer ≥2–3 hours before or after other medications.
Specific Drugs
Drug
Interaction
Comments
Digitalis
May bind digitalis in the GI tract and decrease absorption
Administer laxative at least 3 hours before or after digitalis
May bind nitrofurantoin in the GI tract and decrease absorption
Administer laxative at least 3 hours before or after nitrofurantoin
Salicylates
May bind salicylate in the GI tract and decrease absorption
Administer laxative at least 3 hours before or after salicylate
Pharmacokinetics
Absorption
Bioavailability
Generally not absorbed following oral administration. Malt soup extract reported to be hydrolyzed and absorbed in the colon.
Onset
Following oral administration, laxative effect usually occurs within 12–72 hours; full effect may not be apparent for 2–3 days.
Elimination
Metabolism
Malt soup extract reportedly metabolized in the liver.
Stability
Storage
Oral
Calcium Polycarbophil Caplets
20–25°C; protect from moisture.
Methylcellulose Caplets
Tightly containers at 15–30°C; protect from moisture.
Methylcellulose Powder
Tight containers at <25°C; protect from humidity.
Psyllium Capsules
Tight containers at room temperature; protect from humidity.
Psyllium Wafer
Room temperature.
Actions
Malt soup extract obtained from the grain of one or more varieties of barley.
Plantago or psyllium seed is the cleaned, dried, ripe seed of Plantago psylliumand related species; the coating has a high hemicellulose mucilage content.
Dissolves or swells in water to form an emollient gel or viscous (bulk) solution. The resulting bulk causes enlargement of lumen of the colon and a softer stool, thereby decreasing intraluminal pressure and straining. Promotes peristalsis and reduces transit time.
Reduces fecal pH and serum cholesterol, and alters the composition of fecal bile acids; may contribute to laxative effect.
Advice to Patients
Importance of informing clinicians before use if abdominal pain, nausea, or vomiting is present or of a sudden change in bowel habits that persists over a period of 2 weeks.
Importance of adequate fluid intake (e.g., ≥250 mL) with each dose to minimize the risk of choking or asphyxiation.
Importance of informing patients with phenylketonuria that Citrucel® Sugar Free Orange Flavor, Metamucil® Smooth Texture Sugar Free Orange Flavor and Berry Flavor, and Citrucel® Fiber Shake, Chocolate Flavor, contain aspartame.
Advise patients sensitive to milk that Citrucel® Fiber Shake, Chocolate Flavor, contains dry milk powder.
Importance of not using laxative products for >1 week unless directed by a clinician.
Importance of stopping use and informing a clinician if a bowel movement does not occur or rectal bleeding occurs after use.
Inform patients of symptoms of esophageal obstruction (e.g., chest pain and/or pressure, regurgitation, vomiting, difficulty in swallowing and/or breathing); advise patients to immediately contact their clinician if such symptoms occur.
Advise patients to take calcium polycarbophil and psyllium laxatives ≥2 hours before or 2 hours after other oral medicines.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Calcium Polycarbophil
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Oral
Caplets
Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.