Attapulgite (Oral-Local)


VA CLASSIFICATION
Primary: GA208

Commonly used brand name(s): Diar-Aid; Diarrest; Diasorb; Diatrol; Donnagel; Fowler's; K-Pek; Kaopectate; Kaopectate Advanced Formula; Kaopectate Maximum Strength; Kaopek; Parepectolin; Rheaban.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antidiarrheal(adsorbent)—

Indications

Note: The efficacy of any antidiarrheal medication for treatment of most cases of nonspecific diarrhea is questionable, especially in children. {16} {18} Preferred treatment for acute, nonspecific diarrhea consists of fluid and electrolyte replacement, nutritional therapy, {18} {20} and, if possible, elimination of the underlying cause of the diarrhea.


Accepted

Diarrhea (treatment)—Attapulgite may be indicated as an adjunct to rest, fluids, and an appropriate diet in the symptomatic treatment of mild to moderately acute diarrhea. Use is recommended in chronic diarrhea only as temporary symptomatic treatment until the etiology is determined. {01} {08} Attapulgite should not be used if diarrhea is accompanied by fever, or if there is blood or mucus in the stool. {13} {14}


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Adsorbent and protectant. Attapulgite is a hydrated magnesium aluminum silicate that supposedly adsorbs large numbers of bacteria and toxins and reduces water loss. Activated attapulgite (contained in most of the products commercially available) is attapulgite that has been carefully heated to increase its adsorptive capacity. Results of animal studies with adsorbent antidiarrheals suggest that the fluidity of the stool is decreased but total water loss appears to be unchanged and sodium and potassium loss may be exacerbated. {02} {03} {04} {08} {09} {18}

Absorption:

Not absorbed. {08} {09} {18}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented. Attapulgite is not absorbed after oral administration.

Breast-feeding

Problems in humans have not been documented. Attapulgite is not absorbed after oral administration.

Pediatrics

In infants and children up to 3 years of age with diarrhea, use is not recommended unless directed by a physician because of the risk of fluid and electrolyte loss. Oral rehydration therapy is recommended in children with diarrhea to prevent loss of fluids and electrolytes. {15} {16} {17}


Geriatrics


In geriatric patients with diarrhea, caution is recommended because of the risk of fluid and electrolyte loss; these patients should be referred to a physician. {03} {09}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Anticholinergics or other medications with anticholinergic activity(See Appendix II ) or
Antidyskinetics or
Digitalis glycosides or
Lincomycins or
Loxapine or
Phenothiazines or
Thioxanthenes or
Xanthines, such as:
Aminophylline
Caffeine
Dyphylline
Oxtriphylline
Theophylline    (concurrent use with attapulgite may impair absorption of these medications when they are administered orally, resulting in decreased therapeutic effectiveness; it is recommended that attapulgite be administered not less than 2 hours before or 3 to 4 hours after oral lincomycins; patients on digitalis should be monitored closely for evidence of altered effect {04} {05})


Oral medications, other    (prolonged use of adsorbents may interfere with absorption of other oral agents administered concurrently; it is recommended that attapulgite be administered at least 2 to 3 hours before or after other oral medications {04} {05})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Dehydration    (although adsorbent antidiarrheals may increase the consistency of feces and decrease the frequency of evacuation, they do not reduce the amount of fluid loss, but only mask its extent; rehydration therapy is essential if symptoms of dehydration, such as dryness of mouth, excessive thirst, wrinkled skin, decreased urination, and dizziness or lightheadedness, are present; fluid loss may have serious consequences, such as circulatory collapse and renal failure, especially in young children and the elderly {06})


Diarrhea, parasite-associated, suspected    (use of adsorbent antidiarrheals may make recognition of parasitic causes of diarrhea more difficult; if parasitic agents are suspected pathogens, appropriate stool analyses should be performed prior to therapy with adsorbents {08})


» Dysentery, acute, characterized by bloody stools and elevated temperature    (sole treatment with adsorbent antidiarrheals may be inadequate; antibiotic therapy may be required {08})


Obstruction of the bowel, suspected    (condition may be aggravated {04})




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention only if they continue or are bothersome
Incidence dose-related
    
Constipation —usually mild and transient, but may rarely lead to fecal impaction{02}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Attapulgite (Oral).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:





Use in children—Not using in infants and children up to 3 years of age unless prescribed by a physician because of risk of dehydration associated with diarrhea; oral rehydration therapy recommended in children with diarrhea






Use in the elderly—Risk of dehydration associated with diarrhea
Other medications; spacing doses of other oral medications 2 to 3 hours before or after doses of attapulgite is recommended
Other medical problems, especially dehydration and acute dysentery

Proper use of this medication
» Not using if diarrhea accompanied by fever or blood or mucus in the stool; contacting physician

Taking after each loose bowel movement until diarrhea is controlled

» Importance of maintaining adequate hydration and proper diet

» Proper dosing

» Proper storage

Precautions while using this medication
» Checking with physician if diarrhea is not controlled within 48 hours and/or fever develops


Oral-Local Dosage Forms

ATTAPULGITE ORAL SUSPENSION

Usual adult and adolescent dose
Antidiarrheal
Oral, 1.2 to 1.5 grams after each loose bowel movement, not to exceed 9 grams in twenty-four hours. {07} {11} {19}


Usual pediatric dose
{07} Antidiarrheal
Children up to 3 years of age: Use is not recommended unless directed by a physician.

Children 3 to 6 years of age: Oral, 300 mg after each loose bowel movement, not to exceed 2.1 grams in twenty-four hours. {11}

Children 6 to 12 years of age: Oral, 600 mg after each loose bowel movement, not to exceed 4.2 grams in twenty-four hours. {11}

Children 12 years of age and over: See Usual adult and adolescent dose .


Note: In general, dietary treatment of diarrhea is preferred in children whenever possible.


Strength(s) usually available
U.S.—


600 mg per 15 mL (OTC) [Donnagel] [Kaopectate Advanced Formula] [Kaopek] [K-Pek] [Parepectolin]


750 mg per 5 mL (OTC) [Diasorb]

Canada—


600 mg per 15 mL (OTC) [Kaopectate]


750 mg per 15 mL (OTC) [Kaopectate]


900 mg per 15 mL (OTC) [Fowler's]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well. {19}

Note: Refer patients with recurrent or persistent diarrhea to a physician. {19}



ATTAPULGITE TABLETS

Usual adult and adolescent dose
Antidiarrheal
Oral, 1.2 to 1.5 grams after each loose bowel movement, not to exceed 9 grams in twenty-four hours. {19}


Usual pediatric dose
Antidiarrheal
Children 3 to 6 years of age: The available strength of the tablet may not conform to the recommended dose for children 3 to 6 years of age; the oral suspension is the preferred dosage form for this age group.

Children 6 to 12 years of age: Oral, 750 mg after each loose bowel movement, not to exceed 4.5 grams in twenty-four hours.

Children 12 years of age and over: See Usual adult and adolescent dose .


Note: In general, dietary treatment of diarrhea is preferred in children whenever possible.


Strength(s) usually available
U.S.—


300 mg (OTC) [Diarrest] [Diatrol]


750 mg (OTC) [Diar-Aid (pectin 150 mg)] [Diasorb] [Kaopectate Maximum Strength] [Rheaban]

Canada—


600 mg (OTC) [Kaopectate]


630 mg (OTC) [Fowler's]


750 mg (OTC) [Kaopectate]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Do not chew. {19}

Note: Refer patients with recurrent or persistent diarrhea to a physician. {19}



ATTAPULGITE CHEWABLE TABLETS

Usual adult and adolescent dose
Antidiarrheal
Oral, 1.2 grams after each loose bowel movement, not to exceed 8.4 grams in twenty-four hours.


Usual pediatric dose
Antidiarrheal
Children up to 3 years of age: Use is not recommended unless directed by a physician.

Children 3 to 6 years of age: Oral, 300 mg after each loose bowel movement, not to exceed 2.1 grams in twenty-four hours.

Children 6 to 12 years of age: Oral, 600 mg after each loose bowel movement, not to exceed 4.2 grams in twenty-four hours.

Children 12 years of age and over: See Usual adult and adolescent dose .


Note: In general, dietary treatment of diarrhea is preferred in children whenever possible.


Strength(s) usually available
U.S.—


300 mg (OTC) [Kaopectate]


600 mg (OTC) [Donnagel]

Canada—


300 mg (OTC) [Kaopectate]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • May be chewed.

Note: Refer patients with recurrent or persistent diarrhea to a physician.




Revised: 04/27/1995



References
  1. Product package.
  1. Reynolds JEF, editor. Martindale, the extra pharmacopoeia. 29th ed. London: The Pharmaceutical Press, 1989: 1077.
  1. Longe LR. Antidiarrheal and other gastrointestinal products. In: Handbook of nonprescription drugs, 8th ed. Washington, DC: American Pharmaceutical Association, 1986: 59-74.
  1. AMA Drug evaluations. 5th ed. Chicago: American Medical Association, April 1983: 1286.
  1. AMA Drug evaluations. 6th ed. Chicago: American Medical Association, September 1986: 963.
  1. Burdock N. The pharmacist's role in patient counseling OTC antidiarrheals. Kentucky Pharmacist 1981: 323.
  1. Fed Regist 1986; 51(83): 16142.
  1. DuPont HL. Using OTC drugs for acute diarrhea. Drug Ther 1983: 127-36.
  1. Dukes GE. Over-the-counter antidiarrheal medications used for the self-treatment of acute nonspecific diarrhea. Am J Med 1990; 88(6A Suppl): 24S-26S.
  1. DuPont HL, Ericsson CD, DuPont MW, et al. A randomized, open-label comparison of nonprescription loperamide and attapulgite in the symptomatic treatment of acute diarrhea. Am J Med 1990; 88(6A Suppl): 20S-23S.
  1. Parepectolin package insert (Rhone-Poulenc Rorer—US), Rev 11/91, Rec 7/14/94.
  1. Brownlee HJ. Family practitioner's guide to patient self-treatment of acute diarrhea. Am J Med 1990; 88(6A Suppl): 27S-29S.
  1. Industry plans voluntary warning for anti-diarrheals. Washington Drug Letter 1993: 25: 1.
  1. Labeling changes for OTC attapulgite products. US Pharmacist 1993: 28.
  1. Balistreri WF. Oral rehydration in acute infantile diarrhea. Am J Med 1990; 88(6A Suppl): 30S.
  1. Kenyon J, Caldwell M, editors. Oral rehydration is the cornerstone of diarrhoea therapy in children. Drugs and Therapy Perspectives 1993; 1: 15-6.
  1. Bezerra JA, Stathos TH, Duncan B, et al. Treatment of infants with acute diarrhea: what's recommended and what's practiced. Pediatrics 1992; 90: 1-4.
  1. Diarrhoeal Disease Control Programme. Guide for improving diarrhoea treatment practices of pharmacists and licensed drug sellers. Geneva: World Health Organization, 1993: 53-5, 65-7.
  1. Fowler's package insert (Sandoz—Canada), Rec 5/16/94.
  1. International Health Advisory Panel Meeting, 6/10/94.
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