Kaolin and Pectin (Oral-Local)


VA CLASSIFICATION
Primary: GA208

Commonly used brand name(s): Donnagel-MB; K-P; Kao-Spen; Kapectolin.

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. {07} {13} Preferred treatment for acute, nonspecific diarrhea consists of fluid and electrolyte replacement, nutritional therapy, {07} {16} and, if possible, elimination of the underlying cause of the diarrhea.


Accepted

Diarrhea (treatment)—Kaolin and pectin 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} {11} Kaolin and pectin combination should not be used if diarrhea is accompanied by fever or if there is blood or mucus in the stool. {10}


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Adsorbent and protectant. Kaolin is a natural hydrated aluminum silicate {07} that is believed to adsorb large numbers of bacteria and toxins and reduce water loss. Pectin is a polyuronic polymer for which the mechanism of action is unknown. Pectin consists of purified carbohydrate extracted from citrus fruit or apple pomace. {07} Studies have shown no decrease in stool frequency or fecal weight and water content with this combination even though stools appeared more formed. {07} {11}

Absorption:

Not absorbed (up to 90% of pectin is decomposed in gastrointestinal tract). {03} {04} {07}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented. Kaolin and pectin combination is poorly absorbed after oral administration.

Breast-feeding

Problems in humans have not been documented. Kaolin and pectin combination is poorly absorbed after oral administration. {12}

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. {08} {13} {14}


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.

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{07} or
Lincomycins{07} or
Loxapine or
Phenothiazines or
Thioxanthenes    (concurrent use with kaolin and pectin combination may impair absorption of these medications when it is administered orally, resulting in decreased therapeutic effectiveness; it is recommended that kaolin and pectin combination be administered not less than 2 hours before or 3 to 4 hours after oral lincomycins; patients receiving digitalis should be monitored closely for evidence of altered effect {03} {04} {05})


Oral medications, other    (prolonged use of adsorbents may interfere with absorption of other oral agents administered concurrently; it is recommended that kaolin and pectin combination be administered at least 2 to 3 hours before or after other oral medications {02} {04})


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 signs or 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 {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 {11})


» Dysentery, acute, characterized by bloody stools and elevated temperature    (sole treatment with adsorbent antidiarrheals may be inadequate; antibiotic therapy may be required {11})




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{05}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Kaolin and Pectin (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 medical problems, especially dehydration and acute dysentery

Proper use of this medication
» Not using if diarrhea is accompanied by fever or by 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

Taking doses of other oral medications 2 to 3 hours before or after doses of kaolin and pectin combination


Oral Dosage Forms

KAOLIN AND PECTIN ORAL SUSPENSION

Usual adult dose
Antidiarrheal
Oral, 60 to 120 mL after each loose bowel movement.


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, 15 to 30 mL after each loose bowel movement.

Children 6 to 12 years of age: Oral, 30 to 60 mL after each loose bowel movement.

Children 12 years of age and over: Oral, 45 to 60 mL {15} after each loose bowel movement.


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


Strength(s) usually available
U.S.—


5.2 grams of kaolin and 260 mg of pectin per 30 mL (OTC) [Kao-Spen] [K-P]


5.85 grams of kaolin and 130 mg of pectin per 30 mL (OTC) [Kapectolin][Generic]

Canada—


6 grams of kaolin and 143 mg of pectin per 30 mL (OTC) [Donnagel-MB (alcohol 3.8%)]

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.

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




Revised: 08/04/94



References
  1. Product package.
  1. AMA Drug evaluations. 5th ed. Chicago: American Medical Association, April 1983: 1286.
  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. 6th ed. Chicago: American Medical Association, September 1986: 963.
  1. American Hospital Formulary Service.
  1. Burdock N. The pharmacist's role in patient counseling OTC antidiarrheals. Kentucky Pharmacist 1981: 323.
  1. Diarrhoeal Disease Control Programme. Guide for improving diarrhoea treatment practices of pharmacists and licensed drug sellers. Geneva: World Health Organization, 1993: 53-5.
  1. Balistreri WF. Oral rehydration in acute infantile diarrhea. Am J Med 1990; 88(6A Suppl): 30S.
  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 antidiarrheals. Wash Drug Letter 1993; 25: 1.
  1. DuPont HL. Using OTC drugs for acute diarrhea. Drug Ther 1983: 127-36.
  1. Aust J Hosp Pharm 1988; 18: 161.
  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. Panel comment, 5/94.
  1. International Health Advisory Panel Meeting, 6/10/94.
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