Professional Drug Information > Kaolin, Pectin, Hyoscyamine Sulfate, Atropine Sulfate, and Scopolamine Hydrobromide

Kaolin, Pectin, and Belladonna Alkaloids (Systemic)

VA CLASSIFICATION
Primary: GA208

Commonly used brand name(s): Donnagel.

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

^*Not commercially available in the U.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. ^{{09} {25}} Preferred treatment for acute, nonspecific diarrhea consists of fluid and electrolyte replacement, nutritional therapy, ^{{09} {12}} and, if possible, elimination of the underlying cause of the diarrhea.


Unaccepted
The U.S. Food and Drug Administration (FDA) has banned the inclusion of belladonna alkaloids in antidiarrheal preparations because of lack of proof of their effectiveness. FDA has requested that manufacturers wishing to obtain the agency's approval for inclusion of these ingredients in their product provide FDA with evidence that the ingredients are safe and effective for their intended use. ^{13} This medication has been replaced by equally or more effective, and safer, agents for the treatment of diarrhea. ^{27}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Atropine: 289.38 ^{23}
    Hyoscyamine sulfate: 712.86 ^{23}
    Scopolamine hydrobromide: 438.32 ^{23}

Mechanism of action/Effect:

Kaolin and pectin—Adsorbent and protectant. ^{{03} {11}} Kaolin is a natural hydrated aluminum silicate that is believed to adsorb large numbers of bacteria and toxins and to 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. ^{09} Studies have shown no decrease in stool frequency or fecal weight and water content with this combination even though stools appeared more formed. ^{{09} {11}}

Belladonna alkaloids (atropine, hyoscyamine, and scopolamine)—Control hypermotility and hypersecretion in the gastrointestinal tract. However, their efficacy in the treatment of diarrhea has not been demonstrated. ^{13}


Duration of effect

3 to 4 hours.

Absorption:

Kaolin and pectin—Not absorbed (up to 90% of pectin is decomposed in the gastrointestinal tract). ^{{03} {09}}

Belladonna alkaloids—Rapidly absorbed from the gastrointestinal tract. ^{16}

Biotransformation:

Belladonna alkaloids—Hepatic.

Elimination:
    Belladonna alkaloids—Renal.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other belladonna alkaloids or derivatives may be sensitive to this medication also.

Pregnancy/Reproduction

Pregnancy—
Belladonna alkaloids cross the placenta. Problems in humans have not been documented.

Breast-feeding

Belladonna alkaloids are distributed into breast milk. ^{16} However, problems in humans have not been documented.

Pediatrics

In infants and children up to 6 years of age with diarrhea, use of kaolin, pectin, and belladonna alkaloids combination is not recommended unless directed by a physician because use of this combination does not preclude, and may aggravate, the risk of fluid and electrolyte loss; oral rehydration therapy is recommended in children with diarrhea to prevent loss of fluids and electrolytes. ^{{24} {25} {26}}

Infants and young children are especially susceptible to the side/adverse effects of belladonna alkaloids. ^{16}


Geriatrics


In geriatric patients with diarrhea, caution is recommended because use of this combination does not preclude, and may aggravate, the risk of fluid and electrolyte loss; these patients should be referred to a physician. ^{10}

Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of belladonna alkaloids. These drugs block the actions of acetylcholine, which is responsible for many functions of the brain, including memory functions. ^{02}


Dental

Prolonged use of belladonna alkaloids may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort. ^{05}

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.

» Alcohol or
Anesthetics, general or
Antihypertensives with central nervous system (CNS) depressant effects such as clonidine, guanabenz, methyldopa, and metyrosine or
» CNS depressants, other (See Appendix II ) or
Magnesium sulfate, parenteral    (concurrent use may increase the CNS depressant effects of these medications )


Anticholinergics, other (See Appendix II ) or
Antidyskinetics or
Dicyclomine or
Digitalis glycosides ^{09} or
Lincomycins ^{09} or
Loxapine or
Phenothiazines or
Thioxanthenes    (concurrent use with kaolin and pectin combinations may impair absorption of these medications when they are administered orally, resulting in decreased therapeutic effectiveness; it is recommended that kaolin and pectin–containing medications be administered not less than 2 hours before or 3 to 4 hours after oral lincomycins; patients receiving digitalis glycosides concurrently with kaolin and pectin–containing medications should be monitored closely for evidence of altered effect ^{{03} {04}})

    (concurrent use of antidyskinetics, dicyclomine, loxapine, phenothiazines, thioxanthenes, or other anticholinergics with belladonna alkaloids may enhance anticholinergic effects or produce paralytic ileus)


Antidepressants, tricyclic    (concurrent use with belladonna alkaloids may intensify anticholinergic effects; dosage adjustments may be necessary during and after concurrent therapy with belladonna alkaloids)


Antimyasthenics    (concurrent use with belladonna alkaloids may further reduce intestinal motility ^{{14} {15}})


» Ketoconazole    (belladonna alkaloids may increase gastrointestinal pH; concurrent administration of ketoconazole with belladonna alkaloids may result in a marked reduction in absorption of ketoconazole; patients should be advised to take belladonna alkaloids at least 2 hours after ketoconazole ^{07})


Metoclopramide    (concurrent use with belladonna alkaloids may antagonize the effects of metoclopramide on gastrointestinal motility ^{17})


Molindone or
» Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline    (concurrent use with belladonna alkaloids may intensify anticholinergic effects; dosage adjustments may be necessary ^{{18} {19} {20}})

    (concurrent use may increase the CNS effects of these medications)


Opioid (narcotic) analgesics    (concurrent use with belladonna alkaloids may increase risk of severe constipation, which may lead to paralytic ileus, and/or urinary retention)

    (concurrent use may increase the CNS depressant effects of these medications )


Oral medications, other    (prolonged use of adsorbents [e.g., kaolin and pectin] may interfere with absorption of other oral medications administered concurrently; also, because of decreased gastrointestinal motility and delayed gastric emptying, absorption of other oral medications may be decreased during concurrent use with belladonna alkaloids ^{03})


» Potassium chloride, especially wax-matrix preparations     (concurrent use with belladonna alkaloids may increase severity of potassium chloride–induced gastrointestinal lesions ^{21})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
» Gastric acid secretion test    (concurrent use of belladonna alkaloids may antagonize the effect of pentagastrin and histamine in the evaluation of gastric acid secretory function; administration of belladonna alkaloids is not recommended during the 24 hours preceding the test)


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).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Colitis, severe    (increased risk for development of toxic megacolon)


Risk-benefit should be considered when the following medical problems exist
» Asthma, acute attack or
» Respiratory disease or impairment, especially chronic obstructive pulmonary disease    (depression of mucus secretion and inhibition of mucociliary clearance caused by belladonna alkaloids is undesirable in these patients ^{16})


Brain damage, in children    (central nervous system [CNS] effects may be exacerbated by belladonna alkaloids )


Chronic ulcerative colitis or other intestinal disease    (belladonna alkaloids may suppress intestinal motility, possibly causing paralytic ileus; also, use may precipitate or aggravate toxic megacolon)


Coronary artery disease    (belladonna alkaloids may precipitate angina)


» 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 and the elderly ^{{06} {11}})


» Diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract
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})


Down's syndrome    (abnormal increase in pupillary dilation and acceleration of heart rate may occur with the use of belladonna alkaloids)


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


» Glaucoma, predisposition to    (mydriatic effect of belladonna alkaloids may result in increased intraocular pressure, possibly precipitating an acute attack of angle-closure glaucoma ^{{01} {22}})


» Hepatic function impairment ^{01}    (decreased metabolism of belladonna alkaloids)


Hernia, hiatal, associated with reflux esophagitis    (belladonna alkaloids may aggravate condition ^{22})


» Prostatic hyperplasia ^{01} or
» Urinary retention, or predisposition to    (belladonna alkaloids may precipitate or aggravate urinary retention)


» Renal function impairment    (decreased excretion may increase the risk of side effects ^{22})


Sensitivity to belladonna alkaloids ^{01}
Spastic paralysis, in children    (response to belladonna alkaloids may be increased)


Xerostomia    (prolonged use of belladonna alkaloids may further reduce limited salivary flow)




Side/Adverse Effects

Note: When belladonna alkaloids are given to patients in locations where the environmental temperature is high, there is risk of a rapid increase in body temperature because of suppression of sweat gland activity. ^{16}
Infants, blonds, and children with spastic paralysis or brain damage may show an increased response to belladonna alkaloids, thus increasing the potential for side 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
Incidence rare
    
Allergic reaction (skin rash or itching)
    
CNS depression (shortness of breath; troubled breathing)
    
hallucinations
    
increased intraocular pressure (eye pain)
    
paralytic ileus or toxic megacolon (bloating; constipation; loss of appetite; severe stomach pain with nausea and vomiting)
    
slow heartbeat



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
—with large doses    
Confusion —especially in the elderly
    
constipation —usually mild and transient, but may rarely lead to fecal impaction
    
decreased sweating
    
difficult urination^{01}
    
drowsiness
    
dryness of mouth,^{01} nose, throat, or skin
    
fast heartbeat
    
headache
    
histamine release (flushing or redness of face; increased sweating)
    
loss of memory^{02} —especially in the elderly with continued use
    
orthostatic hypotension (dizziness; faintness; lightheadedness)

Incidence less frequent
    
Blurred vision^{01}
    
decreased sexual ability
    
increased sensitivity of eyes to sunlight
    
nervousness
    
reduced sense of taste





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Kaolin, Pectin, and Belladonna Alkaloids (Systemic).

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

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to any of the belladonna alkaloids

Pregnancy—Belladonna alkaloids cross the placenta





Breast-feeding—Belladonna alkaloids are distributed into breast milk





Use in children—Not using in infants and children up to 6 years of age because use does not preclude, and may aggravate, risk of dehydration associated with diarrhea; oral rehydration therapy recommended in children with diarrhea; increased susceptibility to side/adverse effects of belladonna alkaloids






Use in the elderly—Risk of dehydration associated with diarrhea; increased sensitivity to effects of belladonna alkaloids





Dental—Possible development of dental problems because of decreased salivary flow
Other medications, especially CNS depressants, ketoconazole, MAO inhibitors, or potassium chloride
Other medical problems, especially acute dysentery, asthma or respiratory disease, dehydration, diarrhea caused by poisoning, glaucoma, hepatic and/or renal function impairment, prostatic hyperplasia or urinary retention, or severe colitis

Proper use of this medication
Taking with food or meals if gastric irritation occurs

» Importance of not taking more medication than the amount prescribed

Proper administration technique

» Importance of maintaining adequate hydration and proper diet ^{10}

» Proper dosing

» Proper storage

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

Possible interference with laboratory values

» Avoiding use of alcohol or other CNS depressants

» Caution if drowsiness occurs

Possible increased sensitivity of eyes to light

» Caution during exercise and hot weather; overheating may result in heatstroke

Possible dryness of mouth, nose, and throat; using sugarless candy or gum, ice, or saliva substitute for relief; checking with physician or dentist if dry mouth continues for more than 2 weeks


Side/adverse effects
Signs of potential side effects, especially allergic reaction, CNS depression, hallucinations, increased intraocular pressure, paralytic ileus or toxic megacolon, or slow heartbeat


General Dosing Information
This medication may be taken with food or meals to lessen gastric irritation.

Reduction of intestinal motility in patients with traveler's diarrhea may result in prolonged fever by slowing expulsion of infectious organisms that penetrate intestinal mucosa (for example, Shigella, Salmonella, and certain strains of Escherichia coli ).

Inhibition of peristalsis may produce fluid retention in the bowel, which may aggravate and mask dehydration and depletion of electrolytes, especially in young children, and may also increase variability of response to the medication. If dehydration or electrolyte imbalance occurs, antidiarrheal medication should be withheld until appropriate corrective therapy has begun. ^{11}

To reduce the risk of toxic megacolon in patients with acute ulcerative colitis, treatment with antidiarrheal medication should be discontinued promptly if abdominal distention or other specific gastrointestinal symptoms occur.

A reduction in dosage is recommended for patients with impaired hepatic function who require prolonged treatment with this medication.

Treatment with antidiarrheal medication should be continued for 24 to 36 hours before it is considered ineffective in the treatment of acute diarrhea.


Oral Dosage Forms

KAOLIN, PECTIN, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDE ORAL SUSPENSION

Usual adult and adolescent dose
Oral, 30 mL every three hours as needed to control diarrhea. ^{01}

Usual adult prescribing limits
Four doses in twenty-four hours.

Usual pediatric dose
Children up to 6 years of age: Use is not recommended unless directed by a physician.

Children over 6 years of age: Oral, 5 to 10 mL every three hours as needed to control diarrhea, ^{01} up to four doses in twenty-four hours.

Note: In general, oral rehydration therapy and dietary treatment of diarrhea in children are preferred whenever possible.


Usual geriatric dose
See Usual adult and adolescent dose .

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—
Not commercially available.

Canada—


6 grams of kaolin, 142.8 mg of pectin, 104 mcg (0.104 mg) of hyoscyamine sulfate, 19 mcg (0.019 mg) of atropine sulfate, and 7 mcg (0.007 mg) of scopolamine hydrobromide per 30 mL (Rx) [Donnagel (alcohol 3.8%) (sodium <2.6 mg per 5 mL) (sugar )]

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

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.
   • Do not take other medicines without your doctor's advice.
   • Keep out of reach of children.
   • Shake well before using. ^{01}

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

Revised: 04/27/1995

References

1. Donnagel (Wyeth-Ayerst). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 402.
   

2. Miller P. Association of low serum anticholinergic levels and cognitive impairment in elderly presurgical patients. Am J Psychiatry 1988; 145: 342-5.
   

3. Longe LR. Antidiarrheal and other gastrointestinal products. In: Handbook of nonprescription drugs. 8th ed. Washington, DC: American Pharmaceutical Association, 1986: 59-74.
   

4. AMA Drug evaluations. 5th ed. Chicago: American Medical Association, April 1983: 1286.
   

5. Council on Dental Therapeutics, editor. Accepted dental therapeutics. 40th ed. Chicago: American Dental Association, 1984: 82.
   

6. Burdock N. The pharmacist's role in patient counseling OTC antidiarrheals. Kentucky Pharmacist 1981: 323.
   

7. Ketoconazole package insert (Nizoral, Janssen—US), Rev 3/89.
   

8. Binder HJ. Net fluid and electrolyte secretion: the pathophysiologic basis of diarrhea. In: Binder HJ, editor. Mechanism of intestinal secretion. New York: Alan R Liss Inc., 1979: 1-15.
   

9. Diarrhoeal Disease Control Programme. Guide for improving diarrhoea treatment practices of pharmacists and licensed drug sellers. Geneva: World Health Organization, 1993: 53-5.
   

10. Brownlee HJ. Family practitioner's guide to patient self-treatment of acute diarrhea. Am J Med 1990; 88 (6A Suppl): 27S-29S.
    

11. DuPont HL. Using OTC drugs for acute diarrhea. Drug Ther 1983: 127-36.
    

12. International Health Advisory Panel Meeting 6/10/94.
    

13. U.S. Department of Health and Human Services. Food and Drug Administration, HHS News. Nov 1990.
    

14. Nagairb M, Gomaa M. Atropine-neostigmine mixture: a dose-response study. Can J Anaesth 1989; 36: 412-7.
    

15. Salem M, Ahearn R. Atropine or glycopyrrolate with neostigmine 5 mg: a comparative dose-response study. J R Soc Med; 79: 19-21.
    

16. Brown JH. Atropine, scopolamine, and related antimuscarinic drugs. In: Gilman AG, Rall TW, Nies AS, Taylor P, editors. Goodman and Gilman's the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press, 1990: 150-65.
    

17. Metoclopramide package insert (Lederle—US), Rev 10/85, Rec 4/89.
    

18. Isocarboxazid (Marplan, Roche). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 577-8.
    

19. Panel comment, 10/91.
    

20. Panel comment, 10/91.
    

21. Potassium chloride package insert (K+10, Alra—US), Rev 9/87.
    

22. Anisotropine package insert (Valpin 50, DuPont—US), Rev 8/85, Rec 10/88.
    

23. Fleeger CA, editor. USP dictionary of USAN and international drug names. 1995 ed. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1994: 63, 337, 605.
    

24. Balistreri WF. Oral rehydration in acute infantile diarrhea. Am J Med 1990; 88(6A Suppl): 30S.
    

25. Kenyon J, Caldwell M, editors. Oral rehydration is the cornerstone of diarrhoea therapy in children. Drugs Ther Perspect 1993; 1: 15-6.
    

26. 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.
    

27. Reviewers' consensus on monograph revision of 2/95.
    

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