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Medical Nutrition Therapy
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STOPPER ®
RAZIONALE SCIENTIFICO

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Stopper: complemento nutrizionale ad azione addensante fecale, utile nella diarrea di varia origine e nell'incontinenza fecale.

 

 

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1) da DRUGDEX DRUG EVALUATIONS: KAOLIN/PECTIN

  • 0.0 OVERVIEW
    • A. KAOLIN and PECTIN are adsorbent products.
    • B. DOSING INFORMATION: Kaopectate(R) Concentrated: adults and children 12 years of age and older - 2 tablespoonfuls; children 6 to 12 years - 1 tablespoonful; children 3 to 6 years - 1/2 tablespoonful.
    • C. PHARMACOKINETICS: No pharmacokinetic data is available.
    • D. CAUTIONS: If diarrhea is not controlled in 48 hours and/or fever develops, the patient should consult a physician. Constipation may occur in children and in the elderly.
    • E. CLINICAL APPLICATIONS: KAOLIN/PECTIN combinations are used for treatment of diarrhea.
  • 1.0 DOSING INFORMATION
    • 1.1 DOSAGE FORMS
      • A. Information on specific products and dosage forms can be obtained by referring to the Product Index.
    • 1.3 ADULT DOSAGE
      • 1.3.1 NORMAL DOSE
        • A. ORAL
          • 1. For the treatment of diarrhea, the dose of KAOLIN-PECTIN (caolino-pectina) varies with the preparation. The recommended dose of regular strength KAOLIN-PECTIN (caolino-pectina) for adults is 60 to 120 milliliters at the first sign of diarrhea and after each bowel movement or as needed (USPDI, 1994). For the concentrated KAOLIN-PECTIN (caolino-pectina) preparation, the recommended dosage is 2 tablespoonfuls (30 milliliters) at first sign of diarrhea and after each loose bowel movement (Prod Info Kaopectate(R) Concentrate, 1994).
    • 1.4 PEDIATRIC DOSAGE
      • 1.4.1 NORMAL DOSE
        • A. ORAL
          • 1. For the treatment of diarrhea, the dose of KAOLIN-PECTIN (caolino-pectina) varies with the preparation. The recommended dose of regular strength KAOLIN-PECTIN (caolino-pectina) for children over 12 years is 60 milliliters, for children 6 to 12 years is 30 to 60 milliliters, and for children 3 to 6 years is 15 to 30 milliliters; children under 3 years should be directed by a physician. An initial dose should be taken at the first sign of diarrhea and then after each bowel movement or as needed (USPDI, 1994). For the concentrated KAOLIN-PECTIN (caolino-pectina) preparation, the recommended dosage for children 6 to 12 years is 1 tablespoonful (15 milliliters); children 3 to 6 years - 1/2 tablespoonful (7.5 milliliters) (Prod Info Kaopectate(R) Concentrate, 1994).
  • 3.0 CAUTIONS
    • 3.1 CONTRAINDICATIONS
      • A. Hypersensitivity to kaolin/pectin products
    • 3.2 PRECAUTIONS
      • A. Do not use for diarrhea from pseudomembranous enterocolitis or toxigenic bacteria.
    • 3.3 ADVERSE REACTIONS
      • 3.3.5 GASTROINTESTINAL
        • A. CONSTIPATION
          • 1. Constipation may occur in children and the elderly with use of KAOLIN-PECTIN (caolino-pectina) (USPDI, 1994).
      • 3.3.12 OTHER
        • A. OVERDOSE See POISINDEX(R) Management "NON-TOXIC INGESTION"
        • B. DEHYDRATION
          • 1. Dehydration associated with diarrhea may occur in children and the elderly (USPDI, 1994).
    • 3.4 TERATOGENICITY/EFFECTS IN PREGNANCY
      • A. TERATOGENICITY
        • 1. U.S. Food and Drug Administration's Pregnancy Category C (Briggs et al, 1992).
      • B. EFFECTS IN PREGNANCY
        • 1. IRON deficiency anemia and hypokalemia have occurred secondary to clay (containing KAOLIN) ingestion (Talington et al, 1970; Roselle, 1970).
    • 3.5 DRUG INTERACTIONS
      • 3.5.1 DRUG-DRUG COMBINATIONS
        • A. CHLOROQUINE
          • 1. Summary: The peak plasma concentration and bioavailability of chloroquine was decreased by concomitant administration with kaolin (McElnay et al, 1982). Kaolin and magnesium-containing antacids should be avoided in patients taking chloroquine for the treatment or prophylaxis of malaria.
          • 2. Adverse Effect: decreased efficacy of chloroquine
          • 3. Clinical Management: Concomitant administration of kaolin and chloroquine should be avoided. Their administration should be separated by at least four hours.
          • 4. Severity: moderate
          • 5. Onset: delayed
          • 6. Documentation: fair
          • 7. Probable Mechanism: chloroquine adsorption results in a decreased amount of drug available for absorption
          • 8. Literature Reports:
            • a. Six healthy male volunteers ingested 1 gram of chloroquine diphosphate (600 mg of chloroquine base) to establish control parameters in a study to determine the effect of concomitant chloroquine with magnesium trisilicate and kaolin. During the test periods, the subjects were given magnesium trisilicate 1 gram or kaolin 1 gram every eight hours, beginning 24 hours prior to chloroquine administration. Maximum concentration (Cmax) of chloroquine during chloroquine monotherapy was 184.5 mcg/L and decreased to 121 mcg/L during coadministration with kaolin. Other chloroquine parameters which were altered during combined therapy with chloroquine and kaolin included Tmax (6.04 hours vs. 7.01 hours) and AUC from time zero to 144 hours after drug administration (9630 mcg/h/L vs. 6877 mcg/h/L). The decreased Cmax and AUC reflect the adsorption of chloroquine onto the kaolin, resulting in a lesser amount of drug available for systemic absorption (McElnay et al, 1982).
        • B. CLINDAMYCIN
          • 1. Summary: When lincomycin or clindamycin are given concurrently with kaolin their absorption is reduced by greater than 70% and greater than 60% respectively (McCall et al, 1967; McGehee et al, 1968).
          • 2. Adverse Effect: decreased clindamycin effectiveness
          • 3. Clinical Management: If kaolin is required, administer either two hours prior to or four hours after the administration of lincomycin or clindamycin. Because staggered administration may not be completely reliable, aggressively monitor these patients for continued antibiotic efficacy.
          • 4. Severity: moderate
          • 5. Onset: rapid
          • 6. Documentation: fair
          • 7. Probable Mechanism: decreased absorption
        • C. DIGOXIN
          • 1. Summary: Commonly used anti-diarrheal products containing kaolin have been demonstrated to reduce the absorption of digoxin tablets by 20% to 62%. Less of a reduction in bioavailability occurs with the digoxin tablets (Prod Info Lanoxin(R), 2001; Rodin & Johnson, 1988; Albert et al, 1981).
          • 2. Adverse Effect: decreased digoxin effectiveness
          • 3. Clinical Management: If both drugs are required, give kaolin at least two to three hours after digoxin therapy.
          • 4. Severity: moderate
          • 5. Onset: rapid
          • 6. Documentation: good
          • 7. Probable Mechanism: altered absorption
        • D. HMGCOA REDUCTASE INHIBITORS
          • 1. Summary: Pectin may impair absorption and effectiveness of HMG-CoA reductase inhibitors as illustrated by 3 case reports of patients taking lovastatin with pectin fiber (Richter et al, 1991).
          • 2. Adverse Effect: reduced effectiveness of HMG CoA reductase inhibitors
          • 3. Clinical Management: Administer pectin two hours before or four to six hours after an HMG CoA reductase inhibitor. If this is not possible, separate administration times as much as possible.
          • 4. Severity: moderate
          • 5. Onset: delayed
          • 6. Documentation: poor
          • 7. Probable Mechanism: reduced absorption of the HMG CoA reductase inhibitor
          • 8. Literature Reports:
            • a. Low-density lipoprotein (LDL) cholesterol significantly increased in 3 patients taking lovastatin 80 milligrams and pectin fiber 15 grams daily for hypercholesterolemia after 4 weeks. When pectin was discontinued, LDL decreased to baseline levels. Patient A had baseline LDL of 4.27 millimoles/Liter (mmol/L) which increased to 4.79 mmol/L after 4 weeks of concomitant pectin therapy, then decreased to 4.14 mmol/L four weeks after discontinuation of pectin. Patient B had baseline LDL of 3.81 mmol/L, which increased to 5.80 mmol/L, then decreased to 4.04 mmol/L. Patient C had baseline LDL of 5.36 mmol/L, which increased to 8.5 mmol/L, then decreased to 4.82 mmol/L (Richter et al, 1991).
        • E. LINCOMYCIN
          • 1. Summary: When kaolin is given at the same time as oral lincomycin, serum lincomycin levels may be approximately 5 to 10% of those produced when lincomycin is given alone (McCall et al, 1967; McGehee et al, 1968; Wagner, 1968).
          • 2. Adverse Effect: decreased lincomycin effectiveness
          • 3. Clinical Management: Concurrent administration of lincomycin and kaolin is not recommended. If concurrent use cannot be avoided, kaolin should be taken at least two to three hours before or four hours after lincomycin. Because staggered administration may not be completely reliable, aggressively monitor these patients for continued antibiotic efficacy.
          • 4. Severity: moderate
          • 5. Onset: rapid
          • 6. Documentation: good
          • 7. Probable Mechanism: decreased gastrointestinal absorption
  • 4.0 CLINICAL APPLICATIONS
    • 4.3 PLACE IN THERAPY
      • A. KAOLIN-PECTIN (caolino-pectina) may provide symptomatic improvement by restoring stool consistency in patients with diarrhea, but has little or no value in the treatment of acute infectious diarrhea (Powell & Szauter, 1993; Gilman et al, 1990).
    • 4.4 MECHANISM OF ACTION/PHARMACOLOGY
      • A. MECHANISM OF ACTION
        • 1. KAOLIN adsorbs large numbers of bacteria and toxins and reduces water loss. The mechanism of action of PECTIN is unknown (USPDI, 1994).
    • 4.5 THERAPEUTIC USES
      • A. DIARRHEA 
§ FDA Labeled Indication
        • 1. OVERVIEW: 
§ FDA APPROVAL: Adult, yes; pediatric, yes (over 3 years) 
§ EFFICACY: Adult, effective; pediatric, good 
§ DOCUMENTATION: Adult, good; pediatric, good
        • 2. SUMMARY: 
§ - Kaolin/pectin relieves diarrhea from some causes but not others 
§ - It should not be used for diarrhea from pseudomembranous enterocolitis or toxigenic bacteria
        • 3. ADULT:
          • a. In a study comparing KAOLIN-PECTIN (caolino-pectina) 60 milliliters 4 times daily with ACTIVATED CHARCOAL 5 grams 3 times daily, DIPHENOXYLATE 5 milligrams 3 times daily, and diet, none of the treatments had an effect on the frequency or consistency of stools in ACUTE NONSPECIFIC DIARRHEA (Alestig et al, 1979).
          • b. In another study comparing DIPHENOXYLATE/ATROPINE and NEOMYCIN with a KAOLIN/MORPHINE, DIPHENOXYLATE/ATROPINE and NEOMYCIN reduced the frequency of bowel actions more rapidly than the KAOLIN mixture (Lee, 1968).
      • B. MUCOSITIS, RADIATION-INDUCED
        • 1. OVERVIEW: 
§ FDA APPROVAL: Adult, no; pediatric, no 
§ EFFICACY: Adult, effective 
§ DOCUMENTATION: Adult, poor
        • 2. SUMMARY: 
§ - Kaolin/pectin may reduce the degree of mucositis resulting from radiation therapy
        • 3. ADULT:
          • a. The daily use of an oral rinse of SUCRALFATE (1 gram/15 mL) or 15 milliliters of a solution containing KAOLIN/PECTIN/DIPHENHYDRAMINE (50:50) provided comparable mucosal protection in 12 patients receiving radiation to the oral cavity and neck. No significant difference existed between the two treatment groups regarding weight loss, and the degree of mucositis and pain. One patient who was receiving the KAOLIN/PECTIN/DIPHENHYDRAMINE solution lost more than 5% of the pretreatment weight. Radiation therapy was not interrupted due to severe mucositis in either group (Barker et al, 1991).
    • 4.6 COMPARATIVE EFFICACY AND EVALUATION WITH OTHER SIMILAR THERAPEUTIC AGENTS
      • A. CHARCOAL
        • 1. DIARRHEA
          • a. In a study comparing kaolin/pectin 60 milliliters 4 times daily with charcoal 5 grams 3 times daily, diphenoxylate 5 milligrams 3 times daily, and diet, none of the treatments had an effect on the frequency or consistency of stools in ACUTE NONSPECIFIC DIARRHEA (Alestig et al, 1979).
      • B. DIPHENOXYLATE
        • 1. DIARRHEA
          • a. In a study comparing kaolin/pectin 60 milliliters 4 times daily with charcoal 5 grams 3 times daily, diphenoxylate 5 milligrams 3 times daily, and diet, none of the treatments had an effect on the frequency or consistency of stools in ACUTE NONSPECIFIC DIARRHEA (Alestig et al, 1979).
          • b. In another study comparing diphenoxylate/atropine plus neomycin with a kaolin/morphine mixture, diphenoxylate/atropine plus neomycin reduced the frequency of bowel actions more rapidly than the kaolin mixture (Lee, 1968).
      • C. NEOMYCIN
        • 1. DIARRHEA
          • a. In another study comparing diphenoxylate/atropine plus neomycin with a kaolin/morphine mixture, diphenoxylate/atropine plus neomycin reduced the frequency of bowel actions more rapidly than the kaolin mixture (Lee, 1968).
      • D. SUCRALFATE
        • 1. MUCOSITIS, RADIATION-INDUCED
          • a. The daily use of an oral rinse of sucralfate (1 gram/15 mL) or 15 mL of a solution containing kaolin/pectin/diphenhydramine (50:50) provided comparable mucosal protection in 12 patients receiving radiation to the oral cavity and neck. No significant difference existed between the two treatment groups regarding weight loss and the degree of mucositis and pain. One patient, who was receiving the kaolin/pectin/diphenhydramine solution, lost more than 5% of the pretreatment weight. Radiation therapy was not interrupted due to severe mucositis in either group (Barker et al, 1991).
  • 6.0 REFERENCES
    • 1. Albert KS, Elliot WJ, Abbott RD et al: Influence of kaolin-pectin suspension on steady-state plasma digoxin levels. J Clin Pharmacol 1981; 21:449-455.
    • 2. Alestig K, Trollfors B & Stenqvist K: Acute non-specific diarrhoea: studies on the use of charcoal, kaolin/pectin and diphenoxylate. Practitioner 1979; 222:859-862.
    • 3. Barker G, Loftus L, Cuddy PD et al: The effects of sucralfate suspension and diphenhydramine syrup plus kaolin-pectin on radiotherapy-induced mucositis. Oral Surg Oral Med Oral Pathol 1991; 71:288-293.
    • 4. Briggs GG, Freeman RK & Yaffe SJ: Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 4th ed. Williams & Wilkins, Baltimore, MD, 1992.
    • 5. Gilman AG, Rall TW, Nies AS et al (eds): Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed. Pergamon Press, New York, NY, 1990.
    • 6. Hansten PD & Horn JR: Drug Interactions, 6th ed. Lea & Febiger, Philadelphia, PA, 1990.
    • 7. Lee IK: Comparative trial of lomotil-with-neomycin and kaolin-and-morphine mixture in general practice. Br J Clin Pract 1968; 22:347-348.
    • 8. McCall CE, Steigbigel NH & Finland M: Lincomycin: activity in vitro and absorption and excretion in normal young men. Am J Med Sci 1967; 254:144-155.
    • 9. McElnay JC, Mukhtar HA, D'Arcy PF et al: The effect of magnesium trisilicate and kaolin on the in vivo absorption of chloroquine. J Trop Med Hygiene 1982; 85:159-163.
    • 10. McGehee RF Jr, Smith CB, Wilcox C et al: Comparative studies of antibacterial activity in vitro and absorption and excretion of lincomycin and clindamycin. Am J Med Sci 1968; 256:279-292.
    • 11. McGehee RF Jr, Smith CB, Wilcox C et al: Comparative studies of antibacterial activity in vitro and absorption and excretion of lincomycin and clinimycin. Am J Med Sci 1968; 256:279-292.
    • 12. Powell DW & Szauter KE: Nonantibiotic therapy and pharmacotherapy of acute infectious diarrhea. Gastroenterol Clin North Am 1993; 22:683-707.
    • 13. Product Information: Kaopectate(R) Concentrate, kaolin/pectin. UpJohn, Kalamazoo, MI, 1994.
    • 14. Product Information: Lanoxin(R), digoxin. GlaxoSmithKline, Research Triangle Park, NC (PI revised 9/2001) reviewed 1/2003.
    • 15. Richter WO, Jacob BG, Schwandt P: Interaction between fibre and lovastatin. Lancet 1991; 338(8768): 706.
    • 16. Rodin SM & Johnson BF: Pharmacokinetic interactions with digoxin. Clin Pharmacokinet 1988; 15:227-244.
    • 17. Roselle HA: Association of laundry starch and clay ingestion with anemia in New York City. Arch Intern Med 1970; 125:57-61.
    • 18. Talington KM, Gant NF Jr, Scott DE et al: Effect of ingestion of starch and some clays on iron absorption. Am J Obstet Gynecol 1970; 108:262-267.
    • 19. USPDI: Drug Information for the Health Care Professional, 14th ed. US Pharmacopeial Convention, Inc, Rockville, MD, 1994.
    • 20. Wagner JG: Pharmacokinetics 1 definitions modeling and reasons for measuring blood levels and urinary excretion. Drug Intell Clin Pharm 1968; 2:38.
  • 7.0 AUTHOR INFORMATION 
· Original publication:  12/90 
· Most recent revision:  09/98 
· List of contributors: 1.  DRUGDEX(R) Editorial Staff.
For further information on contributing authors, see editorial board listings

END OF DOCUMENT

 

 

2) da MARTINDALE - The Complete Drug Reference: KAOLIN

See Also GASTROINTESTINAL DRUGS

Physical And Pharmaceutical Properties

o Synonyms: Bolus Alba; E559; Weisser Ton.

o CAS Registry: 1332-58-7.

o Pharmacopoeias: In Chin., Eur. (see Ref.), Int., Jpn, US, and Viet. Some pharmacopoeias do not differentiate between the heavy and light varieties.

Proprietary Names

o Childrens Diarrhoea Mixture, Entrocalm, Kao-Pront (FM), Kaopectate

Multi-Ingredient Preparations

o ADM (FM), Alkamine, Alopate, Alupep, Anacidase (FM), Antacil, Anti-H, Antiphlogistine (DI), Anusol a l'Hydrocortisone (FM), Anusol-A, Argeal, Argent, Aruto-Magenpulver (FM), Aruto-Magenpulver-forte (FM), Atalin (FM), Balsamo BOI (FM), Beakopectin, Bebia (FM), Betapect, Bipectinol, Bis-Pectin, Biskapect, Calamine-D, Caopecfar, Carbonaphtine Pectinee (FM), Carbotiol (FM), Chloropect, Cicafissan, Coccila, Codella (FM), Colfur, Collis Browne's, Collodyne (FM), Contefur, Coralzul, Curumbil (FM), De Witt's Antacid, De Witts Antacid (FM), Decongestine (FM), Di-Su-Frone, Diaguard (FM), Diaguard Forte (FM), Diarcalm (FM), Diarex (FM), Diastat (FM), Dibapec Compuesto, Difuran, Digastril, Digestif-Ara, Diolin (FM), Disento, Disento PF, Donnagel (DI), Donnagel (FM), Donnagel-MB (FM), Donnagel-PG (FM), Droximag, Dystomin E (FM), Endomicina, Enterolyte, Enterosan (FM), Estreptokectil (FM), Eviprostat (DI), Facetin-D, Farpectol, Fissan, Furasian, Furopectin, Fuzotyl, Gastranil, Gastropax, Gastropect, Gastrosanol (FM), Gelogastrine (FM), Glucomagma (FM), Gyrosan, Hidromagma, Isocar, Junior Kao-C, K-C, KLN, Kal Sept, Kao, Kao-Paverin, Kao-Spen, Kaobrol, Kaodene, Kaodene Non-Narcotic, Kaodyne (FM), Kaofort (FM), Kaolin Mixture BP 2002, Kaolin Poultice BP 2002, Kaolin and Morphine Mixture BP 2002, Kaologeais, Kaomagma, Kaomagma (FM), Kaomagma with Pectin (FM), Kaomuth, Kaomuth sans Bismuth (FM), Kaomycin, Kaomycin (FM), Kaomycine (FM), Kaoneo (FM), Kaopectal, Kaopectal-N (FM), Kaopectate, Kaopectate (DI), Kaopectate (FM), Kaopectate (FM) (DI), Kaopectate N (FM), Kaopectin, Kaoprompt-H, Kaostase, Kaostase Suspension, Kaostatex, Kapectin Forte, Kaptin, Karayal, Katoxyn, Katulcin (FM), Keracnyl, Kontabletten (FM), Lactopectin, Magnesia Bisurata (FM), Med-Kafuzone, Medipect (FM), Mexsana, Moorland, Munari (FM), Neo Zeta-Foot (FM), Neo-Decongestine (FM), Neo-Kap, Neopec (FM), Neoxil (DI), Neutracido (FM), Neutrose S Pellegrino, Neutroses, Neutroses (FM), Noratex (FM), Norquinol (FM), Noventerol (FM), Olam, Opazimes, Opocarbon, Opocler, Optazol, Padma-Lax, Pectalin, Pectimax (FM), Pectin-K, Pectipar (FM), Pectolin (FM), Pectrolyte, Pekolin (FM), Pektan N (FM), Peterpect (FM), Phlogantine (FM), Plastolin Poultice (FM), Plexo Enterin (FM), Quimefuran, Streptomagma (DI), Streptomagma (FM), Tapzol (FM), Tapzol con Neomicina, Thovaline (FM), Treda, Trilor, Uni-Kaotin, Yodozona, Zeta-Foot (FM), Zincod, rohasal

o Physicochemical Characteristics

§ Pharmacopoeial description.

§ Ph. Eur. 4.5: Heavy kaolin is a purified, natural, hydrated aluminium silicate of variable composition. It is a fine, white or greyish-white, unctuous powder. Practically insoluble in water and in organic solvents.

§ BP 2002: Light Kaolin is a native hydrated aluminium silicate, freed from most of its impurities by elutriation, and dried. It contains a suitable dispersing agent. It is a light, white, odourless or almost odourless, unctuous powder free from gritty particles. Practically insoluble in water and in mineral acids.

§ Light Kaolin (Natural) is Light Kaolin which does not contain a dispersing agent. It is a light, white, odourless or almost odourless, unctuous powder free from gritty particles. Practically insoluble in water and in mineral acids.

§ NOTE. The BP 2002 directs that when Kaolin or Light Kaolin is prescribed or demanded, Light Kaolin must be dispensed or supplied unless it is ascertained that Light Kaolin (Natural) is required.

§ USP 26: Kaolin is a native hydrated aluminium silicate, powdered and freed from gritty particles by elutriation. It is a soft, white or yellowish-white powder or lumps with an earthy or clay-like taste and when moistened with water assumes a darker colour and develops a marked clay-like odour. Insoluble in water, in cold dilute acids, and in solutions of alkali hydroxides.

o Profile

§ Light kaolin and light kaolin (natural) are adsorbent antidiarrhoeal agents that have been used as adjuncts to rehydration therapy in the management of diarrhoea (Ref.). They may be taken by mouth in doses of about 2 to 6 g every four hours as required. Kaolin is often given in combination with other antidiarrhoeals, especially pectin.

§ Kaolin can form insoluble complexes with a number of other drugs in the gastrointestinal tract and reduce their absorption; concomitant oral administration should be avoided.

§ Externally, light kaolin is used as a dusting powder. Kaolin is liable to be heavily contaminated with bacteria, and when used in dusting powders, it should be sterilised.

§ Heavy kaolin is used in the preparation of kaolin poultice, which is applied topically with the intention of reducing inflammation and alleviating pain (see Rubefacients and Topical Analgesia, Ref.).

§ Light kaolin is also used as a food additive.

END OF DOCUMENT

 

 

3) da DrugPoints® System: KAOLIN/PECTIN

Common Tradenames (See Complete Tradename Listing)

o DIARRHEA RELIEF

o KAO-SPEN

o KAODENE NN

Class

o antidiarrheal

Dosage, Adult (usual)

o Diarrhea: 60-120 mL ORALLY (kaolin 5.8 grams/pectin 130 mg per 30 mL) ORALLY after each loose bowel movement

o Mucositis, radiation-induced: 15 mL 50:50 (kaolin 5.8 grams/pectin 130 mg per 30 mL) and diphenhydramine ORAL rinse

Dosage, Pediatric, (usual)

o Diarrhea: (3-6 yrs) 15-30 mL (kaolin 5.8 grams/pectin 130 mg per 30 mL) ORALLY after each loose bowel movement

o Diarrhea: (6-12 yrs) 30-60 mL (kaolin 5.8 grams/pectin 130 mg per 30 mL) ORALLY after each loose bowel movement

o Diarrhea: (12 yrs and over) 45-60 mL (kaolin 5.8 grams/pectin 130 mg per 30 mL) ORALLY after each loose bowel movement

Administration

o if no improvement within 48 hours, discontinue therapy

How Supplied

o 5.8 GM-130 MG/30 ML LIQ

o 3.9 GM-194.4 MG/30 ML, 5.2 GM-260 MG/30 ML SUS

Indications

o FDA labeled indications

§ Diarrhea

o Non-FDA labeled indications

§ Mucositis, radiation-induced

Contraindications

o hypersensitivity to kaolin/pectin products

o diarrhea secondary to pseudomembranous enterocolitis or toxigenic bacteria

Precautions

o consult physician if diarrhea is not controlled in 48 hours

o consult physician if fever develops

Adverse Effects

o COMMON

§ constipation

Drug Interactions

o chloroquine

o clindamycin

o digoxin

o lincomycin

Pregnancy Category

o NR

Breast Feeding

o safe

Notes

o do not use for diarrhea from pseudomembranous enterocolitis or toxigenic bacteria.

END OF DOCUMENT

 

 

4) USP DI(R) Drug Information for the Health Care Professional

Kaolin and Pectin (Oral-Local)
Category
Commonly used brand name(s)
Indications
Pharmacology/Pharmacokinetics
Precautions to Consider
Side/Adverse Effects
Patient Consultation
Oral Dosage Forms
Related Monographs
References

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

Related Monographs

Kaolin and Pectin (Oral) - Advice for the Patient

References

Product package.
AMA Drug evaluations. 5th ed. Chicago: American Medical Association, April 1983: 1286.
Longe LR. Antidiarrheal and other gastrointestinal products. In: Handbook of nonprescription drugs. 8th ed. Washington, DC: American Pharmaceutical Association, 1986: 59-74.
AMA Drug evaluations. 6th ed. Chicago: American Medical Association, September 1986: 963.
American Hospital Formulary Service.
Burdock N. The pharmacist's role in patient counseling OTC antidiarrheals. Kentucky Pharmacist 1981: 323.
Diarrhoeal Disease Control Programme. Guide for improving diarrhoea treatment practices of pharmacists and licensed drug sellers. Geneva: World Health Organization, 1993: 53-5.
Balistreri WF. Oral rehydration in acute infantile diarrhea. Am J Med 1990; 88(6A Suppl): 30S.
Brownlee HJ. Family practitioner's guide to patient self-treatment of acute diarrhea. Am J Med 1990; 88(6A Suppl): 27S-29S.
Industry plans voluntary warning for antidiarrheals. Wash Drug Letter 1993; 25: 1.
DuPont HL. Using OTC drugs for acute diarrhea. Drug Ther 1983: 127-36.
Aust J Hosp Pharm 1988; 18: 161.
Kenyon J, Caldwell M, editors. Oral rehydration is the cornerstone of diarrhoea therapy in children. Drugs and Therapy Perspectives 1993; 1: 15-6.
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.
Panel comment, 5/94.
International Health Advisory Panel Meeting, 6/10/94.

 

5) REPROTEXT: KAOLIN

1.0 ADMINISTRATION

o 1.1 SYNONYMS

§ ALTOWHITES, ARCILLA BLANCA; ARGILLA; ARGILLA ALBA; BENTONE; BOL BLANC; BOLUS ALBA; CHINA CLAY; CLAY; CONTINENTAL; DIXIE; ELECTROS; EMATHLITE; FITROL; FITROL DESSICATE 25; GLOMAX; HYDRATED ALUMINUM SILICATE; HYDRITE; KAO-GEL; KAOLIN; KAOLIN COLLOIDAL; KAOPAOUS;  KAOPHILLS-2; LANGFORD; LIGHT KAOLIN; MCNAMEE; OSMO-KAOLIN; PARCLAY; PEERLESS; PIGMENT WHITE; PORCELAIN CLAY; SNOW TEX; SODIUM ALUMINOSILICATE; WHITE BOLE

o 1.2 IDENTIFIERS

§ 1.2.1 CAS REGISTRY NUMBER

§ A) 1332-58-7 (Kaolin)

§ 1.2.2 NIOSH/RTECS NUMBER

§ A) GF1670500

o 1.3 FORMULA

§ A) H2Al2Si2O8(H2O) (variable)

o 1.4 GENERAL TOXICITY HAZARD RATING

§ 2

o 1.5 REPRODUCTIVE HAZARD RATING

§ B-

2.0 INTRODUCTION

o A) FORMS

§ 1) Kaolin is a hydrated aluminosilicate compound that is mined from deposits as the mineral kaolinite. It is one of a number of clay mineral compounds. Kaolin typically consists of 38.5% aluminum oxide, 45.5% silicon dioxide, 13.5% water, 1.5% titanium dioxide with small amounts of calcium oxide, magnesium oxide and iron oxide. Kaolinite is a sheet silicate similar to mica. Kaolin consists of hexagonal platelets with widths ranging from 0.1 to 8 microns. Single crystals consist of a layer of aluminum oxide covalently bonded to layer of silicon dioxide (ACGIH, 1991)(Clayton & Clayton, 1993)

§ 2) Kaolin may be graded based on particle size and color and is also available in pharmaceutical, technical, NF. It may be a dry powder or slurry (HSDB , 1998)(Lewis, 1993).

o B) SOURCES

§ 1) Much of the domestic kaolin is mined in Georgia while foreign sources include England, France, Germany and China (Ashford, 1994)(Clayton & Clayton, 1993).

o C) USES

§ 1) Since kaolin is relatively inert over a wide pH range, it has many uses ranging from ceramics to pharmaceuticals. It is used to produce ultramarine and color lakes as well as fillers and pigment for paints, inks, coatings and paper sizing. Kaolin may be added to rubber for reinforcement and stiffening, and to plastics since it imparts a smooth finish and reduces shrinkage during the curing process. USP grade kaolin is used in cosmetic and pharmaceutical preparations, most often in anti-diarrheal medications. Since kaolin is one of the most refractory of all clays, it is used in making refractory glass fibers, refractory mortar and brick, electrical and heat insulators and many other ceramic or porcelain products. It is also used in some pesticide products, fertilizers and Portland Cement. Kaolin is commonly used as an adsorbent to clarify liquids, catalyst carriers and to produce molecular filters (Budavari, 1996)(HSDB , 1998)(Lewis, 1993).

3.0 EFFECTS OF ACUTE EXPOSURE

o A) At the time of this review, no acute exposure studies were found for kaolin in humans or experimental animals. However, it may be predicted to be an eye, respiratory tract, and possibly a skin irritant from frictional action.

4.0 EFFECTS OF CHRONIC EXPOSURE

o A) Inhalation of kaolin dust can cause a particular type of pneumoconiosis, called KAOLINOSIS. It is characterized by positive X-ray findings and mild reductions in pulmonary function (Alterkruse et al, 1984; (Kennedy, 1983).

o B) Pure kaolin is apparently not fibrogenic and does not induce debilitating silicosis; however, it may be contaminated with CRYSTALLINE SILICA. There are several reports of chronic exposure to kaolin dust producing severe lung effects, including emphysema and pulmonary fibrosis, due to contaminating silica (Lesser, 1978)(Lynch & Mciver, 1954).

o C) Kaolin from Georgia (USA) appears to be relatively pure; exposure to the dust of this kaolin has produced only mild pulmonary effects (Alterkruse et al, 1984; (Kennedy, 1983). A Russian kaolin was found to contain 4.5 to 64% silica, however (Ivanova-Dzhubrilova & Petrov, 1976). Chronic inhalation of kaolin contaminated with silica would confer a risk for silicosis. Relatively benign kaolinosis, however, is distinct from the severe pulmonary fibrosis induced by SILICA (Lapenas, 1984).

o D) When taken orally over a long period of time, kaolin can cause granulomas of the stomach (HSDB).

5.0 CARCINOGENIC EFFECTS

o 5.1 IARC CATEGORY

§ A) IARC Carcinogenicity Ratings for CAS1332-58-7 (IARC, 2003):

§ 1) Not Listed

o 5.2 HUMAN, SUMMARY

§ A) At the time of this review, no studies were found on the possible carcinogenic activity of kaolin in humans.

o 5.4 ANIMAL, SUMMARY

§ A) At the time of this review, no studies were found on the possible carcinogenic activity of kaolin in experimental animals.

6.0 GENETIC EFFECTS

o 6.1 SUMMARY

§ A) At the time of this review, no genetic studies were found for kaolin.

7.0 REPRODUCTIVE EFFECTS

o 7.1 SUMMARY

§ A) At the time of this review, no reproductive studies were found for kaolin in humans. It is not uncommon for some pregnant women to eat clay (HSDB), a condition called GEOPHAGIA. Apparently, GEOPHAGIA has no ill effects.

o 7.3 PREGNANCY EFFECTS

§ A) ANIMAL STUDIES

§ 1) Kaolin is used to induce experimental hydrocephalus in laboratory animals (Edwards, 1984). However, this effect is produced by direct injection into the fetal brain inside the uterus, and is thus not relevant to human occupational exposure.

§ 2) The only reproductive study found involving kaolin was a feeding study in pregnant rats; 20 percent kaolin in the diet caused anemia in the mothers and low birth weight in the newborns (Patterson & Staszak, 1977). The kaolin effects were prevented by supplementary iron in the diet.

8.0 PREDISPOSING CONDITIONS

o A) MEDICAL: Persons with pre-existing respiratory conditions, especially chronic obstructive lung disease or emphysema, might be more sensitive.

9.0 BIOMONITORING

o 9.1 ACGIH BEI

§ A) ACGIH BEI Values for CAS1332-58-7 (ACGIH, 2003):

§ 1) Not Listed

11.0 SUMMARY AND CONCLUSIONS

o A) Kaolin is largely biologically inert, but it can cause mild reduction in lung function as a result of accumulation in the lungs with many years of inhalation exposure. Therefore, kaolin is in Class 2 (may cause irreversible effects generally not life-threatening) for general toxicity. Some kaolins may contain significant amounts of CRYSTALLINE SILICA, and these could cause debilitating SILICOSIS.

o B) Kaolin in the diet caused low birth weights in one rat study; it is therefore in Class B- (few reproductive effects in animals but no human data) for reproductive hazard. The actual human reproductive hazard is unknown.

o C) As with all chemicals, unnecessary exposure should be avoided.

12.0 REFERENCES

o 12.2 SPECIFIC REFERENCES

§ 1. 29 CFR 1910.1000: Occupational Safety and Health Administration - Limits for Air Contaminants. National Archives and Records Associations (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 2. 29 CFR 1910.119 - App. A: Occupational Safety and Health Administration - List of Highly Hazardous Chemicals, Toxics, and Reactives. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 3. 40 CFR 261.33 e-f: Environmental Protection Agency - Discarded commercial chemical products, off-specification species, container residues, and spill residues thereof, Acutely Hazardous Wastes and Toxic Wastes. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 4. 40 CFR 302.4 - App. B: Environmental Protection Agency - List of Hazardous Substances and Reportable Quantities, Appendix B: Radionuclides. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 5. 40 CFR 302.4: Environmental Protection Agency - List of Hazardous Substances and Reportable Quantities. National Archives and Records Association (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 6. 40 CFR 355 - App. B: Environmental Protection Agency - List of Extremely Hazardous Substances and Their Threshold Planning Quantities (CAS Number Order). National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 7. 40 CFR 372.28: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Lower thresholds for chemicals of special concern. National Archives and Records Administration (NARA) and the Government Printing Office (GPO). Washington, DC. Final rules current as of Nov 20, 2003.

§ 8. 40 CFR 372.65: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Chemicals and Chemical Categories to which this part applies. National Archives and Records Association (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 9. 49 CFR 172.101 - App. B: Department of Transportation - Table of Hazardous Materials, Appendix B: List of Marine Pollutants. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 10. 49 CFR 172.101: Department of Transportation - Table of Hazardous Materials. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Nov 20, 2003.

§ 11. 62 FR 58840: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 1997.

§ 12. 65 FR 14186: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.

§ 13. 65 FR 39264: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.

§ 14. 65 FR 77866: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.

§ 15. 66 FR 21940: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2001.

§ 16. 67 FR 7164: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2002.

§ 17. 68 FR 42710: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2003.

§ 18. ACGIH: 2003 Threshold Limit Values (TLVs(R)) for Chemical Substances and Physical Agents and Biological Exposure Indices (BEIs(R)), American Conference of Governmental Industrial Hygienists, Cincinnati, OH, 2003.

§ 19. ACGIH: Documentation of the Threshold Limit Values and Biological Exposure Indices, 6th ed, Am Conference of Govt Ind Hyg, Inc, Cincinnati, OH, 1991.

§ 20. AIHA: 2003 Emergency Response Planning Guidelines and Workplace Environmental Exposure Level Guides Handbook, American Industrial Hygiene Association, Fairfax, VA, 2003.

§ 21. Ashford R: Ashford's Dictionary of Industrial Chemicals, Wavelength Publications Ltd, London, England, 1994.

§ 22. Budavari S: The Merck Index, 12th ed, Merck & Co, Inc, Whitehouse Station, NJ, 1996.

§ 23. Clayton GD & Clayton FE: Patty's Industrial Hygiene and Toxicology, Vol 2A, Toxicology, 4th ed, John Wiley & Sons, New York, NY, 1993.

§ 24. DFG: List of MAK and BAT Values 2002, Report No. 38, Deutsche Forschungsgemeinschaft, Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Wiley-VCH, Weinheim, Federal Republic of Germany, 2002.

§ 25. DOE: ERPGs and TEELs for Chemicals of Concern, Revision 19. Department of Energy, Subcommittee on Consequence Assessment and Protective Actions. Washington DC. 2002. Available from URL: http://tis.eh.doe.gov/web/chem_safety/teel.html. As accessed Feb 10, 2003.

§ 26. EPA: Search results for Toxic Substances Control Act (TSCA) Inventory Chemicals. US Environmental Protection Agency, Substance Registry System, U.S. EPA's Office of Pollution Prevention and Toxics. Washington, DC. 2003. Available from URL: http://www.epa.gov/srs/. As accessed Mar 27, 2003.

§ 27. ERG: Emergency Response Guidebook. A Guidebook for First Responders During the Initial Phase of a Dangerous Goods/Hazardous Materials Incident., US Department of Transportation, Washington, DC, 2000.

§ 28. Edwards MS: J Neurosurg 1984; 60:115-122.

§ 29. HSDB : Hazardous Substances Data Bank. National Library of Medicine. Bethesda, MD (Internet Version). Edition expires 1998; provided by Thomson MICROMEDEX, Greenwood Village, CO.

§ 30. IARC: List of all agents, mixtures and exposures evaluated to date - IARC Monographs Overall Evaluations of Carcinogenicity to Humans Volumes 1-82, 1972-PRESENT. World Health Organization, International Agency for Research on Cancer. Lyon, FranceAvailable from URL: http://monographs.iarc.fr/monoeval/crthall.html. As accessed Mar 28, 2003.

§ 31. ICAO: Technical Instructions for the Safe Transportation of Dangerous Goods by Air, International Civil Aviation Organization, Montreal, Quebec, 2003.

§ 32. IRIS: IRIS Substance Reports. United States Environmental Protection Agency, Integrated Risk Information System, Office of Research and Development, National Center for Environmental Assessment. Washington DCAvailable from URL: http://www.epa.gov/iris/subst/index.html. As accessed Jan 03, 2003.

§ 33. Ivanova-Dzhubrilova ST & Petrov ZH: Strotelny Materiali I Silikatna Promishlenost 1976; 17:33-35.

§ 34. Kennedy T: Am Rev Respir Dis 1983; 127:215-220.

§ 35. Lapenas D: Am Rev Respir Dis 1984; 130:282-288.

§ 36. Lesser M: South Med J 1978; 71:1242-1246.

§ 37. Lewis RJ: Hawley's Condensed Chemical Dictionary, 12th ed, Van Nostrand Reinhold Company, New York, NY, 1993.

§ 38. Lewis RJ: Sax's Dangerous Properties of Industrial Materials, 9th ed, Van Nostrand Reinhold Company, New York, NY, 1996.

§ 39. Lynch KM & Mciver FA: Am J Pathol 1954; 30:1117-1127.

§ 40. NFPA: Fire Protection Guide to Hazardous Materials, 13th ed., National Fire Protection Association, Quincy, MA, 2002.

§ 41. NIOSH : Pocket Guide to Chemical Hazards. National Institute for Occupational Safety and Health. Cincinnati, OH (Internet Version). Edition expires 1998; provided by Thomson MICROMEDEX, Greenwood Village, CO.

§ 42. NIOSH: Pocket Guide to Chemical Hazards, National Institute for Occupational Safety and Health, Cincinnati, OH, 2003.

§ 43. NRC: Acute Exposure Guideline Levels for Selected Airborne Chemicals - Volume 1, Subcommittee on Acute Exposure Guideline Levels, Committee on Toxicology, Board on Environmental Studies and Toxicology, Commission of Life Sciences, National Research Council. National Academy Press, Washington, DC, 2001.

§ 44. NRC: Acute Exposure Guideline Levels for Selected Airborne Chemicals - Volume 2, Subcommittee on Acute Exposure Guideline Levels, Committee on Toxicology, Board on Environmental Studies and Toxicology, Commission of Life Sciences, National Research Council. National Academy Press, Washington, DC, 2002.

§ 45. NRC: Acute Exposure Guideline Levels for Selected Airborne Chemicals - Volume 3, Subcommittee on Acute Exposure Guideline Levels, Committee on Toxicology, Board on Environmental Studies and Toxicology, Commission of Life Sciences, National Research Council. National Academy Press, Washington, DC, 2003.

§ 46. NTP: National Toxicology Program - Report on Carcinogens, Tenth Edition. U.S. Department of Health and Human Services, Public Health Service, Research Triangle Park. . 2002. Available from URL: http://ehp.niehs.nih.gov/roc/toc10.html. As accessed Nov 22, 2002.

§ 47. Patterson EC & Staszak DJ: J Nutr 1977; 107:2020-2025.

§ 48. RTECS : Registry of Toxic Effects of Chemical Substances. National Institute for Occupational Safety and Health. Cincinnati, OH (Internet Version). Edition expires 1998; provided by Thomson MICROMEDEX, Greenwood Village, CO. (RE1396)

End of Document

6) da TERIS: KAOLIN

Agent Number: 4037 Bibliographic Search Date: 08/03

Agent Name: KAOLIN Review Date: 10/03

Summary of Teratology Studies:

Kaolin, a clay, is composed of hydrated aluminum silicate. It is used as an adsorbent, in dusting powders, and in poultices. It is administered orally in the treatment of diarrhea. Kaolin is practically insoluble.

=========================

MAGNITUDE OF TERATOGENIC

RISK TO CHILD BORN AFTER

EXPOSURE DURING GESTATION

=========================

UNDETERMINED

===============================

QUALITY AND QUANTITY OF DATA

ON WHICH RISK ESTIMATE IS BASED

===============================

VERY LIMITED

========

COMMENTS

========

A SMALL RISK CANNOT BE EXCLUDED, BUT A HIGH RISK OF CONGENITAL ANOMALIES IN THE CHILDREN OF WOMEN TREATED WITH KAOLIN DURING PREGNANCY IS UNLIKELY.

No epidemiological studies of congenital anomalies among the children of women who took kaolin during pregnancy have been reported.

The frequency of malformations was not increased among the offspring of rats fed diets including 20% kaolin during pregnancy (Patterson & Staszak, 1977). Decreased weight was observed among the newborn pups, but this effect was reversed by supplementing the maternal diet with iron.

Key References: (Each paper is classified as a review [R], human case report [C] human epidemiological study [E], human clinical series [S], animal study [A], or other [O].)

1) Patterson EC, Staszak DJ: Effects of geophagia (kaolin ingestion) on the maternal blood and embryonic development in the pregnant rat. J Nutr 107:2020-2025, 1977. [A]

TERIS is a selected compilation of publicly available literature that has been summarized and assessed by a scientific Advisory Board. Neither MICROMEDEX nor the University of Washington make any warranty on the accuracy, validity, or completeness of information cited in the TERIS Database. The information contained in the Database is not a substitute for the professional judgment of users.

End of Document

7) da USP DI(R) Advice for the Patient(R)

KAOLIN AND PECTIN (Oral)
Before Using This Medicine
Other medicines
Other medical problems
Proper Use of This Medicine
Precautions While Using This Medicine
Side Effects of This Medicine
Related Monographs

Some commonly used brand names are:

In the U.S.—

Kao-Spen

Kapectolin

K-P

In Canada—

Donnagel-MB

Generic name product may be available in the U.S.

Category

Antidiarrheal (adsorbent)

Description
Kaolin and pectin (KAY-oh-lin and PEK-tin) combination medicine is used to treat diarrhea.
Kaolin is a clay-like powder believed to work by attracting and holding onto the bacteria or germ that may be causing the diarrhea.
This medicine is available without a prescription; however, the product's directions and warnings should be carefully followed. In addition, your doctor may have special instructions on the proper dose or use of kaolin and pectin combination medicine for your medical condition. Kaolin and pectin combination is available in the following dosage form:

Oral
Oral suspension (U.S. and Canada)

Before Using This Medicine
If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For kaolin and pectin combination, the following should be considered:

Pregnancy—This medicine is not absorbed into the body and is not likely to cause problems.

Breast-feeding—This medicine is not absorbed into the body and is not likely to cause problems.

Children—The fluid loss caused by diarrhea may result in a severe condition. For this reason, antidiarrheals must not be given to young children (under 3 years of age) without first checking with their doctor. In older children with diarrhea, antidiarrheals may be used, but it is also very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Older adults—The fluid loss caused by diarrhea may result in a severe condition. For this reason, elderly persons with diarrhea, in addition to using an antidiarrheal, must receive a sufficient amount of liquids to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of kaolin and pectin. Make sure you tell your doctor if you have any other medical problems, especially:

Dysentery—This condition may get worse; a different kind of treatment may be needed.

Proper Use of This Medicine
Do not use kaolin and pectin combination to treat your diarrhea if you have a fever or if there is blood or mucus in your stools . Contact your doctor.
Take this medicine, following the directions in the product package, after each loose bowel movement until the diarrhea is controlled, unless otherwise directed by your doctor.
Importance of diet and fluid intake while treating diarrhea :

In addition to using medicine for diarrhea, it is very important that you replace the fluid lost by the body and follow a proper diet . For the first 24 hours you should eat gelatin and drink plenty of clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, and broth. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholic beverages may make the condition worse.
If too much fluid has been lost by the body due to the diarrhea, a serious condition may develop. Check with your doctor as soon as possible if any of the following signs or symptoms of too much fluid loss occur:

o Decreased urination

o Dizziness and lightheadedness

o Dryness of mouth

o Increased thirst

o Wrinkled skin

Dosing—The dose of kaolin and pectin combination will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of kaolin and pectin.

The number of tablespoonfuls of suspension that you take depends on the strength of the medicine.

For diarrhea:

o For oral dosage form (suspension):

§ Adults—The usual dose is 4 to 8 tablespoonfuls (60 to 120 milliliters [mL]) taken after each loose bowel movement.

§ Children 12 years of age and over—The usual dose is 3 to 4 tablespoonfuls (45 to 60 mL) taken after each loose bowel movement.

§ Children 6 to 12 years of age—The usual dose is 2 to 4 tablespoonfuls (30 to 60 mL) taken after each loose bowel movement.

§ Children 3 to 6 years of age—The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL) taken after each loose bowel movement.

§ Children up to 3 years of age—Use and dose must be determined by your doctor.

Storage—To store this medicine:

Keep out of the reach of children.

Store away from heat and direct light.

Keep this medicine from freezing.

Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor if your diarrhea does not stop after 1 or 2 days or if you develop a fever .

If you are taking any other medicine, do not take it within 2 to 3 hours of taking kaolin and pectin . Taking the medicines together may prevent the other medicine from being absorbed by your body. If you have any questions about this, check with your health care professional.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. No serious side effects have been reported for this medicine. However, this medicine may cause constipation in some patients, especially if they take a lot of it. Check with your doctor as soon as possible if constipation continues or is bothersome.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Related Monographs

Kaolin and Pectin (Oral-Local) - Drug Information for the Health Care Professional

Revised: 08/04/1994

Copyright 2000 - 2004. Thomson MICROMEDEX. All rights reserved.
USP DI® and Advice for the Patient® are registered trademarks of USP used under license to MICROMEDEX.
Information is for End User's use only and may not be sold, redistributed, or otherwise used for commercial purposes.
The information above is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

 

^ Inizio