ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Psyllium: Drug information

Psyllium: Drug information
(For additional information see "Psyllium: Patient drug information" and see "Psyllium: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Evac [OTC];
  • Geri-Mucil [OTC] [DSC];
  • Konsyl Daily Fiber [OTC];
  • Konsyl Original Daily Fiber [OTC];
  • Konsyl Original Formula [OTC] [DSC];
  • Konsyl [OTC] [DSC];
  • Konsyl-D [OTC] [DSC];
  • Metamucil MultiHealth Fiber [OTC];
  • Metamucil [OTC];
  • Mucilin SF [OTC] [DSC];
  • Mucilin [OTC] [DSC];
  • Natural Fiber Therapy [OTC] [DSC];
  • Natural Psyllium Seed [OTC];
  • Natural Vegetable Fiber [OTC];
  • OneLAX Daily Fiber [OTC];
  • OneLAX Fiber Therapy [OTC];
  • Reguloid [OTC] [DSC]
Pharmacologic Category
  • Antidiarrheal;
  • Fiber Supplement;
  • Laxative, Bulk-Producing
Dosing: Adult

General dosing guidelines; consult specific product labeling; however, the dose of psyllium should be gradually increased to effect along with dietary intake changes.

Constipation

Constipation: Oral: Psyllium: 2.5 to 30 g per day in divided doses

Reduce risk of CHD

Reduce risk of CHD: Oral: Soluble fiber ≥7 g (psyllium seed husk ≥10.2 g) per day (DHHS 1998)

Diabetes mellitus, type 2

Diabetes mellitus, type 2 (adjunctive therapy) (off-label use): Oral: 6.8 to 13.6 g/day in 2 divided doses (Abutair 2016; Feinglos 2013)

Irritable bowel syndrome

Irritable bowel syndrome (off-label use): Oral: 10 g/day in 1 or 2 divided doses (ACG [Ford 2014]; Bijkerk 2009).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Psyllium: Pediatric drug information")

Adequate intake for total fiber: Oral: Note: The definition of "fiber" varies; however, the soluble fiber in psyllium is only one type of fiber which makes up the daily recommended intake of total fiber; contribution from other food sources should also be considered when assessing intake. Reported requirements variable:

AAP/NHLBI recommendation (NHLBI 2011): Minimum intake: Children 2 to 10 years: Daily dietary intake (g/day) = Age (years) + 5 g

IOM recommendation:

Children 1 to 3 years: 19 g/day.

Children 4 to 8 years: 25 g/day.

Children and Adolescents 9 to 13 years: Male: 31 g/day; Female: 26 g/day.

Adolescents: 14 to 18 years: Male: 38 g/day; Female: 26 g/day.

Bowel movement regularity: Note: Ensure adequate water intake. Use of fiber (either dietary or supplemental) has not shown efficacy in pediatric patients for treatment of constipation and NASPGHAN guidelines do not recommend the use of fiber supplements (NASPGHAN [Tabbers 2014]).

General dosing guidelines (Federal Register 1985); consult specific product labeling for details:

Children 6 to <12 years: Oral: 1.25 to 15 g/day in 1 to 3 divided doses.

Children ≥12 years and Adolescents: Oral: 2.5 to 30 g/day in 1 to 3 divided doses.

Hypercholesterolemia; adjunct treatment with dietary management (NHLBI 2011):

Children 2 to <12 years: Oral: 6 g/day in 1 to 3 divided doses.

Children ≥12 years and Adolescents: Oral: 12 g/day in 1 to 3 divided doses.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral [preservative free]:

Reguloid: 400 mg [DSC] [fish derivative free, gluten free, milk free, no artificial flavor(s), nut free, soy free, starch free, sugar free, yeast free]

Packet, Oral:

Konsyl: 60.3% (30 ea [DSC]) [gluten free, kosher certified, sugar free; contains aspartame, fd&c yellow #6 (sunset yellow)]

Konsyl: 60.3% (1 ea [DSC], 30 ea [DSC]) [gluten free, kosher certified, sugar free; contains aspartame, fd&c yellow #6 (sunset yellow); orange flavor]

Konsyl Daily Fiber: 28.3% (1 ea [DSC], 30 ea [DSC]) [gluten free; contains fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10); orange flavor]

Konsyl Daily Fiber: 100% (1 ea [DSC], 30 ea [DSC], 100 ea) [gluten free, kosher certified, sugar free; bland flavor]

Konsyl Daily Fiber: 60.3% (30 ea [DSC]) [gluten free, sugar free; contains fd&c yellow #6 (sunset yellow)]

Konsyl Original Daily Fiber: 100% (30 ea) [gluten free, sugar free]

Metamucil: 28% (30 ea) [contains fd&c yellow #6 (sunset yellow); orange flavor]

Metamucil MultiHealth Fiber: 58.12% (30 ea) [gluten free, sugar free; contains aspartame, fd&c yellow #6 (sunset yellow); orange flavor]

Mucilin: 49% (30 ea [DSC]) [contains fd&c yellow #6 (sunset yellow), saccharin sodium, sodium benzoate]

Mucilin SF: 70% (30 ea [DSC]) [sugar free; contains aspartame, fd&c yellow #6 (sunset yellow)]

Powder, Oral:

Geri-Mucil: 68% (368 g [DSC])

Geri-Mucil: 68% (368 g [DSC]) [contains fd&c yellow #6(sunset yellow)alumin lake]

Geri-Mucil: 68% (283 g [DSC]) [sugar free]

Geri-Mucil: 68% (283 g [DSC]) [sugar free; contains aspartame, fd&c yellow #6(sunset yellow)alumin lake]

Konsyl: 30.9% (397 g [DSC]) [gluten free, kosher certified; contains fd&c yellow #6 (sunset yellow); orange flavor]

Konsyl: 60.3% (450 g [DSC]) [gluten free, kosher certified, sugar free; contains aspartame, fd&c yellow #6 (sunset yellow); orange flavor]

Konsyl: 71.67% (300 g [DSC]) [gluten free, kosher certified, sugar free; bland flavor]

Konsyl: 60.3% (283 g [DSC]) [sugar free; contains aspartame, fd&c yellow #6 (sunset yellow); orange flavor]

Konsyl Daily Fiber: 28.3% (538 g) [gluten free; contains fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10); orange flavor]

Konsyl Daily Fiber: 100% (300 g [DSC], 450 g [DSC]) [gluten free, kosher certified; bland flavor]

Konsyl Daily Fiber: 60.3% (450 g) [gluten free, sugar free; contains fd&c yellow #6 (sunset yellow)]

Konsyl Original Formula: 100% (402 g [DSC]) [gluten free, kosher certified]

Konsyl-D: 52.3% (397 g [DSC]) [flavor free; sweet flavor]

Metamucil: 28.3% (575 g [DSC]) [orange flavor]

Metamucil MultiHealth Fiber: 63% (660 g) [gluten free, sugar free]

Mucilin SF: 70% (400 g [DSC]) [sugar free; contains aspartame, fd&c yellow #6 (sunset yellow)]

Natural Fiber Therapy: 48.57% (368 g [DSC], 538 g [DSC])

Natural Fiber Therapy: 28.3% (368 g [DSC], 538 g [DSC]) [contains fd&c yellow #6 (sunset yellow), fd&c yellow #6(sunset yellow)alumin lake]

Natural Psyllium Seed: 100% (480 g) [animal products free, gelatin free, gluten free, kosher certified, lactose free, no artificial color(s), no artificial flavor(s), starch free, sugar free, yeast free]

Natural Vegetable Fiber: 48.57% (368 g)

OneLAX Daily Fiber: 83% (300 g) [sugar free]

OneLAX Fiber Therapy: 25% (368 g) [gluten free, sugar free; contains fd&c yellow #6 (sunset yellow), sodium benzoate; orange flavor]

Reguloid: 48.57% (369 g [DSC], 540 g [DSC])

Reguloid: 28.3% (369 g [DSC], 540 g [DSC]) [contains fd&c yellow #6 (sunset yellow), fd&c yellow #6(sunset yellow)alumin lake; orange flavor]

Reguloid: 58.6% (426 g [DSC]) [sugar free]

Reguloid: 58.6% (284 g [DSC]) [sugar free; natural flavor]

Reguloid: 58.6% (284 g [DSC], 426 g [DSC]) [sugar free; contains aspartame, fd&c yellow #6 (sunset yellow), fd&c yellow #6(sunset yellow)alumin lake]

Generic: 28.3% (368 g)

Powder, Oral [preservative free]:

Evac: (480 g) [dye free]

Generic Equivalent Available: US

May be product dependent

Dosage Forms Considerations

Psyllium hydrophilic mucilloid 3.4 g is equivalent to 2 g Soluble fiber

Administration: Adult

Inhalation of psyllium dust may cause sensitivity to psyllium (eg, runny nose, watery eyes, wheezing). Drink at least 8 ounces of liquid with each dose. Powder must be mixed in a glass of water or juice. Capsules should be swallowed one at a time. When more than one dose is required, they should be divided throughout the day. Separate dose by at least 2 hours from other drug therapies.

Diabetes mellitus, type 2 (adjunctive therapy) (off-label use): Administer just prior to meals (Abutair 2016; Feinglos 2013).

Irritable bowel syndrome (off-label use): Administer with meals by mixing with food, preferably yogurt (Bijkerk 2009).

Administration: Pediatric

Oral: Granules and powder must be mixed in 240 mL (8 ounce) of water or juice; drink 240 mL (8 ounce) of liquid with each dose of wafers or capsules; capsules should be swallowed one at a time. When more than one dose is required, divide throughout the day. Separate dose by at least 2 hours from other drug therapies. Avoid inhalation of psyllium dust; inhalation may cause sensitivity to psyllium (eg, runny nose, watery eyes, wheezing).

Use: Labeled Indications

Constipation: Treatment of occasional constipation

Reduce risk of coronary heart disease: To reduce risk of coronary heart disease (CHD)

Dietary fiber supplement: Use as a dietary fiber supplement

Use: Off-Label: Adult

Diabetes mellitus, type 2 (adjunctive therapy); Irritable bowel syndrome

Medication Safety Issues
Sound-alike/look-alike issues:

Fiberall may be confused with Feverall

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Gastrointestinal: Abdominal cramps, constipation, diarrhea, esophageal obstruction, intestinal obstruction

Hypersensitivity: Anaphylaxis (upon inhalation in susceptible individuals)

Ophthalmic: Allergic conjunctivitis (rhinoconjunctivitis)

Respiratory: Bronchospasm

Contraindications

Hypersensitivity to psyllium or any component of the formulation; fecal impaction; GI obstruction

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Hypersensitivity reactions have been reported with ingestion or inhalation of psyllium in susceptible individuals.

Disease-related concerns:

• Coronary heart disease (CHD): To reduce the risk of CHD, the soluble fiber from psyllium should be used in conjunction with a diet low in saturated fat and cholesterol.

• Gastrointestinal disease: Use with caution in patients with esophageal strictures, ulcers, stenosis, or intestinal adhesions or difficulty swallowing

Special populations:

• Older adult: Use with caution in the elderly; may have insufficient fluid intake which may predispose them to fecal impaction and bowel obstruction.

Dosage form specific issues:

• Calcium: Some products may contain calcium.

• Phenylalanine: Some products may contain phenylalanine.

• Potassium: Some products may contain potassium.

• Sodium: Some products may contain sodium.

• Soy lecithin: Some products may contain soy lecithin.

Other warnings/precautions:

• Administration: Products must be taken with at least 8 ounces of fluid in order to prevent choking.

• Self-medication (OTC use): When used for self-medication (OTC), do not use in the presence of abdominal pain, nausea, or vomiting. Notify healthcare provider in case of sudden changes of bowel habits which last >2 weeks or in case of rectal bleeding. Not for self-treatment of constipation lasting >1 week.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Psyllium is not absorbed systemically. When administered with adequate fluids, use is considered safe for the treatment of occasional constipation during pregnancy (Wald, 2003).

Dietary Considerations

Products should be taken with at least 8 ounces of fluids. Some products may contain phenylalanine, potassium, sodium, as well as additional ingredients. Check individual product information for caloric and nutritional value.

When used to reduce the risk of CHD, the amount of soluble fiber from psyllium should be ≥7 g/day and it should be used in conjunction with a diet low in saturated fat and cholesterol.

Adequate intake for total fiber: Note: The definition of “fiber” varies; however, the soluble fiber in psyllium is only one type of fiber which makes up the daily recommended intake of total fiber.

1 to 3 years: 19 g/day

4 to 8 years: 25 g/day

9 to 13 years: Males: 31 g/day; Females: 26 g/day

14 to 18 years: Males: 38 g/day; Females: 26 g/day

19 to 50 years: Males: 38 g/day; Females: 25 g/day

≥51 years: Males: 30 g/day; Females: 21 g/day

Pregnancy: 28 g/day

Lactation: 29 g/day

Mechanism of Action

Psyllium is a soluble fiber. It absorbs water in the intestine to form a viscous liquid which promotes peristalsis and reduces transit time.

Pharmacokinetics

Onset of action: Relief of constipation: 12-72 hours

Absorption: None; small amounts of grain extracts present in the preparation have been reportedly absorbed following colonic hydrolysis

Pricing: US

Pack (Metamucil MultiHealth Fiber Oral)

58.12% (per each): $0.44

Powder (OneLAX Daily Fiber Oral)

83% (per gram): $0.03

Powder (OneLAX Fiber Therapy Oral)

25% (per gram): $0.03

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Agiocur (HK, IL, TH);
  • Agiofibe (AU);
  • Agiofibra (MX);
  • Colofiber (BE);
  • Defenorm (UA);
  • Euromucil (CL, PE);
  • Evanox (MX);
  • Fiberad (PK);
  • Fibermate (PH, VN);
  • Fibral (CO);
  • Fibrasol (CL);
  • Fibrocol (PK);
  • Fibrolax (IT);
  • Finalex (MX);
  • Fybogel (GB, IE, MY, NZ, SG, TH);
  • Konsyl (AR, IL);
  • Laxamucil (FI);
  • Lunelax (SE);
  • Metamucil (AR, AU, HK, NL, NZ);
  • Motasil (HK);
  • Mucilin (SG);
  • Mucofalk (PH);
  • Mucofalk Orange (EE, UA);
  • Mutacil (KR);
  • Pal Mucil Polvo Vegetal Fino (PY);
  • Plantaben (AR, CL, TH);
  • Plenum (UY);
  • Pybogel (AU);
  • Regulan (GB);
  • Transilane (KW);
  • Vegeta (ID)


For country code abbreviations (show table)
  1. Abutair AS, Naser IA, Hamed AT. Soluble fibers from psyllium improve glycemic response and body weight among diabetes type 2 patients (randomized control trial). Nutr J. 2016;15(1):86. [PubMed 27733151]
  2. Bijkerk CJ, de Wit NJ, Muris JW, Whorwell PJ, Knottnerus JA, Hoes AW. Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial. BMJ. 2009;339:b3154. doi: 10.1136/bmj.b3154. [PubMed 19713235]
  3. Department of Health and Human Services (DHHS), Food and Drug Administration, Federal Register, 1985.
  4. “Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids,” Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine, National Academy of Sciences, Washington, DC: National Academy Press, 2005. Available at http://www.nap.edu.
  5. Feinglos MN, Gibb RD, Ramsey DL, Surwit RS, McRorie JW. Psyllium improves glycemic control in patients with type-2 diabetes mellitus. Bioactive Carbohydrates and Dietary Fibre I. 2013;156-161.
  6. Ford AC, Moayyedi P, Lacy BE, et al; task force on the management of functional bowel disorders. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014;109(suppl 1:S2-26); quiz S27. doi: 10.1038/ajg.2014.187. [PubMed 25091148]
  7. Gibb RD, McRorie JW, Russell DA, Hasselblad V, Alessio DA. Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus. Am J Clin Nutr. 2015;102:1604-1614. [PubMed 26561625]
  8. IOM (Institute of Medicine), Dietary Reference Intakes for Calcium and Vitamin D, Washington, DC: The National Academies Press, 2010.
  9. IOM (Institute of Medicine), Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Washington, DC: The National Academies Press, 2005.
  10. James SL, Muir JG, Curtis SL, et al, “Dietary Fibre: A Roughage Guide,” Intern Med J, 2003, 33(7):291-6. [PubMed 12823674]
  11. Konsyl Original Daily Fiber (psyllium husk powder) [prescribing information]. Easton, MD: Konsyl Pharmaceuticals, Inc; March 2022.
  12. Metamucil Therapy for Regularity (psyllium husk powder) [prescribing information]. The Procter & Gamble Manufacturing Company; November 2021.
  13. National Heart, Lung, and Blood Institute, "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents," Clinical Practice Guidelines, 2011. Available at http://www.nhlbi.nih.gov/guidelines/cvd_ped/peds_guidelines_full.pdf
  14. Original Formula Daily Fiber (psyllium) [prescribing information]. Easton, MD: Konsyl Pharmaceuticals; received July 2018.
  15. Psyllium Husk Powder [prescribing information]. New Rochelle, NY: Parchem; November 2015.
  16. Reguloid (psyllium) [prescribing information]. Livonia, MI: Rugby Laboratories; received January 2019.
  17. Singh B, “Psyllium as Therapeutic and Drug Delivery Agent,” Int J Pharm, 2007, 334(1-2):1-14. [PubMed 17329047]
  18. Tabbers MM, DiLorenzo C, Berger MY, et al. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014;58(2):258-274. doi:10.1097/MPG.0000000000000266 [PubMed 24345831]
  19. US Department of Health & Human Services (DHHS). Food labeling: health claims; soluble fiber from certain foods and coronary heart disease. Final rule. Fed Regist. 1998;63(32):8103-8121.
  20. Wald A, "Constipation, Diarrhea, and Symptomatic Hemorrhoids During Pregnancy," Gastroenterol Clin North Am, 2003, 32(1):309-22. [PubMed 12635420]
  21. Williams CL, Bollella M, and Wynder EL. A new recommendation for dietary fiber in childhood. Pediatrics. 1995;96(5 Pt 2):985-988. [PubMed 7494677]
Topic 9834 Version 281.0