Ispaghula

Synonyms: Egyiptomi útifűmag (ispaghula seed); Egyiptomi útifűmaghéj (ispaghula husk); Ispagula; Ispagulafrö (ispaghula seed); Ispagulafröskal (ispaghula husk); Ispagulansiemen (ispaghula seed); Ispagulansiemenkuori (ispaghula husk); Kiaušininių gysločių sėklų luobelės (ispaghula husk); Kiaušininių gysločių sėklos (ispaghula seed); Osemení jitrocele vejčitého (ispaghula husk); Semeno jitrocele vejčitého (ispaghula seed); Шелуха Исфагулы (ispaghula husk)

Read code: y08Ce [Gastrointestinal Bulk Laxative]; y01RI; y0A1Q [Lipid Lowering Use]

Pharmacopoeias. Monographs for the husk and seed are included in Europe and US.

European Pharmacopoeia, 6th ed. (Ispaghula Husk Plantaginis Ovatae Seminis Tegumentum). The episperm and collapsed adjacent layers removed from the seeds of Plantago ovata (Plantago ispaghula). The powdered drug loses not more than 12.0% of its weight on drying. Protect from light.

European Pharmacopoeia, 6th ed. (Ispaghula Seed Plantaginis Ovatae Semen). The dried ripe seeds of‘Plantago ovata (Plantago ispaghula). The powdered drug loses not more than 10.0% of its weight on drying. Protect from light.

The United States Pharmacopeia 31, 2008 (Psyllium Husk). The cleaned, dried seed coat (epidermis), in whole or in powdered form, separated by winnowing and threshing from the seeds of Plantago ovata (known in commerce as Blond Psyllium, Indian Psyllium, or Ispaghula), or from Plantago arenaria (Plantago psyllium), known in commerce as Spanish or French Psyllium.

The United States Pharmacopeia 31, 2008 (Plantago Seed). The cleaned, dried, ripe seed of Plantago ovata, or of Plantago psyllium, or of Plantago indica (Plantago arenaria).

Psyllium Hemicellulose (USAN)

CAS — 9034-32-6.

Pharmacopoeias. In US.

The United States Pharmacopeia 31, 2008 (Psyllium Hemicellulose). The alkali soluble fraction of the husk from Plantago ovata consisting of highly substituted arabinoxylan polysaccharides. These poly sac charides are linear chains of xylose units to which are attached single units of arabinose and additional xylose. Rhamnose, galactose, glucose, and rhamnosyluronic acid residues are also present as minor constituents. It contains not less than 75.0% of dietary soluble fibre, calculated on the dried basis. Store in airtight containers at a temperature of 25°, excursions permitted between 15° and 30°.

Psyllium Seed

Synonyms: Blešníkové semeno; Bolhafűmag; Flea Seed; Loppfrö; Psilio, semilla de; Psyllii Semen; Psylliuminsiemen; Smiltyninių gysločių sėklos

Pharmacopoeias. In Europe. Also in US under the title of Plantago Seed.

European Pharmacopoeia, 6th ed. (Psyllium Seed). The ripe, whole, dry seeds of Plantago afra (Plantago psyllium) or Plantago indica (Plantago arenaria). It loses not more than 14.0% of its weight on drying. Protect from light and moisture.

The United States Pharmacopeia 31, 2008 (Plantago Seed). The cleaned, dried, ripe seed of Plantago ovata, or of Plantago psyllium, or of Plantago indica (Plantago arenaria) (see also Ispaghula).

Adverse Effects and Precautions

Large quantities of ispaghula and other bulk laxatives may temporarily increase flatulence and abdominal distension hypersensitivity reactions have been reported. There is a risk of intestinal or oesophageal obstruction and faecal impaction, especially if such compounds are taken with insufficient fluid. Therefore, they should always be taken with at least 150 mL of water or other liquid. Ispaghula and bulk laxatives should not be taken immediately before going to bed because reduced gastric motility may impair intestinal passage and cause obstruction. They should be avoided by patients who have difficulty swallowing.

Bulk laxatives should not be given to patients with preexisting faecal impaction, intestinal obstruction, or colonic atony.

Hypersensitivity.

Hypersensitivity reactions associated with the ingestion or inhalation of ispaghula or psyllium have been reported. Symptoms have included rash, rhinitis, urticaria, bronchospasm, and anaphylactic shock in one case, anaphylaxis was fatal. In most patients, sensitisation was thought to have occurred during occupational exposure.

Interactions

Ispaghula and other bulk-forming laxatives may delay or reduce the gastrointestinal absorption of other drugs such as cardiac glycosides, coumarin derivatives, lithium, or vitamins (such as vitamin B₁₂) and minerals (such as calcium, iron, or zinc). Intervals of 30 minutes to 1 hour are recommended between ispaghula and other drugs or food, although some recommend as much as 3 hours between bulk-forming laxatives and other drugs. The dose of insulin may need to be reduced in diabetic patients taking ispaghula.

Lithium.

For reference to ispaghula possibly reducing the absorption of lithium, see Gastrointestinal Drugs.

Uses and Administration

Ispaghula seed, ispaghula husk, and psyllium seed are bulk laxatives. They absorb water in the gastrointestinal tract to form a mucilaginous mass which increases the volume of faeces and hence promotes peristalsis. They are used in the treatment of constipation, especially in diverticular disease and irritable bowel syndrome, and when excessive straining at stool must be avoided, for example after anorectal surgery or in the management of haemorrhoids. The ability to absorb water and increase faecal mass means that they may also be used in the management of diarrhoea and for adjusting faecal consistency in patients with colostomies. The usual oral dose is about 3.5 g one to three times daily, although higher doses have been given. It should be taken immediately after mixing in at least 150 mL water or fruit juice. The full effect may not be achieved for up to 3 days.

Ispaghula is also given for mild to moderate hypercholesterolaemia as an adjunct to a lipid-lowering diet. The recommended dose is about 7 g daily.

Hyperlipidaemias.

Preparations of ispaghula have been reported” to lower serum-cholesterol concentrations in patients with mild to moderate hypercholesterolaemia. They have also been given with reduced doses of a bile-acid binding resin in the treatment of hyperlipidaemia, which is reported to be effective and better tolerated than full doses of the resin alone. Similarly, psyllium supplementation with 10 mg of simvastatin was found to be as effective in lowering cholesterol as 20 mg of simvastatin alone. However, ispaghula or psyllium should be regarded as adjuncts to dietary modification rather than substitutes for it. For a discussion of the hyperlipidaemias and their management.

Preparations

British Pharmacopoeia 2008: Ispaghula Husk Effervescent Granules Ispaghula Husk Granules; Ispaghula Husk Oral Powder

The United States Pharmacopeia 31, 2008: Psyllium Hydrophilic Mucilloid for Oral Suspension.

Proprietary Preparations

Argentina: Agarol Fibras Naturales Agiofibras Herbaccion Laxante † Konsyl Lostamucil Metamucil Motional Mucofalk Plantaben

Australia: Agiofibe Ford Fibre Fybogel Metamucil Mucilax † Natural Fibre

Austria: Agiocur Laxans Metamucil

Belgium: Colofiber Fybogel Spagulax

Brazil: Agiofibra Fibracare Loraga Metamucil Plantaben

Canada: Laxucil Metamucil Mucillium Natural Source Laxative Novo-Mucilax Prodiem Plain

Chile: Euromucil Fibrasol Metamucil † Plantaben

Denmark: Vi-Siblin

Finland: Agiocur Laxamucil Vi-Siblin

France: Mucivital Spagulax Spagulax Mucilage Transilane

Germany: Agiocur Flosa Flosine Laxiplant Soft † Metamucil Mucofalk Pascomucil

Hong Kong: Agiocur Fibermate Fybogel Metamucil Mucofalk Naturlax Transilane

India: Isogel

Indonesia: Mucofalk Mulax

Ireland: Fybogel Regulan

Israel: Agiocur Konsyl Mucivital † Planten

Italy: Agiofibre Fibre lax Planten Psyllogel

Malaysia: Fybogel Mucofalk

Mexico: Agiofibra Fibromucil Finalax Fybogel Hormolax Konsyl Metamucil Mucilag Mugasin Novagon Plantaben Siludane

The Netherlands: Metamucil Mucofalk Regucol Volcolon

Norway: Lunelax Vi-Siblin

New Zealand: Isogel Metamucil Mucilax

Philippines: Fibermate Mucofalk

Poland: Mucofalk

Portugal: Agiocur Laxat Mucofalk Prontolax Vetilax

South Africa: Agiobulk Agiogel Fybogel Metamucil †

Singapore: Fybogel Mucilin Mucofalk

Spain: Biolid Cenat Duphafibra Laxabene Laxisoft Metamucil Plantaben

Sweden: Lunelax Vi-Siblin

Switzerland: Agiolax mite Colosoft † Laxiplant Soft Metamucil Mucilar Valverde regulateur du transit intestinal granules

Thailand: Agiocur † Fybogel Metamucil Mucilin Mucofalk

Turkey: Otaci Musillium

UK: Fibrelie Fybogel Isogel Ispagel Konsyl Regulan

USA: Fiberall Hydrocil Instant Konsyl Konsyl-D Metamucil Mylanta Natural Fiber † Reguloid Serutan Syllact

Venezuela: Agiofibe Siliumbran

Multi-ingredient

Argentina: Agiolax Cholesterol Reducing Planf Gelax Isalax Fibras Kronolax † Medilaxan Mermelax Prompt Rapilax Fibras Salutaris

Australia: Agiolax Bioglan Psylli-Mucil Plus Herbal Cleanse Nucolox PC Regulax †

Austria: Agiolax

Belgium: Agiolax Spagulax K Spagulax Sorbitol

Brazil: Agiolax Parapsyl Plantax

Canada: Prodiem Plus

Chile: Bilaxil

Czech Republic: Agiolax

Finland: Agiolax

France: Agiolax Carres Parapsyllium Filigel Imegul Parapsyllium Spagulax au Citrate de Potassium Spagulax au Sorbitol

Germany: Agiolax

Hong Kong: Agiolax Fybogel Mebeverine

Ireland: Fybogel Mebeverine

Israel: Agiolax

Italy: Agiolax Agioslim Duolaxan Fibrolax Complex Psyllogel Fermenti

Mexico: Agiolax Psilumax

The Netherlands: Agiolax

Norway: Agiolax

New Zealand: Nucolox

Poland: Agiolax Laxamix Otrebuski

Portugal: Agiolax Excessf

South Africa: Agiolax

Spain: Agiolax

Sweden: Agiolax Vi-Siblin S

Switzerland: Agiolax Mucilar Avena

Thailand: Agiolax

Turkey: Otaci Diyet Life Psyllium Plus

UK: Cleansing Herbs Fibre Dophilus Fibre Plus Fybogel Mebeverine Lion Cleansing Herbs Manevac

USA: Perdiem Senna Prompt

Venezuela: Agiolax Avensyl Fiberfull Fibralax † Senokotcon Fibra