Ispaghula

Registered South African indications: 

• Dysregulated bowel function

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients 
• Change in bowel habit that has persisted for more than two weeks
• Rectal bleeding
• Constrictions in the gastrointestinal tract
• Intestinal obstruction
• Faecal impaction
• Reduced gut motility 
• Colonic atony
• Difficulty in swallowing or any throat problems
• Diseases of the oesophagus and cardia

Cautions

• Elderly
• Abdominal pain
• Nausea and vomiting 
• Ingestion with inadequate fluid amounts
• Debilitated patients
• Should not be taken immediately before going to sleep
• Phenylketonuria
• Accidental inhalation

Forms avail. in SA and covered in this monograph: gra

Constipation

• Oral (gra): 10g, after evening meal; Followed by 5g, before morning meal if needed

Diarrhoea

• Oral (gra): Initial: 10g, 8hrly for 1-3 days; Maintenance: 5g, 8hrly if needed

Bowel function regulation
- Alternating diarrhoea and constipation
- Irritable bowel syndrome
- Diverticulosis

• Oral (gra): 10g, after evening meal; Followed by 5g, before morning meal if needed

Stir in a full glass of water and drink after a meal

Paed. froms avail. in SA and covered in this monograph: gra

Diarrhoea

Younger than 6 years

• Not established for use

Between 6-12 years

• Oral (gra): Initial: 5g, 8hrly for 1-3 days; Maintenance: 2.5g, 8hrly, as needed

Older than 12 years

• See adult dosage

Constipation
Bowel function regulation
- Alternating diarrhoea and constipation
- Irritable bowel syndrome
- Diverticulosis
- Bowel sluggishness

Younger than 6 years

• Not established for use

Between 6-12 years

• Oral (gra): 5g, after evening meal; Followed by 2.5g before morning meal if needed

Older than 12 years

• See adult dosage

Stir in a full glass of water and drink after a meal

Pregnancy

• Safe
• There are limited amount of data (less than 300 pregnancy outcomes) from the use of ispaghula husk in pregnant women. Animal studies are insufficient with respect to reproductive toxicity 
• The use of ispaghula husk may be considered during pregnancy, if necessary, and if a change of nutrition is not successful. Laxative bulk producers should be used before using other purgatives

Breastfeeding

• Compatible
• The use of ispaghula husk may be considered during breastfeeding, if necessary, and if a change of nutrition is not successful. Laxative bulk producers should be used before using other purgatives

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Non-regulated product 
  Non-regulated products are not subjected to rigorous controls to verify its efficacy, safety, nor that the ingredients, dosages and claims listed on the label are indeed accurate, therefore authorities caution athletes against the risk of using these products

Respiratory Disorders

• Rhinitis

Gastrointestinal Disorders

• Flatulence
• Abdominal distension 
• Intestinal obstruction
• Oesophageal obstruction
• Faecal impaction

Skin and Subcutaneous Tissue Disorders

• Skin rash

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity disorders

Sensory Disorders

• Conjunctivitis

• Minerals
• Vitamin B12
• Cardiac glycosides
• Warfarin
• Carbamazepine 
• Lithium 
• Antidiabetic agents
• Thyroid hormones  

None routine

Ispaghula husk is rich in alimentary fibres and mucilages. It is capable of absorbing up to 40 times its own weight in water. Ispaghula husk, when taken with sufficient amount of liquid, produces an increased volume of intestinal contents, thus causing a stretch stimulus, which triggers defecation. At the same time the swollen mass of mucilage forms a lubricating layer, which makes the transit of intestinal contents easier

Ispaghula is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

Granules

• Agiobulk (Nycomed)
• Fybogel (Reckitt)

COMBINATION PREPARATIONS

Seeds of Plantago ovata/ Ispaghula husk

Granules (per 5g) 3.25g/ 0.11g

• Agiolax (Takeda)