(British Approved Name, rINN)
INNs in main languages (French, Latin, Russian, and Spanish):
Pharmacopoeias. In US.
The United States Pharmacopeia 31, 2008 (Polycarbophil). It is polyacrylic acid cross-linked with divinyl glycol. White to creamy-white granules, with a characteristic, ester-like odour. Swells in water to a range of volumes, depending primarily on the pH. Insoluble in water, in common organic solvents, and in dilute acids and alkalis. A 1 % mixture in water has a pH of not more than 4.0. Store in airtight containers.
(British Approved Name Modified, rINNM)
International Nonproprietary Names (INNs) in main languages (French, Latin, and Spanish):
Pharmacopoeias. In US.
The United States Pharmacopeia 31, 2008 (Calcium Polycarbophil). A white to creamy-white powder. Insoluble in water, in common organic solvents, and in dilute acids and alkalis. It loses not more than 10% of its weight on drying and contains not less than 18% and not more than 22% of calcium, calculated on the dried basis. Store in airtight containers.
Adverse Effects and Precautions
As for Ispaghula. Polycarbophil calcium releases calcium ions in the gastrointestinal tract and should be avoided by patients who must restrict their calcium intake. There is a risk of intestinal or oesophageal obstruction and faecal impaction, especially if such bulk laxatives are swallowed dry. Therefore, they should always be taken with sufficient fluid and should not be taken immediately before going to bed. They should be avoided by patients who have difficulty swallowing.
The calcium component of polycarbophil calcium may produce interactions typical of calcium salts, such as reducing the absorption of tetracyclines from the gastrointestinal tract it should not be taken within 2 hours of the antibacterial. Polycarbophil calcium has also been reported to decrease the absorption of ciprofloxacin and mycophenolate mofetil.
Uses and Administration
Polycarbophil calcium has similar properties to ispaghula and is used as a bulk laxative and for adjusting faecal consistency. After ingestion calcium ions are replaced by hydrogen ions from gastric acid and the resultant polycarbophil exerts a hydrophilic effect in the intestines.
It is given orally in a usual dose equivalent to 1 g of polycarbophil up to four times daily, as necessary. Doses should be taken with at least 250 mL of water.
Polycarbophil is used topically as a vaginal moisturiser and as an ocular lubricant.
Argentina: Fibercon †
Austria: Fibercon †
Belgium: Replens †
Greece: Fibercon †
Israel: Fibercon †
Italy: Modula Replens
Mexico: Fibercon †
The Netherlands: Fibercon †
Spain: Replens †
Thailand: Fibercon †
USA: Equalactin; Fiber-Lax; Fibercon; FiberNorm; Mitrolan; Replens.
Italy: Ormobyl CM †
USA: Aquasite †
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