(British Approved Name, rINN)
International Nonproprietary Names (INNs) in main languages (French, Latin, and Spanish):
Pharmacopoeias. In China, and Europe.
European Pharmacopoeia, 6th ed. (Phenolphthalein). A white or almost white powder. Practically insoluble in water soluble in alcohol. Protect from light.
Adverse Effects and Precautions
As for Bisacodyl. Hypersensitivity reactions, usually as skin rashes or eruptions, have occurred with phenolphthalein. Phenolphthalein may cause pink discoloration of alkaline urine. Tumours have occurred in rats and mice given very high doses of phenolphthalein there does not appear to be evidence of carcinogenicity in humans, but phenolphthalein-containing products have been withdrawn in many countries because of concerns about long-term safety.
Effects on the skin. Reports of skin reactions associated with phenolphthalein include fixed drug eruptions, erythema multi-forme reactions, and toxic epidermal necrolysis.
Overdosage. The most likely consequence of phenolphthalein overdosage is excessive purgation, which may require fluid and electrolyte replacement. However, a possible association with acute pancreatitis occurred in a 34-year-old man who inadvertently ingested phenolphthalein 2 g. There was complete recovery with no sequelae from the pancreatitis. Widespread organ failure with disseminated intravascular coagulation, massive liver damage, pulmonary oedema, renal failure, and myocardial damage in a second patient were attributed to self-poisoning with an unknown quantity of phenolphthalein-containing laxative, although the diagnosis was problematic. The patient died despite intensive support.
Up to 15% of phenolphthalein given orally is subsequently excreted in the urine. Enterohepatic circulation occurs and the glucuronide is excreted in the bile. Elimination may take several days.
Uses and Administration
Phenolphthalein is a diphenylmethane stimulant laxative that has been used for the treatment of constipation and for bowel evacuation before investigational procedures or surgery. It has been withdrawn in many countries because of concern over its carcinogenic potential after reports of tumours in rodents. It has been given in pills or tablets, and as an emulsion with liquid paraffin. Yellow phenolphthalein, an impure form, has been used similarly.
The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.
Argentina: Fructines; Australia: Figsen¤; Laxettes; Belgium: Caolax¤; Brazil: Teutolax¤; Canada: Alophen¤; Espotabs¤; Neo-Prunex¤; Chile: Felaxen¤; Czech Republic: Confetto Falqui; France: Purganol¤; Hong Kong: Regulim¤; Israel: Easylax; Italy: Bom-Bon¤; Confetto¤; Euchessina¤; Fructine-Vichy¤; Neopurghes¤; Prunetta¤; Purgestol¤; South Africa: Brooklax; Dr Mackenzies Veinoids; Laxador; Laxatone¤; Laxene; Laxicaps P¤; SB Strong-Lax; Super-Tabs; Surge; Singapore: Regulim¤; Spain: Laxen Busto¤; Purgante¤; Sure-Lax¤; Switzerland: Euchessina¤; Reguletts; Thailand: Purmolax¤; Regulim; United Kingdom: Bonomint¤; Brooklax¤; Reguletts¤; Sure-Lax¤; United States: Alophen Pills¤; Espotabs¤; Evac-U-Lax¤; Fletchers Childrens Laxative¤; Laxative Pills¤; Medilax¤; Phenolax¤; Prulet¤; Venezuela: Agarolax
Argentina: Cascara Sagrada Bouzen; Cascara Sagrada Puler¤; Genolaxante; Veracolate; Australia: Alophen¤; Ford Pills; Mackenzies Menthoids¤; Medimonth¤; Veracolate¤; Austria: Waldheim Abfuhrdragees forte; Belgium: Agarol¤; Boldolaxine Aloes¤; Grains de Vals; Sanicolax¤; Brazil: Agarol; Dioctosal¤; Emagrex; Esbelt¤; Esbeltrat¤; Fenogar; Lacto-Purga¤; Laxantil¤; Macroten¤; Magroton¤; Manolio; Manon¤; Normagrin¤; Obesidex; Obesifran; Prisoventril; Purgoleite¤; Canada: Agarol¤; Aid-Lax¤; Alsiline¤; Calcium Docuphen¤; Caroid¤; Doulax¤; Doxidan¤; Evac-Q-Kwik¤; Ex-Lax Light¤; Herbalax Forte¤; Laxa¤; Laxarol¤; Le 100 B¤; Phillips Gelcaps¤; Phytolax¤; Thunas Bilettes¤; Triolax¤; Vesilax¤; Chile: Agarol; Bulgarolax; Fenokomp 39; Fenolftaleina Compuesta¤; Oblax A-1-1; France: Boldolaxine¤; Mucinum¤; Pluribiase¤; Germany: Dragees 19¤; Lax-Lorenz¤; Obstinol¤; Vencipon N¤; Hungary: Artin; Bilagit; India: Agarol; Jetomisol-P; Ireland: Agarol¤; Alophen¤; Petrolagar No. 2¤; Petrolagar with Phenolphthalein¤; Israel: Laxative Comp; Laxative; Italy: Agarbil¤; Agarol¤; Amaro Lassativo¤; Bilagar¤; Confetti Lassativi¤; Confetto Complex¤; Crisolax¤; Emulsione Lassativa¤; Flamlax¤; Ormobyl¤; Pillole Lassative Aicardi¤; Pillole Schias¤; Reolina¤; Rim¤; Verecolene Complesso¤; Netherlands: Agarol¤; Portugal: Byl; Caroid¤; South Africa: Agarol¤; Brooklax Pills; Dietaid¤; Laxicaps¤; Redupon; SB 3 Triple Action Pills; Veracolate¤; Spain: Agarol¤; Lactolaxine¤; Laxante Bescansa Aloico; Laxante Bescansa¤; Laxante Geve¤; Laxante Richelet¤; Laxo Vian¤; Mahiou; Switzerland: Agarol¤; Carter Petites Pilules¤; Falqui¤; Laxativum¤; Paragar; Thailand: Emulax; Veracolate; Zenda; United Kingdom: Agarol¤; Alophen¤; Carters¤; Correctol¤; Fam-Lax; Juno Junipah¤; Nylax¤; United States: Agoral; Colax¤; Dialose Plus¤; Disolan¤; Docucal-P¤; Doxidan¤; Ex-Lax Extra Gentle Pills¤; Feen-a-mint Pills¤; Femilax¤; Kondremul with Phenolphthalein¤; Modane Plus¤; Phillips’ Laxative Gelcaps¤; Phillips’ Laxcaps¤; Unilax¤; Veracolate¤; Venezuela: Agarol