Switch to
| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
3
|
| pubmed:dateCreated |
1995-6-7
|
| pubmed:abstractText |
5-Aminosalicylic acid-O-sulfate (5-ASA sulfate), a new agent for the treatment of ulcerative colitis and Crohn's disease of the large intestine, was investigated for its pharmacokinetic and toxicological properties, following local and systemic application. 5-ASA sulfate can be considered as a non-toxic agent after single oral intake in rats (14-day LD50 > 6000 mg/kg b.w.). Oral application of 2500 mg 5-ASA sulfate/kg b.w./d for 28 days to rats resulted in significantly increased body weight gain and food and water consumption. Alanine aminotransferase and alkaline phosphatase values were elevated in high-dosed (2500 mg/kg b.w./d p.o.) males. Relative liver weights were significantly increased in high-dosed males and females and the macroscopical inspection revealed thickened liver margins. The no-effect level following 28 days of oral application to rats was determined as 500 mg 5-ASA sulfate/kg b.w./d. In acute local tolerance studies in rabbits, 5-ASA sulfate is rated as non-irritant to the skin and the eye. After a single oral administration of 1800 mg 5-ASA sulfate to 5 healthy human test subjects, 5-ASA sulfate was almost completely metabolized by all test subjects within 3 days; mean urinary and faecal excretion of unchanged 5-ASA sulfate amounted to only 6.7% of the administered dose. A high faecal excretion of the active metabolite 5-aminosalicylic acid (5-ASA) (21.2% of the administered dose) and a low urinary excretion (1.4% of the administered dose) were observed.
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:chemical | |
| pubmed:status |
MEDLINE
|
| pubmed:month |
Mar
|
| pubmed:issn |
0004-4172
|
| pubmed:author | |
| pubmed:issnType |
Print
|
| pubmed:volume |
45
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
300-3
|
| pubmed:dateRevised |
2006-11-15
|
| pubmed:meshHeading |
pubmed-meshheading:7741789-Aminosalicylic Acids,
pubmed-meshheading:7741789-Animals,
pubmed-meshheading:7741789-Eating,
pubmed-meshheading:7741789-Eye,
pubmed-meshheading:7741789-Feces,
pubmed-meshheading:7741789-Female,
pubmed-meshheading:7741789-Humans,
pubmed-meshheading:7741789-Intestinal Absorption,
pubmed-meshheading:7741789-Irritants,
pubmed-meshheading:7741789-Lethal Dose 50,
pubmed-meshheading:7741789-Male,
pubmed-meshheading:7741789-Mesalamine,
pubmed-meshheading:7741789-Organ Size,
pubmed-meshheading:7741789-Rabbits,
pubmed-meshheading:7741789-Rats,
pubmed-meshheading:7741789-Rats, Wistar,
pubmed-meshheading:7741789-Skin,
pubmed-meshheading:7741789-Weight Gain
|
| pubmed:year |
1995
|
| pubmed:articleTitle |
Experimental studies on the pharmacokinetics and toxicity of 5-aminosalicylic acid-O-sulfate following local and systemic application.
|
| pubmed:affiliation |
Henning Berlin GmbH, Germany.
|
| pubmed:publicationType |
Journal Article,
Clinical Trial,
In Vitro
|