Hepatic impairment is an important, but often neglected, factor determining drug dosage in patients with liver disease. heparbase decision support database includes a concise, up-to-date information on the safety and detailed dosage recommendations of different drugs and other substances, such as vitamins and micronutrients in patients with hepatic impairment. All information has been produced according to standard operation procedures including both published medical information and the manufacturer provided and EMA and FDA approved information. All texts are produced and approved by medical doctors specialised in clinical pharmacology and therapeutics.
heparbase analyses the pharmacokinetics and safety of various drugs and substances by dividing them into 3 categories based on the degree of hepatic impairment (mild, moderate, severe), according to the Child-Pugh classification as recommended by the European Medicines Agency (EMA; see classification). The information in heparbase is divided into four parts. The DOSAGE RECOMMENDATION is divided into four categories, using a colour coding (see classification) and the user is always provided with an evidence based recommendation for dosage modification. A free text part, ADDITIONAL INFORMATION provides the user with a detailed, in some cases indication specific, information on what is known on the pharmacokinetics and use of each drug during hepatic impairment as well as recommendations for clinical and laboratory monitoring when prescribing/dispensing a specific agent. In heparbase, the potential for HEPATOTOXICITY of each drug has been evaluated, which makes possible a listing and printing out such lists for patients. The REFERENCES are PubMed-linked to enable a quick access to the original publications.
heparbase is updated four times a year. Copyright and the trademark of heparbase belongs to Medbase Ltd, Turku, Finland.
In heparbase, the degree of hepatic impairment, based on Child-Pugh classification is divided into three categories, as recommended by the European Medicines Agency (EMA) and the U.S. FDA:
Child-Pugh A (score 5-6) - mild hepatic impairment
Child-Pugh B (score 7-9) - moderate hepatic impairment
Child-Pugh C (score >10) - severe hepatic impairment
In heparbase, the safety and need for dosage recommendations is classified into four different categories (A to D), clarified by a colour coding system:
||No need for dosage modification|
||The information is not available or the recommendation is estimated based on the pharmacokinetic characteristics of the substance|
||Modification of the dose or dosage interval is needed|
||The use should be avoided|
For categories B and C, detailed numerical information on the magnitude of dosage modification is provided whenever available.