By the time medicinal products are granted a marketing authorisation, knowledge about their safety is incomplete because the clinical trials investigating the safety profile and efficacy are usually performed with a relatively small number of subjects. Furthermore these subjects are selected with regard to special aspects and in general do not represent the average patient in medical practices. Therefore, rare or very rare adverse drug reactions, interactions or other hazards related to the use of a medicinal product cannot be observed during clinical trials. Especially the rarely occurring serious adverse reactions are very important for the overall assessment of a new medicinal product. New findings regarding the safety of a medicinal product may occur even long time after its authorisation and depend on new developments in medical science.
The dose of HALDOL Decanoate 50 or HALDOL Decanoate 100 should be expressed in terms of its haloperidol content. The starting dose of haloperidol decanoate should be based on the patient's age, clinical history, physical condition, and response to previous antipsychotic therapy. The preferred approach to determining the minimum effective dose is to begin with lower initial doses and to adjust the dose upward as needed. For patients previously maintained on low doses of antipsychotics (. up to the equivalent of 10 mg/day oral haloperidol), it is recommended that the initial dose of haloperidol decanoate be 10–15 times the previous daily dose in oral haloperidol equivalents; limited clinical experience suggests that lower initial doses may be adequate.