Titration package for neramexane and its use in the treatment of an inner ear disorder

摘要

The present invention relates to a titration scheme for the administration of a 1-amino-alkylcyclohexane derivative which allows for quick attainment of an effective dose of a 1-amino-alkylcyclohexane derivative while minimizing side effects. The present invention further relates to a titration package for providing a 1-amino-alkylcyclohexane derivative (e.g., neramexane or a pharmaceutically acceptable salt thereof) in at least two different dosages. The present titration scheme/titration package may be useful in the treatment of various diseases, including tinnitus.

主权项

1. A method of treating tinnitus, in a subject in need thereof, comprising administration of a therapeutically effective amount of a 1-amino-alkylcyclohexane derivative selected from neramexane and pharmaceutically acceptable salts thereof, wherein the 1-amino-alkylcyclohexane derivative is administered in a titration scheme comprising up titration of the 1-amino-alkylcyclohexane derivative in increasing dosages of 25 mg or 12.5 mg steps at weekly intervals over a period of four weeks to achieve a body weight-adjusted target dose of 50 mg/day for patients with a body weight of up to 90 kg, or over a period of five weeks to achieve a body weight-adjusted target dose of 75 mg/day for patients with a body weight of equal to or greater than 90 kg.