Low dose topiramate/phentermine composition and methods of use thereof

摘要

A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.

主权项

1. A unit dosage form for weight loss for oral administration to a patient having a body mass index of at least 25 kg/m2, comprising a combination of:
an immediate release phentermine formulation containing a unit dosage of phentermine of 3.75 mg or 7.5 mg; and a controlled release topiramate formulation containing a unit dosage of topiramate of 23 mg or 46 mg, wherein the controlled release topiramate formulation reaches a maximum plasma concentration (Cmax) at about 6 to about 10 hours (Tmax) after administration.