Phentermine 30mg/Topiramate 12.5mg SR Capsule

Phentermine

Phentermine is an oral sympathomimetic amine used as an adjunct for short-term (e.g., 8—12 weeks) treatment of exogenous obesity. The pharmacologic effects of phentermine are similar to amphetamines. Phentermine resin complex was approved by the FDA in 1959, but is no longer marketed in the US. Phentermine hydrochloride was FDA approved in 1973. In the mid-90s, there was renewed interest in phentermine in combination with another anorectic, fenfluramine, for the treatment of obesity and substance abuse, however, little scientific data support this practice. On July 8, 1997, the FDA issued a 'Dear Health Care Professional' letter warning physicians about the development of valvular heart disease and pulmonary hypertension in women receiving the combination of fenfluramine and phentermine; fenfluramine was subsequently withdrawn from the US market in fall of 1997. Use of phentermine with other anorectic agents for obesity has not been evaluated and is not recommended. In May 2011, the FDA approved a phentermine hydrochloride orally disintegrating tablet (Suprenza) for the treatment of exogenous obesity.1

Topiramate

Topiramate is an oral antiepileptic drug (AED) used for partial-onset, generalized primary tonic-clonic seizures, and as an adjunct therapy in Lennox-Gastaut syndrome. It is derived from the naturally occurring monosaccharide D-fructose and is structurally different from other AEDs. Unlike other AEDs, topiramate appears to block the spread of seizures rather than raise the seizure threshold. Topiramate possesses more than one mechanism of action, which may explain why it can be effective in patients with various seizures that are refractory to other agents. Topiramate continues to be studied as both add-on therapy and monotherapy in various refractory epilepsies in children and adults, including infantile spasms associated with West syndrome. It is also used for migraine prophylaxis in adult and pediatric patients. There is some evidence of a role for topiramate treatment 'off-label' for eating disorders such as binge-eating disorder, for tics due to Tourette's syndrome or other chronic tic disorders, or for substance abuse disorders such as alcohol dependence.