TABLE 2.
Indications and contraindications of approved phentermine and topiramate agents
| Generic name | Indication(s) | Contraindications |
| Phentermine HCl [19,20] (15 mg, 30 mg, 37.5 mg) | Short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioural modification and caloric restriction in the management of exogenous obesity for patients with an initial BMI ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g. hypertension, diabetes, hyperlipidaemia) | • History of cardiovascular disease (e.g. coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) |
| • During or within 14 days following the administration of monoamine oxidase inhibitors | ||
| • Hyperthyroidism | ||
| • Glaucoma | ||
| • Agitated states | ||
| • History of drug abuse | ||
| • Pregnancy | ||
| • Nursing | ||
| • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines | ||
| Phentermine resin [18] (15 mg, 30 mg) | Short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioural modification and caloric restriction in the management of exogenous obesity for patients with an initial BMI ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (e.g. hypertension, diabetes, hyperlipidaemia) | • Advanced arteriosclerosis, cardiovascular disease, moderate-to-severe hypertension |
| • During or within 14 days following the administration of monoamine oxidase inhibitors | ||
| • Hyperthyroidism | ||
| • Glaucoma | ||
| • Agitated states | ||
| • History of drug abuse | ||
| • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines | ||
| Topiramate immediate-release (tablets: 25 mg, 50 mg, 100 mg, and 200 mg; Sprinkle capsules: 15 mg and 25 mg) [65,66] | • Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures | • Hypersensitivity to the active substance or to any of the excipientsa |
| • Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome | • Migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective methods of contraceptiona | |
| • Migraine: Treatment for adults for prophylaxis of migraine headache | ||
| Phentermine and topiramate extended-release [26] | Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI ≥30 kg/m2 or ≥27 kg/m2 in the presence of ≥1 weight-related comorbidity (hypertension, type 2 diabetes mellitus or dyslipidaemia) | • Pregnancy |
| • Glaucoma | ||
| • Hyperthyroidism | ||
| • During or within 14 days of taking monoamine oxidase inhibitors | ||
| • Known hypersensitivity or idiosyncrasy to sympathomimetic amines |
aContraindications listed for topiramate immediate-release apply to the product's European package leaflet. The US package insert lists the contraindications as ‘none’.