Duromine (Phentermine) Classification in Australia
Phentermine (Duromine) is classified as a Schedule IV controlled substance, not an S4D medication in Australia. 1
Understanding Phentermine's Classification
- Phentermine is a sympathomimetic amine anorectic medication that acts as an adrenergic agonist, promoting weight loss by activating the sympathetic nervous system 2
- It is approved for short-term use (typically 12 weeks) for weight management in obesity 2
- Phentermine is chemically and pharmacologically related to amphetamines, which is why it's classified as a controlled substance 1
- As a Schedule IV medication, it has recognized potential for abuse and dependence, though lower than Schedule II or III substances 1
Regulatory Status and Prescribing Considerations
- Phentermine is available in various formulations including capsules (15 mg, 30 mg, 37.5 mg) and tablets (8 mg, 37.5 mg) 2
- Despite being approved only for short-term use, many clinicians prescribe phentermine for longer durations as off-label therapy for continued weight management 2
- Prescribers should be aware of local laws and regulations regarding prescribing controlled substances 2
- If using phentermine long-term (beyond 12 weeks), documentation of specific benefits, tolerance, and adverse effects is recommended 2
Clinical Considerations and Safety Profile
Common side effects include dry mouth, insomnia, dizziness, irritability, constipation, and headache 2
Phentermine should be avoided in patients with:
Blood pressure and heart rate should be monitored periodically during treatment 2
Phentermine has potential for drug-drug interactions, particularly with other sympathomimetic amines and certain antidepressants 3
Efficacy in Weight Management
- When combined with lifestyle interventions, phentermine can achieve approximately 5-10% body weight loss in successful patients 2
- In clinical trials, phentermine (15 mg daily) was associated with 6.0 kg weight loss at 28 weeks compared to placebo 2
- About 46% of subjects achieved ≥5% weight loss and 20.8% achieved ≥10% weight loss with phentermine, compared to 15.5% and 6.8% with placebo, respectively 2
Important Distinctions
- While phentermine is a controlled substance due to its chemical similarity to amphetamines, studies examining abrupt cessation have not demonstrated typical withdrawal symptoms seen with amphetamine dependence 4
- The primary concerns with long-term use relate to cardiovascular effects rather than addiction potential 2
- Phentermine should be distinguished from the previously available "fen-phen" combination (phentermine with fenfluramine), which was associated with valvular heart disease and pulmonary hypertension 2