Is Duromine (phentermine) classified as a S4D (Schedule 4, Drug) medication in Australia?

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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:

    • Cardiovascular disease or uncontrolled hypertension 2
    • History of drug abuse 2
    • Glaucoma or hyperthyroidism 2
    • During or within 14 days of taking monoamine oxidase inhibitors (MAOIs) 2
    • Pregnancy (Category X) 1
  • 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

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Potential drug-drug interactions with phentermine among long-term phentermine consumers: A retrospective analysis.

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2023

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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