Can Naltrexone Tablets Be Split?
Yes, naltrexone 50 mg tablets can be split—they are specifically designed with a breakline/scoreline for this purpose 1.
Tablet Design and Splitting Capability
The FDA-approved naltrexone hydrochloride 50 mg tablets are manufactured with a breakline on one side and '50' debossed on the other side 1. This scored design indicates the manufacturer's intention for the tablet to be divisible.
Clinical Context for Splitting
The FDA labeling explicitly describes a 25 mg starting dose for opioid dependence treatment, achieved by splitting the 50 mg tablet 1. The prescribing information states: "Treatment should be initiated with an initial dose of 25 mg of naltrexone hydrochloride. If no withdrawal signs occur, the patient may be started on 50 mg a day thereafter" 1.
Important Considerations
When Splitting is Appropriate:
- Dose titration: Starting at 25 mg to assess for withdrawal symptoms in opioid dependence treatment 1
- Dose flexibility: The scored design supports accurate halving of the tablet
- Standard practice: The FDA labeling directly references this 25 mg (half-tablet) dosing strategy 1
Critical Caveat - Extended-Release Formulations:
Do NOT split naltrexone/bupropion ER combination tablets 2. These extended-release formulations contain 8 mg naltrexone and 90 mg bupropion in a sustained-release matrix. Splitting would destroy the extended-release mechanism, potentially causing:
The naltrexone/bupropion ER tablets must be swallowed whole and should be avoided with fatty meals 2.
Practical Splitting Guidance:
- Use a tablet splitting device rather than scissors or knives for more accurate division 5
- Scored tablets like naltrexone 50 mg generally split more uniformly than unscored tablets 6
- Naltrexone has a wide therapeutic index, making minor dose variations from splitting less clinically significant 6
The standard 50 mg naltrexone tablet is designed to be split and the FDA labeling supports this practice for dose initiation at 25 mg 1.