Biphentin Dosing and Administration
Biphentin (methylphenidate multilayer-release) capsules should never be chewed, as this destroys the extended-release mechanism and can lead to immediate release of the entire dose, increasing the risk of adverse effects and abuse potential. 1, 2
Proper Administration Method
Biphentin capsules must be swallowed whole to maintain the multilayer-release formulation that provides once-daily dosing. 1, 2 The multilayer technology is specifically designed to deliver methylphenidate over an extended period, and crushing, chewing, or opening the capsules defeats this purpose. 2
Alternative Options for Patients Unable to Swallow Capsules
For patients who cannot swallow capsules whole, consider these alternatives:
- Switch to methylphenidate extended-release oral suspension (Quillivant) - provides similar extended-release properties in liquid form 2
- Use methylphenidate extended-release chewable tablets (QuilliChew ER) - specifically designed to be chewed while maintaining extended-release properties 2
- Consider methylphenidate extended-release orally disintegrating tablets (Cotempla XR-ODT) - dissolves in the mouth without chewing 2
Do not open Biphentin capsules and sprinkle contents on food or mix with liquids, as this is not an approved administration method and will compromise the extended-release formulation. 2
Dosing Guidelines
Pediatric Patients (6 years and older)
- Starting dose: 5 mg orally twice daily (before breakfast and lunch, preferably 30-45 minutes before meals) 3
- Titration: Increase gradually in increments of 5-10 mg weekly 3
- Maximum daily dose: 60 mg - doses above this are not recommended 3
Note: While the FDA label references immediate-release methylphenidate dosing, Biphentin's multilayer-release formulation allows for once-daily administration rather than twice-daily dosing. 1 Studies demonstrate that Biphentin given once daily produces equivalent behavioral and cognitive improvements with a duration of effect at least as long as immediate-release methylphenidate given twice daily. 1
Adult Patients
- Administer in divided doses 2-3 times daily, preferably 30-45 minutes before meals 3
- Average dosage: 20-30 mg daily 3
- Maximum recommended daily dose: 60 mg 3
- For patients with insomnia: Administer last dose before 6 PM to minimize sleep disturbances 3
Important Safety Considerations
Pretreatment Assessment Required
Before initiating Biphentin, assess for:
- Cardiac disease - perform careful history, family history of sudden death or ventricular arrhythmia, and physical examination 3
- Family history of tics or Tourette's syndrome - clinically evaluate patients for motor or verbal tics 3
Contraindications
Absolute contraindications include:
- Known hypersensitivity to methylphenidate (risk of angioedema and anaphylaxis) 3
- Current treatment with MAOIs or within 14 days of MAOI discontinuation (risk of hypertensive crisis) 3
- Known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, or coronary artery disease 3
Common Pitfalls to Avoid
- Never crush, chew, or open capsules - this creates immediate release of the entire dose, increasing risk of adverse effects including agitation, tachycardia, hypertension, and potential for abuse 4, 2
- Avoid late-day dosing - can cause insomnia and sleep disturbances 3
- Do not use unapproved methods of administration such as snorting or injection, which significantly increase overdose risk and death 3
- Monitor for abuse and diversion - methylphenidate has high abuse potential and is a Schedule IV controlled substance 3
Monitoring Requirements
- Blood pressure and heart rate - CNS stimulants cause mean increases of 2-4 mmHg in blood pressure and 3-6 bpm in heart rate 3
- Signs of abuse, misuse, or addiction - reassess throughout treatment 3
- Response to therapy - if no improvement after appropriate dosage adjustment over one month, discontinue treatment 3