Every Patient Has Unique Needs
Methylphenidate ER is now available in a range of dosing options for easy titration to achieve the necessary therapeutic range. This means you can harness an ideal dose to help patients get the therapy they need in a convenient, affordable once-daily solution.
Josh, Age 20
Titration 18-mg + 18-mg + 9 additional mg = 45-mg (in one daily dose)
Diagnosis: ADHD
Current Medications: Patient started on 18-mg of Methylphenidate ER six months ago and has recently titrated to 36-mg in two Methylphenidate ER tablets daily (18-mg + 18-mg). The doctor does not want to move patient all the way up to 54-mg, so the new in-between once-daily 45-mg provides a better option to titrate more gradually as the next step.
Situation: ADHD symptoms have improved, but a dose adjustment may provide better control. Patient requires titration to 45-mg daily but is resistant to taking more tablets and is more comfortable in making a more gradual increase.
Joey, Age 14
Quantity Limit = 30 Tablets
Diagnosis: ADHD
Current Medications: 63 mg in two Methylphenidate ER tablets daily (18-mg + 45-mg)
Situation: The patient's prescription plan imposes a monthly quantity limit of 30 tablets, so he incurs higher out-of-pocket costs. Taking a single 63-mg Methylphenidate ER tablet brings Alex within the monthly quantity limits and reduces the monthly prescription cost.
Isabella, Age 18
1 Manufacturer =
Same Appearance
Diagnosis: ADHD and generalized anxiety disorder
Current Medications: (2x36-mg) Methylphenidate ER tablets daily and medications for anxiety
Situation: Patient switched from branded Methylphenidate HCl extended-release tablets to a generic methylphenidate extended-release product to reduce out-of-pocket costs. She is now concerned about receiving tablets that vary in shape, size, and color from fill to fill. She prefers a product produced by the same manufacturer with each fill.
Alex, Age 30
Convenience = One 72-mg* tablet
versus Two 36-mg tablets
Diagnosis: ADHD
Current Medications: (2x36-mg) methylphenidate ER tablets daily
Situation: Patient and parents may prefer the convenience of taking one 72-mg* tablet daily versus two 36-mg tablets daily.
Not actual patients. For illustrative purposes only.
Pharmacokinetic Study:
Methylphenidate ER Once-Daily Dosing Efficacy
The study exhibits how once-daily Methylphenidate ER 72-mg works as effectively as twice-daily doses.
Methylphenidate ER 72-mg has demonstrated bioequivalence to two 36-mg branded methylphenidate HCl extended-release tablets.2
Pharmacokinetic study of mean methylphenidate plasma concentration over time — Administration of one Methylphenidate ER 72-mg tablet versus two 36-mg branded methylphenidate HCl extended-release tablets.2
Per revised FDA guidance in 2014, additional bioequivalence metrics are required to ensure that a new Methylphenidate ER alternative is therapeutically equivalent to branded methylphenidate HCl extended-release tablets.3
- 36
- 36
- 72
Demonstrated bioequivalence to two 36-mg branded methylphenidate HCl extended-release tablets2
- Metrics
- meets fda bioequivalent criteria3
- Cmax
- AUC(0-∞)
- AUC(0-3)
- AUC(3-7)
- AUC(7-12)
References: 1. Methylphenidate hydrochloride extended-release tablets [package insert]. Trigen Laboratories, LLC; 2022. 2. Data on file, Osmotica Pharmaceutical US LLC. 3. US Food and Drug Administration. Draft Guidance on Methylphenidate Hydrochloride. Revised November 2014. Accessed July 2018.
*Click here to see full Prescribing Information Including Boxed Warning for Methylphenidate ER 72-mg Tablets
**Co-pay cards are available for prescription coverage assistance for qualified patients. For terms and conditions, click here. Offer void where prohibited. Other restrictions apply. The use of this Savings Card is limited to prescriptions of Methylphenidate ER 45-mg, 63-mg and 72-mg tablets.