Can Qelbree Capsules Be Opened and Sprinkled?
Yes, Qelbree (viloxazine extended-release) capsules can be opened and sprinkled on applesauce or pudding for patients who cannot swallow capsules whole. 1
FDA-Approved Administration Methods
The FDA label for Qelbree explicitly permits opening capsules and sprinkling the contents, with specific instructions 1:
- Open the capsule and sprinkle the entire contents over a teaspoonful or tablespoonful of pudding or applesauce 1
- Swallow the food mixture immediately without chewing 1
- Timing requirements: Consume within 15 minutes for pudding, or within 2 hours for applesauce 1
- Do not store the food mixture for future use 1
Evidence Supporting This Practice
Pharmacokinetic studies confirm that sprinkling does not significantly alter drug absorption. A randomized crossover study in healthy adults demonstrated that viloxazine ER sprinkled on applesauce had bioequivalence to intact capsules, with the 90% confidence intervals for all pharmacokinetic parameters (Cmax, AUClast, AUCinf) falling within the predetermined 80-125% no-difference limits 2. The least-squares geometric mean ratios were 90.10% for Cmax, 93.71% for AUClast, and 95.37% for AUCinf when comparing sprinkled versus intact administration 2.
Critical Safety Requirements
Never allow patients to chew the pellets inside the capsule, as this could disrupt the extended-release mechanism and potentially cause overdose 1. The pellets must be swallowed intact within the food mixture 1.
Additional Considerations for Dysphagia Patients
For patients with significant swallowing difficulties, applesauce is an appropriate vehicle for medication administration as it maintains medication formulation integrity 3. However, patients with more severe dysphagia may require formal swallowing evaluation to ensure safe administration of medications mixed with food 3.