Medical Professionals Reference (MPR)FDA-Approved Sdamlo Provides New Option for Amlodipine Administration

Sdamlo, a powder-for-oral-solution formulation of amlodipine, is now commercially available for patients with dysphagia. Unit-dose bottles deliver 2.5 mg, 5 mg, or 10 mg of amlodipine; the solution is prepared with 15 mL of water and must be consumed within 60 minutes of preparation.

Clinical Considerations

• Sdamlo carries the same indications as tablet amlodipine: hypertension in adults and pediatric patients 6 and older, chronic stable angina, vasospastic angina, and CAD risk reduction.
• The unit-dose format eliminates compounding variability, a meaningful safety improvement over crushed tablet or extemporaneous liquid preparations.
• Formulation is free of alcohol, preservatives, and sucralose, reducing concern for patients with sensitivities or dietary restrictions.
• Pediatric hypertension patients 6 and older are an included population; dysphagia is not exclusive to older adults.

Practice Applications

• Identify current patients on crushed or compounded amlodipine preparations who would benefit from a standardized approved alternative.
• Document dysphagia in the medication record to support formulary justification and prior authorization if required.
• Counsel patients on the 60-minute consumption window after preparation; stability beyond that point is not established.
• Consider Sdamlo for pediatric hypertension patients aged 6 and older with swallowing difficulties before defaulting to compounded formulations.

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