Amantadine immediate-release capsules - Alembic US label
- Product / population
- Immediate-release 100 mg capsules; adult renal instructions. Not GOCOVRI or OSMOLEX ER.
- Renal measure
- Source prints indexed creatinine clearance, mL/min/1.73 m2.
For the US immediate-release product use its applicable official label; do not blend the conflicting mirror interval or extend the table to ER products.
Renal guidance and important limits
Renal accumulation has caused fatal toxicity when doses exceeded recommendations. Hemodialysis removes negligible amounts.
Monitor CNS effects, edema and orthostatic hypotension. Do not abruptly discontinue in Parkinson disease. Historical influenza indications are not a current antiviral recommendation.
| Indexed CrCl (mL/min/1.73 m2) | Source-specific instruction |
|---|---|
| 30-50 | 200 mg on day 1, then 100 mg daily |
| 15-29 | 200 mg on day 1, then 100 mg on alternate days |
| <15 | 200 mg every 7 days |
Dialysis guidance - separate source-specific schedules
| Setting | Source-specific instruction |
|---|---|
| Hemodialysis | 200 mg every 7 days |
Read the retained text before reformatting
Amantadine immediate-release - US label renal table
| Indexed CrCl (mL/min/1.73 m2) | Source-specific instruction |
|---|---|
| 30-50 | 200 mg on day 1, then 100 mg daily |
| 15-29 | 200 mg on day 1, then 100 mg on alternate days |
| <15 | 200 mg every 7 days |
Amantadine immediate-release - US label HD
| Setting | Source-specific instruction |
|---|---|
| Hemodialysis | 200 mg every 7 days |
Renal accumulation has caused fatal toxicity when doses exceeded recommendations. Hemodialysis removes negligible amounts.
Monitor CNS effects, edema and orthostatic hypotension. Do not abruptly discontinue in Parkinson disease. Historical influenza indications are not a current antiviral recommendation.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4157d9a7-a53f-4dde-b051-fe3e9a674913