AMANTADINE HYDROCHLORIDE
Amantadine hydrochloride is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. It is also indicated for the treatment of parkinsonism and drug-induced extrapyramidal reactions. As a chemoprophylactic supplement to annual vaccination, it is used to provide protection during the two- to four-week window required to develop an antibody response. It is not a substitute for annual vaccination and is not effective against influenza B or other respiratory viral infections.
How AMANTADINE HYDROCHLORIDE Works
The mechanism of action of amantadine hydrochloride involves two distinct pathways: 1. **Antiviral Activity:** Amantadine inhibits the viral M2 protein ion channel of the influenza A virus. This prevents the acidification of the viral interior, which is a necessary step for viral uncoating and the subsequent release of viral RNA into the host cell. 2. **Antiparkinsonian Activity:** The exact mechanism is not fully established but is believed to involve weak, non-competitive NMDA (N-methyl-D-aspartate) receptor antagonism. This action reduces the overstimulation of glutamatergic neurons. Additionally, amantadine has been shown to facilitate the release of dopamine from presynaptic terminals and may inhibit dopamine reuptake.
Details
- Status
- Prescription
- First Approved
- 1987-01-07
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, SYRUP, CAPSULE, EXTENDED RELEASE
Companies
AMANTADINE HYDROCHLORIDE Approval History
What AMANTADINE HYDROCHLORIDE Treats
2 indicationsAMANTADINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Influenza A
- Parkinsonism
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMANTADINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.