Application Nr Approved Date Route Status External Links
ANDA209047 2017-06-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Amantadine Hydrochloride Capsules Are Indicated For The Prophylaxis And Treatment Of Signs And Symptoms Of Infection Caused By Various Strains Of Influenza A Virus. Amantadine Hydrochloride Capsules Are Also Indicated In The Treatment Of Parkinsonism And Drug-Induced Extrapyramidal Reactions. Influenza A Prophylaxis Amantadine Hydrochloride Capsules 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 Develop Immune Responses To Natural Disease Or Vaccination And May Be Protected When Later Exposed To Antigenically Related Viruses. Following Vaccination During An Influenza A Outbreak, Amantadine Prophylaxis Should Be Considered For The 2- To 4-Week Time Period Required To Develop An Antibody Response. Influenza A Treatment Amantadine Hydrochloride Capsules Are Also Indicated In The Treatment Of Uncomplicated Respiratory Tract Illness Caused By Influenza A Virus Strains Especially When Administered Early In The Course Of Illness. There Are No Well-Controlled Clinical Studies Demonstrating That Treatment With Amantadine Hydrochloride Capsules Will Avoid The Development Of Influenza A Virus Pneumonitis Or Other Complications In High Risk Patients. There Is No Clinical Evidence Indicating That Amantadine Hydrochloride Capsules Are Effective In The Prophylaxis Or Treatment Of Viral Respiratory Tract Illnesses Other Than Those Caused By Influenza A Virus Strains. The Following Points Should Be Considered Before Initiating Treatment Or Prophylaxis With Amantadine Hydrochloride Capsules. Amantadine Hydrochloride Capsules Are Not A Substitute For Early Vaccination On An Annual Basis As Recommended By The Centers For Disease Control And Prevention Advisory Committee On Immunization Practices. Influenza Viruses Change Over Time. Emergence Of Resistance Mutations Could Decrease Drug Effectiveness. Other Factors (for Example, Changes In Viral Virulence) Might Also Diminish Clinical Benefit Of Antiviral Drugs. Prescribers Should Consider Available Information On Influenza Drug Susceptibility Patterns And Treatment Effects When Deciding Whether To Use Amantadine Hydrochloride Capsules. Parkinson’s Disease/syndrome Amantadine Hydrochloride Capsules Are Indicated In The Treatment Of Idiopathic Parkinson’s Disease (paralysis Agitans), Postencephalitic Parkinsonism And Symptomatic Parkinsonism Which May Follow Injury To The Nervous System By Carbon Monoxide Intoxication. It Is Indicated In Those Elderly Patients Believed To Develop Parkinsonism In Association With Cerebral Arteriosclerosis. In The Treatment Of Parkinson’s Disease, Amantadine Is Less Effective Than Levodopa, (-)-3-(3,4-Dihydroxyphenyl)-L-Alanine, And Its Efficacy In Comparison With The Anticholinergic Antiparkinson Drugs Has Not Yet Been Established. Drug-Induced Extrapyramidal Reactions Amantadine Hydrochloride Is Indicated In The Treatment Of Drug-Induced Extrapyramidal Reactions. Although Anticholinergic-Type Side Effects Have Been Noted With Amantadine When Used In Patients With Drug-Induced Extrapyramidal Reactions, There Is A Lower Incidence Of These Side Effects Than That Observed With The Anticholinergic Antiparkinson Drugs.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Ethylcelluloses ETHYLCELLULOSES Unresolved
4. Gelatin GELATIN Unresolved
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. Shellac SHELLAC Unresolved
10. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amantadine Hydrochloride AMANTADINE HYDROCHLORIDE ZINC968256

Comments