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Drug overview for GOCOVRI (amantadine hcl):
Generic name: amantadine HCl (a-MAN-ta-deen)
Drug class: Antiviral - Influenza A
Therapeutic class: Central Nervous System Agents
Amantadine hydrochloride is a synthetic adamantane derivative that has Amantadine hydrochloride, an adamantane derivative, is a synthetic antiviral agent that is active against influenza A virus. pharmacologic activity as an anti-Parkinson and antiviral agent.
No enhanced Uses information available for this drug.
Generic name: amantadine HCl (a-MAN-ta-deen)
Drug class: Antiviral - Influenza A
Therapeutic class: Central Nervous System Agents
Amantadine hydrochloride is a synthetic adamantane derivative that has Amantadine hydrochloride, an adamantane derivative, is a synthetic antiviral agent that is active against influenza A virus. pharmacologic activity as an anti-Parkinson and antiviral agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
GOCOVRI ER 68.5 MG CAPSULE
GOCOVRI ER 137 MG CAPSULE
The following indications for GOCOVRI (amantadine hcl) have been approved by the FDA:
Indications:
Idiopathic parkinsonism
Professional Synonyms:
Paralysis agitans
Primary Parkinson's disease
Indications:
Idiopathic parkinsonism
Professional Synonyms:
Paralysis agitans
Primary Parkinson's disease
The following dosing information is available for GOCOVRI (amantadine hcl):
Dosage of amantadine hydrochloride conventional tablets, capsules, and oral solution is expressed in terms of amantadine hydrochloride; dosage of amantadine hydrochloride extended-release capsules is expressed in terms of amantadine.
Deaths from overdosage of amantadine have occurred; the lowest reported acute lethal dose was 1 g. Acute toxicity may be attributed to the anticholinergic effects of the drug. Overdosage also has been reported in patients with renal impairment who were prescribed higher than recommended doses of amantadine for their level of renal function.
Deaths from overdosageof amantadine have occurred; the lowest reported acute lethal dose was 1 g. Acute toxicity may be attributed to the anticholinergic effects of the drug. Overdosage also has been reported in patients with renal impairment who were prescribed higher than recommended doses of amantadine for their level of renal function.
Deaths from overdosage of amantadine have occurred; the lowest reported acute lethal dose was 1 g. Acute toxicity may be attributed to the anticholinergic effects of the drug. Overdosage also has been reported in patients with renal impairment who were prescribed higher than recommended doses of amantadine for their level of renal function.
Deaths from overdosageof amantadine have occurred; the lowest reported acute lethal dose was 1 g. Acute toxicity may be attributed to the anticholinergic effects of the drug. Overdosage also has been reported in patients with renal impairment who were prescribed higher than recommended doses of amantadine for their level of renal function.
Amantadine hydrochloride is administered orally as conventional (i.e., immediate-release) tablets, conventional capsules, extended-release capsules,or a conventional oral solution. Amantadine hydrochloride is administered orally. Adverse effects (e.g., CNS effects) may be minimized if the daily dosage is given in 2 equally divided doses. Amantadine hydrochloride is commercially available as tablets or liquid-filled capsules containing 100 mg of the drug and as an oral solution containing 50 mg/5 mL.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| GOCOVRI ER 68.5 MG CAPSULE | Maintenance | Adults take 2 capsules (137 mg) by oral route once daily at bedtime |
| GOCOVRI ER 137 MG CAPSULE | Maintenance | Adults take 2 capsules (274 mg) by oral route once daily at bedtime |
No generic dosing information available.
The following drug interaction information is available for GOCOVRI (amantadine hcl):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Influenza Virus Vaccine Live/Selected Antiviral Agents SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir,(5) may inactivate the intranasal live influenza virus vaccine, preventing the body from developing an immune response. CLINICAL EFFECTS: Administration of amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir,(5) may render the intranasal live influenza virus vaccine ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturers of amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir(4), baloxavir(5), and the intranasal live influenza virus vaccine(6) state that these agents should not be initiated within 2 weeks of the administration of the intranasal live influenza virus vaccine and that the vaccine should not be administered within 48 hours of the discontinuation of these agents. Inactivated influenza vaccine may be used at any time.(1) DISCUSSION: Because antiviral drugs such as amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir (5) inhibit the replication of live viruses, these agents may interfere with the efficacy of the intranasal live influenza virus vaccine. |
FLUMIST TRIVALENT 2024-2025 |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Memantine/N-Methyl-D-Aspartate (NMDA) Antagonists SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: N-methyl-D-aspartate (NMDA) antagonists act at the same receptor system as does memantine.(1,2) CLINICAL EFFECTS: Concurrent use may result in more frequent and more pronounced side effects, especially CNS-related effects.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The UK manufacturer of memantine states that the concurrent use of memantine with N-methyl-D-aspartate (NMDA) antagonists such as amantadine or ketamine should be avoided.(1) The US manufacturer of memantine states that concurrent use should be approached with caution.(2) DISCUSSION: Because N-methyl-D-aspartate (NMDA) antagonists act at the same receptor system as does memantine, concurrent use may result in more frequent and more pronounced side effects, especially CNS-related effects. Therefore, the UK manufacturer of memantine states that the concurrent use of memantine with NMDA antagonists such as amantadine or ketamine should be avoided.(1) The US manufacturer of memantine states that concurrent use should be approached with caution.(2) In a study in 52 healthy subjects, concurrent memantine (20 mg daily) and dextromethorphan/quinidine (30/30 mg daily) resulted in no changes in dextromethorphan or memantine levels. There was a slight increase in dizziness as measured by the dizziness visual analog scale (VAS) when compared to memantine alone but not the combination of dextromethorphan/quinidine alone. For other pharmacodynamic assessments, there was either no effect or improvement on some subscales.(3) |
MEMANTINE HCL, MEMANTINE HCL ER, MEMANTINE HCL-DONEPEZIL HCL ER, NAMENDA, NAMENDA XR, NAMZARIC |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Memantine; Amantadine/Urinary Alkalinizers SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Memantine and amantadine elimination is impaired by urinary alkalinization.(1,2) CLINICAL EFFECTS: Potentiation of memantine or amantadine effects may be observed. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Monitor patient for adverse reactions such as dizziness, headache, or confusion if a urinary alkalinizer is required. The memantine or amantadine dose may need to be adjusted when a urinary alkalinizer is started or stopped.(1,2) DISCUSSION: The clearance of memantine was reduced by about 80% under alkaline urine conditions at pH 8. Urine alkalinization may lead to an accumulation of memantine with a possible increase in adverse effects. Urine pH is also altered by diet and clinical state of the patient (e.g., renal tubular acidosis or severe infections of the urinary tract). Hence, memantine should be used with caution under these conditions.(1) A study in rats showed that concomitant administration of sodium bicarbonate with amantadine caused a decrease in amantadine renal clearance (1.16 vs. 0.76). Amantadine's area-under-the-curve (AUC) was increased approximately 78%.(3) A study in 12 healthy subjects showed that plasma concentrations of memantine are dependent on urine pH. Alkaline urine pH caused a 79% reduction in renal clearance.(4) |
ACETAZOLAMIDE, ACETAZOLAMIDE ER, ACETAZOLAMIDE SODIUM, DICHLORPHENAMIDE, K-PHOS NO.2, K-PHOS ORIGINAL, KEVEYIS, METHAZOLAMIDE, ORACIT, ORAL CITRATE, ORMALVI, POTASSIUM CITRATE ER, SODIUM ACETATE, SODIUM BICARBONATE, SODIUM BICARBONATE-D5W, SODIUM BICARBONATE-WATER, THAM, TROMETHAMINE, TROMETHAMINE-STERILE WATER, UROCIT-K, UROQID-ACID NO.2, VAXCHORA BUFFER COMPONENT |
| Amantadine; Foslevodopa; Levodopa/Bupropion SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Amantadine, levodopa, and bupropion have dopamine agonist effects. Toxicity may result from cumulative dopamine agonist effects.(1) Foslevodopa is a prodrug of levodopa.(2) CLINICAL EFFECTS: Concurrent administration of amantadine/levodopa and bupropion may result in CNS toxicity, such as, restlessness, agitation, tremor, ataxia, gait disturbance, vertigo, and dizziness.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Use caution when amantadine/levodopa and bupropion are used concurrently. Monitor for signs of CNS toxicity, which may include restlessness, agitation, tremor, ataxia, gait disturbance, vertigo, and dizziness.(1) DISCUSSION: CNS toxicity has been reported with concurrent administration of amantadine and bupropion. Three out of six nursing home residents administered concurrent bupropion and amantadine developed confusion, restlessness, agitation, gross motor tremors, ataxia, gait disturbance, dizziness, and vertigo. Two patients had severe symptoms and were hospitalized.(3) In a case report, bupropion (75 mg twice daily) was added to amantadine, haloperidol, and benztropine. The patient became disoriented and agitated, developed visual and auditory hallucinations, impaired attention and memory, a fluctuating level of awareness, and unsteady gait.(4) |
APLENZIN, AUVELITY, BUPROPION HCL, BUPROPION HCL SR, BUPROPION XL, CONTRAVE, FORFIVO XL, WELLBUTRIN SR, WELLBUTRIN XL |
The following contraindication information is available for GOCOVRI (amantadine hcl):
Drug contraindication overview.
*Patients with known hypersensitivity to amantadine hydrochloride or any ingredients in the formulations. *Patients with known hypersensitivity to amantadine hydrochloride or any ingredients in the formulations.
*Patients with known hypersensitivity to amantadine hydrochloride or any ingredients in the formulations. *Patients with known hypersensitivity to amantadine hydrochloride or any ingredients in the formulations.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
There are 8 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Angle-closure glaucoma |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Drug abuse |
| Psychotic disorder |
| Seizure disorder |
| Suicidal ideation |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
| Eczema |
| Edema |
| Malignant melanoma |
| Orthostatic hypotension |
The following adverse reaction information is available for GOCOVRI (amantadine hcl):
Adverse reaction overview.
The most common adverse effects (5-10%) of amantadine administered as The most common adverse effects (5-10%) of amantadine include nausea, conventional (immediate-release) preparations include nausea, dizziness, dizziness, and insomnia. and insomnia. The most common adverse effects (>10%) with extended-release amantadine capsules include hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.
The most common adverse effects (5-10%) of amantadine administered as The most common adverse effects (5-10%) of amantadine include nausea, conventional (immediate-release) preparations include nausea, dizziness, dizziness, and insomnia. and insomnia. The most common adverse effects (>10%) with extended-release amantadine capsules include hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.
There are 12 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Accidental fall |
Cataracts |
| Rare/Very Rare |
|---|
|
Agranulocytosis Chronic heart failure Corneal deposits Neutropenic disorder Oculogyric crisis Paranoid disorder Seizure disorder Sudden onset of sleep Suicidal Suicidal ideation |
There are 42 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Concentration difficulty Constipation Dizziness Hallucinations Insomnia Nervousness Orthostatic hypotension Peripheral edema Xerostomia |
Acquired dystonia Acute cognitive impairment Anorexia Arthritis Benign prostatic hyperplasia Blurred vision Cough Depression Diarrhea Dream disorder Drowsy Dry eye Dyschromia Fatigue Gait abnormality Headache disorder Irritability Livedo reticularis Muscle spasm Nausea Nightmares Symptoms of anxiety Urinary tract infection Vomiting |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Anticholinergic toxicity Delusional disorder Dry nose Dry throat Impulse control disorder Skin rash Urinary retention Visual changes |
The following precautions are available for GOCOVRI (amantadine hcl):
Safety and efficacy of amantadine for the prevention or treatment of Safety and efficacy of amantadine for the treatment of parkinson disease have not been established in pediatric patients; the majority of infections caused by influenza A viruses have not been established in individuals with parkinson disease are 65 years of age or older. When used neonates or children younger than 1 year of age. in children, amantadine has caused CNS symptoms, which resolved when the drug was discontinued. An increased incidence of seizures has been reported in children with an underlying seizure disorder receiving amantadine.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Amantadine has been reported to be embryotoxic/teratogenic in rats when administered in dosages of 50 and 100 mg/kg daily (1.5 and 3 times, respectively, the maximum recommended human dosage on a mg/m2 basis), but not when administered in a dosage of 37 mg/kg daily (the maximum recommended human dosage on a mg/m2 basis). One woman with a movement recommended human dosage on a mg/m2. One woman with a movement disorder disorder similar to parkinsonian syndrome who may have been treated with similar to parkinsonian syndrome who may have been treated with amantadine amantadine hydrochloride (100 mg daily) during the first trimester of hydrochloride (100 mg daily) during the first trimester of pregnancy delivered a child with a complex cardiovascular lesion (single ventricle pregnancy delivered a child with a complex cardiovascular lesion (single and pulmonary atresia) that may have been caused by the drug.
There are no ventricle and pulmonary atresia) that may have been caused by the drug. adequate and well-controlled studies using amantadine in pregnant women, Fallot and tibial hemimelia (normal karyotype) were reported in an infant and the drug should be used during pregnancy only when the potential exposed to oral amantadine hydrochloride during the first trimester of benefits outweigh the possible risks to the fetus. pregnancy (100 mg daily for 7 days during week 6 and 7 of gestation). There are no adequate and well-controlled studies using amantadine in pregnant women, and the drug should be used during pregnancy only when the potential benefits outweigh the possible risks to the fetus.
There are no ventricle and pulmonary atresia) that may have been caused by the drug. adequate and well-controlled studies using amantadine in pregnant women, Fallot and tibial hemimelia (normal karyotype) were reported in an infant and the drug should be used during pregnancy only when the potential exposed to oral amantadine hydrochloride during the first trimester of benefits outweigh the possible risks to the fetus. pregnancy (100 mg daily for 7 days during week 6 and 7 of gestation). There are no adequate and well-controlled studies using amantadine in pregnant women, and the drug should be used during pregnancy only when the potential benefits outweigh the possible risks to the fetus.
Because amantadine is distributed into human milk, some manufacturers state that the drug should not be used in nursing women.
Geriatric adults may have decreased renal function and because individuals The majority of individuals with parkinson disease are 65 years of age or older. Clearance of amantadine is reduced, plasma concentrations of the with renal impairment may be at increased risk of amantadine-induced drug are increased, and elimination half-life may be prolonged in healthy toxicity, the dosage of amantadine hydrochloride for adults in this age geriatric adults compared with healthy young adults. group should not exceed 100 mg daily.
This dosage may need to be reduced further in some geriatric patients. Reduced dosages may be needed in geriatric patients >=65 years of age because of renal decline in such patients.
This dosage may need to be reduced further in some geriatric patients. Reduced dosages may be needed in geriatric patients >=65 years of age because of renal decline in such patients.
The following prioritized warning is available for GOCOVRI (amantadine hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for GOCOVRI (amantadine hcl)'s list of indications:
| Idiopathic parkinsonism | |
| G20 | Parkinson's disease |
| G20.A | Parkinson's disease without dyskinesia |
| G20.A1 | Parkinson's disease without dyskinesia, without mention of fluctuations |
| G20.A2 | Parkinson's disease without dyskinesia, with fluctuations |
| G20.B | Parkinson's disease with dyskinesia |
| G20.B1 | Parkinson's disease with dyskinesia, without mention of fluctuations |
| G20.B2 | Parkinson's disease with dyskinesia, with fluctuations |
| G20.C | Parkinsonism, unspecified |
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