Amantadine
Generic Name: amantadine
Brand Names:
Gocovri
11 DESCRIPTION GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7 ] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula: The molecular formula is C 10 H 17 N∙HCl and the molecular weight is 187.71 (g/mol).
Overview
11 DESCRIPTION GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7 ] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula: The molecular formula is C 10 H 17 N∙HCl and the molecular weight is 187.71 (g/mol).
Uses
1 INDICATIONS AND USAGE GOCOVRI ® is indicated: For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes GOCOVRI ® is indicated: For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications ( 1 ) As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Administer orally once daily at bedtime ( 2.1 , 2.3 ) The initial daily dosage is 137 mg; after 1 week, increase to the recommended daily dosage of 274 mg ( 2.1 ) Swallow whole; may sprinkle contents on soft food ( 2.2 ) May be taken with or without food; avoid use with alcohol ( 2.2 ) A lower dosage is recommended for patients with moderate or severe renal impairment ( 2.3 ) 2.1 Dosing Information The initial daily dosage of GOCOVRI is 137 mg, administered orally once daily at bedtime. After one week, increase to the recommended dosage of 274 mg (two 137 mg capsules) once daily at bedtime. GOCOVRI is not substitutable with other amantadine immediate- or extended-release products. 2.2 Administration Information GOCOVRI should be swallowed whole.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.1 )] Suicidality and Depression [see Warnings and Precautions ( 5.2 )] Hallucinations/Psychotic Behavior [see Warnings and Precautions ( 5.3 )] Dizziness and Orthostatic Hypotension [see Warnings and Precautions ( 5.4 )] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.5 )] Corneal Edema [see Warnings and Precautions ( 5.6 )] Impulse Control/Compulsive Behaviors [see Warnings and Precautions ( 5.7 )] The most commonly observed adverse reactions occurring at a frequency of >10% and greater than placebo were hallucination, dizziness, dry mouth, perip...
Interactions
7 DRUG INTERACTIONS Other Anticholinergic Drugs: Doses should be reduced if atropine-like effects occur ( 7.1 ) Drugs Affecting Urinary pH: Excretion increases with acidic urine; possible accumulation with urine change towards alkaline ( 7.2 ) Live Attenuated Influenza Vaccines: Not recommended during use ( 7.3 ) Alcohol: Concomitant use not recommended ( 7.4 ) 7.1 Other Anticholinergic Drugs Products with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine. The dose of anticholinergic drugs or of GOCOVRI should be reduced if atropine-like effects appear when these drugs are used concurrently. 7.2 Drugs Affecting Urinary pH The pH of the urine has been reported to influence the excretion rate of amantadine.
Warnings
5 WARNINGS AND PRECAUTIONS Falling Asleep During Activities of Daily Living : Advise patients prior to treatment; ordinarily discontinue if occurs ( 5.1 ) Suicidality and Depression : Monitor patients for depressed mood, depression, or suicidal ideation or behavior ( 5.2 ) Hallucinations/Psychotic Behavior: Patients with major psychotic disorder should ordinarily not be treated with GOCOVRI; observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases ( 5.3 ) Dizziness and Orthostatic Hypotension : Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose ( 5.4 ) Withdrawal-Emergent Hyperpyrexia and Confusion : Avoid sudden discontinuation ( 5.5 ) Corneal Edema : Moni... 4 CONTRAINDICATIONS GOCOVRI is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m 2 ) [see Clinical Pharmacology ( 12.3 )]. GOCOVRI is contraindicated in patients with end-stage renal disease ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of amantadine in pregnant women. Animal studies suggest a potential risk for fetal harm with amantadine. In mice and rats, adverse developmental effects (embryolethality, increased incidence of malformations, and reduced fetal body weight) were observed when amantadine was administered to pregnant animals at clinically relevant doses [see Data]. In the U.S.
Storage
16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Amantadine used for?▼
1 INDICATIONS AND USAGE GOCOVRI ® is indicated: For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes GOCOVRI ® is indicated: For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications ( 1 ) As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes ( 1 )
What are the side effects of Amantadine?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.1 )] Suicidality and Depression [see Warnings and Precautions ( 5.2 )] Hallucinations/Psychotic Behavior [see Warnings and Precautions ( 5.3 )] Dizziness and Orthostatic Hypotension [see Warnings and Precautions ( 5.4 )] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.5 )] Corneal Edema [see Warnings and Precautions ( 5.6 )] Impulse Control/Compulsive Behaviors [see Warnings and Precautions ( 5.7 )] The most commonly observed adverse reactions occurring at a frequency of >10% and greater than placebo were hallucination, dizziness, dry mouth, perip...
Can I take Amantadine during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of amantadine in pregnant women. Animal studies suggest a potential risk for fetal harm with amantadine. In mice and rats, adverse developmental effects (embryolethality, increased incidence of malformations, and reduced fetal body weight) were observed when amantadine was administered to pregnant animals at clinically relevant doses [see Data]. In the U.S.
What are the important warnings for Amantadine?▼
5 WARNINGS AND PRECAUTIONS Falling Asleep During Activities of Daily Living : Advise patients prior to treatment; ordinarily discontinue if occurs ( 5.1 ) Suicidality and Depression : Monitor patients for depressed mood, depression, or suicidal ideation or behavior ( 5.2 ) Hallucinations/Psychotic Behavior: Patients with major psychotic disorder should ordinarily not be treated with GOCOVRI; observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases ( 5.3 ) Dizziness and Orthostatic Hypotension : Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose ( 5.4 ) Withdrawal-Emergent Hyperpyrexia and Confusion : Avoid sudden discontinuation ( 5.5 ) Corneal Edema : Moni... 4 CONTRAINDICATIONS GOCOVRI is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m 2 ) [see Clinical Pharmacology ( 12.3 )]. GOCOVRI is contraindicated in patients with end-stage renal disease ( 4 )
Related Medications
Clematis Erecta
clematis erecta
Flex Drops
flex drops
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Memantine And Donepezil Hydrochlorides
memantine and donepezil hydrochlorides
11 DESCRIPTION Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.