GOCOVRI 137 mg/1

AMANTADINE · CAPSULE, COATED PELLETS · Supernus Pharmaceuticals

No Recall HistoryCurrently in Shortage

Plain English

GOCOVRI is a capsule, coated pellets containing amantadine at 137 mg/1, taken oral. Manufactured by Supernus Pharmaceuticals.

Key Facts

Brand Name: GOCOVRI
Generic Name: AMANTADINE
NDC Code (Product): 17772-170
Manufacturer: Supernus Pharmaceuticals
Strength: 137 mg/1
Dosage Form: CAPSULE, COATED PELLETS
Route: ORAL
Marketing Status
Application #: NDA208944
Drug Class: Influenza A M2 Protein Inhibitor [EPC]
Marketing Start: 08/24/2017

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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. Do not crush, chew or divide capsules. If needed, GOCOVRI may be administered by carefully opening and sprinkling the entire contents on a small amount (teaspoonful) of soft food, such as applesauce. The drug/food mixture should be swallowed immediately without chewing. Do not store mixture for future use. GOCOVRI can be taken with or without food [see Clinical Pharmacology ( 12.3 )]. Concomitant use of GOCOVRI w…

Contraindications

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 )

Drug 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. Urine pH is altered by diet, drugs (e.g., carbonic anhydrase inhibitors, sodium bicarbonate), and clinical state of the patient (e.g., renal tubular acidosis or severe infections of the urinary tract). Since the excretion rate of amantadine increases rapidly when the urine is acidic, the administration of urine acidifying drugs may increase the elimination of the drug from the body. Alterations of urine pH towards the alkaline condition …

Adverse Reactions

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, peripheral edema, constipation, fall, and orthostatic hypotension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Supernus Pharmaceuticals, Inc. at 1-833-223-2627 or FDA at 1-800-FDA-1088 or http://www/fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be di…

Frequently Asked Questions

What is GOCOVRI used for?

GOCOVRI contains AMANTADINE. It is a capsule, coated pellets taken oral. Consult your doctor for specific uses.

Is GOCOVRI a controlled substance?

GOCOVRI is not classified as a controlled substance by the DEA.

What is the generic name for GOCOVRI?

The generic name for GOCOVRI is AMANTADINE. There are 12 other brand versions of AMANTADINE.

What is the NDC code for GOCOVRI 137 mg/1?

The NDC (National Drug Code) for GOCOVRI 137 mg/1 is 17772-170, listed by Supernus Pharmaceuticals.

Product NDC

17772-170

Package NDC

17772-170-21

Other Amantadine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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