PRINCIPAL DISPLAY PANEL - 100 mg/10 mL Cup Label

Rx Only
Delivers 10 mL
NDC 39328-530-01
Amantadine HCL Oral
Solution, USP
100mg/ 10 mL
For Institutional Use Only
See Insert

Package not Child Resistant
Store at 20 to 25 C (68 to 77 F)
LOT # 052059 EXP: 04/2022

Manufactured For: Patrin Pharma
Skokie, IL 60076

Rev 01.0723

WARNINGS

Deaths

Deaths have been reported from overdose with Amantadine Hydrochloride Oral Solution USP. The lowest reported acute lethal dose was 1 gram. Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension (see OVERDOSAGE).

Deaths due to drug accumulation (overdosage) have been reported in patients with renal impairment, who were prescribed higher than recommended doses of Amantadine Hydrochloride for their level of renal function (see DOSAGE AND ADMINISTRATION; Dosage of Impaired Renal Function and OVERDOSAGE).

Suicide Attempts

Suicide attempts, some of which have been fatal, have been reported in patients treated with Amantadine Hydrochloride Oral Solution USP, many of whom received short courses for influenza treatment or prophylaxis. The incidence of suicide attempts is not known and the pathophysiologic mechanism is not understood. Suicide attempts and suicidal ideation have been reported in patients with and without prior history of psychiatric illness. Amantadine Hydrochloride Oral Solution USP can exacerbate mental problems in patients with a history of psychiatric disorders or substance abuse. Patients who attempt suicide may exhibit abnormal mental states which include disorientation, confusion, depression, personality changes, agitation, aggressive behavior, hallucinations, paranoia, other psychotic reactions, and somnolence or insomnia. Because of the possibility of serious adverse effects, caution should be observed when prescribing Amantadine Hydrochloride Oral Solution USP to patients being treated with drugs having CNS effects, or for whom the potential risks outweigh the benefit of treatment.

CNS Effects

Patients with a history of epilepsy or other "seizures" should be observed closely for possible increased seizure activity.

Patients receiving Amantadine Hydrochloride Oral Solution USP who note central nervous system effects or blurring of vision should be cautioned against driving or working in situations where alertness and adequate motor coordination are important.

Other

Patients with a history of congestive heart failure or peripheral edema should be followed closely as there are patients who developed congestive heart failure while receiving Amantadine Hydrochloride Oral Solution USP.

Patients with Parkinson's disease improving on Amantadine Hydrochloride Oral Solution USP should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis.

Because Amantadine Hydrochloride Oral Solution USP has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma.