Amantadine Hydrochloride Syrup
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Questions & Answers
Side Effects & Adverse Reactions
Deaths have been reported from overdose with amantadine hydrochloride. 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 (overdose) 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 for Impaired Renal Function and OVERDOSAGE).
Suicide attempts, some of which have been fatal, have been reported in patients treated with amantadine hydrochloride, 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 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 to patients being treated with drugs having CNS effects, or for whom the potential risks outweigh the benefit of treatment.
Patients with a history of epilepsy or other “seizures” should be observed closely for possible increased seizure activity.
Patients receiving amantadine hydrochloride 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.
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.
Patients with Parkinson’s disease improving on amantadine hydrochloride should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis.
Because amantadine hydrochloride has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Amantadine hydrochloride oral solution USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride oral solution USP is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
Amantadine hydrochloride oral solution USP is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride 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 hydrochloride prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response.
Amantadine hydrochloride oral solution USP is 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 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 is 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:
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- Amantadine hydrochloride is 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.
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- 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.
Amantadine hydrochloride oral solution USP is 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 hydrochloride 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.
Amantadine hydrochloride oral solution USP is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with Amantadine Hydrochloride 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.
History
There is currently no drug history available for this drug.
Other Information
Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride.
Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform.
Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug.
Amantadine hydrochloride oral solution USP contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, and natural and artificial flavoring.
Sources
Amantadine Hydrochloride Syrup Manufacturers
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Mikart, Inc.
![Amantadine Hydrochloride Syrup [Mikart, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amantadine Hydrochloride Syrup | Mikart, Inc.
The dose of amantadine hydrochloride may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function (see Dosage for Impaired Renal Function).
Dosage for Prophylaxis and Treatment of Uncomplicated Influenza A Virus Illness AdultThe adult daily dosage of amantadine hydrochloride is 200 mg: four teaspoonfuls of oral solution as a single daily dose. The daily dosage may be split into two teaspoonfuls of oral solution twice a day. If central nervous system effects develop in once-a-day dosage, a split dosage schedule may reduce such complaints. In persons 65 years of age or older, the daily dosage of amantadine hydrochloride is 100 mg.
A 100 mg daily dose has also been shown in experimental challenge studies to be effective as prophylaxis in healthy adults who are not at high risk for influenza-related complications. However, it has not been demonstrated that a 100 mg daily dose is as effective as a 200 mg daily dose for prophylaxis, nor has the 100 mg daily dose been studied in the treatment of acute influenza illness. In recent clinical trials, the incidence of central nervous system (CNS) side effects associated with the 100 mg daily dose was at or near the level of placebo. The 100 mg dose is recommended for persons who have demonstrated intolerance to 200 mg of amantadine hydrochloride daily because of CNS or other toxicities.
Pediatric Patients 1 yr. to 9 yrs. of ageThe total daily dose should be calculated on the basis of 2 to 4 mg/lb/day (4.4 to 8.8 mg/kg/day), but not to exceed 150 mg per day.
9 yrs. to l2 yrs. of ageThe total daily dose is 200 mg given as two teaspoonfuls of oral solution twice a day. The 100 mg daily dose has not been studied in this pediatric population. Therefore, there are no data which demonstrate that this dose is as effective as or is safer than the 200 mg daily dose in this patient population.
Prophylactic dosing should be started in anticipation of an influenza A outbreak and before or after contact with individuals with influenza A virus respiratory tract illness.
Amantadine hydrochloride should be continued daily for at least 10 days following a known exposure. If amantadine hydrochloride is used chemoprophylactically in conjunction with inactivated influenza A virus vaccine until protective antibody responses develop, then it should be administered for 2 to 4 weeks after the vaccine has been given. When inactivated influenza A virus vaccine is unavailable or contraindicated, amantadine hydrochloride should be administered for the duration of known influenza A in the community because of repeated and unknown exposure.
Treatment of influenza A virus illness should be started as soon as possible, preferably within 24 to 48 hours after onset of signs and symptoms, and should be continued for 24 to 48 hours after the disappearance of signs and symptoms.
Dosage for Parkinsonism AdultThe usual dose of amantadine hydrochloride is 100 mg twice a day when used alone. Amantadine hydrochloride has an onset of action usually within 48 hours.
The initial dose of amantadine hydrochloride is 100 mg daily for patients with serious associated medical illnesses or who are receiving high doses of other antiparkinson drugs. After one to several weeks at 100 mg once daily, the dose may be increased to 100 mg twice daily, if necessary.
Occasionally, patients whose responses are not optimal with amantadine hydrochloride at 200 mg daily may benefit from an increase up to 400 mg daily in divided doses. However, such patients should be supervised closely by their physicians.
Patients initially deriving benefit from amantadine hydrochloride not uncommonly experience a fall-off of effectiveness after a few months. Benefit may be regained by increasing the dose to 300 mg daily. Alternatively, temporary discontinuation of amantadine hydrochloride for several weeks followed by reinitiation of the drug, may result in regaining benefit in some patients. A decision to use other antiparkinson drugs may be necessary.
Dosage for Concomitant TherapySome patients who do not respond to anticholinergic antiparkinson drugs may respond to amantadine hydrochloride. When amantadine hydrochloride or anticholinergic antiparkinson drugs are each used with marginal benefit, concomitant use may produce additional benefit.
When amantadine hydrochloride and levodopa are initiated concurrently, the patient can exhibit rapid therapeutic benefits. Amantadine hydrochloride should be held constant at 100 mg daily or twice daily while the daily dose of levodopa is gradually increased to optimal benefit.
When amantadine hydrochloride is added to optimal well-tolerated doses of levodopa, additional benefit may result, including smoothing out the fluctuations in improvement which sometimes occur in patients on levodopa alone. Patients who require a reduction in their usual dose of levodopa because of development of side effects may possibly regain lost benefit with the addition of amantadine hydrochloride.
Dosage for Drug-Induced Extrapyramidal Reactions AdultThe usual dose of amantadine hydrochloride is 100 mg twice a day. Occasionally, patients whose responses are not optimal with amantadine hydrochloride at 200 mg daily may benefit from an increase up to 300 mg daily in divided doses.
Dosage for Impaired Renal FunctionDepending upon creatinine clearance, the following dosage adjustments are recommended:
CREATININE CLEARANCE
AMANTADINE HYDROCHLORIDE DOSAGE
(mL/min/1.73m2)
30 to 50
200 mg 1st day and 100 mg each day thereafter
15 to 29
200 mg 1st day followed by 100 mg on alternate days
< 15
200 mg every 7 days
The recommended dosage for patients on hemodialysis is 200 mg every 7 days.
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