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Amantadine (Amantadine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.

Influenza A Prophylaxis

Amantadine Hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection when early vaccination is not feasible or when the vaccine is contraindicated or not available. In the prophylaxis of influenza, early vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee is the method of choice. 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.

Influenza A Treatment

Amantadine Hydrochloride 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.

Parkinson’s Disease/Syndrome

Amantadine Hydrochloride 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.

Drug-Induced ExtrapyramidaI Reactions

Amantadine Hydrochloride 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.

DOSAGE AND ADMINISTRATION

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

Adult

The 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. – 9 yrs. of age

The 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. – l2 yrs. of age

The 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

Adult

The 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 Therapy

Some 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

Adult

The 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 Function

Depending upon creatinine clearance, the following dosage adjustments are recommended:

CREATININE CLEARANCE AMANTADINE HYDROCHLORIDE DOSAGE
(mL/min/1.73m2)
30 – 50200 mg 1st day and 100 mg each day thereafter
15 – 29200 mg 1st day followed by 100 mg on alternate days
< 15200 mg every 7 days

The recommended dosage for patients on hemodialysis is 200 mg every 7 days.

HOW SUPPLIED

Amantadine Hydrochloride Oral Solution USP is available as a clear, fruit punch flavored oral solution containing 50 mg amantadine hydrochloride per 5 mL (1 teaspoonful). It is supplied in containers of 16 fl oz (473 mL).

Store at 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

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