For use as an adjunct in the therapy of all forms of parkinsonism. Useful also
in the control of extrapyramidal disorders (except tardive dyskinesia -
see PRECAUTIONS) due to neuroleptic drugs
DOSAGE AND ADMINISTRATION
Benztropine mesylate tablets should be used when patients are able to take oral medication.
The injection is especially useful for psychotic patients with acute dystonic reactions or other reactions that make oral medication difficult or impossible. It is recommended also when a more rapid response is desired than can be obtained with tablets.
Because of cumulative action, therapy should be initiated with a low dose which is increased gradually at five or six-day intervals to the smallest amount necessary for optimal relief. Increases should be made in increments of 0.5 mg, to a maximum of 6 mg, or until optimal results are obtained without excessive adverse reactions.
Postencephalitic and Idiopathic Parkinsonism -
The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg orally or parenterally.
As with any agent used in parkinsonism, dosage must be individualized according
to age and weight, and the type of parkinsonism being treated. Generally, older
patients, and thin patients cannot tolerate large doses. Most patients with
postencephalitic parkinsonism need fairly large doses and tolerate them well.
Patients with a poor mental outlook are usually poor candidates for therapy.
In idiopathic parkinsonism, therapy may be initiated with a single daily dose of 0.5 to 1 mg at bedtime. In some patients, this will be adequate; in others 4 to 6 mg a day may be required.
In postencephalitic parkinsonism, therapy may be initiated in most patients with 2 mg a day in one or more doses. In highly sensitive patients, therapy may be initiated with 0.5 mg at bedtime, and increased as necessary.
Some patients experience greatest relief by taking the entire dose at bedtime; others react more favorably to divided doses, two to four times a day. Frequently, one dose a day is sufficient, and divided doses may be unnecessary or undesirable.
The long duration of action of this drug makes it particularly suitable for
bedtime medication when its effects may last throughout the night, enabling
patients to turn in bed during the night more easily, and to rise in the morning.
When benztropine mesylate is started, do not terminate therapy with other antiparkinsonian agents abruptly. If the other agents are to be reduced or discontinued, it must be done gradually. Many patients obtain greatest relief with combination therapy.
Benztropine mesylate may be used concomitantly with Carbidopa-Levodopa, or
with levodopa, in which case periodic dosage adjustment may be required in order
to maintain optimum response.
Drug-Induced Extrapyramidal Disorders -
In treating extrapyramidal disorders due to neuroleptic drugs (e.g., phenothiazines),
the recommended dosage is 1 to 4 mg once or twice a day orally or parenterally.
Dosage must be individualized according to the need of the patient. Some patients
require more than recommended; others do not need as much.
When extrapyramidal disorders develop soon after initiation of treatment with
neuroleptic drugs (e.g., phenothiazines), they are likely to be transient. One
to 2 mg of benztropine mesylate tablets two or three times a day usually provides
relief within one or two days. After one or two weeks the drug should be withdrawn
to determine the continued need for it. If such disorders recur, benztropine
mesylate can be reinstituted.
Certain drug-induced extrapyramidal disorders that develop slowly may not respond to benztropine mesylate.
Benztropine Mesylate Tablets, USP are available as follows:
0.5 mg white, round, bisected, compressed tablets, debossed "Par 164", in bottles of 100 (NDC 49884-164-01), 500 (NDC 49884-164-05), and 1000 (NDC 49884-164-10) tablets.
1 mg white, pumpkin seed shaped, bisected, compressed tablets, debossed "Par 165", in bottles of 100 (NDC 49884-165-01), 500 (NDC 49884-165-05), and 1000 (NDC 49884-165-10) tablets.
2 mg white, round, bisected, compressed tablets, debossed "Par 166", in bottles of 100 (NDC 49884-166-01), 500 (NDC 49884-166-05), and 1000 (NDC 49884-166-10) tablets.
Dispense in a well-closed container as defined in the USP.
Store below 30°C (86°F).
Manufactured by: PAR PHARMACEUTICAL, INC., Spring Valley, NY
FDA rev date: 5/22/2001