For use as an adjunct in the therapy of all forms of
parkinsonism (see DOSAGE AND ADMINISTRATION).
Useful also in the control of extrapyramidal disorders
(except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs
DOSAGE AND ADMINISTRATION
Since there is no significant difference in onset of
effect after intravenous or intramuscular injection, usually there is no need
to use the intravenous route. The drug is quickly effective after either route,
with improvement sometimes noticeable a few minutes after injection. In
emergency situations, when the condition of the patient is alarming, 1 to 2 mL
of the injection normally will provide quick relief. If the parkinsonian effect
begins to return, the dose can be repeated.
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 following dosing guidelines were written in reference
to both benztropine mesylate tablets and COGENTIN Injection. Benztropine
mesylate tablets should be used when patients are able to take oral medication.
The usual daily dose is 1 to 2 mg, with a range of 0.5 to
6 mg 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 when given 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 COGENTIN 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.
COGENTIN may be used concomitantly with SINEMET
(Ccarbidopa-Levodopalevodopa), or with levodopa, in which case 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 parenterally. Dosage must be individualized according to the need of the
patient. Some patients require more than recommended; others do not need as
In acute dystonic reactions, 1 to 2 mL of the injection
usually relieves the condition quickly.
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 COGENTIN two or three times a day
usually provides relief within one or two days. If such disorders recur,
COGENTIN can be reinstituted.
Certain drug-induced extrapyramidal disorders that
develop slowly may not respond to COGENTIN.
Injection COGENTIN, 1 mg per mL, is a clear, colorless
solution and is supplied as follows:
NDC 67386-611-52 in boxes of 5 x 2 mL ampuls.
Recommended Storage: Store at 20-25°C (68-77°F). See USP
controlled room temperature.
Manufactured by: Hospira, Inc., McPherson, KS 67460,
U.S.A. For: Lundbeck Inc., Deerfield, IL 60015, U.S.A. Revised April 2013