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Cogentin Indications, Dosage, Storage, Stability - Benztropine
INDICATIONS
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 (e.g. phenothiazines).
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 the 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 p.o. 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 m o r e 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 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, i n 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. In acute dystonrc reactions 1 to 2 mL of the injection usually relieves the condition quickly. After that, the tablets. 1 to 2 mg twice a day, usually prevent recurrence. 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 can be reinstituted. Certain drug-induced extrapyramidal disorders that develop slowly may not respond to benztropine.
HOW SUPPLIED
Benztropine Mesylate Tablets, USP 0.5 mg - Each white, round, compressed tablet is scored and engraved with identification logo INV and 208 on one side.
NDC 62269- 208- 24 in bottles of 100 tablets
NDC 62269- 208- 29 in bottles of 500 tablets
NDC 62269- 208- 30 in bottles of 1000 tablets
Benztropine Mesylate Tablets, USP, 1 mg - Each white, oval shaped, compressed tablet is scored and engraved with identification logo INV and 209 on one side.
NDC 62269- 209- 24 in bottles of 100 tablets
NDC 62269- 209- 29 in bottles of 500 tablets
NDC 62269- 209- 30 in bottles of 1000 tablets
Benztropine Mesyiate Tablets, USP, 2 mg - Each white, round, compressed tablet is scored and engraved with identification logo INV and 210 on one side.
NDC 62269- 210- 24 in bottles of 100 tablets
NDC 62269- 210- 29 in bottles of 500 tablets
NDC 62269- 210- 30 in bottles of 1000 tablets
Dispense in a well- closed container.
Store at controlled room temperature 15°- 30° C (59°- 86°F)
CAUTION: Federal Law prohtbits dispensing without prescription.
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