Benztropine Mesylate (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Benztropine mesylate tablets should be used when patients are able to take oral medication.

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.

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. 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.

HOW SUPPLIED

Benztropine Mesylate Tablets, USP are available as follows:

NDC 63629-9422-01

2 mg: white, round, flat-faced beveled edge, scored tablets, debossed “2327” on one side and debossed “V” on the reverse side, supplied in bottles of 1000.

Dispense in a well-closed container as defined in the USP.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.


Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam — 603 103.
Made in India


Mfg. Lic. No.: TN00002121
OS2433-01-74-01
Issued: 06/2021

Benztropine Mesylate 2 mg Tab #1000

Label
(click image for full-size original)
BENZTROPINE MESYLATE
benztropine mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-9422(NDC:0603-2435)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 2 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 2327;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-9422-1 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040715 03/17/2022
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-9422), RELABEL (63629-9422)

Revised: 08/2022 Bryant Ranch Prepack

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