BENZTROPINE MESYLATE (Page 2 of 2)


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Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206: 1963-1965, Nov. 25, 1968.

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 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.

HOW SUPPLIED:

Benztropine mesylate tablets USP 2 mg — Each white, round compressed tablet is scored and debossed with identification logo cor and 145 on one side.
NDC 21695-286-30 in bottles of 30 tablets

Store at controlled room temperature 15° — 30°C (59° — 86°F) (see USP).
Dispense in well-closed container as defined in the USP.

Manufactured by:
Corepharma LLC
Middlesex, NJ 08846
MF # 276-03

Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401Rev. July 2009

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

Benztropine Mesylate 2mg
(click image for full-size original)

BENZTROPINE MESYLATE benztropine mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-286(NDC:64980-113)
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
Product Characteristics
Color WHITE (White) Score 2 pieces
Shape ROUND (round) Size 8mm
Flavor Imprint Code cor;145
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-286-30 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072266 08/13/2002
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 12/2010 Rebel Distributors Corp

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