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BENZTROPINE MESYLATE tablet
[REMEDYREPACK INC. ]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

DESCRIPTION

Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine.
It is a crystalline white powder, very soluble in water, designated as 35methanesulfonate, with the following structural formula:

MM1




Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate.
Each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

CLINICAL PHARMACOLOGY

Benztropine mesylate possesses both anticholinergic and antihistaminic effects, although only the former have been established as therapeutically significant in the management of parkinsonism.
In laboratory animals, its antihistaminic activity and duration of action approach those of pyrilamine maleate.

INDICATIONS & USAGE

For use as an adjunct in the therapy of all forms of parkinsonism.
Useful also in the control of extrapyramidal disorders (except tardive dyskinesiaseePRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).

CONTRAINDICATIONS

Hypersensitivity to benztropine mesylate tablets.
Because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age, and should be used with caution in older pediatric patients.

WARNINGS

Safe use in pregnancy has not been established.
Benztropine mesylate may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.
When benztropine mesylate is given concomitantly with phenothiazines, haloperidol, or other drugs with anticholinergic or antidopaminergic activity, patients should be advised to report gastrointestinal complaints, fever or heat intolerance promptly. Paralytic ileus, hyperthermia and heat stroke, all of which have sometimes been fatal, have occurred in patients taking anticholinergic-type antiparkinsonism drugs, including benztropine mesylate, in combination with phenothiazines and/or tricyclic antidepressants.
Since benztropine mesylate contains structural features of atropine, it may produce anhidrosis. For this reason, it should be administered with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease, and those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased at the discretion of the physician so that the ability to maintain body heat equilibrium by perspiration is not impaired. Severe anhidrosis and fatal hyperthermia have occurred.

PRECAUTIONS

Safe use in pregnancy has not been established.
Benztropine mesylate may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.
When benztropine mesylate is given concomitantly with phenothiazines, haloperidol, or other drugs with anticholinergic or antidopaminergic activity, patients should be advised to report gastrointestinal complaints, fever or heat intolerance promptly. Paralytic ileus, hyperthermia and heat stroke, all of which have sometimes been fatal, have occurred in patients taking anticholinergic-type antiparkinsonism drugs, including benztropine mesylate, in combination with phenothiazines and/or tricyclic antidepressants.
Since benztropine mesylate contains structural features of atropine, it may produce anhidrosis. For this reason, it should be administered with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease, and those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased at the discretion of the physician so that the ability to maintain body heat equilibrium by perspiration is not impaired. Severe anhidrosis and fatal hyperthermia have occurred.

ADVERSE REACTIONS

The adverse reactions below, most of which are anticholinergic in nature, have been reported and within each category are listed in order of decreasing severity.
Cardiovascular Tachycardia.
Digestive Paralytic ileus, constipation, vomiting, nausea, dry mouth.
If dry mouth is so severe that there is difficulty in swallowing or speaking, or loss of appetite and weight, reduce dosage or discontinue the drug temporarily.
Slight reduction in dosage may control nausea and still give sufficient relief of symptoms. Vomiting may be controlled by temporary discontinuation, followed by resumption at a lower dosage.
Special Senses Blurred vision, dilated pupils.
Urogenital Urinary retention, dysuria.
Metabolic/Immune or Skin Occasionally, an allergic reaction, e.g., skin rash, develops. If this cannot be controlled by dosage reduction, the medication should be discontinued.
Other Heat stroke, hyperthermia, fever.

OVERDOSAGE

Manifestations


Treatment
Physostigmine salicylate, 1 to 2 mg, SC or IV, reportedly will reverse symptoms of anticholinergic intoxication.*

DOSAGE & 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 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.
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

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:
0.5 mg: white, round, flat-faced beveled edge, scored tablets, debossed "2325" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100 and 1000.
1 mg: white, oval, scored tablets, debossed "2326" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100 and 1000.
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 10, 100 and 1000.


Dispense in a well-closed container as defined in the USP.
Store at 20(68[see USP Controlled Room Temperature].


*1965, Nov. 25, 1968.

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811
8182010
R3/08-R1

INACTIVE INGREDIENT

croscarmellose sodium
dibasic calcium phosphate
lactose monohydrate
magnesium stearate
microcrystalline cellulose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Benztropine Mesylate
GENERIC: Benztropine Mesylate
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-656-02
STRENGTH:0.5 mg
COLOR: white
SHAPE: ROUND
SCORE: Two even pieces
SIZE: 6 mm
IMPRINT: 30
QTY: 30







MM2


MM3










BENZTROPINE MESYLATE 
benztropine mesylate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:49349-656(NDC:0603-2433)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE0.5 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
lactose monohydrate 
magnesium stearate 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (TABLET) Size6mm
FlavorImprint Code 2325;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-656-0230 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04073805/10/2011
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2011
 
REMEDYREPACK INC.

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