BENZTROPINE MESYLATE- benztropine mesylate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)
Available from:
Rebel Distributors Corp
INN (International Name):
BENZTROPINE MESYLATE
Composition:
BENZTROPINE MESYLATE 2 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
INDICATIONS AND USAGE: 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). 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. Pediatric Use: Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see CONTRADICTIONS ).
Product summary:
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 07401 Rev. July 2009 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Authorization status:
Abbreviated New Drug Application
Authorization number:
21695-286-30

BENZTROPINE MESYLATE- benztropine mesylate tablet

Rebel Distributors Corp

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BENZTROPINE MESYLATE TABLETS USP

0.5 mg, 1 mg and 2 mg

Rx only

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. It is designated chemically as 3α-

(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C

H NO

CH O S, and its structural formula is:

Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg of benztropine mesylate. Each tablet

contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone

and pregelatinized starch.

CLINICAL PHARMACOLOGY: Benztropine possesses both anticholinergic and antihistaminic

effects, although only the former have been established as therapeutically significant in the management

of parkinsonism.

In the isolated guinea pig ileum, the anticholinergic activity of this drug is about equal to that of

atropine; however, when administered orally to unanesthetized cats, it is only about half as active as

atropine.

In laboratory animals, its antihistaminic activity and duration of action approach those of pyrilamine

maleate.

INDICATIONS AND USAGE: 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).

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 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 in combination with phenothiazines and/or tricyclic antidepressants.

Since benztropine 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:

General

Since benztropine mesylate has cumulative action, continued supervision is advisable. Patients with a

tendency to tachycardia and patients with prostatic hypertrophy should be observed closely during

treatment.

Dysuria may occur, but rarely becomes a problem. Urinary retention has been reported with

benztropine.

The drug may cause complaints of weakness and inability to move particular muscle groups, especially

in large doses. For example, if the neck has been rigid and suddenly relaxes, it may feel weak, causing

some concern. In this event dosage adjustment is required.

Mental confusion and excitement may occur with large doses, or in susceptible patients. Visual

hallucinations have been reported occasionally. Furthermore, in the treatment of extrapyramidal

disorders due to neuroleptic drugs (e.g., phenothiazines) in patients with mental disorders, occasionally

there may be intensification of mental symptoms. In such cases, antiparkinsonian drugs can precipitate a

toxic psychosis. Patients with mental disorders should be kept under careful observation, especially at

the beginning of treatment or if dosage is increased.

Tardive dyskinesia may appear in some patients on long-term therapy with phenothiazines and related

agents or may occur after therapy with these drugs has been discontinued. Antiparkinsonism agents do

not alleviate the symptoms of tardive dyskinesia, and in some instances may aggravate them. Benztropine

is not recommended for use in patients with tardive dyskinesia.

The physician should be aware of the possible occurrence of glaucoma. Although the drug does not

appear to have any adverse effect on simple glaucoma, it probably should not be used in angle-closure

glaucoma.

Drug Interactions

Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see

WARNINGS).

Pediatric Use:

Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric

patients over three years of age (see CONTRADICTIONS ).

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.

Nervous System:

Toxic psychosis, including confusion, disorientation, memory impairment, visual hallucinations;

exacerbation of pre-existing psychotic symptoms; nervousness; depression; listlessness; numbness of

fingers.

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 can not be controlled by dosage

reduction, the medication should be discontinued.

Other:

Heat stroke, hyperthermia, fever.

OVERDOSAGE:

Manifestations — May be any of those seen in atropine poisoning or antihistamine overdosage: CNS

depression, preceded or followed by stimulation; confusion; nervousness; listlessness; intensification

of mental symptoms or toxic psychosis in patients with mental illness being treated with

neuroleptic drugs (e.g., phenothiazines); hallucinations (especially visual); dizziness; muscle weakness;

ataxia; dry mouth; mydriasis; blurred vision; palpitations; tachycardia; elevated blood pressure; nausea;

vomiting; dysuria; numbness of fingers; dysphagia; allergic reactions, e.g., skin rash; headache; hot, dry,

flushed skin; delirium; coma; shock; convulsions; respiratory arrest; anhidrosis; hyperthermia;

glaucoma; constipation.

Treatment — Physostigmine salicylate, 1 to 2 mg, sc or iv, reportedly will reverse symptoms of

anticholinergic intoxication . A second injection may be given after 2 hours if required. Otherwise

treatment is symptomatic and supportive. Induce emesis or perform gastric lavage (contraindicated in

precomatose, convulsive, or psychotic states). Maintain respiration. A short-acting barbiturate may be

used for CNS excitement, but with caution to avoid subsequent depression; supportive care for

depression (avoid convulsant stimulants such as picrotoxin, pentylenetetrazol, or bemegride); artificial

respiration for severe respiratory depression; a local miotic for mydriasis and cycloplegia; ice bags or

other cold applications and alcohol sponges for hyperpyrexia, a vasopressor and fluids for circulatory

collapse. Darken room for photophobia.

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

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

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 07401

Rev. July 2009

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

BENZTROPINE MESYLATE

benztropine mesylate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:216 9 5-28 6 (NDC:6 49 8 0 -113)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZTRO PINE MESYLATE (UNII: WMJ8 TL7510 ) (BENZTROPINE - UNII:1NHL2J4X8 K)

BENZTROPINE MESYLATE

2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STARCH, CO RN (UNII: O8 232NY3SJ)

Rebel Distributors Corp

Product Characteristics

Color

WHITE (White)

S core

2 pieces

S hap e

ROUND (ro und)

S iz e

8 mm

Flavor

Imprint Code

c o r;145

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:216 9 5-28 6 -30

30 in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7226 6

0 8 /13/20 0 2

Labeler -

Rebel Distributors Corp (118802834)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Rebel Distributo rs Co rp

118 8 0 28 34

RELABEL, REPACK

Revised: 12/2010

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