NDC 14789-300 Benztropine Mesylate Injection, Usp

NDC Product Code 14789-300

NDC CODE: 14789-300

Proprietary Name: Benztropine Mesylate Injection, Usp What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Benztropine is used to treat symptoms of Parkinson's disease or involuntary movements due to the side effects of certain psychiatric drugs (antipsychotics such as chlorpromazine/haloperidol). Benztropine belongs to a class of medication called anticholinergics that work by blocking a certain natural substance (acetylcholine). This helps decrease muscle stiffness, sweating, and the production of saliva, and helps improve walking ability in people with Parkinson's disease. Anticholinergics can stop severe muscle spasms of the back, neck, and eyes that are sometimes caused by psychiatric drugs. It can also decrease other side effects such as muscle stiffness/rigidity (extrapyramidal signs-EPS). It is not helpful in treating movement problems caused by tardive dyskinesia and may worsen them. Benztropine should not be used by children younger than 3 years.

NDC Code Structure

  • 14789 - Nexus Pharmaceuticals Inc

NDC 14789-300-02

Package Description: 5 VIAL in 1 PACKAGE > 2 mL in 1 VIAL

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Benztropine Mesylate Injection, Usp with NDC 14789-300 is a product labeled by Nexus Pharmaceuticals Inc. The generic name of Benztropine Mesylate Injection, Usp is . The product's dosage form is and is administered via form.

Labeler Name: Nexus Pharmaceuticals Inc

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nexus Pharmaceuticals Inc
Labeler Code: 14789
Start Marketing Date: 07-29-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Benztropine Mesylate Oral

Benztropine Mesylate Oral is pronounced as (benz' troe peen)

Why is benztropine mesylate oral medication prescribed?
Benztropine mesylate is used to treat the symptoms of Parkinson's disease and tremors caused by other medical problems or drugs.This medication is sometimes prescribed fo...
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Benztropine Mesylate Injection, Usp Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Benztropine mesylate is a synthetic compound containing
structural features found in atropine and diphenhydramine. It is
designated chemically as 8-azabicyclo[3.2.1] octane,
3-(diphenylmethoxy)-, endo, methanesulfonate. Its empirical formula
is C21H25NO•CH4O3S,
and its structural formula is: Benztropine mesylate is a crystalline white powder, very soluble
in water, and has a molecular weight of 403.54.Benztropine mesylate Injection is supplied as a sterile injection
for intravenous and intramuscular use.Each milliliter of the injection contains: Benztropine mesylate 1 mg/mL Sodium chloride 9 mg/mL Water for injection q.s. 1 mL

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 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, it s 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 any component of benztropine mesylate
injection.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
anti-dopaminergic 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
anti-cholinergic-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 andhidrosis and fatal hyperthermia have
occurred.

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 mesylate. 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 mesylate 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 CONTRAINDICATIONS).

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 cannot 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 intoxication1. 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

Since there is no significant difference in onset of effect after
intravenous or intramuscular injection, usually there is no need to use
the intravenous route. The drug is quickly effective after either route,
with improvement sometimes noticeable a few minutes after injection. In
emergency situations, when the condition of the patient is alarming, 1
to 2 mL of the injection normally will provide quick relief. If the
parkinsonian effect begins to return, the dose can be repeated.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
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 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 SINEMET*
(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 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 dystonic reaction, 1 to 2 mL of the injection usually
relieves the condition quickly.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 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.Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to
administration.

How Supplied

Injection benztropine mesylate, 1 mg per mL, is a clear,
colorless solution and is supplied in boxes of 5 x 2 mL vials.Store at 25°C (77°F): excursions permitted to
15° to 30°C (59 to 86°F) [see USP Controlled
room temperature], protect from light, retain in carton until time of
use.NDC Number 14789-300-02Manufactured in the USA for: Nexus Pharmaceuticals, Inc.,
Lincolnshire, IL
60069                                May
2009        PM-301001Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass.
206:1963-1965, Nov.25, 1968*Registered trademark of MERCK & CO.,
Inc.

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