DRUGS & SUPPLEMENTS

Benztropine

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Benztropine uses


8238101/0308

DESCRIPTION

Benztropine is a synthetic compound containing structural features found in atropine and diphenhydramine.

It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula:

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

Each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

Benztropine structural formula

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 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.

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WARNINGS

Safe use in pregnancy has not been established.

Benztropine 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 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, 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.

Pediatric Use

Because of the atropine-like side effects, Benztropine should be used with caution in pediatric patients over three years of age.

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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.

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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 ; 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 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 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 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 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 can be reinstituted.

Certain drug-induced extrapyramidal disorders that develop slowly may not respond to Benztropine.

HOW SUPPLIED

Benztropine 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 unit dose packages of 100 (10x10) NDC 68084-381-01

1 mg: white, oval, scored tablets, debossed "2326" on one side and debossed "V" on the reverse side, supplied in unit dose packages of 100 (10x10) NDC 68084-388-01

2 mg: white, round, flat-faced beveled edge, scored tablets, debossed "2327" on one side and debossed "V" on the reverse side, supplied in unit dose packages of 100 (10x10) NDC 68084-389-01

Store at 20°-25°C (68°-77°F).

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

Manufactured by

Qualitest Pharmaceuticals

Huntsville, AL 35811

Repackaged by

American Health Packaging

Columbus, OH 43217

8238101/0308

NDC 68084-381-01

BENZTROPINE

MESYLATE

TABLETS, USP

0.5 mg

100 Tablets (10 x 10)

EACH TABLET CONTAINS:

Benztropine, USP......................................0.5 mg

USUAL ADULT

Dosage: For parkinsonism, 1 to 2 mg

daily. For drug induced extrapyramidal disorders,

1 to 4 mg once or twice a day. See accompanying insert.

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

Room Temperature].

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from

NDC # 0603-2433, Qualitest Pharmaceuticals.

Packaged and Distributed by:

American Health Packaging

Columbus, Ohio 43217

038101

Rev. 02/2013

0.5 mg Benztropine Carton

BENZTROPINE

MESYLATE

TABLET, USP

0.5 mg

0.5 mg Benztropine Blister

NDC 68084-388-01

BENZTROPINE

MESYLATE

TABLETS, USP

1 mg

100 Tablets (10 x 10)

EACH TABLET CONTAINS:

Benztropine, USP......................................1 mg

USUAL ADULT

Dosage: For parkinsonism, 1 to 2 mg

daily. For drug induced extrapyramidal disorders,

1 to 4 mg once or twice a day. See accompanying insert.

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

Room Temperature].

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from

NDC # 0603-2434, Qualitest Pharmaceuticals.

Packaged and Distributed by:

American Health Packaging

Columbus, Ohio 43217

038801

Rev. 02/2013

1 mg Benztropine Carton

BENZTROPINE

MESYLATE

TABLET, USP

1 mg

1 mg Benztropine Blister

NDC 68084-389-01

BENZTROPINE

MESYLATE

TABLETS, USP

2 mg

100 Tablets (10 x 10)

Each Tablet Contains:

Benztropine, USP........................................................ 2 mg

Usual Adult

Dosage: For parkinsonism, 1 to 2 mg daily. For drug

induced extrapyramidal disorders, 1 to 4 mg once or twice a day.

See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between

15° to 30°C (59° to 86°F).

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from

NDC # 0603-2435, Qualitest Pharmaceuticals.

Packaged and Distributed by:

American Health Packaging

Columbus, Ohio 43217

038901

Rev. 05/2015

2 mg Benztropine Carton

BENZTROPINE

MESYLATE

TABLET, USP

2 mg

2 mg Benztropine Blister

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Benztropine pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Benztropine available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Benztropine destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Benztropine Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Benztropine pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "benztropine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "benztropine". http://www.drugbank.ca/drugs/DB0024... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Benztropine?

Depending on the reaction of the Benztropine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Benztropine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Benztropine addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Benztropine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Benztropine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported doses

What is the dose of Benztropine drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg1
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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