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Benztropine Mesylate 2 mg Tablet, 100-count — NDC 00603-2435-21 package photo

Benztropine Mesylate 2 mg Tablet, 100-count

by Endo USA, Inc. · 100 TABLET in 1 BOTTLE, PLASTIC (0603-2435-21)
NDC 00603-2435-21
🏷️ FDA NDC (as labeled) 0603-2435-21 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.0906 NADAC Per package$9.06 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2525/unit · Part D plans $0.1636/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0603-2435-21
Product NDC 0603-2435
11-digit billing NDC 00603243521
NCPDP billing unit EA — each (per item)
RxCUI 885209, 885213, 885219
UNII WMJ8TL7510
UPC 0306032434210, 0306032433213
Application # ANDA040715
SPL Set ID c19664aa-a797-4192-b5f3-e906a7cac048
Established class (EPC) Anticholinergic; Antihistamine
Mechanism of action Cholinergic Antagonists; Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-17
Route ORAL
Dosage form TABLET
Substance BENZTROPINE MESYLATE
GPI-14 73100010100315
GPI class Benztropine Mesylate
GCN Seq No 004591
GCN 17622
HICL code 001905
Ingredient (HICL) Benztropine Mesylate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6B
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Anticholinergic
AHFS code 12:08.04.00
AHFS class Antiparkinsonian Agents
FDB label name BENZTROPINE MES 2 MG TABLET
FDB brand name Benztropine Mesylate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 0603-2435-21 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00603-2435-21. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Antihistamine
Drug family (ATC) Ethers of tropine or tropine derivatives
How it works Histamine Receptor Antagonists, Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerEndo USA, Inc.
Application holderPH HEALTH LTD
FDA applicationANDA040715 (ANDA)
Labeler code00603
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio101 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BENZTROPINE MES 2 MG TABLET Ingredient Benztropine Mesylate
📗 Our plain-language guide HelloPharmacist
  • Benztropine helps reduce the stiffness, tremors, and movement problems that come with parkinsonism. It works by blocking certain chemical signals in the brain that are out of balan...
  • What exactly is benztropine supposed to do for me?
  • This medication has a long-lasting effect, so many people do best taking their full dose at bedtime — it can help you move more comfortably during the night and make it easier to g...
  • Should I take my tablet in the morning or at night?
📖 Read our full Benztropine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
Imprint2327;V
Size7 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.091 $9.06 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2525 $25.25 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1636 $16.36 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Dec 2023 Mar 2026 Sep 2026 $0.120 $0.091
▼ Down 21% over the last 18 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benztropine Mesylate 2 mgthis 00603-2435-21 Endo 100 tablets $0.091 AA Availability likely —
Benztropine Mesylate 2 mg 00904-7290-61 Major 100 tablets $0.091 AA Availability likely —
Benztropine Mesylate 2 mg 11534-0169-09 SUNRISE 100 tablets $0.091 AA Availability likely —
Benztropine Mesylate 2 mg 50228-0227-01 ScieGen 100 tablets $0.091 AA Availability likely —
Benztropine Mesylate 2 mg 62135-0142-01 Chartwell 100 tablets $0.091 AA Availability likely —
Benztropine Mesylate 2 mg 68084-0389-01 American 100 tablets $0.091 AA Availability likely —
Benztropine Mesylate 2 mg 69315-0138-01 Leading 100 tablets $0.091 AA Availability likely —
Benztropine Mesylate 2 mg 70752-0125-10 QUAGEN 100 tablets $0.091 AA Availability likely —
Benztropine Mesylate 2 mg 00615-8478-39 NCS 30 tablets — AA FDA listed —
Benztropine Mesylate 2 mg 10135-0815-01 Marlex 100 tablets — AA FDA listed —
Benztropine Mesylate 2 mg 61919-0128-30 DIRECT 30 tablets — AA FDA listed —
Benztropine Mesylate 2 mg 67046-0040-03 Coupler 30 tablets — AA FDA listed —
Benztropine Mesylate 2 mg 67046-1675-03 Coupler 30 tablets — AA FDA listed —
Benztropine Mesylate 2 mg 69097-0832-02 Cipla 30 tablets — — FDA listed —
Benztropine Mesylate 2 mg 70518-2677-00 REMEDYREPACK 30 tablets — AA FDA listed —
Benztropine Mesylate 2 mg 72162-1154-01 Bryant 100 tablets — AA FDA listed —
Benztropine Mesylate 2 mg 72162-2596-00 Bryant 1000 tablets — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00603-2435-21, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
48.5K
Units reimbursed last 4 qtrs
2.5M
Gross reimbursed last 4 qtrs
$643.8K
Avg / prescription
$13.28
Avg / unit
$0.2525
Latest quarter Q4 2025
9.6KRx
Medicaid pays / ea
$0.2525
gross reimbursed
vs
NADAC / ea
$0.0906
acquisition cost
=
Spread
+$0.1619
+179% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
53% FFS 47% MCO
Fee-for-service · 25,498 Rx Managed care · 22,965 Rx
State Medicaid map
Alaska: 794 units · 108 per 100k residents AK Maine: 6,952 units · 498 per 100k residents ME Washington: 36,143 units · 463 per 100k residents WA Idaho: 10,956 units · 558 per 100k residents ID Montana: 2,960 units · 261 per 100k residents MT North Dakota: no data reported ND Minnesota: 14,536 units · 253 per 100k residents MN Wisconsin: 25,447 units · 431 per 100k residents WI Michigan: 86,658 units · 863 per 100k residents MI New York: 103,825 units · 531 per 100k residents NY Vermont: no data reported VT New Hampshire: 657 units · 46.9 per 100k residents NH Oregon: 9,538 units · 225 per 100k residents OR Nevada: 35,013 units · 1,096 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 14,712 units · 459 per 100k residents IA Illinois: 80,344 units · 640 per 100k residents IL Indiana: 28,963 units · 422 per 100k residents IN Ohio: 63,196 units · 536 per 100k residents OH Pennsylvania: 42,224 units · 326 per 100k residents PA New Jersey: 46,274 units · 498 per 100k residents NJ Massachusetts: 19,288 units · 276 per 100k residents MA California: 654,325 units · 1,679 per 100k residents CA Utah: 11,108 units · 325 per 100k residents UT Colorado: 9,769 units · 166 per 100k residents CO Nebraska: 4,454 units · 225 per 100k residents NE Missouri: 43,380 units · 700 per 100k residents MO Kentucky: 34,882 units · 771 per 100k residents KY West Virginia: 14,321 units · 809 per 100k residents WV Virginia: 32,904 units · 378 per 100k residents VA Maryland: 31,031 units · 502 per 100k residents MD Connecticut: 19,239 units · 532 per 100k residents CT Rhode Island: 4,102 units · 375 per 100k residents RI Arizona: 32,064 units · 431 per 100k residents AZ New Mexico: 24,761 units · 1,171 per 100k residents NM Kansas: 8,792 units · 299 per 100k residents KS Arkansas: 40,220 units · 1,311 per 100k residents AR Tennessee: 34,399 units · 483 per 100k residents TN North Carolina: 79,030 units · 729 per 100k residents NC South Carolina: 26,239 units · 488 per 100k residents SC Delaware: 5,805 units · 563 per 100k residents DE Oklahoma: 29,928 units · 738 per 100k residents OK Louisiana: 93,910 units · 2,053 per 100k residents LA Mississippi: 38,343 units · 1,304 per 100k residents MS Alabama: 47,913 units · 938 per 100k residents AL Georgia: 74,344 units · 674 per 100k residents GA D.C.: 1,090 units · 161 per 100k residents DC Hawaii: 10,542 units · 735 per 100k residents HI Texas: 168,212 units · 551 per 100k residents TX Florida: 259,968 units · 1,150 per 100k residents FL
Units reimbursed · per 100k residents
46.92,053
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 2,053 /100k
2 California 1,679 /100k
3 Arkansas 1,311 /100k
4 Mississippi 1,304 /100k
5 New Mexico 1,171 /100k
6 Florida 1,150 /100k
7 Nevada 1,096 /100k
8 Alabama 938 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page00603-2435-21 48,463 Rx · $643,777
1000 tablets00603-2435-32 24,597 Rx · $346,127
10 tablets00603-2435-10 No Medicaid data
Drug total (last 4 qtrs): 73,060 Rx · 3,779,648 units · $989,904 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Benztropine Mesylate — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Benztropine Mesylate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$5.58M
Claims incl. refills
428.3K
Beneficiaries
171.1K
Spend / beneficiary
$32.60
Spend / claim
$13.03
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Benztropine mesylate — the ingredient across all brands.

Top reported reactions

Granulocytopenia152
Completed Suicide132
Tremor126
Death125
Diabetes Mellitus120
Drug Interaction119
Weight Increased110

Age at onset

Neonate3
Child6
Adolescent2
Adult174
Elderly36

Reporter sex

2,659 reports
Male · 52%
Female · 48%
Unknown · 1%

Serious outcomes

Hospitalization898
Life-threatening121
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 146 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00603-2435-10 10 TABLET in 1 BOTTLE, PLASTIC (0603-2435-10) — — 2022-03-17 Discontinued by firm
00603-2435-21 You're viewing this 100 TABLET in 1 BOTTLE, PLASTIC (0603-2435-21) $0.0906 / ea $9.06 2022-03-17 Active
00603-2435-32 1000 TABLET in 1 BOTTLE, PLASTIC (0603-2435-32) $0.0906 / ea $90.59 2022-03-17 Active

You're viewing one of 3 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0906 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 66% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00603-2435-21?
NDC 00603-2435-21 is a 100-count package — 100 tablet in 1 bottle, plastic.
What is the difference between NDC 00603-2435-21 and NDC 00603-2435-10?
Both are Benztropine Mesylate 2 mg Tablet — the drug itself is identical. NDC 00603-2435-21 is the 100-count package, while NDC 00603-2435-10 is the 10 tablets package.
What NDC number is used to bill for this package of Benztropine Mesylate 2 mg Tablet?
Bill NDC 00603-2435-21 — the 11-digit billing format is 00603243521. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 37 words ▾

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).

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND 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 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 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 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.

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 ma…

⛔ Contraindications 34 words ▾

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 204 words ▾

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.

🤒 Adverse Reactions 153 words ▾

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.

🔄 Drug Interactions 14 words ▾

Drug Interactions Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see WARNINGS ).

🧒 Pediatric Use 26 words ▾

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 ).

🆘 Overdosage ~2 min read ▾

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.

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.

🧬 Clinical Pharmacology 75 words ▾

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, its antihistaminic activity and duration of action approach those of pyrilamine maleate.

📦 How Supplied / Storage and Handling 129 words ▾

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° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. * Duvoisin, R.C.; Katz, R.J.; Amer. Med.

Ass. 206:1963–1965, Nov. 25, 1968.

📦 Storage and Handling 23 words ▾

Dispense in a well-closed container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 80 words ▾

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

This is an image of the structural formula for benztropine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.