Benztropine

Lub npe dav: Benztropine mesylate
Dosage form: ntsiav tshuaj
Chav kawm tshuaj: Anticholinergic antiparkinson cov neeg ua haujlwm



Benztropine MESYLATE



TABLETS, USP

Rx nkaus xwb



Ntawm nplooj ntawv no
Nthuav

Kev piav qhia

Benztropine mesylate yog cov khoom siv hluavtaws uas muaj cov qauv tsim muaj nyob hauv atropine thiab diphenhydramine.

Nws raug xaiv tshuaj raws li 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Nws cov qauv molecular yog Cnees nkaum ibH25NO •CH4LUB3S, thiab nws cov qauv qauv yog:



Benztropine mesylate yog cov hmoov dawb crystalline, soluble hauv dej, thiab muaj qhov hnyav ntawm 403.54.

Txhua ntsiav tshuaj Benztropine mesylate, USP rau kev tswj qhov ncauj muaj Benztropine mesylate USP 1 mg lossis 2 mg.

Txhua ntsiav tshuaj muaj cov khoom xyaw hauv qab no: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, thiab pregelatinized starch.

Benztropine - Clinical Pharmacology

Benztropine mesylate muaj ob qho tib si anticholinergic thiab antihistaminic teebmeem, txawm hais tias tsuas yog cov qub tau tsim los ua kev kho mob tseem ceeb hauv kev tswj hwm ntawm parkinsonism.

Hauv kev sib cais ntawm guinea npua ileum, cov haujlwm anticholinergic ntawm cov tshuaj no yog hais txog qhov sib npaug ntawm atropine; Txawm li cas los xij, thaum siv qhov ncauj rau cov miv uas tsis muaj tshuaj loog, nws tsuas yog kwv yees li ib nrab ntawm kev ua haujlwm zoo li atropine.

Hauv cov tsiaj sim, nws cov tshuaj tiv thaiv kab mob thiab lub sijhawm ntawm kev txiav txim mus rau cov pyrilamine maleate.

Kev taw qhia thiab kev siv rau Benztropine

Benztropine mesylate ntsiav tshuaj tau qhia rau siv los ua ib qho kev sib txuas hauv kev kho mob ntawm txhua hom kev mob Parkinsonism.

Muaj txiaj ntsig tseem ceeb hauv kev tswj cov kab mob extrapyramidal (tshwj tsis yog tardive dyskinesia-saib COV KEV CEEV FAJ ) vim yog cov tshuaj neuroleptic (piv txwv li, phenothiazine).

Contraindications

Hypersensitivity rau Benztropine mesylate ntsiav tshuaj lossis rau ib qho ntawm cov ntsiav tshuaj.

Vim tias nws cov kev mob tshwm sim zoo li atropine, cov tshuaj no yog contraindicated nyob rau hauv cov neeg mob uas muaj hnub nyoog qis dua peb xyoos, thiab yuav tsum tau siv ceev faj rau cov neeg mob laus.

Ceeb toom

Kev nyab xeeb siv thaum cev xeeb tub tsis tau tsim.

Benztropine mesylate tuaj yeem cuam tshuam rau lub hlwb thiab / lossis lub cev muaj peev xwm xav tau rau kev ua haujlwm ntawm kev ua haujlwm txaus ntshai, xws li kev siv tshuab lossis tsav tsheb.

Thaum Benztropine mesylate tau muab ua ke nrog phenothiazine, haloperidol, lossis lwm yam tshuaj nrog anticholinergic lossis antidopaminergic kev ua haujlwm, cov neeg mob yuav tsum tau qhia kom qhia txog kev tsis txaus siab ntawm plab hnyuv, ua npaws lossis kub tsis haum tam sim ntawd. Paralytic ileus, hyperthermia thiab kub stroke, tag nrho cov uas qee zaum ua rau tuag taus, tau tshwm sim hauv cov neeg mob noj cov tshuaj anticholinergic-type antiparkinsonism, suav nrog Benztropine mesylate, ua ke nrog phenothiazine thiab / lossis tricyclic antidepressants.

Txij li thaum Benztropine mesylate muaj cov yam ntxwv ntawm atropine, nws tuaj yeem tsim anhidrosis. Vim li no, nws yuav tsum tau ua tib zoo saib xyuas thaum huab cua kub, tshwj xeeb tshaj yog thaum muab sib xyaw nrog lwm cov tshuaj atropine zoo li rau cov neeg mob, cov neeg haus dej caw, cov neeg uas muaj kab mob hauv lub paj hlwb, thiab cov neeg ua haujlwm hauv qhov chaw kub. . Anhidrosis tuaj yeem tshwm sim tau yooj yim dua thaum muaj qee qhov cuam tshuam ntawm hws twb muaj lawm. Yog tias muaj pov thawj ntawm anhidrosis, qhov ua tau ntawm hyperthermia yuav tsum tau txiav txim siab. Kev noj tshuaj yuav tsum tau txo qis ntawm qhov kev txiav txim siab ntawm tus kws kho mob kom lub peev xwm los tswj lub cev kub sib npaug los ntawm kev ua pa tawm tsis raug. Mob hnyav anhidrosis thiab tuag taus hyperthermia tau tshwm sim.

Cov kev ceev faj

General

Txij li thaum Benztropine mesylate muaj kev ua haujlwm ntau ntxiv, kev saib xyuas txuas ntxiv yog pom zoo. Cov neeg mob uas nyiam tachycardia thiab cov neeg mob prostatic hypertrophy yuav tsum tau saib xyuas kom zoo thaum kho.

Dysuria tuaj yeem tshwm sim, tab sis tsis tshua muaj teeb meem. Kev tso zis tso zis tau tshaj tawm nrog Benztropine mesylate.

Cov tshuaj tuaj yeem ua rau muaj kev tsis txaus siab ntawm qhov tsis muaj zog thiab tsis muaj peev xwm txav tau qee cov leeg nqaij, tshwj xeeb tshaj yog nyob rau hauv cov koob tshuaj loj. Piv txwv li, yog tias lub caj dab tau nruj thiab maj mam so, nws yuav hnov ​​​​ntxhiab, ua rau muaj kev txhawj xeeb. Hauv qhov kev tshwm sim no, yuav tsum tau hloov cov koob tshuaj.

Kev puas siab puas ntsws thiab kev zoo siab tuaj yeem tshwm sim nrog cov koob tshuaj loj, lossis hauv cov neeg mob uas raug mob. Kev pom kev pom kev pom tshwm sim qee zaus. Tsis tas li ntawd, hauv kev kho cov kab mob extrapyramidal vim yog cov tshuaj neuroleptic (piv txwv li, phenothiazine), hauv cov neeg mob uas muaj kev puas siab puas ntsws, qee zaus yuav muaj kev mob tshwm sim ntawm kev puas hlwb. Hauv qhov no, cov tshuaj antiparkinsonian tuaj yeem ua rau muaj kev puas siab puas ntsws lom. Cov neeg mob uas muaj kev puas siab puas ntsws yuav tsum tau ua tib zoo saib xyuas, tshwj xeeb tshaj yog thaum pib ntawm kev kho mob lossis yog tias ntau npaum li cas.

Tardive dyskinesia tuaj yeem tshwm sim hauv qee cov neeg mob ntawm kev kho mob mus sij hawm ntev nrog phenothiazine thiab cov neeg ua haujlwm cuam tshuam, lossis tuaj yeem tshwm sim tom qab kev kho mob nrog cov tshuaj no tau raug txiav lawm. Cov neeg ua haujlwm Antiparkinsonism tsis txo cov tsos mob ntawm tardive dyskinesia, thiab qee zaus yuav ua rau lawv hnyav dua. Benztropine mesylate tsis pom zoo siv rau cov neeg mob tardive dyskinesia.

Tus kws kho mob yuav tsum paub txog qhov tshwm sim ntawm glaucoma. Txawm hais tias cov tshuaj tsis tshwm sim muaj qhov cuam tshuam tsis zoo rau glaucoma yooj yim, tej zaum nws yuav tsum tsis txhob siv rau hauv lub kaum sab xis kaw glaucoma.

Cov tshuaj sib cuam tshuam

Antipsychotic tshuaj xws li phenothiazine lossis haloperidol; tricyclic antidepressants (saib CEEB TOOM ).

Kev siv menyuam yaus

Vim yog cov kev mob tshwm sim zoo li atropine, Benztropine mesylate yuav tsum tau siv nrog ceev faj hauv cov neeg mob uas muaj hnub nyoog peb xyoos (saib CONTRAINDICATIONS ).

Kev Phem Tsis Zoo

Cov kev phiv tsis zoo hauv qab no, feem ntau yog cov tshuaj anticholinergic hauv qhov xwm txheej, tau tshaj tawm thiab nyob rau hauv txhua pawg tau teev nyob rau hauv kev txiav txim siab txo qis.

Mob plawv

tachycardia.

digestive

Paralytic ileus, cem quav, ntuav, xeev siab, qhov ncauj qhuav.

Yog hais tias qhov ncauj qhuav heev uas muaj teeb meem nqos los yog hais lus, los yog tsis qab los noj mov thiab qhov hnyav, txo cov tshuaj, los yog txiav cov tshuaj ib ntus.

Kev txo qis me ntsis ntawm cov tshuaj tuaj yeem tswj kev xeev siab thiab tseem muab cov tsos mob txaus txaus. Kev ntuav tuaj yeem tswj tau los ntawm kev txiav tawm ib ntus, tom qab ntawd rov pib dua ntawm qhov qis dua.

Nervous System

Toxic psychosis, xws li tsis meej pem, disorientation, nco impairment, pom hallucinations; exacerbation ntawm preexisting psychotic tsos mob; ntxhov siab; kev nyuaj siab; tsis muaj npe; mob ntiv tes.

jaz tshuaj tiv thaiv menyuam yaus

Tshwj xeeb Senses

Qhov muag tsis pom kev, cov menyuam kawm ntawv dilated.

Urogenital

Kev tso zis tso zis, dysuria.

Metabolic/Immune los yog tawv nqaij

Qee lub sij hawm, kev tsis haum tshuaj, xws li daim tawv nqaij ua pob khaus, tsim. Yog tias qhov no tsis tuaj yeem tswj tau los ntawm kev txo koob tshuaj, cov tshuaj yuav tsum tau txiav.

Lwm yam

Thaum tshav kub kub stroke, hyperthermia, kub taub hau.

Kev noj ntau dhau

Kev tshwm sim -Tej zaum yuav yog ib qho ntawm cov uas pom nyob rau hauv atropine lom los yog antihistamine overdosage: CNS kev nyuaj siab, ua ntej los yog ua raws li stimulation; tsis meej pem; ntxhov siab; tsis muaj npe; kev siv zog ntawm kev puas siab puas ntsws los yog kev puas siab puas ntsws lom hauv cov neeg mob uas muaj kev puas siab puas ntsws raug kho nrog cov tshuaj neuroleptic (xws li, phenothiazines); hallucinations (tshwj xeeb yog pom); kiv taub hau; cov leeg tsis muaj zog; ataxia; qhov ncauj qhuav; mydriasis; qhov muag tsis pom kev; palpitations; tachycardia; siab ntshav siab; xeev siab; ntuav; dysuria; loog ntawm ntiv tes; dysphagia; kev tsis haum tshuaj, piv txwv li, daim tawv nqaij ua pob liab vog; mob taub hau; kub, qhuav, tawv nqaij; delirium; coma; poob siab; convulsions; ua pa nres; anhidrosis; hyperthermia; glaucoma; cem quav.

Kev kho mob -Physostigmine salicylate, 1 txog 2 mg, SC lossis IV, tshaj tawm yuav rov qab cov tsos mob ntawm anticholinergic intoxication.* Kev txhaj tshuaj thib ob tuaj yeem muab tom qab 2 teev yog tias xav tau. Lwm yam kev kho mob yog cov tsos mob thiab txhawb nqa. Induce emesis los yog ua plab hnyuv (contraindicated nyob rau hauv precomatose, convulsive, los yog psychotic xeev). Khaws ua pa. Ib tug luv luv-acting barbiturate yuav siv tau rau CNS excitement, tab sis nrog ceev faj kom tsis txhob muaj kev nyuaj siab tom qab; kev txhawb nqa kev nyuaj siab (tsis txhob muaj cov tshuaj stimulants xws li picrotoxin, pentylenetetrazol, los yog bemegride); Artificial ua pa rau kev nyuaj siab ua pa hnyav; ib lub zos miotic rau mydriasis thiab cycloplegia; Cov hnab ntim dej khov lossis lwm yam kev siv txias thiab cov dej cawv sponges rau hyperpyrexia, vasopressor thiab kua dej rau cov hlab ntsha tawg. Tsaus chav rau photophobia.

Benztropine Dosage thiab Administration

Benztropine mesylate ntsiav tshuaj yuav tsum tau siv thaum cov neeg mob muaj peev xwm noj tshuaj qhov ncauj.

Kev txhaj tshuaj yog qhov tshwj xeeb tshaj yog rau cov neeg mob puas siab puas ntsws uas muaj cov tshuaj tiv thaiv dystonic mob lossis lwm yam kev cuam tshuam uas ua rau cov tshuaj hauv qhov ncauj nyuaj lossis ua tsis tau. Nws raug pom zoo los kuj yog thaum xav tau cov lus teb sai dua li tuaj yeem tau txais nrog cov ntsiav tshuaj.

Vim tias qhov kev txiav txim siab sib xyaw, kev kho yuav tsum tau pib nrog cov koob tshuaj tsawg uas tau nce zuj zus ntawm tsib lossis rau hnub ib ntus mus rau qhov tsawg tshaj plaws uas tsim nyog rau kev pom zoo. Kev nce ntxiv yuav tsum tau ua kom nce ntxiv ntawm 0.5 mg, mus rau qhov siab tshaj plaws ntawm 6 mg, lossis kom txog thaum cov txiaj ntsig zoo tau txais yam tsis muaj kev phiv ntau dhau.

Postencephalitic thiab Idiopathic Parkinsonism -Cov koob tshuaj niaj hnub niaj hnub yog 1 txog 2 mg, nrog rau ntau yam ntawm 0.5 mus rau 6 mg ntawm qhov ncauj lossis parenterally.

Raws li nrog rau txhua tus neeg sawv cev siv hauv parkinsonism, ntau npaum li cas yuav tsum yog tus kheej raws li hnub nyoog thiab qhov hnyav, thiab hom Parkinsonism raug kho. Feem ntau, cov neeg mob laus, thiab cov neeg mob nyias nyias tsis tuaj yeem zam cov koob tshuaj loj. Feem ntau cov neeg mob uas muaj postencephalitic parkinsonism xav tau koob tshuaj loj thiab ua rau lawv zoo. Cov neeg mob uas muaj kev puas siab puas ntsws tsis zoo feem ntau yog cov neeg tsis zoo rau kev kho mob.

Hauv idiopathic parkinsonism, kev kho yuav pib nrog ib koob tshuaj ib hnub ntawm 0.5 mus rau 1 mg thaum mus pw. Hauv qee tus neeg mob, qhov no yuav tsim nyog; nyob rau hauv lwm tus neeg 4 mus rau 6 mg ib hnub twg yuav tsum tau.

Hauv postencephalitic parkinsonism, txoj kev kho yuav pib rau cov neeg mob feem ntau nrog 2 mg ib hnub twg hauv ib lossis ntau dua. Hauv cov neeg mob rhiab heev, kev kho yuav pib nrog 0.5 mg thaum sawv ntxov, thiab nce ntxiv raws li qhov tsim nyog.

Qee tus neeg mob tau txais kev pab zoo tshaj plaws los ntawm kev noj tag nrho cov tshuaj thaum mus pw; lwm tus hnov ​​​​zoo dua rau kev faib tshuaj, ob mus rau plaub zaug hauv ib hnub. Feem ntau, ib koob tshuaj ib hnub yog txaus, thiab muab faib cov koob tshuaj yuav tsis tsim nyog lossis tsis xav tau.

Lub sijhawm ntev ntawm kev ua ntawm cov tshuaj no ua rau nws tshwj xeeb tshaj yog haum rau kev siv tshuaj thaum pw tsaug zog thaum nws cov teebmeem yuav kav mus ib txhis, ua rau cov neeg mob tig mus pw thaum hmo ntuj yooj yim dua, thiab sawv ntxov.

Thaum Benztropine mesylate pib, tsis txhob tso tseg txoj kev kho nrog lwm tus neeg ua haujlwm antiparkinsonian sai sai. Yog tias lwm tus neeg ua haujlwm raug txo qis lossis txiav tawm, nws yuav tsum tau ua kom maj mam. Ntau tus neeg mob tau txais kev pab zoo tshaj plaws nrog kev sib xyaw ua ke.

Benztropine mesylate tuaj yeem siv ua ke nrog Carbidopa-Levodopa, lossis nrog levodopa, nyob rau hauv rooj plaub uas yuav tsum tau hloov pauv ntau npaum li cas thiaj li tswj tau cov lus teb zoo.

Drug-Induced Extrapyramidal Disorders - Hauv kev kho cov kab mob extrapyramidal vim yog cov tshuaj neuroleptic (piv txwv li, phenothiazines), cov koob tshuaj pom zoo yog 1 txog 4 mg ib zaug lossis ob zaug hauv ib hnub ntawm qhov ncauj lossis parenterally. Kev noj tshuaj yuav tsum yog tus kheej raws li qhov xav tau ntawm tus neeg mob. Qee cov neeg mob xav tau ntau tshaj qhov pom zoo; lwm tus tsis xav tau ntau npaum li.

Hauv qhov mob dystonic cov tshuaj tiv thaiv, 1 mus rau 2 mL ntawm kev txhaj tshuaj feem ntau txo qhov mob sai. Tom qab ntawd, cov ntsiav tshuaj, 1 mus rau 2 mg ob zaug ib hnub, feem ntau tiv thaiv kev rov tshwm sim.

Thaum cov kab mob extrapyramidal tshwm sim sai tom qab pib kho nrog cov tshuaj neuroleptic (piv txwv li, phenothiazine), lawv yuav zoo li tsis ntev. Ib mus rau 2 mg ntawm Benztropine mesylate ntsiav tshuaj ob lossis peb zaug hauv ib hnub feem ntau muab kev kho mob hauv ib lossis ob hnub. Tom qab ib lossis ob lub lis piam, cov tshuaj yuav tsum tau muab tshem tawm los txiav txim siab qhov xav tau ntxiv rau nws. Yog tias cov teeb meem zoo li no rov tshwm sim, Benztropine mesylate tuaj yeem rov kho dua.

Qee yam tshuaj-induced extrapyramidal mob uas tshwm sim maj mam yuav tsis teb rau Benztropine mesylate.

Yuav ua li cas yog Benztropine Supplied

Benztropine mesylate ntsiav tshuaj, USP 1 mg yog oval zoo li tus, dawb, debossed nrog 'CE' nyob rau sab laug ntawm cov qhab nia ua haujlwm thiab '44' ntawm sab xis ntawm ib sab thiab dawb ntawm lwm sab.

Lawv tau muab rau hauv lub raj mis ntawm 30 (NDC 62135-144-30), 100 (NDC 62135-144-01), thiab 1000 (NDC 62135-144-10).

Benztropine mesylate ntsiav tshuaj, USP 2 mg yog puag ncig, dawb, debossed nrog 'CE' nyob rau sab sauv ntawm cov qhab nia ua haujlwm thiab '42' nyob rau sab qis ntawm ib sab thiab dawb ntawm lwm sab.

Lawv tau muab rau hauv lub raj mis ntawm 30 (NDC 62135-142-30), 100 (NDC 62135-142-01), thiab 1000 (NDC 62135-142-10).

Khaws ntawm 20 ° txog 25 ° C (68 ° txog 77 ° F); Kev mus ncig ua si tso cai rau 15 ° txog 30 ° C (59 ° txog 86 ° F) [saib USP Controlled Room Temperature].

Muab tso rau hauv lub thawv nruj, lub teeb-resistant [saib USP].

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

Tsim los ntawm: Chartwell Pharmaceuticals, LLC.

Congers, NY 10920

Chaw tsim tshuaj paus: Chartwell RX, LLC.

Congers, NY 10920

Ua hauv teb chaws USA

sanell ntxuav tes tsuag

Rev: 11/2020

l70507 ua

PRINCIPAL DISPLAY PANEL

NWS 62135-144-01
Benztropine
Mesylate
Tablets, USP
1mg ib
Rx nkaus xwb
100 ntsiav tshuaj

PRINCIPAL DISPLAY PANEL

NDC 62135-144-10
Benztropine
Mesylate
Tablets, USP
1mg ib
Rx nkaus xwb
1000 ntsiav tshuaj

PRINCIPAL DISPLAY PANEL

NWS 62135-142-01
Benztropine
Mesylate
Tablets, USP
2mg ib
Rx nkaus xwb
100 ntsiav tshuaj

PRINCIPAL DISPLAY PANEL

NDC 62135-142-10
Benztropine
Mesylate
Tablets, USP
2mg ib
Rx nkaus xwb
1000 ntsiav tshuaj

Benztropine MESYLATE
Benztropine mesylate ntsiav tshuaj
Cov ntaub ntawv khoom
Yam khoom HUMAN PRESCRIPTION DRUG LABEL Yam khoom Code (Source) NDC: 62135-144
Txoj kev tswj hwm ORAL DEA Teem caij
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
Benztropine MESYLATE (Benztropine) Benztropine MESYLATE 1mg ib
Cov khoom xyaw uas tsis muaj zog
Cov khoom xyaw npe Lub zog
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE Cellulose
STARCH, CORN
Cov yam ntxwv ntawm cov khoom
Xim dawb Cov qhab nias 2 qab
Cov duab OVAL Loj 10 hli
Nplaim Imprint Code ua; 44
Muaj
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 62135-144-01 100 TABLET hauv 1 BOTTLE, PLASTIC
ob NDC: 62135-144-10 1000 TABLET hauv 1 BOTTLE, PLASTIC
3 NDC: 62135-144-30 30 TABLE nyob rau hauv 1 BOTTLE, PLASTIC
Cov ntaub ntawv lag luam
Kev lag luam qeb Daim ntawv thov Number los yog Monograph Citation Hnub pib ua lag luam Hnub Kawg Ua Lag Luam
KOJ TIAB SA 081265 01.23.1992 dr hab
Benztropine MESYLATE
Benztropine mesylate ntsiav tshuaj
Cov ntaub ntawv khoom
Yam khoom HUMAN PRESCRIPTION DRUG LABEL Yam khoom Code (Source) NDC: 62135-142
Txoj kev tswj hwm ORAL DEA Teem caij
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
Benztropine MESYLATE (Benztropine) Benztropine MESYLATE 2mg ib
Cov khoom xyaw uas tsis muaj zog
Cov khoom xyaw npe Lub zog
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE Cellulose
STARCH, CORN
Cov yam ntxwv ntawm cov khoom
Xim dawb Cov qhab nias 2 qab
Cov duab ROV Loj 7mm ib
Nplaim Imprint Code ib; 42
Muaj
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 62135-142-01 100 TABLET hauv 1 BOTTLE, PLASTIC
ob NDC: 62135-142-10 1000 TABLET hauv 1 BOTTLE, PLASTIC
3 NDC: 62135-142-30 30 TABLE nyob rau hauv 1 BOTTLE, PLASTIC
Cov ntaub ntawv lag luam
Kev lag luam qeb Daim ntawv thov Number los yog Monograph Citation Hnub pib ua lag luam Hnub Kawg Ua Lag Luam
KOJ TIAB SA 081265 01.23.1992 dr hab
Labeler -Chartwell RX, LLC. (079394054)
Chartwell RX, LLC.