Ipratropium thiab Albuterol

Lub npe dav: ipratropium bromide thiab albuterol sulfate
Dosage form: inhalation daws
Chav kawm tshuaj: Kev sib xyaw ua ke ntawm bronchodilator

Ntawm nplooj ntawv no
Nthuav

Ipratropium thiab Albuterol piav qhia

Cov khoom nquag hauv Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog albuterol sulfate thiab ipratropium bromide.



Albuterol sulfate, yog ntsev ntawm racemic albuterol thiab ib qho kev xaiv βob-adrenergic bronchodilator chemically piav raws li α

ib-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2: 1) (ntsev). Nws muaj qhov hnyav molecular ntawm 576.7 thiab cov qauv qhia pom yog (C13Hnees nkaum ibTSIS TAU3)ob• HobYOG4. Nws yog dawb crystalline hmoov, soluble hauv dej thiab me ntsis soluble hauv ethanol. Lub Koom Haum Ntiaj Teb Kev Noj Qab Haus Huv tau pom zoo lub npe rau albuterol puag yog salbutamol.

Daim duab 3.1-1. Cov qauv tshuaj ntawm albuterol sulfate.

Ipratropium bromide yog ib qho tshuaj anticholinergic bronchodilator chemically piav raws li 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (ua, syn)-, (±)-; ib qho hluavtaws quaternary ammonium compound, tshuaj muaj feem xyuam rau atropine. Nws muaj qhov hnyav molecular ntawm 430.4 thiab cov qauv qhia pom yog Cnees nkaumH30BrNO3• HobO. Nws yog cov khoom siv dawb crystalline, dawb do soluble hauv dej thiab qis cawv, thiab insoluble hauv lipophilic kuab tshuaj xws li ether, chloroform, thiab fluorocarbons.

Daim duab 3.1-2. Cov qauv tshuaj ntawm ipratropium bromide.

Txhua 3 mL Sterile Unit-dose Vial muaj 0.5 mg ntawm ipratropium bromide (0.017%) thiab 3 mg Sib npaug rau 2.5 mg albuterol puag albuterol sulfate (0.083%) hauv isotonic, sterile, aqueous daws uas muaj sodium chloride thiab 1 N hydrochloric acid. kho rau pH 4

* Sib npaug rau 2.5 mg albuterol puag

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog cov tshuaj ntshiab, tsis muaj xim. Nws tsis tas yuav dilution ua ntej kev tswj hwm los ntawm nebulization. Rau Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, zoo li tag nrho lwm cov kev kho mob nebulized, tus nqi xa mus rau lub ntsws yuav nyob ntawm tus neeg mob yam, lub dav hlau nebulizer siv, thiab compressor kev ua tau zoo. Siv Pari-LC-Plus ™ nebulizer (nrog lub ntsej muag lub ntsej muag lossis lub qhov ncauj qhov ncauj) txuas nrog PRONEB™ compressor system, nyob rau hauv cov xwm txheej hauv vitro, qhov nruab nrab xa tawm ntawm lub qhov ncauj daim (% nominal koob) yog kwv yees li 46% ntawm albuterol thiab 42. % ntawm ipratropium bromide ntawm tus nqi nruab nrab ntawm 3.6 L / min. Qhov nruab nrab lub sij hawm nebulization yog 15 feeb lossis tsawg dua. Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum tau muab los ntawm lub dav hlau nebulizers ntawm tus nqi txaus, ntawm lub ntsej muag lub ntsej muag lossis lub qhov ncauj (saib

KEV PAB CUAM THIAB KEV PAB CUAM)

Ipratropium thiab Albuterol - Clinical Pharmacology

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog kev sib xyaw ua ke ntawm βob-adrenergic bronchodilator, albuterol sulfate, thiab anticholinergic bronchodilator, ipratropium bromide

Albuterol sulfate

Mechanism ntawm Action

Qhov tseem ceeb tshaj plaws ntawm cov tshuaj β-adrenergic yog los txhawb cov adenyl cyclase, cov enzyme uas ua rau kev tsim ntawm cyclic-3',5'-adenosine monophosphate (cAMP) los ntawm adenosine triphosphate (ATP). Lub cAMP yog li tsim kho cov lus teb ntawm tes.Hauv vitrokev kawm thiabnyobCov kev tshawb fawb kws tshuaj tau pom tias albuterol muaj cov txiaj ntsig zoo rau βob-adrenergic receptors piv nrog isoproterenol. Thaum nws tau lees paub tias βob-adrenergic receptors yog cov tseem ceeb receptors nyob rau hauv bronchial du nqaij, cov ntaub ntawv tsis ntev los no qhia tias 10% mus rau 50% ntawm β-receptors nyob rau hauv tib neeg lub siab tej zaum yuav β.ob- receptors. Txawm li cas los xij, kev ua haujlwm meej ntawm cov receptors no tseem tsis tau tsim. Albuterol tau pom nyob rau hauv feem ntau tswj kev sim tshuaj kom muaj kev cuam tshuam ntau dua ntawm cov kab mob ua pa, nyob rau hauv daim ntawv ntawm bronchial smooth nqaij so, dua li isoproterenol ntawm cov koob tshuaj sib piv thaum tsim cov teebmeem plawv tsawg. Cov kev tshawb fawb soj ntsuam thiab lwm yam kev soj ntsuam tau pom tias nqus tau albuterol, zoo li lwm cov tshuaj β-adrenergic agonist, tuaj yeem ua rau cov hlab plawv tseem ceeb hauv qee cov neeg mob.

Pharmacokinetics

Albuterol sulfate ua haujlwm ntev dua li isoproterenol hauv cov neeg mob feem ntau los ntawm txhua txoj hauv kev ntawm kev tswj hwm, vim tias nws tsis yog ib qho substrate rau cov txheej txheem ntawm tes rau catecholamine los yog rau cov metabolism ntawm catechol-O-methyl transferase. Hloov chaw, cov tshuaj yog conjugatively metabolized rau albuterol 4'-LUB- sulfate.

Tsiaj Pharmacology/Toxicology

Cov kev tshawb fawb hauv cov hlab ntsha hauv cov nas nrog albuterol sulfate tau pom tias albuterol hla cov hlab ntsha-hlwb thiab nce mus txog lub hlwb cov ntsiab lus ntawm kwv yees li 5% ntawm cov ntshav plasma. Hauv cov qauv sab nraud ntawm cov ntshav-hlwb teeb meem (pineal thiab pituitary glands), albuterol concentrations tau pom tias yog 100 npaug ntawm cov pom hauv tag nrho lub hlwb.

Cov kev tshawb fawb hauv cov tsiaj txhu (minipigs, nas, thiab dev) tau pom qhov tshwm sim ntawm lub plawv arrhythmias thiab kev tuag tam sim ntawd (nrog cov pov thawj histological ntawm myocardial necrosis) thaum beta-agonists thiab methyl-xanthines tau noj ib txhij. Lub chaw kho mob tseem ceeb ntawm cov kev tshawb pom no tsis paub.

Ipratropium bromide hmoov

Mechanism ntawm Action

Ipratropium bromide yog ib qho anticholinergic (parasympatholytic) tus neeg sawv cev, uas thaiv cov muscarinic receptors ntawm acetylcholine, thiab, raws li kev tshawb fawb tsiaj, zoo li inhibit vagally mediated reflexes los ntawm antagonizing qhov kev txiav txim ntawm acetylcholine, tus neeg sawv cev tso tawm los ntawm lub paj hlwb. Anticholinergics tiv thaiv qhov kev nce hauv intracellular concentration ntawm cyclic guanosine monophosphate (cGMP), uas tshwm sim los ntawm kev sib cuam tshuam ntawm acetylcholine nrog muscarinic receptors ntawm bronchial du nqaij.

Pharmacokinetics

Lub bronchodilation tom qab nqus pa ntawm ipratropium feem ntau yog ib qho chaw hauv zos, qhov chaw tshwj xeeb, tsis yog ib qho systemic. Feem ntau ntawm ib qho tshuaj inhaled yog nqos raws li qhia los ntawm kev tshawb fawb fecal excretion. Tom qab nebulization ntawm ib koob tshuaj 1-mg rau cov neeg ua haujlwm noj qab haus huv, qhov txhais tau tias ntawm 4% ntawm cov koob tshuaj raug tshem tawm tsis hloov pauv hauv cov zis.

Ipratropium bromide tsawg tsawg (0% txog 9%hauv vitro) khi rau plasma albumin thiab αib- acid glycoproteins. Nws yog ib feem metabolized rau inactive ester hydrolysis khoom. Tom qab txhaj tshuaj, kwv yees li ib nrab ntawm cov zis tsis hloov pauv hauv cov zis. Ib nrab-lub neej ntawm kev tshem tawm yog kwv yees li 1.6 teev tom qab txhaj tshuaj. Ipratropium bromide uas nce mus txog cov kab mob hauv lub cev tau tshaj tawm tawm los ntawm ob lub raum sai sai ntawm tus nqi uas tshaj qhov glomerular pom tus nqi. Cov tshuaj pharmacokinetics ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution lossis ipratropium bromide tsis tau kawm nyob rau hauv cov neeg laus thiab cov neeg mob uas muaj kab mob siab lossis lub raum tsis ua haujlwm (saib CEEB TOOM).

Tsiaj Pharmacology/Toxicology

Cov kev tshawb fawb autoradiographic hauv nas tau pom tias ipratropium tsis nkag mus rau hauv cov ntshav-hlwb teeb meem.

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution

Mechanism ntawm Action

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum ua kom cov lus teb rau kev kho mob hauv cov neeg mob uas muaj kab mob ntsws ntev (COPD) los ntawm kev txo cov bronchospasm los ntawm ob txoj kev sib txawv: sympathomimetic (albuterol sulfate) thiab anticholinergic / parasympatholytic (iprasympatholytic). Kev tswj hwm tib lub sijhawm ntawm ob qho tib si anticholinergic thiab β2-sympathomimetic yog tsim los tsim cov teebmeem bronchodilation ntau dua li cov tshuaj siv ib leeg ntawm nws cov koob tshuaj pom zoo.

Tsiaj Pharmacology/Toxicology

Hauv 30-hnub kev tshawb fawb hauv Sprague-Dawley nas thiab Beagle dev, subcutaneous koob tshuaj txog li 205.5 mcg / kg ntawm ipratropium tswj nrog txog 1000 mcg / kg albuterol hauv nas thiab 3.16 mcg / kg ipratropium thiab 15 mcg / kg. (tsawg tshaj li qhov siab tshaj plaws tau pom zoo kom nqus pa txhua hnub rau cov neeg laus ntawm mg / mobhauv paus) tsis ua rau tuag lossis muaj zog ntawm cardiotoxicity induced los ntawm albuterol tswj ib leeg.

Pharmacokinetics

Nyob rau hauv ob lub qhov muag tsis pom kev, ob lub sij hawm, kev kawm crossover, 15 tus txiv neej thiab poj niam cov ntsiab lus tau muab tshuaj ib zaug ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution los yog albuterol sulfate inhalation tov ntawm ob zaug qhov pom zoo ib koob tshuaj raws li ob lub inhalations sib cais los ntawm 15 feeb. Tag nrho cov koob tshuaj ntawm albuterol sulfate los ntawm ob txoj kev kho mob yog 6 mg thiab tag nrho cov koob tshuaj ipratropium bromide los ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog 1 mg. Peak albuterol plasma concentrations tshwm sim ntawm 0.8 teev tom qab noj rau ob qho kev kho mob. Qhov nruab nrab siab tshaj albuterol concentration tom qab kev tswj hwm ntawm albuterol sulfate ib leeg yog 4.86 (± 2.65) mg / mL thiab nws yog 4.65 (± 2.92) mg / mL rau Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution. AUC qhov tseem ceeb ntawm ob txoj kev kho mob yog 26.6 (± 15.2) ng∙hr/mL (albuterol sulfate ib leeg) piv rau 24.2 (± 14.5) ng∙hr/mL (Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution). Qhov txhais tau tias t1/2Qhov tseem ceeb yog 7.2 (± 1.3) teev (albuterol sulfate ib leeg) thiab 6.7 (± 1.7) teev (Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution). Qhov nruab nrab ntawm 8.4 (± 8.9)% ntawm cov koob tshuaj albuterol raug tshem tawm tsis hloov pauv hauv cov zis tom qab kev tswj hwm ntawm ob lub vials ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution uas zoo ib yam li 8.8 (± 7.3)% uas tau txais los ntawm albuterol sulfate inhalation daws. Tsis muaj qhov sib txawv tseem ceeb hauv cov tshuaj pharmacokinetics ntawm albuterol ntawm ob txoj kev kho mob. Rau ipratropium, qhov txhais tau tias ntawm 3.9 (± 5.1)% ntawm cov koob tshuaj ipratropium bromide raug tshem tawm tsis hloov pauv hauv cov zis tom qab ob lub vials ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, uas yog sib piv nrog cov ntaub ntawv qhia yav dhau los.

Kev sim tshuaj

Hauv 12 lub lis piam, randomized, ob-dig muag, tswj tau zoo, crossover kev kawm ntawm albuterol sulfate, ipratropium bromide, thiab Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, 863 cov neeg mob COPD raug soj ntsuam rau kev ua haujlwm ntawm bronchodilator piv rau ipratropium sulfate thiab sulfate bromide. thiab ipratropium bromide ib leeg.

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution pom tau tias muaj kev hloov pauv zoo dua hauv FEVib, raws li ntsuas los ntawm lub hauv paus rau cov lus teb siab tshaj plaws, thaum piv nrog albuterol sulfate lossis ipratropium bromide. Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution kuj tau pom tias muaj qhov pib nrawm nrog albuterol sulfate, nrog lub sijhawm nruab nrab ntawm FEV.ibntawm 1.5 teev, thiab ncua sij hawm txuas nrog ipratropium bromide nrog lub sijhawm ntawm 15% cov lus teb hauv FEVibua 4,3h.

Daim duab 3. 1-3. Mean Change in FEVib- Ntsuas hnub 14

Txoj kev tshawb no pom tau hais tias txhua yam ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution tau pab txhawb kev txhim kho hauv kev ua haujlwm ntawm lub ntsws, tshwj xeeb tshaj yog nyob rau thawj 4 mus rau 5 teev tom qab noj, thiab cov tshuaj Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution tau ua haujlwm zoo dua li albuterol sulfate lossis ipratropium bromide ib leeg.

Indications thiab siv rau Ipratropium thiab Albuterol

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog qhia rau kev kho mob bronchospasm cuam tshuam nrog COPD hauv cov neeg mob uas xav tau ntau tshaj ib lub bronchodilator.

Contraindications

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog contraindicated nyob rau hauv cov neeg mob uas muaj keeb kwm ntawm hypersensitivity rau ib yam ntawm nws cov Cheebtsam, los yog rau atropine thiab nws derivatives.

Ceeb toom

Paradoxical Bronchospasm

Hauv kev tshawb fawb soj ntsuam ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, paradoxical bronchospasm tsis tau pom. Txawm li cas los xij, paradoxical bronchospasm tau pom nrog ob qho tib si nqus tau ipratropium bromide thiab albuterol cov khoom thiab tuaj yeem ua rau muaj kev phom sij rau lub neej. Yog tias qhov no tshwm sim, Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum tau txiav tam sim ntawd thiab lwm txoj kev kho mob tau tsim.

Tsis txhob tshaj koob tshuaj pom zoo

Cov neeg tuag tau raug tshaj tawm nyob rau hauv kev koom tes nrog kev siv ntau dhau ntawm cov khoom nqus pa uas muaj cov tshuaj sympathomimetic amines thiab nrog kev siv tshuaj hauv tsev ntawm nebulizers.

Mob plawv

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, zoo ib yam li lwm cov beta adrenergic agonists, tuaj yeem tsim cov kev kho mob plawv tseem ceeb hauv qee cov neeg mob raws li ntsuas los ntawm pulse rate, ntshav siab, thiab / lossis cov tsos mob. Txawm hais tias cov teebmeem no tsis tshua muaj tshwm sim rau Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution ntawm cov koob tshuaj pom zoo, yog tias lawv tshwm sim, cov tshuaj yuav tsum tau txiav tawm. Tsis tas li ntawd, beta agonists tau tshaj tawm los tsim ECG hloov pauv, xws li flattening ntawm T-yoj, ncua sij hawm QTc, thiab ST ntu kev nyuaj siab. Lub chaw kho mob tseem ceeb ntawm cov kev tshawb pom no tsis paub. Yog li ntawd, Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, zoo li lwm yam sympathomimetic amines, yuav tsum tau siv nrog ceev faj rau cov neeg mob uas muaj mob plawv, tshwj xeeb tshaj yog coronary insufficiency, plawv arrhythmias, thiab kub siab.

Tam sim Hypersensitivity Reactions

Cov tshuaj tiv thaiv tsis haum tam sim rau albuterol thiab / lossis ipratropium bromide tuaj yeem tshwm sim tom qab kev tswj hwm ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution raws li pom los ntawm cov mob urticaria, angioedema, pob khaus, pruritus, oropharyngeal edema, bronchospasm, thiab.

Cov kev ceev faj

General

1. Cov txiaj ntsig pom nrog cov tshuaj Sympathomimetic

Raws li nrog rau tag nrho cov khoom uas muaj sympathomimetic amines, Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum tau siv nrog ceev faj rau cov neeg mob uas muaj mob plawv, tshwj xeeb tshaj yog coronary insufficiency, plawv arrhythmias, thiab kub siab; nyob rau hauv cov neeg mob convulsive ntshawv siab, hyperthyroidism, los yog ntshav qab zib mellitus; thiab nyob rau hauv cov neeg mob uas txawv txawv teb rau sympathomimetic amines. Cov koob tshuaj loj ntawm cov tshuaj albuterol tau tshaj tawm ua rau ua rau mob ntshav qab zib mellitus thiab ketoacidosis ntau ntxiv. Tsis tas li ntawd, β-agonists tuaj yeem ua rau txo qis hauv cov poov tshuaj hauv cov ntshav hauv qee cov neeg mob, tej zaum los ntawm kev sib txuas hauv lub cev. Qhov txo qis feem ntau yog ncua sijhawm, tsis tas yuav tsum tau ntxiv.

10 325 rp per cocet
2. Cov nyhuv pom nrog cov tshuaj Anticholinergic

Vim tias muaj cov tshuaj ipratropium bromide hauv Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, nws yuav tsum tau siv nrog ceev faj rau cov neeg mob uas muaj qhov nqaim-angle glaucoma, prostatic hypertrophy, lossis zais zis-caj dab.

3. Siv rau kab mob siab lossis raum mob

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution tsis tau kawm hauv cov neeg mob uas muaj kab mob siab lossis lub raum tsis txaus. Nws yuav tsum tau siv nrog ceev faj hauv cov neeg mob no.

Cov ntaub ntawv rau cov neeg mob

Qhov kev txiav txim ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum kav ntev txog 5 teev. Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum tsis txhob siv ntau zaus tshaj li kev pom zoo. Cov neeg mob yuav tsum tau qhia kom tsis txhob nce koob lossis zaus ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yam tsis tau sab laj nrog lawv tus kws kho mob. Yog tias cov tsos mob hnyav dua, cov neeg mob yuav tsum tau qhia kom nrhiav kev sab laj kho mob.

Cov neeg mob yuav tsum tsis txhob nthuav tawm lawv lub qhov muag rau cov khoom no raws li ib ntus ntawm cov menyuam yaus dilation, qhov muag tsis pom kev, qhov muag mob, los yog nag lossis daus los ntawm lub kaum sab xis ntawm glaucoma tuaj yeem tshwm sim, thiab yog li cov txheej txheem nebulizer yuav tsum tau paub tseeb, tshwj xeeb yog siv lub npog ntsej muag.

Yog tias tus neeg mob cev xeeb tub lossis pib laus thaum noj Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, lawv yuav tsum hu rau lawv tus kws kho mob txog kev siv Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution.

Saib cov duab qhia Tus Neeg Mob Cov Lus Qhia rau Kev Siv hauv cov khoom ntim khoom.

Kev Sib Tham Tshuaj

Cov tshuaj anticholinergic

Txawm hais tias ipratropium bromide yog qhov tsawg kawg nkaus absorbed rau hauv lub cev, muaj qee qhov peev xwm rau kev sib txuas ntxiv nrog cov tshuaj anticholinergic concomitantly. Kev ceev faj yog, yog li ntawd, qhia hauv kev tswj hwm ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution nrog rau lwm cov tshuaj uas muaj cov tshuaj anticholinergic.

ß-adrenergic agents

Kev ceev faj yog qhia nyob rau hauv kev sib koom ua ke ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution thiab lwm yam sympathomimetic cov neeg ua haujlwm vim muaj kev pheej hmoo siab ntawm kev mob plawv.

ß-receptor blocking agents

Cov neeg sawv cev no thiab albuterol sulfate inhibit qhov kev ua haujlwm ntawm ib leeg. β-receptor blocking cov neeg ua haujlwm yuav tsum tau siv nrog ceev faj hauv cov neeg mob uas muaj cov kab mob hyperreactive, thiab yog siv, kuj xaiv β.ibCov neeg ua haujlwm xaiv tau raug pom zoo.

Diuretics

Kev hloov pauv ntawm electrocardiogram (ECG) thiab / lossis hypokalemia uas tuaj yeem tshwm sim los ntawm kev tswj hwm ntawm cov tshuaj uas tsis yog-potassium sparing diuretics (xws li lub voj lossis thiazide diuretics) tuaj yeem ua rau mob hnyav los ntawm β-agonists, tshwj xeeb tshaj yog thaum cov koob tshuaj pom zoo ntawm β-agonist yog. tshaj. Txawm hais tias qhov tseem ceeb ntawm cov teebmeem no tsis paub, kev ceev faj tau qhia hauv kev sib koom ua ke ntawm β-agonist-muaj cov tshuaj, xws li Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, nrog cov tshuaj uas tsis yog-potassium sparing diuretics.

Monoamine oxidase inhibitors lossis tricyclic antidepressants

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum tau siv nrog ceev faj heev rau cov neeg mob uas tau kho nrog monoamine oxidase inhibitors los yog tricyclic antidepressants, los yog nyob rau hauv 2 lub lis piam ntawm kev txiav tawm ntawm cov neeg ua hauj lwm vim hais tias qhov kev txiav txim ntawm albuterol sulfate ntawm lub plawv system tej zaum yuav potentiated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Albuterol Sulfate

Hauv 2-xyoo txoj kev tshawb fawb hauv Sprague-Dawley nas, albuterol sulfate ua rau muaj kev cuam tshuam loj heev ntawm cov kab mob leiomyomas ntawm mesovarium ntawm thiab siab dua noj cov koob tshuaj ntawm 2 mg / kg (kwv yees sib npaug rau qhov siab tshaj plaws tau pom zoo noj txhua hnub koob tshuaj. rau cov neeg laus ntawm ib mg / mobhauv paus). Hauv lwm txoj kev tshawb fawb, cov nyhuv no tau thaiv los ntawm kev sib koom tes ntawm propranolol, uas tsis yog xaiv beta-adrenergic antagonist.

Hauv kev tshawb fawb 18-hli hauv CD-1 nas, albuterol sulfate tsis pom muaj pov thawj ntawm qog nqaij hlav ntawm kev noj haus ntau txog 500 mg / kg (kwv yees li 140 npaug ntawm qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm ib mg / m.obhauv paus). Hauv kev tshawb fawb 22-hli hauv Golden hamsters, albuterol sulfate tsis pom muaj pov thawj ntawm qog nqaij hlav ntawm kev noj zaub mov ntau txog 50 mg / kg (kwv yees li 20 npaug ntawm qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm ib mg / m.

obhauv paus)

Albuterol sulfate tsis yog mutagenic hauv Ames kuaj lossis kev hloov pauv hauv cov poov xab. Albuterol sulfate tsis yog clastogenic nyob rau hauv tib neeg peripheral lymphocyte assay lossis hauv AH1 hom nas micronucleous assay.

Cov kev tshawb fawb txog kev yug me nyuam hauv cov nas pom tsis muaj pov thawj ntawm qhov tsis muaj peev xwm ntawm qhov ncauj ntawm koob tshuaj albuterol sulfate txog li 50 mg / kg (kwv yees li 25 npaug ntawm qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm ib mg / m.obhauv paus).

Ipratropium bromide hmoov

Hauv 2-xyoo kev tshawb fawb hauv Sprague-Dawley nas thiab CD-1 nas, ipratropium bromide tsis pom muaj pov thawj ntawm cov qog nqaij hlav ntawm qhov ncauj txog li 6 mg / kg (kwv yees li 15 zaug thiab 8 npaug ntawm qhov siab tshaj plaws tau pom zoo noj tshuaj txhua hnub rau cov neeg laus hauv cov nas thiab. cov nas feem, ntawm ib mg / mobhauv paus).

Ipratropium bromide tsis yog mutagenic nyob rau hauv Ames xeem thiab nas dominant lethal xeem. Ipratropium bromide tsis yog clastogenic hauv nas micronucleous assay.

Ib txoj kev tshawb fawb txog kev yug me nyuam hauv cov nas pom tau tias txo qis kev xav thiab nce resorptions thaum ipratropium bromide tau noj ntawm qhov ncauj ntawm koob tshuaj 90 mg / kg (kwv yees li 240 npaug ntawm qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm ib mg / m.obhauv paus). Cov kev cuam tshuam no tsis tau pom nrog koob tshuaj 50 mg / kg (kwv yees li 140 npaug ntawm qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm mg / m.obhauv paus).

Kev xeeb tub

TERATOGENIC EFFECTS Pregnancy Qeb C

Albuterol sulfate

Cev xeeb tub qeb C

Albuterol sulfate tau pom tias yog teratogenic hauv cov nas. Ib txoj kev tshawb fawb hauv CD-1 nas muab albuterol sulfate subcutaneously pom cleft palate tsim nyob rau hauv 5 ntawm 111 (4.5%) fetuses ntawm 0.25 mg / kg (tsawg tshaj li qhov siab tshaj plaws tau pom zoo noj tshuaj txhua hnub rau cov neeg laus ntawm ib mg / m.obhauv paus) thiab hauv 10 ntawm 108 (9.3%) fetuses ntawm 2.5 mg / kg (kwv yees sib npaug rau qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm mg / m.obhauv paus). Cov tshuaj tsis ua rau lub siab ua rau lub siab tsis ua haujlwm thaum siv tshuaj subcutaneously ntawm koob tshuaj 0.025 mg / kg (tsawg dua li qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm mg / m.obhauv paus). Cleft palate tsim kuj tshwm sim nyob rau hauv 22 ntawm 72 (30.5%) fetuses los ntawm cov poj niam kho subcutaneously nrog 2.5 mg / kg isoproterenol (zoo tswj).

Ib txoj kev tshawb fawb txog kev yug me nyuam hauv Stride luav qhia cranioschisis nyob rau hauv 7 ntawm 19 (37%) fetuses thaum albuterol tau noj ntawm qhov ncauj ntawm koob tshuaj 50 mg / kg (kwv yees li 55 npaug ntawm qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm ib mg / m.obhauv paus).

Ib txoj kev tshawb fawb uas cov nas cev xeeb tub tau txhaj tshuaj nrog radiolabeled albuterol sulfate qhia tau hais tias cov khoom siv tshuaj raug xa mus los ntawm niam txiv mus rau hauv tus menyuam hauv plab.

Thaum lub sij hawm kev lag luam thoob ntiaj teb kev paub, ntau yam kev tsis sib haum xeeb, suav nrog cleft palate thiab limb defects, tau tshaj tawm hauv cov xeeb ntxwv ntawm cov neeg mob tau kho nrog albuterol. Qee leej niam tau noj ntau yam tshuaj thaum cev xeeb tub. Vim tias tsis muaj qhov txawv txav ntawm qhov tsis xws luag tuaj yeem pom, kev sib raug zoo ntawm kev siv albuterol thiab congenital anomalies tsis tau tsim.

Ipratropium Bromide

Cev xeeb tub qeb B

koj tuaj yeem siv tshuaj ntau dhau ntawm unisom

Kev tshawb fawb txog kev yug me nyuam hauv CD-1 nas, Sprague-Dawley nas thiab New Zealand luav tau pom tias tsis muaj pov thawj ntawm teratogenicity ntawm qhov ncauj txog li 10, 100, thiab 125 mg / kg, raws li (kwv yees li 15, 270, thiab 680 npaug ntawm qhov siab tshaj plaws tau pom zoo txhua hnub. Kev nqus pa rau cov neeg laus ntawm ib mg / mobhauv paus). Kev tshawb fawb txog kev yug me nyuam hauv nas thiab luav pom tsis muaj pov thawj ntawm teratogenicity ntawm qhov nqus nqus tau txog li 1.5 thiab 1.8 mg / kg, raws li (kwv yees li 4 thiab 10 npaug ntawm qhov siab tshaj plaws tau pom zoo noj txhua hnub rau cov neeg laus ntawm ib mg / m.obhauv paus). Tsis muaj kev tshawb fawb txaus thiab tswj tau zoo ntawm kev siv Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, albuterol sulfate, lossis ipratropium bromide hauv cov poj niam cev xeeb tub. Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum tau siv thaum cev xeeb tub nkaus xwb yog tias cov txiaj ntsig muaj peev xwm ua rau muaj kev pheej hmoo rau tus menyuam hauv plab.

Kev Ua Haujlwm thiab Kev Xa Khoom

Qhov ncauj albuterol sulfate tau pom tias yuav ncua kev ua haujlwm ua ntej lub sijhawm ua haujlwm hauv qee cov lus ceeb toom. Vim tias muaj peev xwm ntawm albuterol cuam tshuam nrog kev ua haujlwm ntawm lub tsev menyuam, kev siv Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution thaum lub sijhawm ua haujlwm yuav tsum txwv rau cov neeg mob uas cov txiaj ntsig tau pom tseeb tshaj qhov txaus ntshai.

Niam laus

Nws tsis paub meej tias cov khoom ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution tau tawm hauv tib neeg cov mis nyuj. Txawm hais tias lipid-insoluble quaternary bases dhau mus rau hauv cov kua mis, nws tsis zoo li tias ipratropium bromide yuav ncav cuag tus menyuam mos mus rau qhov tseem ceeb, tshwj xeeb tshaj yog thaum noj cov tshuaj nebulized. Vim tias muaj peev xwm ntawm cov qog nqaij hlav pom rau albuterol sulfate hauv qee cov tsiaj, yuav tsum txiav txim siab seb puas yuav tsum tsis tu ncua lossis txiav tawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, xav txog qhov tseem ceeb ntawm cov tshuaj rau leej niam.

Kev siv menyuam yaus

Kev nyab xeeb thiab kev ua tau zoo ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution hauv cov neeg mob qis dua 18 xyoo tsis tau tsim.

Kev siv Geriatric

Ntawm tag nrho cov kev kawm hauv kev tshawb fawb soj ntsuam ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution, 62 feem pua ​​​​yog 65 thiab tshaj, thaum 19 feem pua ​​​​yog 75 thiab tshaj. Tsis muaj qhov sib txawv ntawm kev nyab xeeb lossis kev ua tau zoo ntawm cov kev kawm no thiab cov tub ntxhais hluas, thiab lwm yam kev paub txog kev kho mob tsis tau txheeb xyuas qhov sib txawv ntawm cov lus teb ntawm cov neeg laus thiab cov neeg mob hluas, tab sis qhov rhiab heev ntawm qee cov neeg laus tsis tuaj yeem txiav tawm.

Kev Phem Tsis Zoo

Cov ntaub ntawv tsis zoo tshwm sim txog Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution tau muab los ntawm 12 lub lis piam tswj kev kuaj mob.

TXOJ CAI TSHAJ PLAWS NTAWM ≧ 1% ntawm ≧ 1 QHOV CHAW UA HAUJ LWM HAUJ LWM THIAB HAIV NEEG KEV PAB CUAM KEV PAB CUAM TSHUAJ TIV THAIV TSHAJ PLAWS
Lub cev System



COSTART Term
Albuterol



n (%)
Ipratropium



n (%)
Ipratropium thiab Albuterol



n (%)
NUMBER NTAU TSHAJ PLAWS
761 ib
754 ib
765 ib
N (%) Cov neeg mob nrog AE
327 (43.0) Nws.
329 (43.6) ib.
367 (48.0) hnub
LUB SIJ HAWM
Mob
8 (1.1)
4 (0.5)
10 (1.3)
Mob hauv siab
11 (1.4)
14 (1.9)
20 (2.6) thiab
DIGESTIVE
Mob plab
5 (0.7)
9 (1.2)
14 (1.8)
Dyspepsia
7 (0.9)
8 (1.1)
10 (1.3)
Ntshai
7 (0.9)
6 (0.8)
11 (1.4)
MUSCLE-SKELETAL
Cramps ceg
8 (1.1)
6 (0.8)
11 (1.4)
Ua pa
Mob ntsws
11 (1.4)
13 (1.7)
13 (1.7)
Mob ntsws
36 (4.7) thiab
34 (4.5) thiab
49 (6.4) thiab
Pharyngitis
27 (3.5 hli)
27 (3.6) thiab
34 (4.4) thiab
Mob ntsws o
7 (0.9)
8 (1.1)
10 (1.3)
UROGENITAL
Kab mob urinary ib ntsuj av
3 (0.4)
9 (1.2)
12 (1.6)

Cov kev phiv ntxiv tau tshaj tawm hauv ntau dua 1% ntawm cov neeg mob kho nrog Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution suav nrog cem quav thiab kev hloov suab.

Hauv kev sim tshuaj ntsuam xyuas, muaj 0.3% qhov tshwm sim ntawm kev ua xua rau hom kev ua xua, nrog rau cov pob khaus tawv nqaij, pruritus, thiab urticaria.

Cov ntaub ntawv ntxiv tau muab los ntawm cov ntaub ntawv luam tawm ntawm kev siv albuterol sulfate thiab ipratropium bromide ib leeg los yog ua ke suav nrog nag lossis daus lossis ua rau lub ntsej muag nqaim, mob qhov muag, qhov muag tsis pom kev, mydriasis, paradoxical bronchospasm, hawb pob, exacerbation ntawm COPD. , mob, dej ntws, kab mob ua pa sab sauv, palpitations, saj perversion, siab lub plawv dhia, sinusitis, mob nraub qaum, mob caj pas thiab metabolic acidosis. Vim tias cov tshuaj tiv thaiv no tau lees paub los ntawm cov pej xeem tsis paub meej qhov loj, nws tsis yog ib txwm ua tau kom ntseeg tau tias lawv cov zaus los yog tsim kom muaj kev sib raug zoo rau kev siv tshuaj.

Kev noj ntau dhau

Cov teebmeem ntawm overdosage nrog Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum muaj feem cuam tshuam rau albuterol sulfate, txij li ipratropium bromide tsis zoo-absorbed system tom qab qhov ncauj lossis aerosol tswj. Cov tsos mob uas yuav tsum tau noj ntau dhau yog cov ntau dhau ntawm beta-adrenergic stimulation thiab / los yog tshwm sim los yog exaggeration ntawm cov tsos mob xws li qaug dab peg, angina, kub siab los yog hypotension, tachycardia nrog tus nqi mus txog 200 neeg ntaus ib feeb, arrhythmia, nervousness, taub hau, tshee, qhuav. qhov ncauj, palpitation, xeev siab, kiv taub hau, qaug zog, malaise, insomnia, thiab exaggeration ntawm pharmacological teebmeem nyob rau hauv ADVERSE REACTIONS. Hypokalemia kuj tuaj yeem tshwm sim. Raws li nrog tag nrho cov tshuaj sympathomimetic aerosol, lub plawv nres thiab txawm tias tuag yuav raug cuam tshuam nrog kev tsim txom ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution. Kev kho mob yog txiav tawm ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution ua ke nrog cov kev kho mob uas tsim nyog. Kev txiav txim siab siv cardioselective beta-receptor blocker yuav raug txiav txim siab, ua rau lub siab xav tias cov tshuaj no tuaj yeem ua rau bronchospasm. Muaj cov pov thawj tsis txaus los txiav txim siab seb kev lim ntshav puas muaj txiaj ntsig rau kev noj ntau dhau ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution.

Qhov koob tshuaj nruab nrab ntawm qhov ncauj ntawm albuterol sulfate hauv cov nas yog ntau dua 2000 mg / kg (kwv yees li 540 npaug ntawm qhov siab tshaj plaws tau pom zoo kom nqus tau ib hnub ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution ntawm mg / m.obhauv paus). Cov koob tshuaj subcutaneous nruab nrab ntawm albuterol sulfate hauv cov nas paub tab thiab cov nas me me yog kwv yees li 450 thiab 2000 mg / kg raws li (kwv yees li 240 thiab 1100 npaug ntawm qhov siab tshaj plaws tau pom zoo niaj hnub nqus tshuaj ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution ntawm mg.obhauv paus, ntsig txog). Kev nqus pa nruab nrab ntawm qhov ua kom tuag tsis tau txiav txim siab hauv cov tsiaj. Qhov ncauj qhov nruab nrab ntawm cov tshuaj tua kab mob ipratropium bromide hauv cov nas, nas thiab dev yog ntau dua 1000 mg / kg, kwv yees li 1700 mg / kg thiab kwv yees li 400 mg / kg, raws li (kwv yees li 1400, 4600, thiab 3600 npaug ntawm qhov siab tshaj plaws tau pom zoo noj txhua hnub noj. hauv cov neeg laus ntawm ib mg / mobhauv paus, ntsig txog).

Ipratropium thiab Albuterol Dosage thiab Administration

Cov koob tshuaj pom zoo ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog ib qho 3 mL vial muab 4 zaug hauv ib hnub ntawm nebulization nrog txog 2 ntxiv 3 mL koob tshuaj ib hnub, yog tias xav tau. Kev nyab xeeb thiab kev ua tau zoo ntawm cov koob tshuaj ntxiv lossis ntau zaus ntawm kev tswj hwm ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution dhau ntawm cov lus qhia no tsis tau kawm thiab kev nyab xeeb thiab kev ua tau zoo ntawm cov koob tshuaj ntxiv ntawm albuterol sulfate lossis ipratropium bromide ntxiv rau cov koob tshuaj pom zoo ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution tsis tau kawm.

Kev siv Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution tuaj yeem txuas ntxiv raws li kev kho mob qhia los tswj kev rov tshwm sim ntawm bronchospasm. Yog tias qhov kev tswj hwm yav dhau los ua tsis tau zoo li niaj zaus, cov lus qhia kho mob yuav tsum tau nrhiav tam sim ntawd, vim qhov no feem ntau yog ib qho cim ntawm COPD zuj zus, uas yuav tsum tau rov ntsuam xyuas kev kho mob.

Pari-LC-Plus ™ nebulizer (nrog lub ntsej muag lub ntsej muag lossis lub qhov ncauj qhov ncauj) txuas nrog PRONEB™ compressor tau siv los xa Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution rau txhua tus neeg mob hauv ib qho kev tshawb fawb hauv Teb Chaws Asmeskas. Kev nyab xeeb thiab kev ua tau zoo ntawm Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution xa los ntawm lwm lub tshuab nqus tsev thiab compressors tsis tau tsim.

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum tau muab los ntawm lub dav hlau nebulizer txuas nrog lub tshuab cua compressor nrog cov cua txaus, nruab nrog lub qhov ncauj lossis lub ntsej muag tsim nyog.

Yuav ua li cas yog Ipratropium thiab Albuterol Supplied

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog muab los ua 3-mL sterile tov rau nebulization hauv sterile low-density polyethylene unit-dose vials. Khaws rau hauv lub hnab kom txog thaum siv. Muab nyob rau hauv cartons raws li teev hauv qab no.

NDC 69097-840-53 30 vails ib lub thawv / 1 vial rau ib lub hnab ntawv

NDC 69097-840-87 30 vials ib lub thawv / 30 vials ib lub hnab ntawv

NDC 69097-840-64 60 vials ib lub thawv / 30 vials ib lub hnab ntawv

Khaws ntawm 2 ° C thiab 25 ° C (36 ° F thiab 77 ° F). Tiv thaiv los ntawm lub teeb.

Tsim los ntawm:

Lub Ritedose Corporation

Columbia, SC 29203 rau

pathophysiology ntawm hloov pauv xwm txheej xwm txheej

Ritedose Pharmaceuticals, LLC

Columbia, SC 29203

Muab faib los ntawm:

Cipla USA Inc.

10 Kev ywj pheej Boulevard Suite 300,

Warren, NJ 07059

9/2020

Cov lus qhia ntawm tus neeg mob rau kev siv

Ipratropium Bromide thiab Albuterol Sulfate

Cov tshuaj Inhalation

0.5 mg / 3 mg rau 3 mL

Tus neeg mob cov lus qhia rau kev siv

Nyeem cov ntaub ntawv tus neeg mob no tag nrho txhua lub sij hawm koj daim ntawv sau tshuaj raws li cov ntaub ntawv hloov pauv. Khaws cov lus qhia no nrog koj cov tshuaj raws li koj xav tau rov nyeem dua.

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yuav tsum tsuas yog siv raws li tus kws kho mob cov lus qhia. Koj tus kws kho mob thiab kws muag tshuaj muaj cov ntaub ntawv ntau ntxiv txog Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution thiab cov xwm txheej uas nws tau sau tseg. Hu rau lawv yog tias koj muaj lus nug ntxiv.

Khaws koj Cov Tshuaj

Khaws Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution ntawm 2 ° C thiab 25 ° C (36 ° F thiab 77 ° F). Vials yuav tsum tau tiv thaiv los ntawm lub teeb ua ntej siv, yog li ntawd, khaws cov vials uas tsis siv nyob rau hauv lub hnab ntawv los yog thawv. Tsis txhob siv tom qab hnub tas sij hawm (EXP) luam tawm ntawm lub thawv.

Koob tshuaj

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution yog muab los ua ib koob tshuaj, npaj-rau-siv vial uas muaj 3 mL ntawm cov tshuaj. Tsis xav tau kev sib tov lossis dilution. Siv ib lub vial tshiab rau txhua qhov kev kho mob nebulizer.

Ua raws li cov lus qhia no rau kev siv koj lub NEBULIZER / COMPRESSOR lossis cov lus qhia muab los ntawm koj tus kws kho mob. QHOV TSEEB TSEEM CEEB yog qhia hauv qab no.

Cov lus qhia rau kev siv

1. Tshem tawm ib lub vial ntawm lub hnab ntawv ci. Muab cov vials seem rov qab rau hauv lub hnab kom khaws cia.

2.Twist lub hau tag nrho tawm ntawm lub vial thiab nyem cov ntsiab lus mus rau hauv lub reservoir nebulizer (Daim duab 1)

3. Txuas lub nebulizer rau lub qhov ncauj los yog daim npog ntsej muag (Daim duab 2).

4. Txuas lub nebulizer rau lub compressor.

5.Sit nyob rau hauv ib tug xis, upright txoj hauj lwm; Muab lub qhov ncauj tso rau hauv koj lub qhov ncauj (Daim duab 3) lossis muab lub ntsej muag lub ntsej muag (Daim duab 4); thiab qhib lub compressor.

6. Ua pa kom ntsiag to, sib sib zog nqus thiab sib npaug li sai tau los ntawm koj lub qhov ncauj kom txog thaum tsis muaj huab cua ntxiv nyob rau hauv lub chamber nebulizer (kwv yees li 5-15 feeb). Lub sijhawm no, kev kho mob tiav lawm.

7.Ntev lub tshuab nqus tsev (saib cov chaw tsim khoom cov lus qhia).

Tsim los ntawm:

Lub Ritedose Corporation

Columbia, SC 29203 rau

Ritedose Pharmaceuticals, LLC

Columbia, SC 29203

Muab faib los ntawm:

Cipla USA Inc.

10 Kev ywj pheej Boulevard, Suite 300,

Warren, NJ 07059

9/2020

PATIENT INFORMATION

Ipratropium Bromide thiab Albuterol Sulfate Inhalation Solution

0.5 mg / 3 mg rau 3 mL

Tshuaj tsuas xwb.

Nyeem cov ntaub ntawv tus neeg mob uas tuaj nrog Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg ua ntej koj pib siv nws thiab txhua zaus koj tau txais cov tshuaj ntxiv. Tej zaum yuav muaj cov ntaub ntawv tshiab. Daim ntawv no tsis siv qhov chaw tham nrog koj tus kws kho mob txog koj tus mob lossis koj txoj kev kho mob.

Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg yog dab tsi?

Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg yog kev sib xyaw ntawm ob cov tshuaj hu ua bronchodilators. Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg muaj albuterol sulfate, uas yog beta-adrenergic agonist, thiab ipratropium bromide, uas yog ib qho anticholinergic. Ob cov tshuaj no ua haujlwm ua ke los pab qhib txoj hlab pa hauv koj lub ntsws. Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg yog siv los pab kho cov hlab ntsws nqaim (bronchospasm) uas tshwm sim nrog cov kab mob ntsws ntev (COPD) hauv cov neeg laus uas yuav tsum tau siv ntau tshaj ib cov tshuaj bronchodilator.

hwv 10/325

Leej twg yuav tsum tsis txhob siv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg?

Tsis txhob siv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg yog tias koj: Ua xua rau ib qho ntawm cov khoom xyaw hauv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg lossis atropine.Cov khoom xyaw nquag yog albuterol sulfate thiab ipratropium bromide. Saib qhov kawg ntawm daim ntawv no kom tiav cov npe ntawm cov khoom xyaw hauv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg.

Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg tsis tau kawm hauv cov neeg mob hnub nyoog qis dua 18 xyoo.

Kuv yuav tsum qhia li cas rau kuv tus kws kho mob ua ntej kuv pib siv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg?

Qhia rau koj tus kws kho mob txog tag nrho koj cov mob, suav nrog yog tias koj:

  • Muaj teeb meem plawv. Qhov no suav nrog cov kab mob coronary artery thiab teeb meem lub plawv dhia.
  • Muaj ntshav siab
  • Muaj ntshav qab zib
  • Tau los yog qaug dab peg
  • Muaj teeb meem thyroid hu ua hyperthyroidism
  • Muaj teeb meem qhov muag hu ua qhov nqaim-angle glaucoma
  • Muaj kab mob siab lossis raum
  • Muaj teeb meem tso zis vim lub zais zis-caj dab los yog ib qho loj prostate (txiv neej)
  • cev xeeb tub los yog npaj yuav xeeb tub. Nws tsis paub yog tias Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg tuaj yeem ua mob rau koj tus menyuam hauv plab. Koj thiab koj tus kws kho mob yuav tau txiav txim siab yog tias Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg yog txoj cai rau koj thaum cev xeeb tub.
  • Yog pub niam mis. Nws tsis paub yog tias Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg nkag mus rau hauv koj cov mis nyuj lossis yog tias nws tuaj yeem ua mob rau koj tus menyuam. Koj thiab koj tus kws kho mob yuav tsum txiav txim siab seb koj puas yuav tsum noj Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg lossis pub mis, tab sis tsis yog ob leeg.

Qhia rau koj tus kws kho mob txog txhua yam tshuaj uas koj noj nrog rau cov tshuaj noj thiab tshuaj tsis yog tshuaj, cov vitamins thiab tshuaj ntsuab tshuaj ntsuab. Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg thiab lwm yam tshuaj tuaj yeem cuam tshuam. Qhov no yuav ua rau muaj kev phiv loj heev. Qhia rau koj tus kws kho mob tshwj xeeb yog tias koj noj:

  • Lwm cov tshuaj uas muaj anticholinergics xws li ipratropium bromide. Qhov no kuj suav nrog cov tshuaj siv rau tus kab mob Parkinson.
  • Lwm cov tshuaj uas muaj beta-agonists xws li albuterol sulfate. Cov no feem ntau yog siv los kho cov hlab ntsws nqaim (bronchospasm).
  • Cov tshuaj hu ua beta-blockers. Cov no feem ntau yog siv rau ntshav siab lossis teeb meem plawv.
  • Cov tshuaj hu ua 'cov tshuaj dej' (diuretics)
  • Cov tshuaj rau kev nyuaj siab hu ua monoamine oxidase inhibitors (MAOIs) lossis tricyclic antidepressants.

Nug koj tus kws kho mob lossis tus kws muag tshuaj yog tias koj tsis paub tseeb tias koj noj cov tshuaj no. Paub cov tshuaj koj noj. Khaws ib daim ntawv teev npe thiab qhia rau koj tus kws kho mob thiab kws muag tshuaj thaum koj tau txais cov tshuaj tshiab.

Yuav siv li cas Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg?

  • Nyeem Tus Neeg Mob Cov Lus Qhia rau Kev Siv uas koj tau txais nrog koj cov tshuaj. Tham nrog koj tus kws kho mob lossis kws muag tshuaj yog tias koj muaj lus nug.
  • Noj Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg raws nraim li koj tus kws kho mob tau sau tseg. Tsis txhob hloov koj cov koob tshuaj lossis ntau npaum li cas koj siv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg yam tsis tau tham nrog koj tus kws kho mob. Inhale Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg los ntawm koj lub qhov ncauj thiab rau hauv koj lub ntsws siv lub tshuab hu ua nebulizer.
  • Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg yuav pab qhib koj txoj hlab pa ntev txog 5 teev tom qab noj cov tshuaj no. Yog tias Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg tsis pab koj txoj hlab ntsws nqaim (bronchospasm) lossis koj lub bronchospasm zuj zus, hu rau koj tus kws kho mob tam sim lossis tau txais kev pab xwm txheej ceev yog tias xav tau.

Kuv yuav tsum zam dab tsi thaum siv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg?

Tsis txhob tau Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mghauv koj ob lub qhov muag.Ceev faj tsis txhob tsuag tshuaj Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg rau hauv koj lub qhov muag thaum koj siv koj lub nebulizer. Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg tuaj yeem ua rau muaj teeb meem qhov muag luv luv hauv qab no:

  • Cov menyuam kawm ntawv loj
  • Tsis pom kev
  • Mob qhov muag

Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg tuaj yeem ua rau muaj teeb meem loj qhov muag hu ua qhov nqaim-angle glaucoma lossis ua rau lub ntsej muag nqaim uas koj twb muaj lawm.

Dab tsi yog qhov ua tau tshwm sim nrog Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg?

Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg yuav ua rau muaj kev phiv loj hauv qab no:

  • Kev mob hnyav ntawm qhov nqaim hauv koj txoj hlab ntsws (bronchospasm).Cov kev mob tshwm sim no tuaj yeem ua rau muaj kev phom sij rau lub neej thiab tau tshwm sim nrog ob qho tshuaj uas muaj nyob hauv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg. Nres Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg thiab hu rau koj tus kws kho mob tam sim ntawd lossis tau txais kev pab thaum muaj xwm txheej ceev yog tias koj muaj teeb meem ua pa hnyav dua thaum lossis tom qab siv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg.
  • Kev ua xua hnyav thiab ua rau muaj kev phom sij rau lub neej. Cov tsos mob ntawm kev tsis haum tshuaj loj muaj xws li:
    • Hives, tawm pob
    • o ntawm koj lub ntsej muag, daim tawv muag, daim di ncauj, tus nplaig, lossis caj pas, thiab teeb meem nqos tau
    • Ua rau koj cov teeb meem ua pa tsis zoo xws li hawb pob, hauv siab nruj los yog ua tsis taus pa
    • Shock (poob ntshav siab thiab tsis nco qab)

Feem ntau cov kev mob tshwm sim nrog Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg muaj xws li mob ntsws, mob caj pas, mob hauv siab, cem quav, raws plab, bronchitis, kab mob urinary, ceg cramps, xeev siab, chim plab, suab hloov, thiab mob.

Cov no tsis yog tag nrho cov kev mob tshwm sim nrog Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg. Yog xav paub ntxiv, nug koj tus kws kho mob lossis tus kws muag tshuaj.

Kuv yuav khaws Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg li cas?

  • Khaws Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg ntawm 36 ° thiab 77 ° F (2 ° thiab 25 ° C). Tiv thaiv los ntawm lub teeb. Khaws cov vials uas tsis siv rau hauv hnab ntawv los yog thawv.
  • Muaj kev nyab xeeb pov tseg Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg uas yog dhau los lossis tsis xav tau ntxiv lawm.
  • Khaws Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg thiab tag nrho cov tshuaj tawm ntawm cov menyuam yaus.

Cov lus qhia dav dav txog Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg

Cov tshuaj qee zaum raug muab rau cov xwm txheej uas tsis tau hais hauv cov ntaub ntawv qhia tus neeg mob. Tsis txhob siv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg rau ib qho mob uas tsis tau sau tseg. Tsis txhob muab Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg rau lwm tus, txawm tias lawv muaj cov tsos mob zoo li koj muaj. Nws yuav ua mob rau lawv.

Daim ntawv no qhia txog cov ntaub ntawv tseem ceeb tshaj plaws txog Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg. Yog tias koj xav paub ntau ntxiv, nrog koj tus kws kho mob tham. Koj tuaj yeem nug koj tus kws kho mob lossis tus kws muag tshuaj rau cov ntaub ntawv hais txog Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg uas tau sau rau cov kws kho mob.

Dab tsi yog cov khoom xyaw hauv Ipratropium Bromide 0.5 mg thiab Albuterol Sulfate 3 mg?

Cov khoom xyaw nquag:ipratropium bromide thiab albuterol sulfate

Cov khoom xyaw uas tsis muaj zog:sodium chloride thiab 1 N hydrochloric acid

Txhawm rau tshaj tawm NYEEM NTAWV TXOJ CAI, hu rau The Ritedose Corporation ntawm 1-855-806-3300 lossis FDA ntawm 1-800-FDA-1088 lossis www.fda.gov/medwatch.

Tsim los ntawm:

Lub Ritedose Corporation

Columbia, SC 29203 rau

Ritedose Pharmaceuticals, LLC

Columbia, SC 29203

Muab faib los ntawm:

Cipla USA Inc.

10 Kev ywj pheej Boulevard, Suite 300,

Warren, NJ 07059

9/2020

siv sijhawm ntev ntawm lexapro

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NWS 69097-840-53

Ipratropium Bromide thiab Albuterol Sulfate

Cov tshuaj Inhalation

0.5 mg / 3 mg rau 3 mL

Rau qhov ncauj qhov ncauj xwb

KHOOM PLIG:Tiv thaiv los ntawm lub teeb. Unit-dose vials yuav tsum nyob twj ywm hauv lub hnab ntawv tiv thaiv txhua lub sijhawm. Thaum tshem tawm ntawm lub hnab ntawv ci, tus neeg vials yuav tsum tau siv nyob rau hauv ib lub lis piam

Muab pov tseg yog tias cov tshuaj tsis muaj xim tsis muaj xim

Khaws ntawm 2 ° C thiab 25 ° C (36 ° F thiab 77 ° F)

TUAJ NTAWM ME NYUAM.

USUAL DOSAGE:Saib nrog cov ntaub ntawv sau tshuaj

Tsuas yog siv raws li koj tus kws kho mob qhia

TSIS TAU TXAIS KEV PAB CUAM

ATTENTION PHARMACIST:Tshem tawm 'Tus Neeg Mob Cov Lus Qhia Rau Kev Siv' los ntawm pob ntxig thiab xa nrog kev daws

Rx nkaus xwb

30 x 3 mL Sterile Unit-Dose Vials

NDC 69097-840-64 Rx xwb

Ipratropium Bromide thiab Albuterol Sulfate

Cov tshuaj Inhalation

0.5 mg / 3 mg rau 3 mL

Rau qhov ncauj qhov ncauj xwb

COV KHOOM:

Txhua 3 mL Sterile Unit-dose Vial muaj:

0.5 mg ipratropium bromide (0.017%)

3 mg * albuterol sulfate (0.083%)

* Sib npaug rau 2.5 mg albuterol puag.

Tsis muaj zog: Sodium chloride, 1 N hydrochloric acid (kom kho rau pH 4) thiab dej rau kev txhaj tshuaj.

60 x 3 mL Sterile Unit-Dose Vials (2 hnab ntawm 30 - 3 mL vials txhua)

Tsim los ntawm: Ritedose Corporation

Columbia, SC 29203

Muab los ntawm: Cipla USA, Inc.

10 Independence Boulevard, Suite 300, Warren, NJ 07059

Cipla

IPRATROPIUM BROMIDE thiab ALBUTEROL SULFATE
ipratropium bromide thiab albuterol sulfate daws
Cov ntaub ntawv khoom
Yam khoom HUMAN PRESCRIPTION DRUG LABEL Yam khoom Code (Source) NDC: 69097-840
Txoj kev tswj hwm Ua pa (INHALATION) DEA Teem caij
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
IPRATROPIUM BROMIDE (IPRATROPIUM) IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg 3 mL
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 2.5 mg 3 ml
Cov khoom xyaw uas tsis muaj zog
Cov khoom xyaw npe Lub zog
SODIUM chloride
Dej
HYDROCHLORIC ACID
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 69097-840-53 30 POUCH hauv 1 CARTON
ib NDC: 69097-840-34 1 AMPULE hauv 1 POUCH
ib NDC: 69097-840-00 3 ml hauv 1 AMPULE
ob NDC: 69097-840-64 60 POUCH hauv 1 CARTON
ob NDC: 69097-840-34 1 AMPULE hauv 1 POUCH
ob NDC: 69097-840-00 3 ml hauv 1 AMPULE
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 202496 06/01/2020
Labeler -Cipla USA Inc. (078719707)
Kev tsim kho
Lub npe Chaw nyob ID/FEI Kev ua haujlwm
Lub Ritedose Corporation 837769546 ib MANUFACTURE(69097-840), LABEL(69097-840), PACK(69097-840), ANALYSIS(69097-840)
Cipla USA Inc.