Phentermine Capsules

Lub npe dav: phentermine hydrochloride
Dosage form: tshuaj ntsiav
Chav kawm tshuaj: Anorexiants , CNS stimulants

Ntawm nplooj ntawv no
Nthuav

Kev taw qhia thiab kev siv rau Phentermine Capsules

Phentermine hydrochloride capsules yog qhia raws li lub sij hawm luv luv (ob peb lub lis piam) adjunct nyob rau hauv ib tug regimen ntawm qhov hnyav txo raws li kev tawm dag zog, kev hloov pauv tus cwj pwm thiab kev txwv caloric hauv kev tswj hwm ntawm exogenous rog rau cov neeg mob nrog thawj lub cev qhov hnyav index ≧30 kg / mob, los yog ≧27 kg/mobnyob rau hauv muaj lwm yam kev pheej hmoo (xws li, tswj ntshav siab, ntshav qab zib, hyperlipidemia).



Hauv qab no yog daim ntawv qhia ntawm lub cev qhov ntsuas qhov ntsuas (BMI) raws li ntau qhov siab thiab qhov hnyav.

BMI yog xam los ntawm kev noj tus neeg mob qhov hnyav, hauv kilograms (kg), muab faib los ntawm tus neeg mob qhov siab, hauv meters (m), squared. Metric hloov pauv yog raws li nram no: phaus ÷ 2.2 = kg; luas = 0,0254 m²

Lub cev MASS INDEX (BMI), kg / mob
Qhov siab (feet, inches)
Qhov hnyav
(phaus)
5'0' 5'3' 5'6' 5'9' 6'0' 6'3'
140 27 25 23 nees nkaum ib 19 18
150 29 27 24 22 nees nkaum 19
160 31 28 26 24 22 nees nkaum
170 33 30 28 25 23 nees nkaum ib
180 35 32 29 27 25 23
190 37 3. 4 31 28 26 24
200 39 36 32 30 27 25
210 41 37 3. 4 31 29 26
220 43 39 36 33 30 28
230 Plaub. Tsib 41 37 3. 4 31 29
240 47 43 39 36 33 30
250 49 44 40 37 3. 4 31

Qhov txwv tsis pub muaj txiaj ntsig ntawm cov neeg sawv cev ntawm chav kawm no, suav nrog phentermine, [saib Clinical Pharmacology (12.1 , 12.2) ] yuav tsum tau ntsuas tawm tsam qhov muaj feem yuav tshwm sim hauv lawv txoj kev siv xws li cov lus piav qhia hauv qab no.

Phentermine Capsules Dosage and Administration

Exogenous Obesity

Kev noj tshuaj yuav tsum yog tus kheej kom tau txais cov lus teb txaus nrog cov koob tshuaj qis tshaj plaws.

Cov koob tshuaj ib txwm muaj rau cov neeg laus yog 15 mg rau 30 mg raws li kws kho mob tau sau tseg, ntawm kwv yees li 2 teev tom qab noj tshais rau kev tswj qab los noj mov. Kev tswj hwm ntawm ib koob tshuaj 30 mg txhua hnub tau pom tias muaj kev txaus siab rau kev nyuaj siab ntawm kev qab los noj mov rau 12 mus rau 14 teev. Phentermine tsis pom zoo siv rau cov neeg mob menyuam yaus ≦ 16 xyoo.

Cov tshuaj noj yav tsaus ntuj yuav tsum tau zam vim tias muaj peev xwm ua rau insomnia.

Dosage nyob rau hauv cov neeg mob nrog raum tsis ua hauj lwm

Qhov pom zoo ntau npaum li cas ntawm phentermine yog 15 mg txhua hnub rau cov neeg mob uas muaj lub raum tsis zoo (eGFR 15 txog 29 mL / min / 1.73mob). Tsis txhob siv phentermine hauv cov neeg mob nrog eGFR tsawg dua 15 mL / min / 1.73moblos yog kab mob raum kawg uas yuav tsum tau lim ntshav [saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.6) thiab Tshuaj Kho Mob (12.3) ].

Daim ntawv siv tshuaj thiab muaj zog

Capsules muaj 15 mg lossis 30 mg phentermine hydrochloride (sib npaug rau 12 mg lossis 24 mg phentermine puag, ntsig txog).

15 mg capsules: grey/daj; imprinted 'EL600' nyob rau hauv tus cwj mem dub ntawm lub hau thiab lub cev, ntim nrog cov hmoov dawb rau cov hmoov dawb.

30 mg capsules: daj; imprinted 'EL601' hauv tus cwj mem dub ntawm lub kaus mom thiab lub cev, ntim nrog cov hmoov dawb mus rau dawb.

Contraindications

  • Keeb kwm ntawm cov kab mob plawv (piv txwv li, kab mob coronary artery, mob stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)
  • Lub sijhawm lossis hauv 14 hnub tom qab kev tswj hwm ntawm monoamine oxidase inhibitors
  • Hyperthyroidism
  • Glaucoma
  • Agitated xeev
  • Keeb kwm ntawm kev siv yeeb tshuaj
  • Kev xeeb tub [saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.1) ]
  • Nursing [saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.3) ]
  • Paub qhov tsis hnov ​​​​tsw, lossis idiosyncrasy rau sympathomimetic amines

Ceeb toom thiab ceev faj

Kev sib koom tes nrog lwm cov khoom siv tshuaj rau kev poob phaus

Phentermine hydrochloride capsules yog qhia tsuas yog raws li lub sij hawm luv luv (ob peb lub lis piam) monotherapy rau kev tswj ntawm exogenous rog. Kev nyab xeeb thiab kev ua tau zoo ntawm kev sib xyaw ua ke nrog phentermine thiab lwm yam khoom siv tshuaj rau kev poob phaus suav nrog cov tshuaj kws kho mob, kev npaj hauv khw muag khoom, thiab cov khoom siv tshuaj ntsuab, lossis cov tshuaj serotonergic xws li xaiv serotonin reuptake inhibitors (xws li, fluoxetine, sertraline, fluvoxamine, paroxetine), tsis tau tsim. Yog li ntawd, coadministration ntawm phentermine thiab cov khoom siv tshuaj no tsis pom zoo.

Primary Pulmonary Hypertension

Primary Pulmonary Hypertension (PPH) - ib qho tsis tshua muaj, feem ntau tuag taus ntawm lub ntsws - tau raug tshaj tawm tias tshwm sim hauv cov neeg mob tau txais kev sib xyaw ntawm phentermine nrog fenfluramine lossis dexfenfluramine. Qhov ua tau ntawm kev koom tes ntawm PPH thiab kev siv phentermine ib leeg tsis tuaj yeem txiav txim siab; muaj tsawg zaus ntawm PPH hauv cov neeg mob uas tau tshaj tawm tias tau noj phentermine ib leeg.Thawj cov tsos mob ntawm PPH feem ntau yog dyspnea. Lwm cov tsos mob thawj zaug tuaj yeem suav nrog angina pectoris, syncope lossis qis qis qis. Cov neeg mob yuav tsum tau qhia kom tshaj tawm tam sim muaj kev cuam tshuam ntawm kev ua haujlwm siab ntev. Kev kho mob yuav tsum tau txiav rau hauv cov neeg mob uas tsim cov tsos mob tshiab, yam tsis tau piav qhia ntawm dyspnea, angina pectoris, syncope lossis qis kawg nkaus edema, thiab cov neeg mob yuav tsum raug soj ntsuam rau qhov muaj peev xwm ntawm pulmonary hypertension.

Kab mob plawv Valvular

Mob hnyav regurgitant cardiac valvular kab mob, feem ntau cuam tshuam rau lub mitral, aortic thiab / los yog tricuspid li qub, tau raug tshaj tawm nyob rau hauv lwm tus neeg noj qab haus huv uas tau noj ib tug ua ke ntawm phentermine nrog fenfluramine los yog dexfenfluramine rau poob phaus. Qhov ua tau lub luag hauj lwm ntawm phentermine nyob rau hauv lub etiology ntawm cov valvulopathies tsis tau tsim thiab lawv cov chav kawm nyob rau hauv cov tib neeg tom qab cov tshuaj nres yog tsis paub. Qhov ua tau ntawm kev koom tes ntawm valvular mob plawv thiab kev siv phentermine ib leeg tsis tuaj yeem txiav txim siab; muaj tsawg zaus ntawm cov kab mob valvular hauv cov neeg mob uas tau tshaj tawm tias tau noj phentermine ib leeg.

Kev Txhim Kho ntawm Kev Ua Siab ntev, Kev Txiav Txim Siab Hauv Cov Cai ntawm Kev Ua Siab ntev

Thaum ua siab ntev rau cov nyhuv anorectant tshwm sim, cov koob tshuaj pom zoo yuav tsum tsis pub tshaj nyob rau hauv kev sim ua kom cov nyhuv; es, cov tshuaj yuav tsum tau txiav.

Qhov cuam tshuam rau Kev Muaj Peev Xwm los koom nrog cov haujlwm uas muaj peev xwm txaus ntshai

Phentermine tej zaum yuav impair lub peev xwm ntawm tus neeg mob mus koom nyob rau hauv tej yam uas muaj kev phom sij xws li kev khiav hauj lwm machinery los yog tsav tsheb lub cev muaj zog; yog li ntawd tus neeg mob yuav tsum tau ceev faj raws li.

Risk of Abuse thiab Dependence

Phentermine muaj feem xyuam rau chemically thiab pharmacologically rau amphetamine (d- thiab dll-amphetamine) thiab rau lwm yam tshuaj stimulant uas tau raug tsim txom ntau heev. Qhov muaj peev xwm ntawm kev tsim txom ntawm phentermine yuav tsum tau khaws cia nyob rau hauv lub siab thaum ntsuam xyuas lub desirability ntawm xws li ib tug tshuaj raws li ib feem ntawm ib tug luj qhov kev pab cuam. Saib Kev siv tshuaj yeeb thiab kev cia siab (9) thiab Kev noj ntau dhau (10) .

Yam tsawg kawg nkaus yuav tsum tau muab tshuaj los yog muab tso rau hauv ib lub sij hawm txhawm rau txo qhov muaj peev xwm ntawm kev noj ntau dhau.

Kev siv cawv

Concomitant siv cawv nrog phentermine tej zaum yuav ua rau muaj kev phiv tshuaj tiv thaiv.

Siv rau cov neeg mob ntshav siab

Siv ceev faj nyob rau hauv tshuaj phentermine rau cov neeg mob uas txawm mob me ntsis kub siab (kev pheej hmoo ntawm nce ntshav siab).

Siv rau cov neeg mob ntawm Insulin lossis Oral Hypoglycemic Tshuaj rau Mob Ntshav Qab Zib

Kev txo qis ntawm cov tshuaj insulin los yog qhov ncauj hypoglycemic tshuaj nyob rau hauv cov neeg mob ntshav qab zib mellitus yuav xav tau.

Kev Phem Tsis Zoo

Cov kev tsis zoo hauv qab no tau piav qhia, lossis piav qhia ntau dua, hauv lwm ntu:

-
Primary pulmonary hypertension [saib Ceeb toom thiab ceev faj (5.2) ]
-
Kab mob plawv valvular [saib Ceeb toom thiab ceev faj (5.3) ]
-
Qhov cuam tshuam rau kev muaj peev xwm los koom nrog cov dej num uas muaj kev phom sij [saib Ceeb toom thiab ceev faj (5.5) ]
-
Kev rho tawm cov teebmeem tom qab lub sijhawm ntev ntawm kev noj tshuaj ntau ntau [saib Kev siv tshuaj yeeb thiab kev cia siab (9.3) ]

Cov nram qab no tsis zoo tshwm sim rau phentermine tau raug txheeb xyuas:

Mob plawv

Thawj pulmonary hypertension thiab / lossis regurgitant cardiac valvular kab mob, palpitation, tachycardia, nce ntshav siab, cov xwm txheej ischemic.

Central Nervous System

phentermine 37.5 mg siab

Overstimulation, nyob tsis tswm, kiv taub hau, insomnia, euphoria, dysphoria, tshee, mob taub hau, psychosis.

plab hnyuv

Qhuav ntawm lub qhov ncauj, tsis kaj siab saj, raws plab, cem quav, lwm yam kab mob gastrointestinal cuam tshuam.

Ua xua

Urticaria.

Endocrine

Impotence, hloov hauv libido.

Kev Sib Tham Tshuaj

Monoamine Oxidase Inhibitors

Kev siv phentermine yog contraindicated thaum lub sij hawm los yog nyob rau hauv 14 hnub tom qab kev tswj hwm ntawm monoamine oxidase inhibitors vim muaj kev pheej hmoo ntawm hypertensive ntsoog.

Cawv

Concomitant siv cawv nrog phentermine tej zaum yuav ua rau muaj kev phiv tshuaj tiv thaiv.

Cov tshuaj insulin thiab qhov ncauj Hypoglycemic tshuaj

Cov kev xav tau tuaj yeem hloov pauv [saib Ceeb toom thiab ceev faj (5.9) ].

Adrenergic Neuron Thaiv Cov Tshuaj

Phentermine yuav txo cov nyhuv hypotensive ntawm adrenergic neuron thaiv cov tshuaj.

Siv rau hauv cov neeg tshwj xeeb

Kev xeeb tub

Cev xeeb tub Qeb X

Phentermine yog contraindicated thaum cev xeeb tub vim poob phaus tsis muaj peev xwm pab tau rau tus poj niam cev xeeb tub thiab tej zaum yuav ua rau fetal mob. Kev nce qhov hnyav tsawg kawg nkaus, thiab tsis muaj qhov hnyav, tam sim no pom zoo rau txhua tus poj niam cev xeeb tub, suav nrog cov neeg uas twb rog dhau los lossis rog dhau lawm, vim qhov yuav tsum tau ua kom hnyav ntxiv uas tshwm sim hauv cov ntaub so ntswg niam thaum cev xeeb tub. Phentermine muaj cov tshuaj pharmacologic zoo ib yam li amphetamine (d- thiab dll-amphetamine) [saib Clinical Pharmacology (12.1) ]. Kev tshawb fawb txog tsiaj yug tsiaj tsis tau ua nrog phentermine. Yog tias cov tshuaj no tau siv thaum cev xeeb tub, lossis yog tus neeg mob cev xeeb tub thaum noj cov tshuaj no, tus neeg mob yuav tsum tau pom tias muaj kev phom sij rau tus menyuam hauv plab.

Niam laus

Nws tsis paub yog tias phentermine tawm hauv tib neeg cov mis nyuj; Txawm li cas los xij, lwm yam tshuaj amphetamines muaj nyob hauv tib neeg cov kua mis. Vim tias muaj peev xwm ua rau muaj kev cuam tshuam loj heev hauv cov menyuam mos, kev txiav txim siab yuav tsum txiav txim siab seb yuav tsum tsis tu ncua lossis txiav cov tshuaj, suav nrog qhov tseem ceeb ntawm cov tshuaj rau leej niam.

Kev siv menyuam yaus

Kev nyab xeeb thiab kev ua tau zoo hauv cov neeg mob menyuam yaus tsis tau tsim. Vim tias kev rog dhau ntawm menyuam yaus yog qhov mob ntev uas yuav tsum tau kho mus ntev, kev siv cov khoom no, pom zoo rau kev kho lub sijhawm luv, tsis pom zoo.

Kev siv Geriatric

Feem ntau, kev xaiv koob tshuaj rau tus neeg mob laus yuav tsum tau ceev faj, feem ntau pib ntawm qhov qis kawg ntawm qhov ntau npaum li cas, qhia txog qhov ntau dua ntawm kev txo qis hauv siab, lub raum, lossis lub plawv ua haujlwm, thiab ntawm cov kab mob sib kis lossis lwm yam tshuaj kho.

Cov tshuaj no tau paub tias yuav raug tshem tawm los ntawm lub raum, thiab qhov kev pheej hmoo ntawm cov tshuaj lom neeg cov tshuaj no yuav muaj ntau dua rau cov neeg mob uas lub raum tsis ua haujlwm. Vim tias cov neeg laus muaj feem yuav ua rau lub raum tsis ua haujlwm, yuav tsum tau saib xyuas hauv kev xaiv tshuaj, thiab nws yuav pab tau rau kev saib xyuas lub raum ua haujlwm.

Lub raum tsis zoo

Raws li kev tshaj tawm excretion ntawm phentermine nyob rau hauv cov zis, exposure tsub kom yuav tsum tau nyob rau hauv cov neeg mob uas lub raum tsis ua hauj lwm [saib Tshuaj Kho Mob (12.3) ].

Siv ceev faj thaum muab phentermine rau cov neeg mob lub raum tsis ua hauj lwm. Hauv cov neeg mob uas muaj lub raum tsis zoo (eGFR 15 txog 29 mL / min / 1.73mob), txwv cov koob tshuaj phentermine rau 15 mg txhua hnub [saib Dosage thiab Administration (2.2) ]. Phentermine tsis tau kawm hauv cov neeg mob nrog eGFR tsawg dua 15 mL / min / 1.73mob, nrog rau cov kab mob raum kawg uas yuav tsum tau lim ntshav; zam kev siv hauv cov neeg no.

Drug Abuse thiab Dependence

Tshuaj tswj

Phentermine yog Schedule IV tswj cov khoom.

Kev tsim txom

Phentermine muaj feem xyuam rau chemically thiab pharmacologically rau cov amphetamines. Amphetamines thiab lwm yam tshuaj stimulant tau raug tsim txom ntau heev thiab muaj peev xwm ntawm kev tsim txom ntawm phentermine yuav tsum tau khaws cia nyob rau hauv lub siab thaum ntsuam xyuas lub desirability ntawm xws li ib tug tshuaj raws li ib feem ntawm ib tug yuag kev pab cuam.

Kev vam meej

Kev tsim txom ntawm amphetamines thiab lwm yam tshuaj yuav cuam tshuam nrog kev mob siab rau kev puas siab puas ntsws thiab kev ua haujlwm tsis zoo hauv zej zog. Muaj cov lus ceeb toom ntawm cov neeg mob uas tau nce qhov koob tshuaj ntawm cov tshuaj no mus rau ntau zaus dua li kev pom zoo. Kev tshem tawm sai sai tom qab kev siv tshuaj ntau ntau ua rau qaug zog thiab kev nyuaj siab heev; Cov kev hloov pauv tseem raug sau tseg ntawm kev pw tsaug zog EEG. Kev tshwm sim ntawm kev qaug cawv ntev nrog cov tshuaj anorectic muaj xws li mob hnyav dermatoses, cim insomnia, chim siab, hyperactivity thiab hloov tus cwj pwm. Ib qho kev tshwm sim loj ntawm kev qaug cawv ntev ntev yog kev puas siab puas ntsws, feem ntau kho tsis tau los ntawm tus mob schizophrenia.

Kev noj ntau dhau

Yam tsawg kawg nkaus yuav tsum tau muab tshuaj los yog muab tso rau hauv ib lub sij hawm txhawm rau txo qhov muaj peev xwm ntawm kev noj ntau dhau.

Mob Overdosage

Cov tsos mob ntawm tus mob overdosage muaj xws li nyob tsis tswm, tshee, hyperreflexia, ua pa sai, tsis meej pem, assaultiveness, hallucinations, thiab ceeb lub xeev. Kev qaug zog thiab kev nyuaj siab feem ntau ua raws li lub hauv paus stimulation. Cov teebmeem ntawm cov hlab plawv muaj xws li arrhythmia, kub siab lossis hypotension, thiab cov hlab ntsha tawg. Cov tsos mob ntawm plab hnyuv muaj xws li xeev siab, ntuav, raws plab thiab mob plab. Kev noj ntau dhau ntawm cov tshuaj pharmacologically zoo sib xws tau ua rau muaj kev phom sij txaus ntshai feem ntau xaus rau hauv convulsions thiab coma.

Kev tswj tus mob phentermine hydrochloride intoxication yog cov tsos mob loj heev thiab suav nrog lavage thiab sedation nrog barbiturate. Kev paub nrog hemodialysis lossis peritoneal dialysis tsis txaus kom tso cai pom zoo hauv qhov no. Acidification ntawm cov zis nce phentermine excretion. Intravenous phentolamine (Regitine®, CIBA) tau raug pom zoo los ntawm cov chaw muag tshuaj rau qhov ua tau mob hnyav, kub siab hnyav, yog tias qhov no cuam tshuam ntau dhau.

tshiab fda tso cai tshuaj tshiab

Mob ntshav qab zib

Kev tshwm sim ntawm kev qaug cawv ntev nrog cov tshuaj anorectic muaj xws li mob hnyav dermatoses, cim insomnia, chim siab, hyperactivity thiab hloov tus cwj pwm. Qhov tshwm sim hnyav tshaj plaws ntawm kev mob ntshav siab ntev yog kev puas siab puas ntsws, feem ntau kho tsis tau los ntawm tus mob schizophrenia. Saib Kev siv tshuaj yeeb thiab kev cia siab (9.3) .

Phentermine Capsules Description

Phentermine hydrochloride yog ib qho sympathomimetic amine anorectic. Nws lub npe tshuaj yog α, α,-dimethylphenethylamine hydrochloride. Tus qauv qauv yog raws li nram no:

Phentermine hydrochloride yog ib tug dawb, tsw, hygroscopic, crystalline hmoov uas yog soluble nyob rau hauv dej thiab qis cawv, me ntsis soluble nyob rau hauv chloroform thiab insoluble nyob rau hauv ether.

Phentermine hydrochloride capsules USP yog muaj nyob rau hauv lub qhov ncauj capsule muaj 15 mg los yog 30 mg ntawm phentermine hydrochloride (sib npaug rau 12 mg los yog 24 mg ntawm phentermine puag).

Txhua phentermine hydrochloride capsule muaj cov khoom xyaw hauv qab no: hmoov txhuv nplej siab 1500, lactose monohydrate thiab magnesium stearate. Phentermine hydrochloride capsules 15 mg kuj muaj D&C daj No. 10, FD&C liab No. 3, FD&C xiav No 1, FD&C liab No. 40, gelatin thiab titanium dioxide. Phentermine hydrochloride capsules 30 mg kuj muaj D&C daj No. 10, FD&C liab No. 3, gelatin thiab titanium dioxide. Cov tshuaj pleev xim rau cov tshuaj ntsiav muaj cov khoom xyaw hauv qab no: shellac glaze hauv ethanol, hlau oxide dub, n-butyl cawv, propylene glycol, SDA 3A cawv, methanol, FD&C xiav No. 2, FD&C liab No. 40, FD & C xiav No. 1, thiab D&C daj No. 10.

Phentermine Capsules - Chaw Kho Mob Pharmacology

Mechanism ntawm Action

Phentermine yog ib qho sympathomimetic amine nrog cov tshuaj pharmacologic zoo ib yam li cov qauv tshuaj ntawm cov chav kawm no siv rau kev rog, amphetamine (d- thiab d.ll-amphetamine). Cov tshuaj ntawm cov chav kawm no siv rau kev rog rog feem ntau hu ua 'anorectics' lossis 'anorexigenics'. Nws tsis tau raug tsim los ua qhov tseem ceeb ntawm cov tshuaj no hauv kev kho kev rog rog yog ib qho kev noj qab haus huv vim tias lwm yam kev ua haujlwm hauv nruab nrab paj hlwb, lossis cov teebmeem metabolic, kuj tuaj yeem koom nrog.

Pharmacodynamics

Cov kev ua ntawm amphetamines muaj xws li central paj hlwb stimulation thiab nce ntshav siab. Tachyphylaxis thiab kam rau ua tau pom nrog tag nrho cov tshuaj ntawm cov chav kawm no uas cov phenomena tau saib rau.

Pharmacokinetics

Ua raws li kev tswj hwm ntawm phentermine, phentermine ncav cuag qhov siab tshaj plaws (Cmax) tom qab 3 mus rau 4.4 teev.

Cov pejxeem tshwj xeeb

Lub raum tsis zoo

Cov urinary excretion ntawm phentermine nyob rau hauv uncontrolled urinary pH tej yam kev mob yog 62% -85%.

Kev raug mob ntawm phentermine tuaj yeem nce mus txog 91%, 45%, thiab 22% hauv cov neeg mob uas muaj mob hnyav, nruab nrab, thiab lub raum tsis zoo, raws li [saib Dosage thiab Administration (2.2) thiab Siv hauv Cov Pej Xeem Tshwj Xeeb (8.6) ].

Kev Sib Tham Tshuaj

Nyob rau hauv ib tug tib-dose txoj kev kawm muab piv cov exposures tom qab lub qhov ncauj kev tswj ntawm ib tug ua ke capsule ntawm 15 mg phentermine thiab 92 mg topiramate rau cov exposures tom qab lub qhov ncauj tswj ntawm ib tug 15 mg phentermine capsule los yog ib tug 92 mg topiramate capsule, tsis muaj qhov tseem ceeb topiramate raug hloov. nyob rau hauv lub xub ntiag ntawm phentermine. Txawm li cas los nyob rau hauv lub xub ntiag ntawm topiramate, phentermine Cmaxthiab AUC nce 13% thiab 42%, feem.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Kev tshawb fawb tsis tau ua nrog phentermine los txiav txim lub peev xwm rau carcinogenesis, mutagenesis lossis impairment ntawm fertility.

Kev tshawb fawb soj ntsuam

Hauv kev sim tshuaj luv luv, cov neeg laus rog rog tau qhia hauv kev tswj hwm kev noj zaub mov thiab kho nrog 'anorectic' cov tshuaj poob ntau qhov hnyav ntawm qhov nruab nrab dua li cov uas tau kho nrog cov placebo thiab noj zaub mov.

Qhov loj ntawm kev poob phaus ntawm cov neeg mob kho cov tshuaj ntau dua cov neeg mob uas tau txais cov placebo tsuas yog ib feem ntawm ib phaus ib lub lim tiam. Tus nqi ntawm kev poob phaus yog qhov loj tshaj plaws nyob rau hauv thawj lub lis piam ntawm kev kho mob rau ob qho tib si tshuaj thiab cov placebo cov ntsiab lus thiab yuav txo tau nyob rau hauv lub lis piam ua tiav. Lub hauv paus muaj peev xwm ntawm qhov poob phaus ntxiv vim muaj ntau yam tshuaj cuam tshuam tsis tau tsim. Tus nqi ntawm kev poob phaus cuam tshuam nrog kev siv cov tshuaj 'anorectic' nws txawv ntawm kev sim mus sim, thiab qhov kev poob phaus nce ntxiv zoo li muaj feem cuam tshuam rau qee qhov kev hloov pauv uas tsis yog cov tshuaj tau sau tseg, xws li tus kws kho mob-tus kws tshawb fawb, cov pej xeem kho. thiab cov zaub mov uas tau sau tseg. Cov kev tshawb fawb tsis tso cai rau cov lus xaus txog qhov tseem ceeb ntawm cov tshuaj thiab cov tshuaj tsis yog tshuaj rau kev poob phaus.

Cov keeb kwm ntawm kev rog rog yog ntsuas ntau xyoo, qhov kev tshawb fawb tau txwv rau ob peb lub lis piam lub sijhawm; Yog li, tag nrho cov kev cuam tshuam ntawm kev noj tshuaj vim poob phaus dhau ntawm kev noj zaub mov ib leeg yuav tsum tau txiav txim siab kho mob txwv.

Yuav Ua Li Cas Muab / Cia thiab tuav

Muaj raws li

Phentermine hydrochloride capsules USP, 15 thiab 30 mg yog muab raws li:

15 mg capsules, grey / daj; imprinted 'EL600' nyob rau hauv tus cwj mem dub ntawm lub hau thiab lub cev, ntim nrog cov hmoov dawb rau cov hmoov dawb. Lawv muaj nyob rau hauv fwj ntawm 100 (NDC 51224-203-50) thiab 1000 (NDC 51224-203-70).

30 mg capsules, daj; imprinted 'EL601' hauv tus cwj mem dub ntawm lub kaus mom thiab lub cev, ntim nrog cov hmoov dawb mus rau dawb. Lawv muaj nyob rau hauv fwj ntawm 100 (NDC 51224-202-50) thiab 1000 (NDC 51224-202-70).

Khaws ntawm 20 ° txog 25 ° C (68 ° txog 77 ° F) [Saib USP Controlled Room Temperature].

Dispense rau hauv lub thawv nruj raws li tau teev tseg hauv USP, nrog rau kev kaw me nyuam yaus (raws li xav tau).

Khaws kom deb ntawm cov menyuam yaus.

Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob

Cov neeg mob yuav tsum tau ceeb toom tias phentermine hydrochloride yog ibluv luv(ob peb lub lis piam) adjunct nyob rau hauv ib tug regimen ntawm yuag poob raws li kev tawm dag zog, kev hloov tus cwj pwm thiab caloric txwv nyob rau hauv kev tswj ntawm exogenous rog, thiab hais tias coadministration ntawm phentermine nrog rau lwm yam tshuaj rau poob phaus tsis pom zoo [saib Kev taw qhia thiab kev siv (1) thiab Ceeb toom thiab ceev faj (5.1) ].

Cov neeg mob yuav tsum tau qhia ntau npaum li cas phentermine coj, thiab thaum twg thiab yuav ua li cas coj nws [saib Dosage thiab Administration (2) ].

Qhia cov poj niam cev xeeb tub thiab cov niam laus kom tsis txhob siv phentermine (saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.1 , 8.3) ].

Cov neeg mob yuav tsum raug ceeb toom txog qhov txaus ntshai ntawm kev siv phentermine (xws li cov kev pheej hmoo uas tau tham hauv Kev Ceeb Toom thiab Kev Ceeb Toom), txog cov tsos mob ntawm qhov tsis zoo tshwm sim thiab thaum twg yuav tiv tauj ib tus kws kho mob thiab / lossis ua lwm yam. Cov kev pheej hmoo suav nrog, tab sis tsis txwv rau:

Saib ntxiv, piv txwv li, Kev tsis pom zoo (6) thiab Siv nyob rau hauv cov neeg tshwj xeeb (8) .

Cov neeg mob yuav tsum tau qhia txog

Qhia rau cov neeg mob kom phentermine nyob rau hauv ib qho chaw nyab xeeb los tiv thaiv tub sab nyiag, tsis siv neeg overdose, misuse los yog tsim txom. Muag los yog muab phentermine yuav ua mob rau lwm tus thiab yog txhaum txoj cai.

Yog xav paub ntxiv hu rau TAGI Pharma, Inc. ntawm 1-855-225-8244 lossis e-mail druginfo@tagipharma.com

Tsim los ntawm:
Elite Laboratories, Inc.
Northvale, NJ 07647

Muab faib los ntawm:
TAG Pharma
Sab Qab Teb Beloit, IL 61080

Kho tshiab lub Tsib Hlis 2019
ib 0501

PRINCIPAL DISPLAY PANEL - 15 mg Capsule Bottle Label

NDC 51224-203-70

CIV

Phentermine
Hydrochloride
Capsules USP

15 mg ib

Grey/daj

Rx xwb

1000 Capsules

tag PHARMA

PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label

NDC 51224-202-70

CIV

Phentermine
Hydrochloride
Capsules USP

30 mg

Daj

Rx xwb

1000 Capsules

tag PHARMA

PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride ntsiav tshuaj
Cov ntaub ntawv khoom
Yam khoom HUMAN PRESCRIPTION DRUG LABEL Yam khoom Code (Source) NDC: 51224-203
Txoj kev tswj hwm ORAL DEA Teem caij CIV
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 15 mg ib
Cov khoom xyaw uas tsis muaj zog
Cov khoom xyaw npe Lub zog
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, TAPIOCA
D&C YELLOW NO. 10
FD & C RED NO. 3
TITANIUM DIOXIDE
GELATIN, tsis paub meej
FD&C BLUE NO. 1
FD & C RED NO. 40
Cov yam ntxwv ntawm cov khoom
Xim YEEB, GREY Cov qhab nias tsis muaj qhab nias
Cov duab CAPSULE Loj 16 hli
Nplaim Imprint Code TSI 600
Muaj
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 51224-203-50 100 CAPSULE hauv 1 BOTTLE
ob NDC: 51224-203-70 1000 CAPSULE hauv 1 BOTTLE
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 202248 02/17/2012
PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride ntsiav tshuaj
Cov ntaub ntawv khoom
Yam khoom HUMAN PRESCRIPTION DRUG LABEL Yam khoom Code (Source) NDC: 51224-202
Txoj kev tswj hwm ORAL DEA Teem caij CIV
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 30 mg
Cov khoom xyaw uas tsis muaj zog
Cov khoom xyaw npe Lub zog
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, TAPIOCA
D&C YELLOW NO. 10
FD & C RED NO. 3
TITANIUM DIOXIDE
GELATIN, tsis paub meej
Cov yam ntxwv ntawm cov khoom
Xim YAJ Cov qhab nias tsis muaj qhab nias
Cov duab CAPSULE Loj 16 hli
Nplaim Imprint Code TIAB SA 601
Muaj
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 51224-202-50 100 CAPSULE hauv 1 BOTTLE
ob NDC: 51224-202-70 1000 CAPSULE hauv 1 BOTTLE
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 202248 02/17/2012
Labeler -TAGI Pharma, Inc (963322560)
Sau npe -TAGI Pharma, Inc (963322560)
Kev tsim kho
Lub npe Chaw nyob ID/FEI Kev ua haujlwm
Elite Laboratories, Inc. 785398728 ib LABEL(51224-203), MANUFACTURE(51224-202)
TAGI Pharma, Inc.