Nalbuphine Hcl Kinz 20mg Injection by Sami 1 amp

Description

Kinz Injection

(Nalbuphine HCL)

DESCRIPTION:

Kinz* (Nalbuphine hycir^:~r cr.’;? 5 a s^the i’c narcotic agonist;’ antagonist analgesic of the phenanlhrene series. !t is che[rt!C3:’y reiaied i’j both the wtW: Jsad narcotic antagonist, natoxune, andihe poleni narcotic analgesic. oxyrr.s’^ri’Jne, Kinz’ a a sterile solution suitable for subcutaneous, intramuscular or intravenous injection

COMPOSITION;

Kinz’ lO mg Injection

^a:?¹ ml contains. :,,….-..piT.i; HCL MS… ………..tumg

Kinz 20 mg Injection Each ml contains:

Nalbuphine HCL.,.20 mg

PHARMACOLOGY:

Kinz” is 3 potent a-3 ^i : its analgesic potency is essentially equivalent lo ‘.hat of morphine on a milligram basis. Receptor studies show that Kinz^ bind to Mu. I^ppa, and Udta receptor:;, but not to Sigma receptors. Kinz^ ;s :”-‘”‘a”:y a Kappa agonist / partial mj 3,”to 3on:st analgesic

The onset of action c’f Kinz’- o::-‘s w,;f ” 2 ;: 3 ynirutes after intravenous administration, and in less than 15 minutes f chowing subcutaneous or ‘intramuscular injection, The plasma haif-‘ife of Nalbuphine is 5 hours and in climcsi s”,c es the di.ra’iG'”. of analgesic activity has been reported to range from 3 to 6 hours”‘e “arcaticanlagoniJ’a:'”.!!^^^” ;s one-fourtn as potent as r^orpr-ir-.e and ‘0 times trial of Plasticine.

Ksnz. may pfcdiJce trie adnie a&yiee of rysDirdtGly deproisiun as siitiianaSQesic uuatis yi i”i’ik;i’Fhi’i&. Hc’ncVijr- kirb Sf^iclis a celling affeci sui;h mat increases \n ijose gi’Kaier iten ?0mg do .101 proiiui-s further respiratory depression in the absence of other CNS active medications affecting respiration.

INDICATIONS AND USAGE:

Kini ^ :~^ ^’rg to'” the reilaf ofmofieraie to severe pain. Kinz” can also be used as a suppiement to balanced anaesthesia, for preoperative ant! postoperative anaiges’s, and for obsietrical ardtgesia during iabc.L; ar. •.^i’.er,

CONTRAINDICATIONS / WARNINGS:

Kinz’ £!”-..; c ‘••o¹ ^e a.”‘”‘ •’•ste^ej ic oat’ems ^”c arp ^.’pe’sensitive to naifc-JFhine nydrcch’oride

Kinz- may impar ;’e ^e.’ilsl oroTySiCri; aGilili&a reqLire.’; for ir;t; per’criiirir.i.^ -• ^oten’^’!/ danycrcus »33′.5 ^i-;^ a? during a car ornperaling mach’rery, Tn£’c’lor>-‘ Kinz’ ‘:’cud be ^dminislfcrri.. wih i;au!lQ[ to ambufatoPi’ p^t^e”^ ‘^”: shou!d be ‘.’/arned to avoid such hazards. Maintain patient under otissrvatfcr; unlii recovered from Kinz effects (hat would affect driving or other potentiality dangerous tasks Pregnancy

Teratogenic Effects: Pregnancy Category B

Safe use of Kinz” in prri_;-an;y has no! been established. Although animal reproductive studies have not re<,’t,aied allergenic or embryo toxin- effects Nalbuphine should tiR administrative to pregnant women 3ily ifdeariy needed

Use During Labor and Delivery

The placental transfer 0; r;a:b’JFh;r;e is h.’Ji, ra?:d anG •••^•.doie *:[h a msterna; tc ‘eiai ra;;o ranging from 1,0,37 ‘; “,:6. Fetal and neonatal adverse effects lha; have been reported following the administration

.j? n.-iio’.iDhine id the mother 1-^1-1 r;g ‘afcor ,,–‘ude fetd! brt-‘dvca’d;3. rescTdtorv cieufession at birth, apnea, cyanosis and riypolonia. Maternal administration of naloxone during tabor has normalized these effects ‘n some cases SB’/sre ai’i! pr,;;;”^;? :”e-?., st^.];’:^^ has ^fit rspurisd Po’msr-s-;! i^L.r^XG,.,;^! ijsn^e 5i;r;:;.,;s.”i ‘.-i fsal bradyea.-aia pas occufrsd, A sinuso;aal fe:^¹ hear’ ‘ale p;i”?rn Rssoc^s^d with the use of Nalbuphine has been reported, Kinz- si-isuld iu- used i.'<!!h caution in ‘.’.omen during iabur ?tid delivery, and ne/.borns .shouid be fnoi’];iored for respiratory depression, aFi’e.: L’radyRardia and a’-hitr’niaa fKinz” has been used Head ‘riJury and increased Intracraniai Pressure

Trie 3^ss;i;!e respiratory depressant effects and the potential ct poient ansigesies to eisvate cerebrospins’ fluid pressure (resuiti^g froir, vaSGdtiatior, ;0!f0,’;!’-g C0.-relent!cn; Tiay be markedly exaqgsiafsfl in ‘he p”6sencE Gf head iniuiv, intracranial ‘esions or a pre-sxisling increase in intracranial pressure fi. Fijilhenriore. potefil anaiges.ss can produce effects which may ooscure the clinical course o¹ patients with hes’;’ ‘”iLries. Therefore, Kinz • should be used in thesa circumstances only when essential and then shauld be gdffiiriisisred •.’.itr’ eKtreme caiition interaction.

A;;’-cu9h Kinr possesses rarccli: aniagonist activity, thsre is evidsncs that ;n nondecendent patients ft wi!i no; aniagoniss a narcotic anaisesicadminisieis^iust before, concurrently, 0? just afe”- an ‘njsciion cf Kinz- . Therefore, palienis receding a narcotic analgesic, general anaesthetics, phe w, hi a^nes, 01 uther t:anqu;]i-‘ers. ^.idati.’es- hvpnolics, or other CNS Gepressants (Including alt.’-.rol; cr.nLOii^ar,;!,’ w^i

Kinz’ may ex;iicit an additive effect- When such combined therapy is contemplated, the dsss of one or both agents shcuia be reG;iced

PRECAUTIONS:

Impaired Respiration

At t’-s u;ujt aduii dose oS 1 L;:Ttg,’70kg, Kina;-” causes sonne respiratory Qeprsssior’ apFreximately equa! to that produced by equa! dosss of morpnine, HGi’.e’.’er. in contrast ^ mcfpi’ine, respirator/ ijepression i^ nc; dC^reciatilv increiiseci .vith hghe'” doses ofKInt-‘. Respiratory depress:-)-” ‘ndiJCRil b^Nalbuphine car. be reversed by I’Nal-‘xonHf.ydrochioride; when indicated. Kinz’ should he admir.isiered with caution si ica dQs°= to patients ‘••’.th :mpaireti respiration

Impaired Renal or Hepatic Function

Because Kinz-‘ .s meiabo^sG •n !r;e ;[ver anc ex;’eted by !f5 kidneys, Knu-‘ slicLiiti bs used aii^ csulior. ?i: paiients ‘.yili; renai or ir./sf d^^nc’.’o,’ ana ;iaministRrei: in reduced amounts Myocardia] infarclion.

As :’;’:h a^! (iOSen’ analgesics, Kiiiz shou;^ be used with caiiiion in patients with myocardiat interaction wiio have nausea or vomiting.

Biliary Tract Surgery

As with ail n&rwiQ anafQesics, Kfnz” shoi-‘iij be used win cation in patient about to undergo surgery’ of the billiard tract sine⁰ !t nin/ csuse spasm of the sphincter of Dddi

Cardiovascular System

During eva^llJa⁽.,l,•; cf Kinz– in aiiaesthe&ia. a higher mcidenc’i or bradycardia has been reported in patienis, .vrto did not (eeeivs a’rcpinfi preoperativeiy