DuraQuln”
(QUINIDINEGLUCONATE TABLETS)sustained-release tablets, 330 mg Bnef summary continued from previous page 4 Because qulnidlne antagonizes the effect 01 vagal exc~lalion upon Ihe alwm and the A-V node the adm~nlstrallon 01 parasympathomlmetlc drugs (choline esters) or the use of any other procedure lo enhance vagal acl~vify may Iail 10 termlnale paroxysmal supraven lwcular tachvcardla I” pat,ents rece~wnq aulnidlne 5 Qu,“,d,“~should be used with extre&! cauhon I” a) The presence 01 ~ncom~lele A V block. since a complele block and asyslole may result Ou,n,d,‘ne may cause unpredlclable abnormalllles ot rhythm in dlgllallzed hearts Therefore. II should be used with caution I” the presence of dlgllalls ~nlox~cat~on (see 1 (b) above) b) ParIn bundle branch block c) Severe congeswe heart faNlure and hypoienwe stales due lo the depressant efk’cls of qulnidlne on myocardlal contractilkty and arler~al pressure d) Poor renal Iunction. especially renal tubular acldos,s. because 01 the potenl~al accumw latlon 01 qulnldnz I” plasma leadmg to toxx concentrations PRECAUTIONS: 1. Test Dose A prel~rnnary lest dose of a single tablet 01 qulnidme w/fare should be admnstered pnor to the !n,trai!on of the sustalned release gluconale lo detemwx? whether Ihe patient has an ldlosyncrasy 10 the Clundlne molecule 2. Hypersensitivity--During the llrst weeks of therapy. hypersens~tlwty lo quinldlne a+ though rare. should be considered (eg angloedema. purpura. acute asthmatic episode ~ascilarcollapse) 3. Long-TermTherapy-Perlodlc blood counts and lover and kidney function tests should be performed during long-term therapy and the drug should be dlsconllnued 11blood dyscraslas or signs of hepafic or renal disorders occur 4. Larae Doses-ECG mon~lor~na and delerm~nallon 01 plasma qund!ne levels are reck ommended when doses greater than 2 5 g/day are admnslered 5. Usage in Pregnancy-The use 01 qulnldlne. I” pregnancy, Should be reserved only for lhose cases where the bewilts outweIgh the possible hazards to the patlent and fetus 6. Nursing Mothers-The drug should be used wh extreme caution in nuwng mothers because the drug is excreted I” breast milk 7. General-In pal~entsexh~b~l~ng asthma. muscle weakness. and ~ntectlon with leverprror 10qundlne admlmstratlon, hypersens~Mfy reacttons to the drug may be masked DRUG INTERACTIONS: 1 Caution should be used when qulnid~ne and its analogs are admlntslered concurrently with caumar~n anticoagulants This comblnatlon may reduce prolhrombln levels and cause bleeding 2 Qwxd~ne. a weak base. may have 11shall-Me prolonged in patients who are concurrently takmg drugs that can alkailze lhe urine. such as thiarlde dlurencs, sodium bicarbonate and carbonic anhvdrase inhlbllors Oulnldlne and druos which alkallre the urine should be used together cautiously 3 Oulnidlne exhlblts a dlstlncl antlchollnerglc actlwty I” lhe myocardlal tissues An addltlve vagolytlc effect may be seen when qundine and drugs having anllchollwrg~c blocking actwtv are used foaelher Druas hawnq chollnerqlc acl!wty may be antagonized by qu,m&ne 4 Cjuinldlne and other antlarrhythmlc agents may produce additive cardiac depressant elfeels when admlnlsteredlogether 5 Oumtdlne mleracl~or wth cardiac glycosldes (dlgoxlnl See WARNINGS 6 AntacIds may delay absorplnn of qundme bul appear unlikely to cause mcomplete absorpllon 7 Phenobarbital and phenytoln may reduce plasma tKof qulnldlne by50% 8 Oulnldlne may potentlate the neuromuscular blockIng eflect in venlllarory depresston of paflenls recwtng decamelhonium, rubocurare, or succlnylchol~ne ADVERSE REACTIONS: Symptoms of clnchonlsm (rlnglng I” the ears. headache d!s tutbed VISIONSme” aooear I” sensli~ve patients after a slnqle dose of Ihe druq Gastrointesiinai: The most common side effecls encour?ered with quinldlne are relerable 10 lhls system Diarrhea frequently occurs. bul ,t rarely necessitates wIthdrawal of the drug Nausea vomiting. and abdomln~l paln also occur Some 01 these effecls may be mtmmwed by admlnlslerrng the drug with meals Cardiovascular: wldenlng of ORS complex, cardiac asystole. ventncular eclow beats. ldlovenrrlcular rhythms ncludlng ventricular tachycardlas and fibrMallon paradoxical tachycardIa. arier~al embolism and hypotenslon Hematologic: acute hemolytlc anemia. hypoprothromblnemla. lhrombocytopenlc purpura. agranulocytosls CNS: headache, fever vertigo, apprehension. exc~temenl, confusIon dellrlum and sync cope, dIsturbed hearing (I~nn~tus, decreased audltory acu~ly), dlsturbed YISIO” (mydrlasls blurred “IS~O”. dIsturbed color perceptIon. photophobia dlplopla, night blindness. scotomala). optic neuritis Dermatologic: cutaneous flushng wth ntense prurltus Hypersensitivity reactions: angloedema, acule asthmatic episode. vascular collapse. respmtory arrest DOSAGE AND ADMINISTRATION: Dosage should be titrated to give the desired clinical affect, e.g., elimination of paroxysmal rhythm or reduction in premature contractions (See CLINICAL PHARMACOLOGY). This will often require prolonged ambulatory ECG monitoring, as hour-to-hour variability renders brief ECG recordings unreliable. When doses larger than 2.5 g/day are used, quinidine blood levels should be monitored, if possible, and serial ECGs should be followed (See WARNINGS and PRECAUTIONS). For preventlo” of premature contractions and maintenance of normal sinus rhythm folIowIng spontaneous reversion or eieclrlcal conversion the usual dosage IS from 330 mg to 660 mg every eight hours, most pat,ents requ\r,ng the higher dose In elderly patients, and in patienls m the lower end 01 the normal weight range plasma qulnldlne determlnatlons should be consldered Dosage adjustments may be required OVERDOSAGE: Card~otox effects of qulnldlne may be reversed m part by molar sodturn lactate the hypotenslon may be reversed by vasoconstwtors and by catecholamlnes (since the vasodMon IS partly due to alpha~adrenerglc blockade) HOW SUPPLIED: N 0071-0850 (P-C 850) Duraquln (qulnidlne gluconate tablets) 330.mg tablets are SupplIed in bottles of 100 tablets YD AHFSCategory24 04
PARKE-DAV1S Diwsion of Warner-Lambert Vorris Plains. NJ 07950 A64
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