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Profile Profile Profile Profile Uses and Administration Adverse Effects And 640 Antihistamines Propiomazine Hydrochloride {BANM, r!NNMJ P..r�p�rc:Jti()n.� ............................ m (details are given in Volume B) propiorf,azina; to o azine; Chiorhydrate ProprietaryPreparations HidrodoruroPropi<;>rn deazini HydrochloridP pium; f1ponvtot,la3Y!Ha China: Qi Qi Hung. : de; Single-ingredient Preparafions. Loderixt. CIH'f); rMAPOX!10p!'\A. C;cJcl1_,--N_,QS,HCI�3.76_91 Rupatadine is an antihistamine with platelet-activating CAS 240) 5-9. factor (PAF) antagonist activity that is used for the Terfenadine (BAN, USAN, r!NN) treatment of allergic rhinitis (p. 612.1) and chronic 1 idiopathic urticaria (p. 612.3). It is given as the fumarate although doses are expressed in terms of the base; rupatadine fumarate 12.8 mg is equivalent to about 10 mg of rupatadine. The usual oral dose is the equivalent of 10 mg once daily of rupatadine. Izquierdo I. et a!. Rupatadine: a new selective histamine HI receptor and platelet-activating factor (PAF) antagonist: a review of pharmacological profile and clinical management of allergic rhinitis. Drugs Today 2003; 39: 451-68. 2. Kearn SJ,Plosker GL. Rupatadine: a review of its use in the management of allergic disorders. Drugs 2007; 67: 457-74. 3. Fantin et at. International Rupatadine study group. A 12-week 5, 8: (Terfenadine). A white or almost white, placebo-controlled study of rupatadine 10 mg once daily compared with Ph. Bur. cetirizine IO mg once daily, in the treatment of persistent allergic crystalline powder. It shows polymorphism. Very slightly rhinitis. Allergy 2008; 63: 924-3 1. soluble in water and in dilute hydrochloric acid; freely 4. Valero A, et a!. Safety ofrupatadine administered over a period of 1 year soluble in dichloromethane; soluble in methyl alcohol. in the treatment of persistent allergic rhinitis; a multicentre, open-label Protect from light. Profile study in Spain. Drug Safety 2009; 32: 33-42. Propiomazine, a phenothiazine derivative, is a sedating antihistamine (p, 610,1) that has been used for its sedative Effects on the cardiovascular system. Licensed product Uses and Administration and antiemetic properties in insomnia (p. 611.2) and nausea information states that the cardiac safety of rupatadine has and vomiting (p, 61 L 3). been assessed; no adverse ECG effects were noted when Terfenadine, a piperidine derivative, is a non -sedating Propiomazine is given as the maleate but doses are rupatadine was given in doses of up to 10 times the nor­ antihistamine. It does not have significant antimuscarinic expressed in terms of the base; propiomazine maleate mal dose. Nevertheless, it is recommended that rupatadine actions. It has been used for the symptomatic relief of 1.3 mg is equivalent to about 1 mg of propiomazine. Doses is used with caution in patients with known prolongation allergic conditions including rhinitis (p. 612.1) and equivalent to 25 to 50 mg orally at night have been given as of the QT interval, uncorrected hypokalaemia, or condi­ conjunctivitis (p. 611.1) and skin disorders such as urticaria a hypnotic. tions such as bradycardia or acute myocardial ischaemia. (p. 612.3). Propiomazine hydrochloride has been given parenter­ A review of Spanish and Portuguese spontaneous The maximum oral dose of terfenadine is 120 mg daily ally. reporting scheme data found 5 cases of heart rhythm given either as 60 mg twice daily or 120 mg in the morning; disturbances in patients taking rupatadine.1 Such effects a starting dose of 60 mg daily in a single dose or in two Porphyria. The Drug Database for Acute Porphyria, com­ included palpitations and tachycardia and 1 case of torsade divided doses is recommended for rhinitis and conjunctiv­ piled by the Norwegian Porphyria Centre (NAPOS) and de pointes in an elderly man. itis. For dosage in renal impairment see below. the Porphyria Centre Sweden, classifies propiomazine as I. Carvajal A, et al. Heart rhythm disturbances associated with rupatadine: not porphyrinogenic; it may be used as a drug of first a case series from the Spanish and Portuguese pharmacovigilance choice and no precautions are needed.1 systems. Clin Pharmacol Ther 2009; 85: 481-4. Administration in renal impairment. Half the usual oral 1. The Drug Database for Acute Porphyria. daily dose of terfenadine (see above) has been suggested drugs-porphyria.org (accessed 07/10/11) for patients with creatinine clearance less than 40 mL/mi­ nute. Preparations ProprietaryPreparations (details are given in Volume B) Single-ingredient Preparations. Arg.: Rupafin; Austria: Rupafin; ProprietaryPreparations (details are given in Volume B) Belg. : Rupatall; Braz.: Rupafin; Cz.: Tamalis; Fr. : Wystamm; Adverse Effects and Precautions Rupafint; Urtimed; Rupafin; Levostar-R; Single�ingredient Preparations. Swed.: Propavan. Ger.: Gr.: India: Irl.: As for the non-sedating antihistamines in general, p. 613.1. Rupafin; Ital.: Pafinur; Rupafin; Neth.: Rupafin; Pol.: Rupafin; Erythema multiforme and galactorrhoea have also been Port.: Rinialer; Spain: Alergoliber; Rinialer; Rupafin; Thai.: Rupafin; Turk.: Rupafin; UK: Rupafin. reported. Quifenadine Hydrochloride (r!NNMJ 1 Ventricular arrhythmias, including torsade de pointes, have occurred rarely with terfenadine, particularly in Hicirodorvro <)uifenadiha; Qlji(ena<:line. Ch!orhydrat,-;.d�; 1 association with raised blood concentrations (see Arrhyth­ QuifenadiQI Hydrde ochiorldum; Xt<l<j)eHagvtHa ff11lPO:><JJOPY11l• Sequifenadine (riNNJ mias, below). To reduce the risk of developing such a,a, Oipheny!· 3,qulnudidil1emethanol hydrochloride. Bicarphene (s"(juifenadine s�qoifi!Mdine nydrqch!oricie); arrhythmias the recommended dose should not be C;cH73NO,HCI-=3299 . or (sequifenadine exceeded and terfenadine should be avoided in patients · Bikarfen · or . .sequifenadine. hydrochloride); . .. ... '-'- . Sequifenadina; Sequiferradlp,e; Sequifenadinum; with cardiac or significant hepatic disease, with hypokal­ CA S 10447,39-9 (q uifenadirlei; )0447-38-8 {quifenadine CexvujleH-1At<!-} aemia or other electrolyte imbalance, or with known or hydrochlor!d e!- P.o·Di�o;tqlyl"3f.uit\udklineruerhariol.· suspected prolonged QT intervaL Use with drugs liable to ATC ,....,. R06AX3 1. C21H27N0=321.S interfere with the hepatic metabolism of terfenadine, other A[CVet � OR06AX31. potentially arrhythmogenic drugs including those that Profile .0\S 5773+69'7. prolong the QT interval, and drugs likely to cause electrolyte imbalance is contra-indicated (see Interactions, p. 641.1). UNJI �CJQ3T8R3F';>.. Quifenadine is an antihistamine given orally as the If palpitations, dizziness, syncope, or convulsions occur hydrochloride. Profile terfenadine should be withdrawn and the patient investigated for potential arrhythmias. Preparat ons Sequifenadine is an antihistamine used in a wide range of i allergic conditions. A usual dose is 50 to I 00 mg given orally Proprietary Preparations (details are given in Volume B) 2 or 3 times daily. Sequifenadine is reported also to have Alopecia. Hair loss was associated with use of terfenadine in a 24-year-old patient.1 Regrowth occurred when treat­ Rus.: Phencarol (cl>eHKapon); antiserotonin properties. Single-ingredient Preparations. ment was stopped. Ukr.: Phencarol (<PeHKapon). Preparat ons 1. Jones SK. Morley WN. Terlenadine causing hair loss. BMJ 1985; 291: i 940. Proprietary Preparations (details are given in Volume B) Rupatadine (r!NNJ Single-ingredient Preparations. Rus.: Histafen (!HcTalj>eH); Ukr.: Arrhythmias. Ventricular arrhythmias including torsade Rupatadina; Rupatadinum; Gistaphen (fncTaclJeH). de pointes have occurred with terfenadine at doses greater 8-Chror�c6J ·dihydro" 11-{F[(5P)1hara,itvtH,-methyi-J·pyr idy[)methyl)'4, than those recommended1 and also at normal doses in piperidy;idenc)-5H-benLo[5,6Jcy1 clohepta{1 .2-b]pyridine. patients whose metabolism of terfenadine is impaired by Setastine Hydrochloride (r!NNMJ drugs or by liver disease. Generalised convulsions and a C;.oH,,;CIN.=416.0 quinine-like effect on the ECG have also been reported - Hkfro oruro de. ietastina; .Setastina, CA S 158876-82'5. d after a presumed overdose of terfenadine 2 Consequently --­ hidrodorurEGIS·2062; .oEGYT:f062; de: Chlorhydrate Setastini ATC recommendations have ·been made to reduce the risk of 1--!yd(oChloridum; (eTaSetastlne,Ha rwt1po:>mopr 1):!. de;. ATC vet SI' . ·· .· • developing serious arrhythmias (see Adverse Effects and --' do tll!VI<I.K'-�" 1-(2-[(p,Chloro.'a•m.etbyt'a'phen�lbeQzyl)oxy]ethyJlh. �· xahy- Precautions, above, for details), including those from the UN/! · dro- N,azepine hydrochloride, UK CSM. 3.4 Terfenadine should be stopped immediately, Rupatadine Fumarate {r!NNMJ C12H18CJ INO,HCI=394A. and the patient evaluated for potential arrhythmias, in those who have syncope, palpitations, dizziness, or con­ ru atadln Fumar te --, 6429+9s-7 ; Rupatadrne, � vulsions after taking terfenadine. RupaFurna.ratoadini. deFurnaras; p JJ R,1a 2592 Fumarate; PynaraAMHade; 0\5 (setastiner t Studies' have suggested that the ventricular arrhythmias Profile are due to terfenadine itself rather than its active metabolite 8-Ch!oro·f,,(j)yMapar .1 1•dihydro•1.1-{1 cf(S�methyl:�· yrid l)methyl]-4- p jf Setastine hydrochloride, a derivative of clemastine, is an fexofenadine (p. 629.1). Terfenadine has been shown to piperldylidene)·5Hcbenzo[5,6]cydohepta(1 ,2-b)pyridlne antihistan1ine that has been claimed to have no sedative inhibit cardiac potassium channels, which results in 2-butenedioate. (E); activity. It is given for the symptomatic relief of prolongation of the QT interval. a risk factor for developing C16H"6CIN1,C,H,04=532 Q hypersensitivity disorders. arrhythmias, while the non -sedating antihistamines cetir- All cross-references refer to entries in Volume A .
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