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Profile Profile Uses and Administration Adverse Effects and Precautions Oxapium lodide/Pantoprazole 1875 fentanyl citrate 50 micrograms/mL • i Oxyphencyclimine Hydrochloride P.��P.���t ?.n.�.............. ... ................. heparin sodium 100 units/mL . ············ ............................ (BANM, rfNNMJ • hydromorphone hydrochloride 500 micrograms/mL Praprietary Preparations (details are given in Volume B) • lidocaine hydrochloride 10mg/mL • Single-ingredient Preparations. Austria: Aloxi; Belg.: Aloxi; morphine sulfate 15 mg/mL • Braz. : Onicit; Chile: Onidt; China: Jiouting ("'�"RXW); Zhiruo pethidine hydrochloride 10 mg/mL • (ll:O!f);Cz. : Aloxi; Denm.: Aloxi; Ger.: Aloxi; Gr. : Aloxi; Hung.: potassium chloride 100 rnmol!litre • Aloxi; India: Palnox; Palonew; Palzen; Indon.: Palo xi; Irl. : sufentanil l2.5 micrograms/mL (as sufentanil citrate) • Aloxi; Israel: Paloxi; Ital.: Alox:i; Jpn: Aloxi; Mex. : Onicit; 1. Trissel LA, Xu QA. Physical and chemical stability of palonosetron HCI in Neth.: Aloxi; Norw. : Aloxi; Pol. : Aloxi; Port. : Aloxi; S.Afr. : Oni­ 4 infusion solutions. Ann Pharmacother 2004; 38: 1608-ll. cit; Singapore: Alox:i; Spain: Alox:i; Swed.: Aloxi; Switz. : Alox:i; et al. 2. Trissel IA Physical and chemical stability of palonosetron Thai. : Aloxi; Turk. : Aloxi; UK: Aloxi; USA: Aloxi; Venez. : Oni· hydrochloride with five opiate agonists during simulated Y �site administration. Am J Health-Syst Pharm 2007; 64: 1209-13. cit. 3. Kupiec TC, et al. Physical and chemical stability of palonosetron hydrochloride with five common parenteral drugs during simulated Y � site administration. Am J Health-SystPharm 2008; 65: 1735-9. Uses and Administration Profile Palonosetron is a 5-HT3 antagonist used in the prevention of nausea and vomiting induced by cytotoxic chemotherapy Oxyphencyclimine hydrochloride is a tertiary amine and for the prevention of postoperative nausea and antimuscarinic with effects similar to those of atropine vomiting. Palonosetron is given as the hydrochloride but (p. 1312.1). It has been used as an adjunct in the treatment doses are expressed in terms of the base; 280.8 micrograms of peptic ulcer disease and for the relief of smooth muscle of palonosetron hydrochloride is equivalent to about spasms in gastrointestinal disorders. 250micrograms of palonosetron. i For the prevention of acute and delayed nausea and P.�����t ?.n.�. ..... ... ........ vomiting associated with initial and repeat courses of . .. .. ················································ ProprietaryPreparations (details are given in Volume B) moderately or highly emetogenic cancer chemotherapy, a dose of 250 micrograms is given intravenously over 30 Single-ingredient Preparations. Hong Kong: Daricon; Thai.: KB Duode; Oxynot; Procliroine; Weicon. seconds about 30 minutes before chemotherapy. Palonose­ tron can also be given orally to prevent acute nausea and Multi-ingredient Preparations. China: Rudd·U (:lL!itr); Hong vomiting associated with initial and repeat courses of Kong: Aluvit-Ut; Thai.: Bismocane; Turk. : Spazmo-Valibrio. moderately emetogenic chemotherapy. A dose of 500 micr­ ograms is given about 1 hour before the start of chemotherapy. For the prevention of postoperative nausea and vomiting, for up to 24 hours after surgery, a single dose of 75 micrograms is given intravenously over 10 seconds immediately before the induction of anaesthesia. Efficacy beyond 24 hours has not been shown. Pharmacopoeias. In Chin., Bur. (see p. vii), and US. Reviews Ph. Bur. 8: (Pantoprazole Sodium Sesquihydrate). A white 64: 1. Siddiqui MAA, Scott U. Palonosetron. Drugs 2004; 1125-32. 2. Tonini G, et a!. New drugs for chemotherapy-induced nausea and or ahnost white powder. Freely soluble in water and in vomiting: focus on palonosetron. ExpertOpin Drug Metab Toxicol 2005; 1: alcohol; practically insoluble in hexane. Protect from light. 143-9. USP 36: (Pantoprazole Sodium). A white to off-white 3. Celio L, et al. Clinical update on palonosetron in the management of chemotherapy-induced nausea and vomiting. Tumori2008; 94: 447-52. powder. Freely soluble in water, in dehydrated alcohol, and 4. Yang LPH, Scott LJ. Palonosetron: in the prevention of nausea and in methyl alcohol; practically insoluble in dichloromethane vomiting. Drugs 2009; 69: 2257-78. and in hexane. Protect from light. 5. Navari RM. Palonosetron: a second generation 5-hydroxytryptamine 3 receptor antagonist. Expert Opin Drug Metab Toxicol 2009; 5: 1577-86. Stability. A suspension of pantoprazole 2 mg/mL in sterile Pharmacopoeias. In Pol. 6. Ruhlmann C, Herrstedt J. Palonosetron hydrochloride for the prevention of chemotherapy-induced nausea and vomiting. ExpertRev water and sodium bicarbonate was deemed to be physi­ Anticancer Ther 2010; 10: 137-48. cally and chemically stable' in amber polyethylene ter­ 7. Saito M, Tsukuda M. Review of palonosetron: emerging data Profile ephthalate bottles for 62 days at 2 degrees to 8 degrees. distinguishing it as a novel 5-HT3 receptor antagonist for chemother­ Oxyphenonium bromide is a quaternary ammonium apy-induced nausea and vomiting. Expert Opin Pharmacother 2010; 11: 1. Dentinger PJ, et a!. Stability of pantoprazole in an extemporaneously antimuscarinic with peripheral effects similar to those of 1003-14. Correction. ibid.; 1231. compounded oral liquid. Am J Health·Syst Pharm 2002; 59: 953-6. atropine (p. 1312.1). It has been given orally in a usual dose of 5 to 10 mg three or four times daily to relieve visceral Adverse Effects and Precautions Uses and Administration spasms. As for Ondansetron, p. 1873.2, although no dosage Pantoprazole is a proton pump inhibitor with actions and P. i reduction is considered necessary in hepatic impairment. uses similar to those of omeprazole (p. 1867.2). It is given as .���.��.t ?.n.�.................................................................. ......... Diarrhoea, fatigue, and abdominal pain may also occur. the sodium salt but doses are expressed in terms of the base. Praprietory Preparations (details are given in Volume B) Patients with a history of constipation or signs of subacute Pantoprazole sodium 11.28mg is equivalent to about 10mg Single-ingredient Preparations. India: Antrenyl; Pol.: Spasmo­ intestinal obstruction should be monitored if given of pantoprazole. phent. palonosetron. In the treatment of gastro-oesophageal reflux disease (p. 1807.2), the usual oral dose is 20 to 40 mg once daily, Effects on the cardiovascular system. For a discussion of which may be increased up to 80 mg dally. Treatment is Palonosetron Hydrochloride the effects of 5-HT3 antagonists on the cardiovascular sys· usually given for 4 weeks, increased to 8 weeks if necessary; tern, see under Ondansetron, p. 1873.3. in the USA, up to 16 weeks of therapy is permitted for (USAN, rfNNMJ healing of erosive oesophagitis. For maintenance therapy, Effectsthe on nervous system. For mention of a seizure treatment can be continued with 20 to 40 mg daily. associated with palonosetron see under Ondansetron, Alternatively, for recurring symptoms, an on-demand p. 1874. 1. regimen of 20 mg daily may be given. The usual dose for the treatment of peptic ulcer disease (p. 1813.2) is 40 mg once daily, increased up to 80 mg daily Interactions if needed. Treatment is usually given for 2 to 4 weeks for As for Ondansetron, p. 1874.2. duodenal ulceration, or 4 to 8 weeks for benign gastric ulceration. For the eradication of Helicobacter pylori pantoprazole may be combined with two antibacterials in Pharmacokinetics a 1-week triple therapy regimen. Effective regimens Palonosetron is well absorbed after oral dosing, with an include pantoprazole 40 mg twice daily combined with absolute bioavailability of about 97%. Peak plasma clarithromycin 500 mg twice daily and amoxicillin 1 g twice concentrations occur about 5 hours after an oral dose. daily, or combined with clarithromycin 250 mg twice daily Stability. The stability of palonosetron hydrochloride at Palonosetron has a volume of distribution of around 7 to 8 and metronidazole 400 mg twice daily. concentrations of 5 and 30 micrograms/mL was assessed in litres/kg; plasma protein binding is about 62%. About 50% Patients who require prophylaxis for NSAID-asso­ PVC bags of the following 4 infusion solutions: glucose of a dose is metabolised in the liver by cytochrome P450 ciated ulceration may take 20 mg daily. 5%, sodium chloride 0.9%, glucose 5% in sodium chlor­ isoenzymes (notably CYP2D6, but also CYP3A4 and In the treatment of pathological hypersecretory states ide 0.45%, and glucose 5% in lactated Ringer's solution. CYP1A2). About 80% of a dose is recovered in the urine such as the Zollinger-Ellison syndrome (p. 1814.3), the All solutions were considered to be physically and chemi­ within 144 hours, as palonosetron and its metabolites. The initial dose is 80 mg daily in a single dose or 2 divided doses, cally stable for at least 48 hours at room temperature mean terminal elimination half-life is reported to be about adjusted as required; up to 240 mg daily has been used. exposed to light, and for 14 days under refrigeration.' 40 hours. Daily doses greater than 80 mg should be given in 2 divided Palonosetron 50micrograms/mL (as palonosetron References. doses. hydrochloride) was found to be physically and chemically 1. Hunt TL, et al. Evaluation of safety and pharmacokinetics of consecutive PARENTERAL DOSAGE. stable during simulated Y-site administration with the multiple-day dosing of palonosetron in healthy subjects. J Clin Pharmacol Pantoprazole may also be given intravenously, as the 45: following drugs:2•3 2005; 589-96. sodium salt, over
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