DOCSLIB.ORG

Article Randomized Clinical Trial of Sodium Polystyrene Sulfonate For

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Article Randomized Clinical Trial of Sodium Polystyrene Sulfonate For Article Randomized Clinical Trial of Sodium Polystyrene Sulfonate for the Treatment of Mild Hyperkalemia in CKD Laurence Lepage,* Anne-Claude Dufour,* Jessica Doiron,* Katia Handfield,* Katherine Desforges,* Robert Bell,* | Michel Valle´e,†‡ Michel Savoie,* Sylvie Perreault,§ Louis-Philippe Laurin,†‡ Vincent Pichette,†‡ ¶ and | Jean-Philippe Lafrance† ¶ *Department of Pharmacy and Abstract †Division of Background and objectives Hyperkalemia affects up to 10% of patients with CKD. Sodium polystyrene sulfonate Nephrology, has long been prescribed for this condition, although evidence is lacking on its efficacy for the treatment of mild Maisonneuve- hyperkalemia over several days. This study aimed to evaluate the efficacy of sodium polystyrene sulfonate in the Rosemont Hospital, Montreal, Canada; treatment of mild hyperkalemia. ‡ Department of Medicine, §Faculty of Design, setting, participants, & measurements In total, 33 outpatients with CKD and mild hyperkalemia Pharmacy, and (5.0–5.9 mEq/L) in a single teaching hospital were included in this double–blind randomized clinical trial. ¶Department of We randomly assigned these patients to receive either placebo or sodium polystyrene sulfonate of 30 g orally Pharmacology, University of one time per day for 7 days. The primary outcome was the comparison between study groups of the mean Montreal, Montreal, difference of serum potassium levels between the day after the last dose of treatment and baseline. Canada; and | Maisonneuve- Results The mean duration of treatment was 6.9 days. Sodium polystyrene sulfonate was superior to placebo in Rosemont Hospital the reduction of serum potassium levels (mean difference between groups, 21.04 mEq/L; 95% confidence in- Research Center, Montreal, Canada terval, 21.37 to 20.71). A higher proportion of patients in the sodium polystyrene sulfonate group attained normokalemia at the end of their treatment compared with those in the placebo group, but the difference did not Correspondence: Dr. reach statistical significance (73% versus 38%; P=0.07). There was a trend toward higher rates of electrolytic Jean-Philippe disturbances and an increase in gastrointestinal side effects in the group receiving sodium polystyrene sulfonate. Lafrance, Division of Nephrology, Conclusions Sodium polystyrene sulfonate was superior to placebo in reducing serum potassium over 7 days in Maisonneuve- Rosemont Hospital, patients with mild hyperkalemia and CKD. 5415 Boulevard de Clin J Am Soc Nephrol 10: 2136–2142, 2015. doi: 10.2215/CJN.03640415 l’Assomption, Montreal, Quebec, Canada H1T 2M4. Email: jean-philippe. Introduction with the lack of strong data on its efficacy affect clini- [email protected] Hyperkalemia affects up to 10% of patients suffering cians’ willingness to use SPS as a first-line treatment of from CKD and up to 42% of patients with an eGFR,20 hyperkalemia (10). ml/min per 1.73 m2 (1). Hyperkalemia can cause fatal Efficacy of SPS in the treatment of chronic hyper- cardiac arrhythmias and has been associated with in- kalemia was evaluated in a retrospective observational creased mortality in patients with CKD (2–4). Reduc- study in 14 patients with CKD and cardiovascular dis- tion of dietary intake, modification of contributing ease taking medication affecting the renin-angiotensin medications, and use of cation-exchange resins are system (11). The small sample size and the lack of con- presently the cornerstone of treatment of mild chronic trol group made it difficult to differentiate the effect of hyperkalemia (5–8). Sodium polystyrene sulfonate SPS from that of other factors, such as dietary restric- (SPS) is a cation-exchange resin that was approved by tions and medication changes. Our double–blind, ran- the US Food and Drug Administration (FDA) in 1958, domized, placebo–controlled trial aimed to evaluate the 4yearsbeforetheKefauver–Harris Drug Amendments use of SPS in the treatment of mild hyperkalemia in were passed to ensure drug efficacy and safety. Conse- outpatients with CKD. quently, data on SPS in the treatment of mild hyper- kalemia are insufficient, especially when used over several days in a population of patients with CKD. Materials and Methods SPS has historically been used combined with sorbitol. Study Design In September of 2009, the FDA released a black box The study was conducted at the nephrology and pre- warning about the increased risk of intestinal necrosis dialysis outpatient clinics of Maisonneuve-Rosemont with this combination (9). This new warning along Hospital between February and September of 2014, 2136 Copyright © 2015 by the American Society of Nephrology www.cjasn.org Vol 10 December, 2015 Clin J Am Soc Nephrol 10: 2136–2142, December, 2015 Sodium Polystyrene Sulfonate in Hyperkalemia, Lepage et al. 2137 which was the predetermined end date. The trial was were completed. The placebo was similar in taste, texture, registered on ClinicalTrials.gov (NCT 02065076) and funded and appearance to SPS. Both were supplied as individual by the Nephrology Research Axis of Maisonneuve-Rosemont doses in tinted bottles. Patients were instructed to mix Hospital, the Dean’s Circle of the Faculty of Pharmacy each dose with 150 ml water immediately before adminis- of the University of Montreal, and the Department of tration and take their study medication in the evening Pharmacy of Maisonneuve-Rosemont Hospital. The pla- starting on the day of randomization. Their final follow- cebo (carob gum and lactose; Galenova Inc.) and SPS up was scheduled the day after their last dose. (Kayexalate; Sanofi Aventis) powders were purchased Three days after randomization, investigators contacted from Galenova Inc., an independent firm, to ensure blind- patients by telephone to assess side effects using a standard- ing. Neither products contained sorbitol. Study protocol ized questionnaire. Seven days after randomization, patients was approved by the Institutional Scientific Committee returned for blood tests and completed the same side effects and Research Ethics Board. All patients provided written questionnaire as on day 3. For patients’ convenience, a 1-day informed consent. All authors declare their adherence to difference was tolerated, meaning that patients could receive the Declaration of Helsinki. between six and eight doses. They were instructed to return all bottles (including empty ones) to investigators on the day of their final follow-up to allow an objective assessment of Study Population compliance, which was also evaluated with a modified ver- Patients ages 18 years old and older with eGFR,40 ml/min sion of a validated questionnaire. per 1.73 m2 (calculated using the Modification of Diet in Although no formal diet education was part of this trial, Renal Disease four–variable equation) were assessed for all patients with CKD and hyperkalemia followed in our eligibility according to their serum potassium levels mea- nephrology and predialysis outpatient clinics routinely sured for their usual follow-up with their nephrologist and receive information on a low–potassium intake diet by a on the day of randomization (12). Patients who had taken nutritionist, and patients were instructed not to modify SPS in the 7 days before their initial visit were eligible if their diet. Average dietary intake of potassium was esti- their serum potassium level measured for their regular mated through a food diary completed by patients for 3 of follow-up was from 4.5 to 5.5 mEq/L (multiply by 1 to con- 7 study days. Compilation was done in accordance with vert to millimoles per liter) inclusively and from 5.0 to the Canadian Nutrient File from Health Canada, which 5.9 mEq/L inclusively after a 7-day washout period was exported to a Microsoft Excel database. (day of randomization). Patients who had not taken SPS in the 7 days before their initial visit were eligible if their serum potassium levels measured for their regular follow- Outcomes up and on the day of randomization were both from 5.0 to Theprimaryoutcomewasthecomparisonbetween 5.9 mEq/L inclusively. study groups of the mean difference in serum potassium Patients on dialysis were not included in this study. levels between the day after the last dose of treatment (day 7) Exclusion criteria included a change in medication affecting and baseline (day 0). Secondary outcomes were to compare potassium levels within 30 days before enrolment. Excep- the proportion of patients achieving normokalemia, de- tion was made for insulin, for which dose modifications fined as a serum potassium level of at least 3.5 mEq/L and occurring .7 days before randomization were accepted or ,5.0 mEq/L, at the end of the study period as well as if more recent modifications were not .10% of the total compare the prevalence of side effects between study daily dose up to a maximum variation of five units. Pa- groups. Specifically, nausea, vomiting, constipation, and tients with changes in dosage of angiotensin–converting diarrhea were assessed on study days 3 and 7. Addition- enzyme inhibitors (ACEIs), angiotensin receptor blockers ally, on day 7, blood tests assessed the frequency of hyper- (ARBs), or aliskiren within 60 days before randomization natremia, hypophosphatemia, hypomagnesemia, and were also excluded. For safety reasons, patients were ex- hypocalcemia. cluded if they were pregnant or breastfeeding, had a con- traindication to SPS, had a lactose intolerance, or had an Statistical Analyses episode of decompensated heart failure in the 30 days be- To detect a mean difference of serum potassium of fore enrolment. Patients with symptomatic
Load more

Recommended publications
  • Evaluation of Single Dose Sodium Polystyrene
    Open Access Original Article Sodium Polystyrene Sulfonate For Management of Hyperkalemia Pak Armed Forces Med J 2019; 69 (1): 37-42 EVALUATION OF SINGLE DOSE SODIUM POLYSTYRENE SULFONATE FOR MANAGEMENT OF HYPERKALEMIA AND ITS EFFECT ON OTHER SERUM ELECTROLYTES Shoaib Alam, Azfar Athar Ishaqui, Masood Ahmed Khan, Adnan Iqbal, Syed Hameez Jawed, Farah Khalid, Mir Muhammad Uzairullah, Muhammad Talha*, Usman Ashfaq*, Najam Zehra* University of Karachi, Karachi Pakistan, *Hamdard University Karachi Pakistan ABSTRACT Objective: To assess the effectiveness of sodium polystyrene sulphonate in treating hyperkalemia and its effect on different serum electrolytes level. Study Design: Quasi-experimental study. Place and Duration of Study: Lyari general hospital, 500 bedded tertiary care public sector hospital at Karachi, from Jan 2017 to Mar 2017. Material and Methods: Hyperkalemic patients were included in study who fulfilled inclusion criteria and were administered with single STAT 30 grams dose of Sodium Polystyrene Sulfonate. Serum electrolytes such as sodium, chloride, magnesium, phosphate and calcium were measured before and after 2 hours of administration of Sodium Polystyrene Sulfonate. Paired t-test was used as tool for statistical analysis. Results: Significant (p<0.05) decrease in serum potassium level with mean decrease of 0.61 mmol/L was observed in hyperkalemic patients (n=83) after single dose of Sodium Polystyrene Sulfonate. Among 83 studied patient, 67 (81%) recovered from hyperkalemia. Besides, there was significant (p<0.05) increase in sodium level with a mean increase of 2.26 mmol/L. Serum magnesium and calcium levels were significantly decreased (p<0.05) with mean difference of 0.02mmol/L and 0.13mmol/L respectively.
    [Show full text]
  • SODIUM POLYSTYRENE SULFONATE, USP Cation-Exchange Resin
    Kayexalate® SODIUM POLYSTYRENE SULFONATE, USP Cation-Exchange Resin DESCRIPTION Kayexalate, brand of sodium polystyrene sulfonate is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula: The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq (in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema. CLINICAL PHARMACOLOGY As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33 percent but the range is so large that definitive indices of electrolyte balance must be clearly monitored. Metabolic data are unavailable. INDICATION AND USAGE Kayexalate is indicated for the treatment of hyperkalemia. CONTRAINDICATIONS Kayexalate is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates (see PRECAUTIONS). WARNINGS Intestinal Necrosis: Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Kayexalate use.
    [Show full text]
  • Dorset Medicines Advisory Group
    Dorset Medicines Advisory Group SHARED CARE GUIDELINE FOR THE USE OF PHOSPHATE BINDERS IN THE MANAGEMENT OF HYPERPHOSPHATAEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE. INDICATION This document provides guidance for the prescribing of phosphate binders for the management of hyperphosphatemia in patients receiving haemodialysis or peritoneal dialysis and patients with chronic kidney disease stage 4 or 5 who are not receiving dialysis. This shared care guideline covers adult patients under the care of the Dorset Renal Unit. Patients with chronic renal failure have reduced ability to excrete phosphate. Phosphate accumulation enhances parathyroid activity and leads to the calcification of arteries, significantly contributing to the excess cardiovascular morbidity in these patients, especially in younger age groups. Adequate control of serum phosphate levels is thought to be beneficial for the prevention of vascular and cardiac calcification in patients with renal failure and control of parathyroid hormone. A number of oral phosphate binders are available which may be used in the context of a multiple therapeutic approach. These include calcium acetate, calcium carbonate, calcium acetate/magnesium carbonate, lanthanum, sevelamer and sucroferric oxyhydroxide. These products may be used in combination with 1-hydroxycholecalciferol (alfacalcidol) or one of its analogues and/or cinacalcet to control the development of secondary hyperparathyroidism and renal bone disease. A calcium-based phosphate binder is generally used as the initial phosphate binder therapy for the treatment for hyperphosphatemia. Calcium acetate is preferred over calcium carbonate due to its lower elemental calcium content for the equivalent phosphate binding capacity, however patient preference in formulation should be taken into consideration. A non-calcium-based phosphate binder should be used in patients who cannot tolerate a calcium-based phosphate binder, whose serum calcium exceeds 2.5mmol/L or whose parathyroid levels are less than 15pmol/L.
    [Show full text]
  • AMBERLITE™ IRP69 Ion Exchange Resin Pharmaceutical Grade Cation Exchange Resin (Sodium Polystyrene Sulfonate USP)
    Product Data Sheet AMBERLITE™ IRP69 Ion Exchange Resin Pharmaceutical Grade Cation Exchange Resin (Sodium Polystyrene Sulfonate USP) Description AMBERLITE™ IRP69[1] resin is an insoluble, strongly acidic, sodium form cation exchange resin supplied as a dry, fine powder. AMBERLITE™ IRP69 Resin is suitable for use in pharmaceutical applications, both as an active ingredient and as a carrier for basic (cationic) drugs. It can be used for sustained release applications with compatible coating technologies. [1] The use of AMBERLITE™ pharmaceutical grade ion exchange resins as components of drug formulations is subject to the Food, Drug, and Cosmetic Act as amended. Regulatory Status A Drug Master File for AMBERLITE™ IRP69 is maintained with the United States Food and Drug Administration. Letters of authorization granting access to the file by FDA in support of NDA and ANDA submittals will be provided upon request. Similar help can also be offered in support of the registration of formulations containing AMBERLITE™ IRP69 in many other countries world- wide. AMBERLITE™ IRP69 is manufactured in accordance with Good Manufacturing Practices (cGMP) for bulk pharmaceutical chemicals Typical Properties AMBERLITE™ IRP69 complies with the compendial specifications for Sodium Polystyrene Sulfonate USP when tested in conformance to the compendial test methods presented in current USP/NF. Physical Properties Copolymer Styrene-divinylbenzene Type Strong acid cation Functional Group Sulfonic acid Physical Form Fine powder Chemical Properties Ionic Form as Shipped Na+ Heavy metals content [1] ≤ 10 ppm Potassium exchange capacity [1] 110–135 mg/g Water content [1] 10.0% maximum Ammonia salts [1] Negative to litmus paper Sodium content [1] 9.4%–11.5% Styrene content [1] 1 ppm maximum Particle Size § > 0.150 mm 1.0% maximum > 0.075 mm 10.0–25.0% §[1] Appears in current USP/NF Page 1 of 6 Form No.
    [Show full text]
  • The Indirect Implication of SARS-Cov-2 Resulting in Kayexalate Toxicity in a Patient with Acute Kidney Injury
    CODON P U B L I C A T I O N S Journal of Renal and Hepatic Disorders CASE REPORT: NEPHROLOGY The Indirect Implication of SARS-CoV-2 Resulting in Kayexalate Toxicity in a Patient with Acute Kidney Injury Charles E Middleton, IV, MD, William Daley, MD, Neha Varshney, MD Department of Pathology, University of Mississippi Medical Center, Jackson, MS, USA Abstract The clinical features of corona virus disease 2019 (COVID-19) are variable, but the majority of patients experience mild flu-like symptoms. The cases of severe disease include complications such as progressive pneumonia, acute kidney injury (AKI), multi-organ failure, and even death. This paper explores the association between COVID-19 and its effect on multiple organ systems and how the subsequent treatment of this dis- ease can itself lead to morbidity and mortality. We present a case that emphasizes the life-threatening gastrointestinal complications associated with the treatment of AKI in a patient with COVID-19. We conclude that the patients whose treatment regimens utilize medical resins should be closely monitored for gastrointestinal complications so as to mitigate the known adverse effects associated with these drugs, such as colonic mucosal ulceration, perforation, or even death. Keywords: acute kidney injury; colonic perforation; COVID-19; Kayexalate; resins; sevelamer Received: 25 November 2020; Accepted after revision: 5 February 2021; Published: 27 February 2021. Author for correspondence: Neha Varshney, MD, Assistant Professor, Department of Pathology, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216-4500, USA. Email: [email protected] How to cite: Middleton CE, et al.
    [Show full text]
  • Estonian Statistics on Medicines 2016 1/41
    Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole
    [Show full text]
  • Case Report Sevelamer Carbonate Crystal-Induced Colitis
    Hindawi Case Reports in Gastrointestinal Medicine Volume 2020, Article ID 4646732, 4 pages https://doi.org/10.1155/2020/4646732 Case Report Sevelamer Carbonate Crystal-Induced Colitis T. Lai ,1 A. Frugoli ,2 B. Barrows,3 and M. Salehpour4 1Community Memorial Health System, Graduate Medical Education, Ventura, CA, USA 2Community Memorial Health System, Graduate Medical Education, Department of Internal Medicine, Pacific Inpatient Physicians, Ventura, CA, USA 3Community Memorial Hospital, Department of Pathology, Ventura, CA, USA 4Community Memorial Hospital, Department of General Surgery, Ventura, CA, USA Correspondence should be addressed to T. Lai; [email protected] Received 19 February 2020; Accepted 30 March 2020; Published 24 July 2020 Academic Editor: Olga I. Giouleme Copyright © 2020 T. Lai et al. )is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Hyperphosphatemia is a common and well-described complication of end-stage renal disease. Despite strict dietary constraints and compliance, phosphate binders such as calcium acetate and/or sevelamer carbonate are also needed to treat secondary hyperparathyroidism. )is case vignette describes an underrecognized adverse effect of a phosphate binder, sevelamer carbonate, inducing colitis in a 47-year-old male with insulin-dependent diabetes complicated by end-stage renal disease. He presented for recurrent abdominal pain with associated nausea and was found to have multiple circumferential lesions on computed to- mography including distal ascending, transverse, and proximal descending colon. Colonoscopy demonstrated nearly obstructing lesions worrisome for colonic ischemia or inflammatory bowel disease. Pathological review of histology demonstrated ragged colonic mucosa with ulcerative debris and nonpolarizing crystalline material at the sites of ulceration, morphologically consistent with the phosphate binder, sevelamer carbonate.
    [Show full text]
  • Kayexalate® (Sodium Polystyrene Sulfonate)
    Kayexalate® (sodium polystyrene sulfonate) – Drug Safety Communication • On October 22, 2015, the FDA announced that it is requiring the manufacturer of Kayexalate (sodium polystyrene sulfonate) to conduct studies to investigate Kayexalate’s potential to bind to other oral medications. • Kayexalate is indicated for the treatment of hyperkalemia. — Sodium polystyrene sulfonate is also generically available. Kionex® and SPS® are branded generics. • This safety communication was prompted by the FDA’s review of another potassium-lowering drug, Veltassa (patiromer). The FDA discovered that Veltassa bound to about half of the medications tested, some of which are commonly used in patients who require potassium-lowering drugs. — Similar to Veltassa, Kayexalate may also bind to other oral medications, which could decrease the effects of these medications. — Currently, the approved label for Kayexalate describes its potential to decrease absorption of lithium and thyroxine; however, extensive drug-drug interaction studies with Kayexalate have not been performed. • Patients should not stop taking their potassium-lowering drugs without talking to their healthcare provider. However, to reduce the risk of binding, prescribers and patients should consider separating the dose of Kayexalate from other oral medications by at least 6 hours. This includes both prescription and over-the-counter medications. • Healthcare providers should monitor blood levels or clinical response to other medications when appropriate. • If the studies conducted by the Kayexalate manufacturer, Concordia Pharmaceuticals, confirm significant interactions with other medications, the FDA will require all manufacturers of sodium polystyrene sulfonate products to update the drug labels to include information about these drug interactions. optumrx.com OptumRx specializes in the delivery, clinical management and affordability of prescription medications and consumer health products.
    [Show full text]
  • Dextromethorphan Polistirex Suspension, Extended
    ROBITUSSIN 12 HOUR COUGH RELIEF- dextromethorphan polistirex suspension, extended release GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ---------- Drug Facts Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP Purpose Cough suppressant Uses temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you get to sleep Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Allergy Alert Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma, or emphysema • cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Directions • shake bottle well before use • measure only with dosing cup provided.
    [Show full text]
  • Pharmaceutical Ion Exchange Resins – a Review
    Vol 4 | Issue 2 | 2014 | 134-145. e-ISSN 2249 – 7706 print-ISSN 2249– 7714 International Journal of Advanced Pharmaceutics www.ijapjournal.com PHARMACEUTICAL ION EXCHANGE RESINS – A REVIEW Ajay Bilandi1* and Amiya Kanta Mishra2 1*Research Scholar at Bhagwant University, Ajmer, Rajasthan, India. 2 Principal, College of Pharmaceutical Sciences, Puri, Orissa, India. ABSTRACT Ion exchange resins are water insoluble cross-linked polymers containing a salt-forming group at repeating positions on the polymer chain and have the ability to exchange counter-ions within aqueous solutions surrounding them. About 90 % of all ion exchange resins are based on a polystyrenic matrix. Synthetic ion exchange resins are usually cast as porous beads with considerable external and pore surface where ions can attach. Strong acid resins are so named because their chemical behaviour is similar to that of a strong acid. These resins are highly ionized in both the acid (R-SO3H) and salt (RSO3Na) form of the sulfonic acid group (-SO3H). Ion exchange is a process in which mobile ions from an external solution are exchanged for ions that are electrostatically bound to the functional groups contained within a solid matrix. There are various pharmaceutical grade resins like AMBERLITE® IRP88 , DUOLITE™ AP143/1083, INDION 204 , INDION 264 , TULSION® 335 TULSION® 345 , Kyron T etc. used as tablet disintegrant, active ingredients, as carrier for basic (cationic) drugs, application with compatible coating technique, mask objectionable taste associated with certain basic drugs, potassium reduction in blood, cholesterol reduction in blood, reduction of bile acid, treatment of hyperkalaemia and Stabilization of vitamin B12. This review covers the IER structure, chemistry, kinetics, ion exchange process, , loading of drug on resin, pharmaceutical grade resins ,drug delivery applications etc.
    [Show full text]
  • KAYEXALATE (Sodium Polystyrene Sulfonate) Is a Cream Or Light Brown Fine Powder of Sodium Polystyrene Sulfonate
    PRESCRIBING INFORMATION ® PrKAYEXALATE (Sodium Polystyrene Sulfonate) Cation - Exchange Resin sanofi-aventis Canada Inc. Date of Revision: 2905 Place Louis R.-Renaud September 19, 2018 Laval, Quebec H7V 0A3 Submission Control No.: 217331 s-a Version 5.0 dated September 19, 2018 KAYEXALATE Prescribing Information Page 1 of 12 DESCRIPTION KAYEXALATE (sodium polystyrene sulfonate) is a cream or light brown fine powder of sodium polystyrene sulfonate. KAYEXALATE is a cation-exchange resin prepared in the sodium phase, with an in vivo exchange capacity of approximately 1 mmol (in vitro approximately 3.1 mmol) of potassium per gram. The sodium content is approximately 4.1 mmol (100 mg) per gram of the drug. KAYEXALATE can be administered either orally or as an enema. ACTION Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract. As the resin passes through the gastrointestinal tract, the resin removes the potassium ions by exchanging it for sodium ions. Most of this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. Potassium exchange also occurs in the colon following retention of the resin, when administered as an enema. The efficiency of this process is limited and unpredictable. It commonly approximates the order of 33 per cent but the range is so large that definite indices of electrolyte balance must be clearly monitored. Metabolic data are unavailable. INDICATION KAYEXALATE is indicated for the treatment of hyperkalemia. CONTRAINDICATIONS KAYEXALATE should not be administered to patients with the following conditions: • serum potassium <5 mmol/L • history of hypersensitivity to polystyrene sulfonate resins • obstructive bowel disease KAYEXALATE should not be administered orally to neonates or in neonates with reduced gut motility (postoperatively or drug induced).
    [Show full text]
  • Reference ID: 4131527
    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ----------------------- WARNINGS AND PRECAUTIONS ----------------------­ KAYEXALATE safely and effectively. See full prescribing information • Intestinal Necrosis: cases of intestinal necrosis and other serious for KAYEXALATE gastrointestinal events have been reported (5.1). • Electrolyte Disturbances: Severe hypokalemia can occur. (5.2). KAYEXALATE (sodium polystyrene sulfonate) powder for suspension, • Fluid overload in patient sensitive to high sodium intake: Monitor patients for oral or rectal use who are sensitive to sodium intake for signs of fluid overload. (5.3). Initial U.S. Approval: 1958 • Risk of aspiration: Acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported. --------------------------- INDICATIONS AND USAGE ---------------------------­ (5.4). KAYEXALATE is a potassium binder indicated for the treatment of hyperkalemia (1). ------------------------------ ADVERSE REACTIONS -----------------------------­ Limitation of Use: Adverse reactions reported include: anorexia, constipation, diarrhea, fecal KAYEXALATE should not be used an emergency treatment for life impaction, gastrointestinal concretions (bezoars), ischemic colitis, nausea, threatening hyperkalemia because of its delayed onset of action (1). vomiting (6). ----------------------- DOSAGE AND ADMINISTRATION ----------------------­ To report SUSPECTED ADVERSE REACTIONS, contact Concordia Oral: The average
    [Show full text]