2011/2011p-0913.02.pdf · astoria, ny 11102 f .....e;~\i ... gerald john director of pharmacy ......
TRANSCRIPT
Michael Nana Nyame-Mireku, Pharm,D" MIT, BCNSPAssistant Director of PharmacyPhannacy703.558.6024 tel703.558.6234 fax
VI RGJ NIA \r HOSPITALCENTER
• Philip Manning, MScPharm, RPhDirector of Pharmacy
Mount Sinai Hospital Queens ~ •r25-10 30th Avenue ,j('
Astoria, NY 11102 f .......e;~\IV \0'\ ::J
r\ OfficeN-mail: 718-267-4295 f"\_....\~~ \ \'JI: Pharmacy: 718-267-4267 C'\...JJ')::)~ ~!i'r'.\;x.Y' Fax: 718-267-4381 ",,, -" j\f'
r~,"-~ [email protected] l{"..,l_·o Ir§
Queens
~ f?lcr-r</~ i- ~MJ bi~Lop,-
NORTH MISSISSIPPI } JMEDICAL CENTER (Vl#tE5Ai
Harold Kornfuhrer, R.Ph., FASHP
Pharmacy Services830 South Gloster Street· Tupelo, MS 38801(662) 377-5747' Fax (662) [email protected]
'.-"St.Francis~MEDICAL CENTER
JOSEPH E, LATINI RPhDIRECTOR OF PHARMACY
PHONE 609.599.5033FAX609.599.6344
www.stfrancismedical.com
601 HAMILTON AVENUE
TRENTON, NJ08629
..- .../ .....1'1u.-lea Ith;~/,1 Na~u University
Together through life.• , Medical Center
A, Holly Patterson Extended Care FacilityFamily Health Centers'
Marcelle levy-Santoro RPh, MS,FNAPHAdministrator/Director of PharmacyAdjunct Clinical Professor, NYU
Affiliate of
~IJ_"'~·"""J", __ '.... uns>"ffill
2201 Hempstead Tpke East Meadow, NY 11554516.572.4796 Fax 516.2962759
[email protected] www.nuhealth.net'In partnersilip .-vith the II Federally Qualified Health Center. Inc
CIJHUNTSVILLEHOSPITAL
MICHAEL R. McDANIEL, R.Ph., MBA, FASHP,)9 Director of PhmmacyCC1 Department of Pharmacy
LSY/.~Phone: 256-265-8419· Fax: 256-265-6558/' \'\CJf E-mail: michael.mcdanie\@hhsys.org.~# 101 Sivley Road • Huntsville, AL 35801
(t~ Aurora Health Care~
Thomas W. Woller, MS, FASHPVice PresidentPharmacy Services
2900 West Oklahoma AvenueMilwaukee, WI 53215T 414-649-7929F 414-649-5428 tom.woller®aurora.orgwww.aurorahealthcare.org
FREEMANHEALTH SYSTEM
Jeff Thompson, PhannD, BepSDirector of Pharmacy Services
Office:417347.3563Cell: 417.385.8582Fax: [email protected]
1102 West 32nd Street]oplin,MO 64804-3599
417.347.1111
G freemanhealth.com
The Memorial Hospital \I.OF SALEM COUNTY .. '\
Adj", 'Jwm 9kA,"" J~Tracie L. Chambers, R.PH. CJ '\.\'f.!;Director of Pharmacy Services "(\
Office: 856-339-6033Beeper: 800-412-3394
Fax: 856-935-6713E-mail: [email protected]
310 Woodstown RoadSalem, NJ 08079-2080www.mhschealth.com
~lCARROLL~j HOSPITAL CENTER
200 Memorial AvenueWestminster, MD 21157-5799 Lan')' P. Siegel,
MAS, Phaml. D.410-871-6907 Fax: 410-871-6579TTY: [email protected]\\~\~I'.CarrollHospitaICenter.org
Direct01;PhannacyServices
• Joanne Meyer, M.S., Pharm.D.Director
Department of Pharmacy
Box 1211
MOUNT SINAI NYU
HEALTH
The Mount Sinai Medical CenterOne Gustave 1. Levy PlaceNew York, NY 10029-6574Tel: (212) 241-6171Fax: (212) 987-0198E-mail: [email protected]
Trinity Health SystemGerald JohnDirector of Pharmacy
4000 Johnson RoadSteubenville, OH 43952Email: [email protected]: (740) 264-8669Fax: (740) 264-8612
Greenville Hospital Sys University Med Ctr
Lynn EthridgePharmacy Informatics Manager
701 Grove RoadGreenville, SC 29605-5601Email: [email protected]: (864) 455-7065Fax: (864) 455-5920
I ~Winth'rop University HospitalBrian Malone M~~t:fY1'-Director of Pharmacy ,
259 First Avenue f{eJ?VerMineola, NY 11501 ...Email: [email protected]: (516! 663-2101 C:!\JVl!fi(3"e,jU'
---,..---
Gouverneur Healthcare ServicesRomualdo ZavalaDirector of Pharmacy
227 Madison StreetNew York, NY 10002Email: [email protected]: (212) 238-7071
KON;ZN\)ALIA (Q..N ~c..HHC to ORG
Community Health SystemsWilliam LordRegional Pharmacy Director
Nashville, TN I?fJEmail: [email protected] Y(fof~ IPhone: (505)514-5669 _. j~l~~
Fax: (505) 268-5300 CfYV \\[3
OfVincent Giambanco,Ms,RPhPharmacy DirectorProcurement & Contracts
nyc.gov/hhc
346 Broadway, Room 504New York, NY 10013Tel: 212-442-3854Fax: 212-442-1823Cell: 646-772-9215
Queens Hospital Center "~e11Joseph AbiQanti Gcv~
Ourtal.Director of Pharmacy Services .82-70 164 StJamaica, NY 11432Email: abinantj@nychhc,orgPhone: (718) 883-3883Fax: (718) 883-6122
~,~ THENEBRASKL\.• " MEDICALCENfERCarisa]. Schweitzer-Masek, PharmDDirector, Pharmaceutical & Nutrition Care
ASSIStant Prafe,sor & VICe Chair, Pharmacy Plactlce,
(~~ dtt, (., UNMC Col/ege :f Pharlllacy~ e.n, -. ~ (402) 559.3683
MaI/lIIg Address ~ {I\ft/ Cell Phone. (402) 443·8761981090 Nebraska Medical Center Fax: (402) 559-4907Omaha, NE 68198·1090 [email protected]
.....--.*.North ['I' I Lenox HillShore 'J Hospital
Paul T. Nowierski, BPharm,
Director of Pharmacy
Clinical Assistant Professor of
Pharmacy, LlU Faculty
100 East 77th StreetNew York, NY 10075T (212) 434-3175F (212) 434-3176C (914) [email protected]
Masoomeh Khamesian, Pharm.D.Director of Pharmacy
Pharmaceutical Services5755 Cedar LaneColumbia, MD 21044-2912410-740-7937 Telephone4 I0-884-4576 Fax410-740-7500 ext.9587 [email protected]
JOHNS HOPKINSMEDICINE
HOWARD COUNTYGENERAL HOSPITAL
Stuart Vigdor, R.Ph.Director-Pharmacy
Somerset Lcu~if\J?te,.M.t~
MEDICAL CENTER ~
G~110 Rehill AvenueSomerville, NJ 08876-2598908.685.2911 F. 908.685.2981somersetmedicalcenter.comsvigdor@somerset-healthcare.comj.~Lutheran
.U Health Network (lutheran Hospital ..·..·....··.··.··.··.··.·.....S:.:·· ..\ ......Mich~el Sievers, R.Ph. I'"'"(0'rOY
. Network Director, Pharmacy Services ~.... \~ ~
260435-7442 office I 260435-7797 fax
7950 W. JEFFERSON BLVD .. FT. WAYNE. IN 46804-4160
<I C~,.j~ENGLEWOOD fA.~
HOSPITAL AND MEDICAL CENTER'
JEFFREY NEMETH, BSP, PHARMD, MPADIRECTOR OF PHARMACY
TEL 201-894-3377FAX 201-569-6113E-MAIL: [email protected]
350 ENGLE STREETENGLEWOOD. NJ 07631
3000 5t. Matthews RoadOrangeburg. SC 29118-1498
P 803-395-2221 • f 803-395-2990www.trmchealth.org Arthur J. Chaput, RPh PharmD
Director of Pharmacy
HpG +rmcthe Regional Medical Center
MOUNT AUBURN HOSPITAL
Greg Sophis, MBA, R.PhDirector of Pharmacy
330 MountAuburn Street, Cambridge, MA 02138
~()'JJ,o~CCv&I"J
(617) 499-5003(617)499·[email protected]
A community teaching hospital of Harvard Medical School
NEW ENGLANDREHABILlTATJON HOSPITALAFi~S\-~-;-Qua\ilye; re H 0 ;Pilal
I/J1CtSSO~/h J 1,"'" /..I I lea :Je:I!,-Michael Ricci, B.S. RPh
Director of Pharmacy
2 REHABILITATION WAY, WOBURN, MA 01801Phone (781) 939-1919Fax (781) 939-1829Email [email protected]
-e=i-AdventistHEALTH SYSTEM
582 )vlonroc Road. Suite 1412Sanford. FL 32771Phone: 407 -805-SS40Fax: 407 -805-8545trcnia. [email protected]
PHARM.D.A YIELDING,TRENI
Director
l?x Plus Pharmacy
Co-rJI"~~ . ~
Fairfield+MEMORIAL HOSPITAL
Frank Badmaev RPh, MSDivision Director
102 US Hwy 321 By-Pass North - PO Box 620· Winnsboro, SC 29180Phone: (803) 635·0251 Fax: (803) 635·1903
E-Mail: [email protected]
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. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of
Reference ID: 2879674
intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (see PRECAUTIONS, Drug Interactions).
• Use only in patients who have normal bowel function. Avoid use in patients who have not had a bowel movement post-surgery.
• Avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction).
• Discontinue use in patients who develop constipation.
Alternative Therapy in Severe Hyperkalemia: Since effective lowering of serum potassium with Kayexalate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.
Hypokalemia: Serious potassium deficiency can occur from therapy with Kayexalate. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with Kayexalate should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient’s clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.
Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.
Electrolyte Disturbances: Like all cation-exchange resins, Kayexalate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving Kayexalate should be monitored for all applicable electrolyte disturbances.
Systemic Alkalosis: Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Kayexalate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Kayexalate with magnesium hydroxide as laxative (See PRECAUTIONS, Drug Interactions).
PRECAUTIONS Caution is advised when Kayexalate is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated.
In the event of clinically significant constipation, treatment with Kayexalate should be discontinued until normal bowel motion is resumed (see WARNINGS, Intestinal Necrosis).
Reference ID: 2879674
Drug Interactions Antacids: The simultaneous oral administration of Kayexalate with nonabsorbable cation-donating antacids and laxatives may reduce the resin’s potassium exchange capability.
Non-absorbable cation-donating antacids and laxatives: Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Kayexalate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Kayexalate with magnesium hydroxide as a laxative.
Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with Kayexalate has been reported.
Digitalis: The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the “normal range” (See WARNINGS).
Sorbitol: Concomitant use of Sorbitol with Kayexalate has been implicated in cases of intestinal necrosis, which may be fatal. Therefore, concomitant administration is not recommended (See WARNINGS).
Lithium: Kayexalate may decrease absorption of lithium.
Thyroxine: Kayexalate may decrease absorption of thyroxine.
Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed.
Pregnancy Category C Animal reproduction studies have not been conducted with Kayexalate. It is also not known whether Kayexalate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Kayexalate should be given to a pregnant woman only if clearly needed.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Kayexalate is administered to a nursing woman.
Pediatric Use The effectiveness of Kayexalate in pediatric patients has not been established. In neonates, Kayexalate should not be given by the oral route. In both children and neonates particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin.
Due to the risk of digestive hemorrhage or intestinal necrosis, particular care should be observed in premature infants or low birth weight infants.
ADVERSE REACTIONS Kayexalate may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, hypomagnesemia and significant sodium retention, and their related clinical manifestations, may occur (see WARNINGS). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (see
Reference ID: 2879674
PRECAUTIONS). Rare instances of intestinal necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with Kayexalate, has been reported.
The following events have been reported from worldwide post marketing experience:
• Fecal impaction following rectal administration, particularly in children; • Gastrointestinal concretions (bezoars) following oral administration; • Ischemic colitis, gastrointestinal tract ulceration or necrosis which could lead to intestinal
perforation; and, • Rare cases of acute bronchitis and/or broncho-pneumonia associated with inhalation of
particles of polystyrene sulfonate.
OVERDOSAGE Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea. Tetany may occur. Electrocardiographic changes may be consistent with hypokalemia or hypocalcemia; cardiac arrhythmias may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium, magnesium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.
DOSAGE AND ADMINISTRATION Suspension of this drug should be freshly prepared and not stored beyond 24 hours.
The average daily adult dose of the resin is 15 g to 60 g. This is best provided by administering 15 g (approximately 4 level teaspoons) of Kayexalate one to four times daily. One gram of Kayexalate contains 4.1 mEq of sodium; one level teaspoon contains approximately 3.5 g of Kayexalate and 15 mEq of sodium (A heaping teaspoon may contain as much as 10 g to 12 g of Kayexalate). Since the in vivo efficiency of sodium-potassium exchange resins is approximately 33 percent, about one third of the resin’s actual sodium content is being delivered to the body.
In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.
Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in syrup. The amount of fluid usually ranges from 20 mL to 100 mL, depending on the dose, or may be simply determined by allowing 3 mL to 4 mL per gram of resin. Healthcare professionals should follow full aspiration precautions when administering this product, such as placing and maintaining the patient in an upright position while the resin is being administered.
The resin may be introduced into the stomach through a plastic tube and, if desired, mixed with a diet appropriate for a patient in renal failure.
The resin may also be given, although with less effective results, in an enema consisting (for adults) of 30 g to 50 g every six hours. Each dose is administered as a warm emulsion (at body temperature) in 100 mL of aqueous vehicle. The emulsion should be agitated gently during administration. The enema should be retained as long as possible and followed by a cleansing enema.
Reference ID: 2879674
After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped in place. The resin is then suspended in the appropriate amount of aqueous vehicle at body temperature and introduced by gravity, while the particles are kept in suspension by stirring. The suspension is flushed with 50 mL or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. A somewhat thicker suspension may be used, but care should be taken that no paste is formed, because the latter has a greatly reduced exchange surface and will be particularly ineffective if deposited in the rectal ampulla. The suspension is kept in the sigmoid colon for several hours, if possible. Then, the colon is irrigated with nonsodium containing solution at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.
The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia. Kayexalate should not be heated for to do so may alter the exchange properties of the resin.
HOW SUPPLIED Kayexalate is available as a cream to light brown, finely ground powder in jars of 1 pound (453.6 g), NDC 0024-1075-01.
Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature]
Rx Only
Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807
Revised December 2010
© 2010 sanofi-aventis U.S. LLC
Reference ID: 2879674
Kalexate
SODIUM POLYSTYRENE SULFONATE, USP
Cation-Exchange Resin
DESCRIPTION Kalexate, 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.
INDICATIONS AND USAGE Kalexate is indicated for the treatment of hyperkalemia.
CONTRAINDICATIONS Kalexate 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 Kalexate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (see PRECAUTIONS, Drug Interactions).
• Use only in patients who have normal bowel function. Avoid use in patients who have not had a bowel movement post-surgery.
• Avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction).
• Discontinue use in patients who develop constipation. Alternative Therapy in Severe Hyperkalemia Since effective lowering of serum potassium with Kalexate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative. Hypokalemia
Serious potassium deficiency can occur from therapy with Kalexate. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with Kalexate should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient’s clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes. Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis. Electrolyte Disturbances
Like all cation-exchange resins, Kalexate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving Kalexate should be monitored for all applicable electrolyte disturbances. Systemic Alkalosis Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Kalexate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as laxative. (See PRECAUTIONS, Drug Interactions.)
PRECAUTIONS Caution is advised when Kalexate is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated.
In the event of clinically significant constipation, treatment with Kalexate should be discontinued until normal bowel motion is resumed (see WARNINGS, Intestinal Necrosis).
Drug Interactions Antacids The simultaneous oral administration of Kalexate with nonabsorbable cation-donating antacids and laxatives may reduce the resin’s potassium exchange capability. Non-absorbable cation-donating antacids and laxatives Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Kalexate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Kalexate with magnesium hydroxide as a laxative. Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with Kalexate has been reported. Digitalis The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the “normal range”. (See WARNINGS.) Sorbitol Concomitant use of Sorbitol with Kalexate has been implicated in cases of intestinal necrosis, which may be fatal. Therefore, concomitant administration is not recommended. (See WARNINGS). Lithium Kalexate may decrease absorption of lithium. Thyroxine Kalexate may decrease absorption of thyroxine. Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed. Pregnancy Category C
Animal reproduction studies have not been conducted with Kalexate. It is also not known whether Kalexate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Kalexate should be given to a pregnant woman only if clearly needed. Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Kalexate is administered to a nursing woman. Pediatric Use
The effectiveness of Kalexate in pediatric patients has not been established. In neonates, Kalexate should not be given by the oral route. In both children and neonates particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin. Due to the risk of digestive hemorrhage or intestinal necrosis, particular care should be observed in premature infants or low birth weight infants.
ADVERSE REACTIONS Kalexate may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, hypomagnesemia and significant sodium retention, and their related clinical manifestations, may occur (see WARNINGS).
Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (see PRECAUTIONS). Rare instances of intetsinal necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with Kalexate, has been reported. The following events have been reported from worldwide post marketing experience: • Fecal impaction following rectal administration, particularly in children; • Gastrointestinal concretions (bezoars) following oral administration; • Ischemic colitis, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and, • Rare cases of acute bronchitis and/or broncho-pneumonia associated with inhalation of particles of polystyrene sulfonate.
OVERDOSAGE Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia .Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea. Tetany may occur. Electrocardiographic changes may be consistent with hypokalemia or hypercalcemia; cardiac arrhythmias may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium, magnesium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.
DOSAGE AND ADMINISTRATION Suspension of this drug should be freshly prepared and not stored beyond 24 hours. The average daily adult dose of the resin is 15 g to 60 g. This is best provided by administering 15 g (approximately 4 level teaspoons) of Kalexate one to four times daily. One gram of Kalexate contains 4.1 mEq of sodium; one level teaspoon contains approximately 3.5 g of Kalexate and 15 mEq of sodium. (A heaping teaspoon may contain as much as 10 g to 12 g of Kalexate.) Since the in vivo efficiency of sodium-potassium exchange resins is approximately 33 percent, about one third of the resin’s actual sodium content is being delivered to the body. In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation. Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in syrup. The amount of fluid usually ranges from 20 mL to 100 mL, depending on the dose, or may be simply determined by allowing 3 mL to 4 mL per gram of resin. Healthcare professionals should follow full aspiration precautions when administering this product, such as placing and maintaining the patient in an upright position while the resin is being administered. The resin may be introduced into the stomach through a plastic tube and, if desired, mixed with a diet appropriate for a patient in renal failure. The resin may also be given, although with less effective results, in an enema consisting (for adults) of 30 g to 50 g every six hours. Each dose is administered as a warm emulsion (at body temperature) in 100 mL of aqueous vehicle. The emulsion should be agitated gently during administration. The enema should be retained as long as possible and followed by a cleansing enema. After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped in place. The resin is then suspended in the appropriate amount of aqueous vehicle at body temperature and introduced by gravity, while the particles are kept in suspension by stirring. The suspension is flushed with 50 mL or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on
pillows or a knee-chest position is taken temporarily. A somewhat thicker suspension may be used, but care should be taken that no paste is formed, because the latter has a greatly reduced exchange surface and will be particularly ineffective if deposited in the rectal ampulla. The suspension is kept in the sigmoid colon for several hours, if possible. Then, the colon is irrigated with nonsodium containing solution at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used. The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia. Kalexate should not be heated for to do so may alter the exchange properties of the resin.
HOW SUPPLIED Kalexate is available as a cream to light brown, finely ground powder in NDC 10702-036-45 Jars of 1 pound (454 g) NDC 10702-074-15 Bottles of 15 g
Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Rx Only Manufactured by: KVK-TECH INC. 110 Terry Drive Newtown, PA 18940 USA.
Item ID # 006119/03 Manufacturer’s Code: 10702 08/11
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KVK-TECH, INC. 110 TERRY DRIVE, SUITE 200 NEWTOWN
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KALEXATE (Sodium Polystyrene Sulfonate, USP) Powder 15 gm/bottle
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