PRESCRIBING INFORMATION
RESONIUM CALCIUM®(calcium polystyrene sulfonate)
Cation-Exchange Resin
sanofi-aventis Canada Inc. 2150 St. Elzear Blvd. West Laval, Quebec H7L 4A8 Date of Revision: November 16, 2010
Submission Control No.: 141321 s-a Version 2.0 dated November 16, 2010
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ACTIONS AND CLINICAL PHARMACOLOGY
Resonium calcium (calcium polystyrene sulfonate) is a cation exchange resin prepared in the calcium pha. Each gram of resin has a theoretical in vitro exchange capacity of about 1.3 to
2 millimoles (mmol) of potassium (K+). In vivo, the actual amount of potassium bound will be less than this. The sodium (Na+)content of the resin is less than 1 mg/g. The calcium content is 1.6 to 2.4 mmol/
g. The resin is insoluble in water. Calcium polystyrene sulfonate is not absorbed from the gastrointestinal tract.
Resonium calcium acts by a cumulative process throughout the gastrointestinal tract, removing potassium ions which are excreted in the feces.
建筑学专业排名As the resin pass through the colon, it comes into contact with fluids containing increasing amounts of potassium. In the cecum the concentration of Na+ and K+ are similar to tho in the small intestine. In the stool water of the sigmoid colon there may be 6-38 mmol/L sodium and
李白诗14-44 mmol/L potassium. The result is that potassium is taken up in increasing amounts in exchange for calcium ions. The length of time the resin remains in the body is a decisive factor in its effectiveness. For this reason oral administration is more effective than the u of enemas which should, if possible, be retained for 9 hours. The efficiency of potassium exchange is unpredictably variable. The resin is not lective for potassium.
INDICATIONS
Resonium calcium (calcium polystyrene sulfonate) is indicated in patients with hyperkalemia associa
ted with anuria or vere oliguria. It reduces rum levels of potassium and removes excess potassium from the body. Resonium calcium is indicated in all states of hyperkalemia due to acute and chronic renal failure; examples include u following abortion, complicated labor, incompatible blood transfusion, crush injury, prostatectomy, vere burns, surgical shock, and in cas of vere glomerulonephritis and pyelonephritis.
Resonium calcium can also be uful in patients requiring dialysis. Serum potassium levels in acute renal failure often reach dangerous heights before a ri in blood urea indicates the need for hemodialysis. Resonium calcium can be ud to reduce the potassium levels and thereby postpone the need for the u of the artificial kidney machine until other caus make it necessary.
Patients on regular hemodialysis therapy may develop shunt difficulties and underdialysis occurs, resulting in rious hyperkalemia. In the circumstances it is advisable to give the resin to control hyperkalemia during the period of underdialysis. Monitoring rum potassium and calcium levels should be undertaken at regular intervals.
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When patients on routine hemodialysis prent a dietary management problem and tend towards hy曼娜的回忆
perkalemia, Resonium calcium can be ud to control blood potassium levels. Similarly, patients on prolonged peritoneal dialysis may develop intermittent hyperkalemia after a few weeks, possibly due to dietary problems. The patients also can be satisfactorily controlled with Resonium calcium.
CONTRAINDICATIONS
Resonium calcium should not be administered to patients with:
•Serum potassium < 5 mmol/L
•Conditions associated with hypercalcemia (e.g. hyperparathyroidism, multiple myeloma, sarcoidosis or metastic carcinoma)
• A history of hypernsitivity to polystyrene sulfonate resins
•Obstructive bowel dia
•Oral administration of Resonium calcium is contraindicated in neonates.
Administration of the resin in neonates with reduced gut motility (postoperatively
or drug induced) is contraindicated.
WARNINGS一年级拼音儿歌
In neonates, Resonium calcium should not be given by the oral route (e CONTRAINDICATIONS).
Gastrointestinal injuries: Cas of ischemic colitis, rectal haemorrhage, gastrointestinal necrosis and intestinal perforation with fatal outcomes have been reported in association with Resonium u. The majority of the cas reported the concomitant u of sorbitol. Risk factors for gastrointestinal adver events were prent in many of the cas including prematurity, history of intestinal dia or surgery, hypovolemia, immunosuppressant therapy, vere burns,and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (e Drug INTERACTIONS and ADVERSE REACTIONS).
PRECAUTIONS
Hypokalemia
During treatment with Resonium calcium the possibility of vere potassium depletion should be considered. Adequate clinical control, as well as biochemical control by daily estimation of rum ele
ctrolytes and blood urea levels, is esntial during treatment especially in patients on digitalis. To prevent rious hypokalemia, administration of the resin should be discontinued as soon as the rum potassium level falls to 5 mmol/L (e DRUG INTERACTIONS).
Other electrolyte disturbances
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Like all cation-exchange resins, Resonium calcium is not totally lective for potassium. Hypomagnemia and/or hypercalcemia may occur. Accordingly, patients should be monitored for all applicable electrolyte disturbances.
Hypercalcemia has been reported in well dialyd patients receiving calcium resin, and occasionally in patients with chronic renal failure.Many patients in chronic renal failure have low rum calcium and high rum phosphate, but some, who cannot be screened out beforehand, show a sudden ri in rum calcium to high levels after therapy with calcium resin. The risk emphasizes the need for adequate biochemical control. Serum calcium levels should be estimated at weekly intervals to detect the early development of hypercalcemia. The do of administered calcium resin should be reduced to levels at which hypercalcemia and hypokalemia are prevented (e REFERENCES).
Other risks
In the event of clinically significant constipation, treatment with the resin should be discontinued until normal bowel motions are resumed. Magnesium-containing laxatives should not be ud (e DRUG INTERACTIONS).
The patient should be positioned carefully when ingesting the resin, to avoid aspiration, which may lead to bronchopulmonary complications.
Children and neonates:
In neonates, Resonium calcium should not be given by the oral route (e CONTRAINDICATIONS).
In both children and neonates, particular care should be obrved with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin.
Due to the risk of gastrointestinal tract hemorrhage or colonic necrosis, particular care should be obrved in premature infants or low birth weight infants.
DRUG INTERACTIONS
日本军部Concomitant u not recommended:
Sorbitol (oral or rectal): Concomitant administration of sorbitol with Resonium calcium is not recommended due to cas of intestinal necrosis, which may be fatal (e WARNINGS and ADVERSE REACTIONS).
To be ud with caution:
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Digitalic drugs: The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and atrioventricular (A-V) nodal dissociation, are likely to be exaggerated if hypokalemia and/or hypercalcemia develop, even in the face of rum digoxin concentrations in the ‘normal range’ (e PRECAUTIONS).
Cation donating agents: The may reduce effectiveness of the resin in binding potassium.
Non-absorbable cation-donating antacids and laxatives: Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with non-absorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate.
Aluminum hydroxide: Intestinal obstruction due to concretions of aluminum hydroxide has been reported when aluminum hydroxide was combined with the resin (sodium form).
Lithium: Possible decrea of lithium absorption.
Thyroxine: Possible decrea of thyroxine absorption.
PREGNANCY
Resonium calcium is not absorbed from the gastrointestinal tract. No data are available about the u of polystyrene sulfonate resins in human pregnancy.
LACTATION
Resonium calcium is not absorbed from the gastrointestinal tract. No data are available about the u of polystyrene sulfonate resins in human lactation.
ADVERSE REACTIONS
Gastrointestinal disorders:
Intestinal intolerance due to the gritty consistency and bulk of the resin may be manifested by the appearance of general adver effects including naua, vomiting, gastric irritation, anorexia, constipation and occasionally, diarrhea. The adver effects may be relieved by intermittent therapy and the u of mild laxatives where constipation is a factor.
Fecal impaction following rectal administration, particularly in children, and gastrointestinal concretions (bezoars) following oral administration, have been reported. Rarely intestinal obstruction has been reported. This could possibly be a reflection of co-existing pathology or inadequate dilution of the resin.
Ischemic colitis, rectal haemorrhage, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation have been reported following administration of calcium polystyrene喝酸奶会胖吗
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sulfonate with or without concomitant u of sorbitol (e WARNINGS and DRUG INTERACTIONS).
Metabolism and nutrition disorders:
In accordance with its pharmacological actions, Resonium calcium may give ri to hypokalemia and
hypercalcemia and their related clinical manifestations (e PRECAUTIONS and OVERDOSAGE). Cas of hypomagnemia have been reported.
Hypercalcemia has been reported in well dialyd patients receiving calcium resin, and occasionally in patients with chronic renal failure (e PRECAUTIONS).
Respiratory, thoracic and mediastinal disorders:
Some cas of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of calcium polystyrene sulfonate have been described.
OVERDOSAGE
Biochemical disturbances resulting from overdosage may give ri to clinical signs and symptoms of hypokalemia, including irritability, confusion, delayed thought process, muscle weakness, hyporeflexia, and eventually frank paralysis. Apnea may be a rious conquence of this progression. Electrocardiographic changes may be consistent with hypokalemia or hypercalcemia; cardiac arrhythmia may occur. Appropriate measures should be taken to correct rum electrolytes (potassium, calcium). The resin should be removed from the alimentary tract by appropriate u of laxatives or enemas.
For management of a suspected drug overdo, contact your regional Poison Control Centre.
DOSAGE AND ADMINISTRATION
反身性Treatment with the resin should be given as soon as the rum potassium level ris above
6 mmol/L (23.5 mg per 100 mL). The action may be delayed for one or two days since maximal exchange probably takes place in the colon. Exchange will continue until all the resin has been voided (this may be one or two days after administration has been discontinued). For this reason, resin therapy should be stopped when the rum potassium level has fallen to 5 mmol/L, otherwi, the continued action may lead to potassium depletion.
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Resonium calcium is for oral or rectal administration only. The following dos are suggested only as a general guide. The preci daily do should be decided on the basis of regular clinical and rum electrolyte determination.
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