Kowa Co., Ltd.
Revised: September 2007 (10th version)
- Serum Potassium-lowering Agent -
< Calcium Polystyrene Sulfonate, The Japanese Pharmacopoeia (JP) >
KALIMATE Powder
Storage
Store at room temperature in a tight
container.
Expiration date
Indicated on package and label on the
bottle.
CONTRAINDICATIONS (KALIMATE Powder is con-
traindicated in the following patients.)
Patients with intestinal obstruction (intestinal perforation
may occur)
DESCRIPTION
Each gram contains 1 g of calcium polystyrene sulfonate (JP).
Composition Calcium polystyrene sulfonate (JP)
Dosage Form Powder
Color Pale yellowish white to light yellow
Odor Nearly odorless
Taste Nearly tasteless
INDICATIONS
Hyperkalemia associated with acute or chronic renal failure
DOSAGE AND ADMINISTRATION
1. Oral Administration
The usual adult dosage is 15 to 30 g daily in two or three di-
vided doses, and each dose should be suspended in 30 to 50
mL of water and taken orally. The dosage may be adjusted
according to the condition of the patient.
2. Rectal Administration
The usual adult dosage is 30 g once daily suspended in 100
mL of water or 2% methylcellulose solution and adminis-
tered rectally. The suspension should be administered rec-
tally after warming to body temperature and left in the intes-
tinal tract for 30 minutes to 1 hour. If leakage of the suspen-
sion is observed, elevate the position of the hips by placing
pillows underneath or have the patient lie in a knees-to-chest
position for a while. A 5% glucose solution may be used in-
stead of water or 2% methylcellulose solution.
PRECAUTIONS1~8)
1. Careful Administration (KALIMATE Powder should
be administered with care in the following patients.)
Standard Commodity Classification No. of Japan
87219
Approval No. 21700AMX00086000
Date of listing in the NHI reimbursement price December 2005
Date of initial marketing in Japan October 1975
(1) Patients who are likely to develop constipation. [In-
testinal obstruction or intestinal perforation may oc-
cur.]
(2) Patients with intestinal stenosis. [Intestinal obstruc-
tion or intestinal perforation may occur.]
(3) Patients with gastrointestinal ulcer. [Administration
of this drug may aggravate symptoms.]
(4) Patients with hyperparathyroidism. [Blood calcium
levels may increase due to ion exchange.]
(5) Patients with multiple myeloma. [Blood calcium lev-
els may increase due to ion exchange.]
2. Important Precautions
(1) Since KALIMATE Powder may induce intestinal
perforation or intestinal obstruction, if any abnormal
findings such as severe constipation, prolonged ab-
dominal pain or vomiting, etc., are observed, admini-
stration of the drug should be discontinued and ap-
propriate therapeutic measures taken.
(2) With oral administration, patients should be in-
structed to monitor bowel movements and consult a
physician, etc. if constipation occurs and is followed
by significant symptoms such as abdominal pain,
feelings of abdominal distension, or vomiting.
(3) Serum potassium and calcium levels should be regu-
larly measured during administration of this drug to
prevent overdosage. If any abnormal findings are
observed, appropriate therapeutic measures taken
such as reducing the dose or temporarily discontinu-
ing the drug.
3. Drug Interactions
Precautions for coadministration (KALIMATE Powder
should be administered with care when coadministered
with the following drugs.)
Drugs Signs, Symptoms, Mechanism and
and Treatment Risk Factors
Digitalis prepara- Effects of digitalis Due to the serum
tions intoxication may be potassium-lowering
2 Kowa Co., Ltd.

Digoxin, etc. enhanced. effect of this drug. 7. Precautions Concerning Use

Antacids or laxa- The effects of this Non-selective (1) Oral administration
tives containing drug may be re- cation exchange 1) The following events have been reported with oral
aluminum, magne- duced. may occur with the administration of sorbitol suspensions of agent with
sium, or calcium drugs listed on the the same indications (sodium polystyrene sul-
left.
Dried aluminum fonate): small intestinal perforation; intestinal mu-
Symptoms of sys- Inhibits neutraliza-
hydroxide gel, cosal necrosis; large intestinal ulcer; and colonic
temic alkalosis, etc. tion of bicarbonates
magnesium hy- necrosis.
have been reported secreted into the
droxide, precipi- 2) With oral administration, caution should be exer-
when coadminis- intestinal tract.2)
tated calcium tered with the drugs cised to avoid accumulation of the drug in the gas-
carbonate, etc. listed on the left.2-4) trointestinal tract, so that the patient does not be-
come constipated.
(2) Rectal administration
4. Adverse Reactions 1) Animal studies (rat) have shown that intestinal ne-
With oral administration of this drug, 169 adverse reac- crosis occurred with rectal administration of sorbi-
tions have been reported in 151 of 1182 patients (12.8%) tol.6,7) Since colonic necrosis has been reported out-
from clinical studies conducted before drug approval and side Japan with rectal administration of a sorbitol
in post-marketing surveillance of the incidence of adverse suspension of a polystyrene sulfonate
reactions. The major adverse reactions were constipation cation-exchange resin6-8), do not use this drug in a
in 109 patients (9.2%), anorexia in 18 patients (1.5%) and sorbitol solution with rectal administration.
nausea in 16 patients (1.4%), etc. Abnormal laboratory 2) To avoid the build-up of residue in the intestinal
data were observed in 13 patients (1.1%). These abnor- tract after administration, always ensure that the
malities consisted of hypokalemia, but this can be con- drug has been excreted. In patients who have diffi-
trolled by adjusting the dosage. (Results at the conclusion culty with natural excretory functions, take appro-
of post-marketing surveillance of the incidence of adverse priate measures to evacuate this drug from the in-
reactions).5) testinal tract.
(1) Clinically significant adverse reactions
As intestinal perforation and intestinal obstruction 8. Other Precautions
Colonic stenosis and colonic ulcer, etc., have been reported
(incidence unknown) may occur, patients should be
with oral administration of sorbitol suspensions of this
carefully monitored. If any abnormalities appear that
drug.
are suggestive of these conditions such as severe con-
stipation, prolonged abdominal pain or vomiting, etc.,
PHARMACOKINETICS9,10)
administration of this drug should be discontinued and
(For reference)
appropriate therapeutic measures taken such as auscul-
This drug is not believed to be absorbed in the body (rabbit).9)
tation, palpation, and diagnostic imaging, etc.1)
However, an experiment with calves reported that fine particles
(2) Other adverse reactions
(≤5 µm) were absorbed through the mucous membranes and
≥5% 5% > ≥0.1% Incidence un-
deposited in tissues in the reticuloendothelial system, etc.10) As
known
a result, this drug is controlled to contain <0.1% of fine parti-
Hypersen- Rash
sitivity cles of ≤5 µm in diameter.
Gastroin- Constipation Nausea, queasi- Constipation (rec-
testinal (oral admini- ness, anorexia, tal administration) CLINICAL STUDIES11)
stration)† stomach discom- Results of a double-blind clinical study (59 patients, oral ad-
fort (oral admini-
ministration) demonstrated that this drug had inhibitory effects
stration)
Electrolytic Hypokalaemia Hypokalaemia
on serum potassium levels equivalent to the control drug (so-
(oral administra- (rectal administra- dium polystyrene sulfonate).11)
tion) tion) The results of an open clinical study conducted in 119 patients
†
Note) See “Important Precautions”(1) are summarized below.
Hyperkalemia: Overall effectiveness against hyperkalemia as-
5. Use in the Elderly sociated with acute or chronic renal failure was 97% (102/105
Since elderly patients often have reduced physiological patients) with oral administration, and 100% (14/14 patients)
function, careful supervision and measures such as reduc- with rectal administration.
ing the dose are recommended.
PHARMACOLOGY11~16)
6. Use during Pregnancy, Delivery or Lactation 1. Pharmacological Action
The safety of this drug for use during pregnancy has not (1) In dried form, this drug contains 7.0-9.0% calcium, 1 g
been established. of which is exchanged for 53 to 71 mg (1.36 to 1.82
mEq/g) of potassium in vitro (KCl solution).12)
 Kowa Co., Ltd. 3

(2) Administration of 15-30 g/day of this drug to adults with
renal failure decreased serum potassium levels by ap-
proximately 1 mEq/L.11,13,14)
(3) Unlike sodium-based resins, this drug does not increase
serum sodium or phosphorus levels or decrease serum
calcium levels when used in patients with renal fail-
ure.11,13,14)
(4) This drug is a calcium-based resin, and can thus be used
in patients on a sodium-restricted diet. This drug may
also be used without risk of the occurrence or aggrava-
tion of sodium-induced edema, hypertension or cardiac
failure.15,16)
2. Mechanism of Action
Following oral or rectal administration, without subse-
quent digestion or absorption, the calcium ions in this
drug are exchanged for potassium ions in the intestinal
tract, particularly in the vicinity of the colon, and the
polystyrene sulfonate resin is excreted in the feces intact.
As a result, potassium in the intestinal tract is removed
from the body.
PHYSICOCHEMISTRY
Nonproprietary name: Calcium polystyrene sulfonate
Structural formula:
Although the steric structure of the compound is irregular
and complex, part is shown as follows:
11) Suzuki Y. et al.: Shinryo to Hoken (Clinical Medicine), 15,
1794, 1973
12) The Japanese Pharmacopoeia Fifteenth Edition, Practical
Guide (Hirokawa Shoten), C-4127, 2006
13) Kataoka K.: Shinryo to Shin-yaku (Medical Consultation
and New Remedies), 10, 1013, 1973
14) Hirasawa Y.: Shinryo to Shin-yaku (Medical Consultation
and New Remedies), 10, 1021, 1973
15) Berlyne, G. M. et al.: Lancet, 1, 167, 1966
16) Berlyne, G. M. et al.: Israel J. Med. Sci., 3, 45, 1967
REQUEST FOR LITERATURE SHOULD BE MADE TO:
Ethical Drug Information Department, Pharmaceutical Divi-
sion
KOWA COMPANY, LTD.
3-4-14 Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan 103-8433
Contact for Product Information:
Pharmaceutical Information Services Center, Pharmaceutical
Division
KOWA COMPANY, LTD.
Telephone: 0120-508-514
03-3279-7587
Hours: 09:00 to 17:00 (except for Saturdays, Sundays, and na-
tional holidays)
Manufactured and Distributed by:
KOWA COMPANY, LTD.
3-4-14,Nihonbashi-Honcho,Chuo-ku, Tokyo

Distributed by:
KOWA PHARMACEUTICAL COMPANY, LTD.
3-4-14,Nihonbashi-Honcho,Chuo-ku, Tokyo

Description:
The substance occurs as a pale yellowish white to light yel
low powder that is tasteless and odorless. The powder is
practically insoluble in water, ethanol (95) and diethyl ether.

PACKAGING
5 g x 126 packets, 500 g / bag

REFERENCES
1) Minford, E. J. et al.: Prostgrad. Med. J., 68, 302, 1992
2) Pedro, C. F. et al.: New Engl. J. Med., 286, 23, 1972
3) Harvey, A. Z. et al.: South. Med. J., 69, 497, 1976
4) Edward, T. S.: Gastroenterology, 56, 868, 1969
5) Ministry of Health, Labour and Welfare, Pharmaceutical
Affairs Bureau, Safety Division. Iyakuhin Fukusayo Joho
(Information on adverse reactions), 40, 9,1979
6) Lillemoe, K. D. et al.: Surgery, 101, 267, 1987
7) Thomas, R. S.: Dis Colon. Rectum., 36, 607, 1993
8) Wootton, F. T. et al.: Ann. Intern. Med., 111, 947, 1989
9) Wachi M. et al.: Kiso to Rinsho (The Clinical Report), 7,
3528, 1973
10) Payne, J. M. et al.: Nature, 188, 586, 1960