Kinelene

Calcium polystyrene sulfonate.

Each sachet contains Calcium polystyrene sulfonate 5.0 g.

Pharmacology: Pharmacodynamics: Calcium polystyrene sulfonate, the calcium salt of sulfonated styrene polymer, is not absorbed from gastrointestinal tract. Calcium polystyrene sulfonate is a cations-exchange resin that exchanges calcium ions for potassium ions and other cations in the gastrointestinal tract (it is estimated that 1 g of calcium polystyrene sulfonate could bind 1.3 to 2 mmol of potassium).
Pharmacokinetics: Calcium is absorbed from GI tract by passive diffusion and active transport. Calcium absorption is increased in the presence of food. Oral bioavailability in adults ranges from 25% to 35% when a 250 mg dose is given with a meal. Absorption from milk was 29% under the same conditions. Normal total serum calcium concentrations range from 9 to 10.4 mg/dL (4.5 to 5.2 mEq/L), but only ionized calcium is active. Calcium crosses the placenta and distributed into milk. Calcium is mainly excreted in the faces. Only small amounts are excreted in the urine.

Treatment of hyperkalemia.

Adult dosage: Oral administration: It is given orally, in a dose of 15 g three or four times daily.
Preparation for oral administration: Reconstituted KINELENE (POWDER FOR SUSPENSION 5 G) in 15-20 mL of water, syrup or sweetened paste (3-4 mL per 1 g of resin). Do not use fruit juices which contain potassium for reconstitution.
Rectal route: The usual daily dose is 30 g given as a suspension in 100 mL of 2% methylcellulose '450' and 100 mL of water and retained, if possible, for at least 9 hours. Initial therapy may involve both oral and rectal routes.
Following retention of the enema, the colon should be irrigated to remove the resin.
Children dosage: Oral administration: Dose for children is 1 g/kg daily in divided doses for acute hyperkalemia, reduced to a maintenance dose of 500 mg/kg daily in divided doses; the oral route is not recommended for neonates.
Rectal route: Children and neonates may be given rectal doses similar to the oral doses suggested for children.
Stability after reconstituted: Suspension of the resin should be freshly prepared. Suspension of KINELENE (POWDER FOR SUSPENSION 5 G) in 15-100 mL water is stable for 24 hours at room temperature (30°C) and stable for 48 hours at refrigerator temperature (2-8°C).
Dosage in geriatric: Refer to adult dosing.

Symptoms: Inadvertent systemic overloading with calcium ions can produce an acute hypercalcemic syndrome characterized by a markedly elevated plasma calcium level, weakness, lethargy, intractable nausea and vomiting, coma and sudden death.
Treatment: It may be life-saving to rapidly lower blood calcium to safe levels. It is now agreed the most effective therapy is IV sodium chloride infusion plus potent natriuretic agents, (e.g., furosemide). Sodium competes with calcium for reabsorption in the distal renal tubule and furosemide potentiates this effect. Together they markedly increase renal calcium clearance and reduce hypercalcemia.

Do not use in patients whose hypersensitivity to Calcium polystyrene sulfonate or any component of the formulation.
Contraindication in patients with hypercalcemia and ventricular fibrillation.
It should be avoided in patients with condition such as hyperparathyroidism, multiple myeloma, sarcoidosis, or metastatic carcinoma who may present with renal failure together with hypercalcemia.

Use of this drug may be associated with electrolyte disturbances including hypokalemia, hypercalcemia, and/or hypomagnesemia. Closely monitor electrolytes during therapy and discontinue if potassium ≤5 mmol/L (5 mEq/L).
Sudden increases in calcium may be observed with use in renal impairment and/or dialysis patients.
Monitor calcium weekly or more frequently if clinically indicated.
Discontinue use of clinically significant constipation.
Avoid magnesium containing laxatives.
Use of similar agent (e.g. sodium polystyrene sulfonate) with sorbital enema may cause colon necrosis or intestinal obstruction. Therefore, avoid concomitant use of rectal sorbital.

Pregnancy category C: It is not known whether this drug can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Use only when clearly need.
Lactation: It is not known. Exercise caution when administering to a pregnant woman.

May cause constipation and headache. Mild hypercalcemia (Ca⁺⁺ greater than 10.5 mg/dL) may be asymptomatic or manifest itself as anorexia, nausea and vomiting. More severe hypercalcemia (Ca⁺⁺ greater than 12 mg/dL) is associated with confusion, delirium, stupor and coma.

Calcium ions are released from the resin in the gastrointestinal tract and this may reduce the absorption of tetracycline given by mouth.
Concomitant administration of calcium salts with bisphosphonates (e.g. alendronate, etidronate, ibandronate, risedronate) may reduce absorption of the bisphosphonate from GI tract. To minimize this effect, calcium salts should be administrated at least 30 minutes after alendronate or risedronate, at least 60 minutes after ibandronate, and not within 2 hours of etidronate administration.
The inotropic and toxic effects of cardiac glycosides and calcium are synergistic and arrhythmias may occur if these drugs are given together.
Concomitant administration of calcium salts and oral iron preparations may result in reduced absorption of iron. Patients should be advised to take the drugs at different times.
Concomitant administration of calcium salts and some fluoroquinolones (e.g. ciprofloxacin) may reduce oral bioavailability of the fluoroquinolones.

Store below 30°C.
Suspension of the resin should be freshly prepared and not stored beyond 24 hours.

Antidotes & Detoxifying Agents

V03AE01 - polystyrene sulfonate ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.
A12AA - Calcium ; Used as dietary supplements.

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