Kionex

Kionex® Sodium Polystyrene Sulfonate may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, 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 colonic necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, 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;
• Gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and,
• Rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate.

Since this medication is usually given in a hospital, it is not likely that you will miss a dose.

Your doctor or pharmacist can provide more information about sodium polystyrene.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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You should not use this medicine if you have low potassium levels or a bowel obstruction.

Do not give sodium polystyrene sulfonate orally (by mouth) to a newborn baby.

Avoid taking other medicines by mouth within 3 hours before or 3 hours after you take sodium polystyrene sulfonate (or 6 hours before/after if you have slow digestion).

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sodium polystyrene sulfonate and call your doctor at once if you have:

• stomach pain, rectal pain;

• constipation, severe stomach pain, bloating;

• fever, chills, vomiting;

• confusion, thinking problems, feeling irritable;

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• low calcium--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

• nausea, vomiting;

• diarrhea; or

• loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• digoxin, digitalis;

• lithium;

• thyroxine; or

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with sodium polystyrene sulfonate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Kayexalate
• Kionex

In Canada

• Pms-Sodium Polystyrene Sulfonate

Available Dosage Forms:

• Suspension
• Powder for Suspension

Therapeutic Class: Exchange Resin

This section provides information on the proper use of a number of products that contain sodium polystyrene sulfonate. It may not be specific to Kionex. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes as a liquid suspension and as a powder that is mixed with water or syrup. If you or your child are not able to swallow the liquid, the medicine can be put in the stomach with a special tube. Talk to your doctor if you have questions about this.

Your doctor will tell you how to mix the powder with water or syrup. Each dose of the powder must be mixed with a liquid right before you take it. Stir the powder mixture to dissolve the medicine. Do not store the liquid mixture to take later.

Measure the liquid suspension with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle of medicine well just before taking each dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (powder, suspension):
  • For treatment of hyperkalemia:
    • Adults—15 grams one to four times a day.
    • Children and infants—Dose is based on potassium blood level and must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

General Interactions

No formal drug interaction studies have been conducted in humans.

Kionex has the potential to bind other drugs. In in vitro binding studies, Kionex was shown to significantly bind the oral medications (n=6) that were tested. Decreased absorption of lithium and thyroxine have also been reported with co-administration of Kionex. Binding of Kionex to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time Kionex is administered. Administer Kionex at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation. Monitor for clinical response and/or blood levels where possible.

Cation-Donating Antacids

The simultaneous oral administration of Kionex with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability and increase the risk of systemic alkalosis.

Sorbitol

Sorbitol may contribute to the risk of intestinal necrosis [see Warnings and Precautions (5.1)] and concomitant use is not recommended.

Applies to sodium polystyrene sulfonate: oral suspension, oral and rectal powder, oral and rectal suspension, rectal enema

Gastrointestinal

Rare (0.01% to 0.1%): Intestinal/colonic necrosis
Frequency not reported: Gastric irritation, nausea, vomiting, constipation, diarrhea, fecal impaction, intestinal obstruction, other serious gastrointestinal (GI) adverse reactions
Postmarketing reports: GI concretions/bezoars, ischemic colitis, GI tract ulceration, intestinal perforation, GI stenosis[Ref]

Nausea, vomiting, and constipation have occurred, especially with high doses. In clinical trials, fecal impaction occurred in geriatric patients given large doses; children have experienced impaction with rectal administration. Following oral administration, intestinal obstruction with aluminum hydroxide concretions and bezoar formation occurred in neonates. In postmarketing reports, gastrointestinal tract ulcerations, necrosis, and ischemic colitis may have resulted in intestinal perforation.[Ref]

Metabolic

Frequency not reported: Anorexia, hypokalemia, hypocalcemia, hypomagnesemia, significant sodium retention[Ref]

Nervous system

Postmarketing reports: Grand mal seizure[Ref]

A grand mal seizure occurred in 1 patient with renal dysfunction and concomitant use of this drug and magnesium hydroxide.[Ref]

Respiratory

Postmarketing reports: Acute bronchitis, bronchopneumonia[Ref]

Bronchitis with/without pneumonia occurred after inhalation of particles of this drug.[Ref]

Some side effects of Kionex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.