Kayexalate

Common Side Effects of Kayexalate

Tell your doctor if any of the following side effects become severe or don't go away:

• Upset stomach
• Nausea
• Loss of appetite
• Vomiting

Serious Side Effects of Kayexalate

Tell your doctor immediately if you experience any of the symptoms listed in the Kayexalate Warnings section above, or any of the following serious side effects:

• Changes in mood, behavior, or emotions
• Confusion
• Dizziness
• Slow, fast, or irregular heartbeat
• Muscle cramps, weakness, or painful spasms
• Seizures
• Severe or watery diarrhea
• Increased thirst
• Swelling of the feet or hands
• Trouble concentrating or thinking
• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)

Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. 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.

Sodium polystyrene sulfonate affects the exchange of sodium and potassium in the body.

Sodium polystyrene sulfonate is used to treat high levels of potassium in the blood, also called hyperkalemia.

Sodium polystyrene sulfonate may also be used for purposes other than those listed here.

Do not use salt substitutes or take potassium or calcium supplements unless your doctor has told you to.

Avoid using antacids or laxatives without your doctor's advice. Antacids or laxatives can make sodium polystyrene sulfonate less effective or cause serious side effects.

Avoid eating or drinking anything that contains sorbitol (a fruit sugar often used as a sweetener in chewing gum, diet drinks, baked goods, or frozen desserts).

You should not use sodium polystyrene sulfonate if you are allergic to it, or if you have:

• low potassium levels (hypokalemia); or

• a bowel obstruction.

To make sure sodium polystyrene sulfonate is safe for you, tell your doctor if you have ever had:

• heart disease or high blood pressure;

• congestive heart failure;

• a weak immune system caused using certain medicine;

• severe constipation or other bowel problems;

• kidney disease (or if you are on dialysis);

• an electrolyte imbalance (such as low levels of potassium, calcium, or magnesium in your blood);

• fluid retention;

• severe burns;

• a bowel disorder, or surgery on your intestines;

• if you are dehydrated; or

• if you are on a low-salt diet.

Because sodium polystyrene sulfonate is not absorbed into the blood stream, this medicine is not expected to be harmful during pregnancy or while nursing a baby. Tell your doctor if you are pregnant or breast-feeding.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sodium polystyrene sulfonate in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in children are not expected.

This medicine should be used with caution in newborn infants who have reduced or slow bowel movements. The oral form should not be given to newborn infants.

Geriatric

No information is available on the relationship of age to the effects of sodium polystyrene sulfonate in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Meloxicam
• Sorbitol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium
• Calcium Carbonate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel blockage or
• Hypokalemia (low potassium in the blood)—Should not be used in patients with these conditions.

• Congestive heart failure, severe or
• Edema (fluid retention) or
• Heart rhythm problems (e.g., arrhythmia, QT prolongation) or
• Hypertension (high blood pressure), severe or
• Hypocalcemia (low calcium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Stomach or bowel problems (e.g., bleeding, colitis, constipation, perforation)—Use with caution. May make these conditions worse.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you are on a low-salt diet (Kayexalate has salt), talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
• This medicine may prevent other drugs taken by mouth from getting into the body. If you take other drugs by mouth, you may need to take them at some other time than this medicine. Talk with your doctor.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Kayexalate while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Kayexalate (sodium polystyrene sulfonate powder), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Kayexalate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Kayexalate.

Review Date: October 4, 2017

Drug Interactions

Advise patients who are taking other oral medication to separate the dosing of Kayexalate by at least 3 hours (before or after) [see Dosage and Administration (2.1), Warnings and Precautions (5.5), and Drug Interactions (7.1)]

Rx Only

Manufactured for:

Concordia Pharmaceutical Inc.
St. Michael, Barbados BB11005

©2015, 2017. Concordia Pharmaceuticals Inc. All rights reserved.

Revised 07/2017

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