Kalexate

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Suspension


• Powder for Suspension

Before Using

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

Breastfeeding

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.

Drug Interactions

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.

• 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


• Levothyroxine


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate

Other Interactions

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)a€”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)a€”Use with caution. May make these conditions worse.

Proper Use

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:
    
    
    
    • Adultsa€”15 grams one to four times a day.
    
    
    • Children and infantsa€”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.

Precautions

It is very important that your doctor check you or your child closely to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: confusion, dry mouth, increased thirst, irregular heartbeat, irritability, muscle cramps, nausea or vomiting, or shortness of breath.

If you are taking aluminum or magnesium-containing antacids or laxatives, talk to your doctor first before using them together with sodium polystyrene sulfonate. These medicines may keep sodium polystyrene sulfonate from working properly and may cause serious side effects.

Do not take other medicines unless they have been discussed with your doctor . This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

Rare

• Bloody vomit


• Chest pain


• Cough


• Cough producing mucus


• Difficulty with breathing


• Fever or chills


• Severe stomach pain


• Shortness of breath


• Sneezing


• Sore throat


• Tightness in the chest


• Troubled breathing


• Wheezing

Incidence not known

• Abdominal or stomach cramps or pain


• Confusion


• Constipation


• Convulsions


• Decrease in the amount of urine


• Diarrhea


• Dry mouth


• Increased thirst


• Irregular heartbeats


• Loss of appetite


• Muscle cramps in the hands, arms, feet, legs, or face


• Nausea or vomiting


• Noisy, rattling breathing


• Numbness and tingling around the mouth, fingertips, or feet


• Severe constipation


• Swelling of the fingers, hands, feet, or lower legs


• Tremor


• Troubled breathing at rest


• Unusual tiredness or weakness


• Weight gain


• Weight loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Dizziness


• Drowsiness


• Fainting


• Fast, slow, or irregular heartbeat


• Lightheadedness


• Muscle cramps


• Muscle spasms (tetany) or twitching


• Pounding or rapid pulse


• Seizures


• Trembling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.