Potassium Chloride Extended Release Tablets

DRUG DESCRIPTION

The Potassium Chloride Extended Release Tablets, USP 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet.

The Potassium Chloride Extended Release Tablets, USP 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet.

These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced.

Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37C and in the absence of out-side agitation, Potassium Chloride Tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride.

Inactive Ingredients: Crospovidone, Ethylcellulose, Hydroxypropyl Cellulose, Magnesium Stearate, and Microcrystalline Cellulose.

What are the precautions when taking potassium chloride extended release tablets (Potassium Chloride Extended Release Tablets)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a high level of potassium in the blood (hyperkalemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as atrioventricular block), certain muscle problem (familial periodic paralysis), kidney problems (such as chronic renal failure, inability to make urine), heat cramps, a severe loss of body...

Read All Potential Precautions of Potassium Chloride Extended Release Tablets


Potassium Chloride Extended Release Tablets Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, gas, abdominal pain/discomfort, and diarrhea may occur. See How to Use section for ways to reduce stomach upset. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: difficult/painful swallowing, feeling as if the tablet is stuck in your throat.

This drug may rarely cause serious stomach or intestinal problems (such as bleeding, blockage, puncture). Stop taking this medication and tell your doctor immediately if any of these unlikely but serious side effects occur: black/bloody stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, dizziness, constipation, abdominal swelling.

This medication may cause high potassium levels in the blood (hyperkalemia). Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle cramps/weakness, severe dizziness, confusion, tingling hands/feet, slow/irregular heartbeat, unusually cold skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a high level of potassium in the blood (hyperkalemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as atrioventricular block), certain muscle problem (familial periodic paralysis), kidney problems (such as chronic renal failure, inability to make urine), heat cramps, a severe loss of body water (dehydration), severe tissue damage (such as burns, injury), stomach/intestinal ulcer, metabolic problems (such as metabolic acidosis, diabetic acidosis), a certain adrenal gland problem (Addison's disease).

Certain types of potassium chloride tablets, when swallowed whole, have rarely caused esophagus/stomach/intestinal ulcers and bleeding. To reduce the risk of these side effects, taking liquid or effervescent forms of potassium chloride are preferred. If you have blockage/narrowing/slowed movement of the esophagus/stomach/intestines (such as diabetic gastroparesis, esophageal compression due to an enlarged heart), you are at greater risk for these side effects. Therefore, you should use liquid or effervescent forms, or follow the directions in the How to Use section for dissolving this medication in water.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the effects of this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. There have been no reports of potassium harming a nursing infant in mothers with a normal potassium level. Consult your doctor before breast-feeding.



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