Klotrix

Serious side effects have been reported with potassium chloride. See “Drug Precautions” section.

Common side effects of potassium chloride include:

• nausea
• vomiting
• diarrhea
• gas
• abdominal pain

This is not a complete list of potassium chloride side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Potassium chloride falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

It is not known if potassium chloride will harm your unborn baby.

Take potassium chloride exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Dose amount is determined according to the individual needs of each patient:

• For the prevention of hypokalemia: typically in the range of 20 mEq per day
• For treatment of potassium depletion: typically in the range of 40-100 mEq per day or more

Dosage should be divided if more than 20 mEq per day. No more than 20 mEq is given in a single dose.

Klotrix® (potassium chloride) is a solid, oral dosage form of potassium chloride containing 750 mg of potassium chloride, USP (equivalent to 10 mEq of potassium) in a film-coated wax-matrix tablet. This formulation is intended to provide a controlled release of potassium from the matrix to minimize the likelihood of producing high, localized concentrations of potassium within the gastrointestinal tract.

Klotrix is an electrolyte replenisher. The chemical name 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.

This product contains the following inactive ingredients: ethylcellulose, FD&C Yellow No. 6 (aluminum lake), glycerin, hydroxypropyl methylcellulose 2910, magnesium stearate, povidone, colloidal silicon dioxide, stearic acid, and titanium dioxide.

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUIDS OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

1. For the treatment of patients with hypokalemia with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
2. For prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however; and, if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE). There also have been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS). The most common adverse reactions to oral potassium salts are nausea, vomiting, abdominal pain and discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals, or reducing the dose.

Applies to potassium chloride: oral tablet extended release

Other dosage forms:

• oral capsule extended release
• intravenous solution
• oral packet, oral solution

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Gas.
• Some products of potassium are in a wax matrix; you may see this in stool. The potassium has been taken into the body, but the wax has not.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.