Micro-K

Potassium chloride is a prescription medication used to treat and prevent low potassium levels due to poor dietary intake, certain diseases, or other drugs.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

• PD-Rx Pharmaceuticals, Inc.

• Ther-RX Corporation

Serious side effects have been reported with potassium chloride including:

• Hyperkalemia. Potassium chloride can lead to dangerously high levels of potassium, which could cause the heart to stop beating. Tell your doctor if you have a history of heart or kidney disease.
• Digestive tract injury. Potassium chloride can remain in the digestive system for too long, leading to injuries in the digestive tract (stomach, intestines). Tell your healthcare provider right away if you have some or all of the following symptoms of digestive tract injury:
  • stomach pain
  • swollen stomach
  • dark or black stools
• Metabolic acidosis (too much acid in the body). Patients should be treated with a particular potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate. Use with potassium chloride is not recommended.

Do not take potassium chloride if you:

• have high potassium levels (hyperkalemia)
• have any physical, disease-related, or drug-related problems that would stop or slow the passage of this medication through the gastrointestinal (stomach and intestines) tract
• have an enlargened heart that narrows the esophagus; a liquid form of this medication should be prescribed instead of the capsule or tablet

Before taking potassium chloride, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of heart or kidney disease
• have an adrenal disease such as Addison’s disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may need to have an ECG checked before starting Micro-K and while taking it. Talk with your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• If your diet has low-salt foods or you are taking a salt substitute, talk with your 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 this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Micro-K as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine with food.
• Take with a full glass of water.
• Swallow whole. Do not chew, break, or crush.
• Do not suck on this product.
• If you have trouble swallowing, talk with your doctor.
• You may sprinkle contents of capsule on applesauce or other soft food. Do not chew. Swallow right away and follow with water or juice.
• Do not mix with hot food.
• After mixing, take your dose right away. Do not store for future use.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

General

The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium, while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

Information for Patients

Physicians should consider reminding the patient of the following: To take each dose with meals and with a full glass of water or other suitable liquid. To take each dose without crushing, chewing, or sucking the capsules. To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations. To check with the physician if there is trouble swallowing capsules or if the capsules seem to stick in the throat.

To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Laboratory Tests

Regular serum potassium determinations are recommended, especially in patients with renal insufficiency or diabetic nephropathy. When blood is drawn for analysis of plasma potassium it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Drug Interactions

Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

Pregnancy

Teratogenic Effects: Category C Animal reproduction studies have not been conducted with Micro-K®. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of potassium chloride extended-release capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Micro-K® Extencaps containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "Micro-K" on the cap and "Ther-Rx 010" on the body, packaged as follows:
NDC 64011-010-04 bottle of 100 capsules
NDC 64011-010-08 bottle of 500 capsules
NDC 64011-010-11 Dis-Co® unit dose packages of 100 capsules

Micro-K® 10 Extencaps® containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "Micro-K 10" on the cap and "Ther-Rx 009" on the body, packaged as follows:
NDC 64011-009-04 bottle of 100 capsules
NDC 64011-009-08 bottle of 500 capsules
NDC 64011-009-11 Dis-Co® unit dose packages of 100 capsules

Store at controlled room temperature 20°-25°C (68°-77°F).

Dispense in tight container.

Mktd. by Ther-Rx Corp. St. Louis, MO 63044

06/05
P3511-4

NDC 64011-010-04 100 Capsules

Micro-K
Extencaps
(potassium chloride)

(600 mg)
8 mEq K

Rx Only Ther-Rx Corporation

NDC 64011-010-08 500 Capsules

Micro-K
Extencaps
(potassium chloride)

(600 mg)
8 mEq K

Rx Only Ther-Rx Corporation

Dis-Co
NDC 64011-010-11

Micro-K
Extencaps
(potassium chloride)

(600 mg)
8 mEq K

Rx Only
100 Capsules (Unit Dose Pack)
Ther-Rx Corporation

NDC 64011-009-04 100 Capsules

Micro-K 10
Extencaps
(potassium chloride)

(750 mg)
10 mEq K

Rx Only Ther-Rx Corporation

NDC 64011-009-08 500 Capsules

Micro-K 10
Extencaps
(potassium chloride)

(750 mg)
10 mEq K

Rx Only Ther-Rx Corporation

Dis-Co
NDC 64011-009-11

Micro-K
Extencaps
(potassium chloride)

(750 mg)
10 mEq K

Rx Only
100 Capsules (Unit Dose Pack)
Ther-Rx Corporation

Applies to potassium chloride: oral tablet extended release

Other dosage forms:

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